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1. Burden of Uncontrolled Severe Asthma With and Without Elevated Type-2 Inflammatory Biomarkers

Author

del Olmo, Ricardo, Anderson, Gary, Reddel, Helen, Rabahi, Marcelo, McIvor, Andrew, Sadatsafavi, Mohsen, Weinreich, Ulla, Burgel, Pierre-Régis, Devouassoux, Gilles, Papi, Alberto, Inoue, Hiromasa, Rendon, Adrián, van den Berge, Maarten, Beasley, Richard, García-Navarro, Alvar Agusti, Faner, Rosa, Rivera, José Olaguibel, Janson, Christer, Bilińska-Izydorczyk, Magdalena, Fagerås, Malin, Fihn-Wikander, Titti, Franzén, Stefan, Keen, Christina, Ostridge, Kristoffer, Chalmers, James, Harrison, Timothy, Pavord, Ian, Price, David, Azim, Adnan, Belton, Laura, Blé, Francois-Xavier, Erhard, Clement, Gairy, Kerry, Hughes, Rod, Lassi, Glenda, Müllerová, Hana, Rapsomaniki, Eleni, Scott, Ian Christopher, Chipps, Bradley, Christenson, Stephanie, Make, Barry, Tomaszewski, Erin, Benhabib, Gabriel, Ruiz, Xavier Bocca, Lisanti, Raul Eduardo, Marino, Gustavo, Mattarucco, Walter, Nogueira, Juan, Parody, Maria, Pascale, Pablo, Rodriguez, Pablo, Silva, Damian, Svetliza, Graciela, Victorio, Carlos F., Rolon, Roxana Willigs, Yañez, Anahi, Baines, Stuart, Bowler, Simon, Bremner, Peter, Bull, Sheetal, Carroll, Patrick, Chaalan, Mariam, Farah, Claude, Hammerschlag, Gary, Hancock, Kerry, Harrington, Zinta, Katsoulotos, Gregory, Kim, Joshua, Langton, David, Lee, Donald, Peters, Matthew, Prassad, Lakshman, Sajkov, Dimitar, Santiago, Francis, Simpson, Frederick Graham, Tai, Sze, Thomas, Paul, Wark, Peter, Delfini Cançado, José Eduardo, Cunha, Thúlio, Lima, Marina, Cardoso, Alexandre Pinto, FitzGerald, J. Mark, Anees, Syed, Bertley, John, Bell, Alan, Cheema, Amarjit, Chouinard, Guy, Csanadi, Michael, Dhar, Anil, Dhillon, Ripple, Kanawaty, David, Kelly, Allan, Killorn, William, Landry, Daniel, Luton, Robert, Mandhane, Piushkumar, Pek, Bonavuth, Petrella, Robert, Stollery, Daniel, Wang, Chen, Chen, Meihua, Chen, Yan, Gu, Wei, Christopher Hui, Kim Ming, Li, Manxiang, Li, Shiyue, Lijun, Ma, Qin, Guangyue, Song, Weidong, Tan, Wei, Tang, Yijun, Wang, Tan, Wen, Fuqiang, Wu, Feng, Xiang, PingChao, Xiao, Zuke, Xiong, Shengdao, Yang, Jinghua, Yang, Jingping, Zhang, Caiqing, Zhang, Min, Zhang, Ping, Zhang, Wei, Zheng, Xiaohe, Zhu, Dan, Bueno, Carlos Matiz, Grimaldos, Fabio Bolivar, Arboleda, Alejandra Cañas, Molina de Salazar, Dora, Bendstrup, Elisabeth, Hilberg, Ole, Kjellerup, Carsten, Raherison, Chantal, Bonniaud, Philippe, Brun, Olivier, Chouaid, Christos, Couturaud, Francis, de Blic, Jacques, Debieuvre, Didier, Delsart, Dominique, Demaegdt, Axelle, Demoly, Pascal, Deschildre, Antoine, Egron, Carole, Falchero, Lionel, Goupil, François, Kessler, Romain, Le Roux, Pascal, Mabire, Pascal, Mahay, Guillaume, Martinez, Stéphanie, Melloni, Boris, Moreau, Laurent, Riviere, Emilie, Roux-Claudé, Pauline, Soulier, Michel, Vignal, Guillaume, Yaici, Azzedine, Bals, Robert, Aries, Sven Philip, Beck, Ekkehard, Deimling, Andreas, Feimer, Jan, Grimm-Sachs, Vera, Groth, Gesine, Herth, Felix, Hoheisel, Gerhard, Kanniess, Frank, Lienert, Thomas, Mronga, Silke, Reinhardt, Jörg, Schlenska, Christian, Stolpe, Christoph, Teber, Ishak, Timmermann, Hartmut, Ulrich, Thomas, Velling, Peter, Wehgartner-Winkler, Sabina, Welling, Juergen, Winkelmann, Ernst-Joachim, Barbetta, Carlo, Braido, Fulvio, Cardaci, Vittorio, Clini, Enrico Maria, Costantino, Maria Teresa, Cuttitta, Giuseppina, di Gioacchino, Mario, Fois, Alessandro, Foschino-Barbaro, Maria Pia, Gammeri, Enrico, Inchingolo, Riccardo, Lavorini, Federico, Molino, Antonio, Nucera, Eleonora, Patella, Vincenzo, Pesci, Alberto, Ricciardolo, Fabio, Rogliani, Paola, Sarzani, Riccardo, Vancheri, Carlo, Vincenti, Rigoletta, Endo, Takeo, Fujita, Masaki, Hara, Yu, Horiguchi, Takahiko, Hosoi, Keita, Ide, Yumiko, Inomata, Minehiko, Inoue, Koji, Inoue, Sumito, Kato, Motokazu, Kawasaki, Masayuki, Kawayama, Tomotaka, Kita, Toshiyuki, Kobayashi, Kanako, Koto, Hiroshi, Nishi, Koichi, Saito, Junpei, Shimizu, Yasuo, Shirai, Toshihiro, Sugihara, Naruhiko, Takahashi, Ken-ichi, Tashimo, Hiroyuki, Tomii, Keisuke, Yamada, Takashi, Yanai, Masaru, Rendon, Adrian, Javier, Ruth Cerino, Peregrina, Alfredo Domínguez, Corzo, Marco Fernández, Gonzalez, Efraín Montano, Ramírez-Venegas, Alejandra, Boersma, Willem, Djamin, R.S., Eijsvogel, Michiel, Franssen, Frits, Goosens, Martijn, Graat-Verboom, Lidwien, Veen, Johannes in 't, Janssen, Rob, Kuppens, Kim, van de Ven, Mario, Bakke, Per, Brunstad, Ole Petter, Einvik, Gunnar, Høines, Kristian Jong, Khusrawi, Alamdar, Oien, Torbjorn, Yoon, Ho Joo, Chang, Yoon-Seok, Cho, Young Joo, Hwang, Yong Il, Kim, Woo Jin, Koh, Young-Il, Lee, Byung-Jae, Lee, Kwan-Ho, Lee, Sang-Pyo, Lee, Yong Chul, Lim, Seong Yong, Min, Kyung Hun, Oh, Yeon-Mok, Park, Choon-Sik, Park, Hae-Sim, Park, Heung-Woo, Rhee, Chin Kook, Yoon, Hyoung-Kyu, Andújar, Rubén, Anoro, Laura, García, María Buendía, Mozo, Paloma Campo, Campos, Sergio, Maldonado, Francisco Casas, Martínez, Manuel Castilla, Serrano, Carolina Cisneros, Casanova, Lorena Comeche, Corbacho, Dolores, Del Campo Matías, Felix, Echave-Sustaeta, Jose, Corral, Gloria Francisco, Setién, Pedro Gamboa, Clemente, Marta García, Núñez, Ignacio García, Robaina, Jose García, Salmones, Mercedes García, Marín Trigo, Jose Maria, Fernandez, Marta Nuñez, Palomo, Sara Nuñez, Pérez de Llano, Luis, Bastida, Ana Pueyo, Rañó, Ana, González-Moro, José Rodríguez, Reig, Albert Roger, Garrido, José Velasco, Curiac, Dan, Lif-Tiberg, Cornelia, Luts, Anders, Råhlen, Lennart, Rustscheff, Stefan, Adams, Frances, Bradman, Drew, Broughton, Emma, Cosgrove, John, Flood-Page, Patrick, Fuller, Elizabeth, Hartley, David, Hattotuwa, Keith, Jones, Gareth, Lewis, Keir, McGarvey, Lorcan, Morice, Alyn, Pandya, Preeti, Patel, Manish, Roy, Kay, Sathyamurthy, Ramamurthy, Thiagarajan, Swaminathan, Turner, Alice, Vestbo, Jorgen, Wedzicha, Wisia, Wilkinson, Tom, Wilson, Pete, Al-Asadi, Lo’Ay, Anholm, James, Averill, Francis, Bansal, Sandeep, Baptist, Alan, Campbell, Colin, Campos, Michael A., Crook, Gretchen, DeLeon, Samuel, Eid, Alain, Epstein, Ellen, Fritz, Stephen, Harris, Hoadley, Hewitt, Mitzie, Holguin, Fernando, Hudes, Golda, Jackson, Richard, Kaufman, Alan, Kaufman, David, Klapholz, Ari, Krishna, Harshavardhan, Lee, Daria, Lin, Robert, Maselli-Caceres, Diego, Mehta, Vinay, Moy, James N., Nwokoro, Ugo, Parikh, Purvi, Parikh, Sudhir, Perrino, Frank, Ruhlmann, James, Sassoon, Catherine, Settipane, Russell A., Sousa, Daniel, Sriram, Peruvemba, Wachs, Richard, Ding, Bo, Chen, Stephanie, Quinton, Anna, Cook, William, and Reddel, Helen K.

Published
2024
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2. Cluster Analyses From the Real-World NOVELTY Study: Six Clusters Across the Asthma-COPD Spectrum

Author

Olmo, Ricardo del, Anderson, Gary, Reddel, Helen, Rabahi, Marcelo, McIvor, Andrew, Sadatsafavi, Mohsen, Weinreich, Ulla, Burgel, Pierre-Régis, Devouassoux, Gilles, Papi, Alberto, Inoue, Hiromasa, Rendon, Adrián, van den Berge, Maarten, Beasley, Richard, García-Navarro, Alvar Agusti, Faner, Rosa, Olaguibel Rivera, José, Janson, Christer, Bilińska-Izydorczyk, Magdalena, Fagerås, Malin, Fihn-Wikander, Titti, Franzén, Stefan, Keen, Christina, Ostridge, Kristoffer, Chalmers, James, Harrison, Timothy, Pavord, Ian, Price, David, Azim, Adnan, Belton, Laura, Blé, Francois-Xavier, Erhard, Clement, Gairy, Kerry, Hughes, Rod, Lassi, Glenda, Müllerová, Hana, Rapsomaniki, Eleni, Scott, Ian Christopher, Chipps, Bradley, Christenson, Stephanie, Make, Barry, Tomaszewski, Erin, Benhabib, Gabriel, Ruiz, Xavier Bocca, Lisanti, Raul Eduardo, Marino, Gustavo, Mattarucco, Walter, Nogueira, Juan, Parody, Maria, Pascale, Pablo, Rodriguez, Pablo, Silva, Damian, Svetliza, Graciela, Victorio, Carlos F., Rolon, Roxana Willigs, Yañez, Anahi, Baines, Stuart, Bowler, Simon, Bremner, Peter, Bull, Sheetal, Carroll, Patrick, Chaalan, Mariam, Farah, Claude, Hammerschlag, Gary, Hancock, Kerry, Harrington, Zinta, Katsoulotos, Gregory, Kim, Joshua, Langton, David, Lee, Donald, Peters, Matthew, Prassad, Lakshman, Sajkov, Dimitar, Santiago, Francis, Simpson, Frederick Graham, Tai, Sze, Thomas, Paul, Wark, Peter, Cançado, José Eduardo Delfini, Cunha, Thúlio, Lima, Marina, Cardoso, Alexandre Pinto, FitzGerald, J. Mark, Anees, Syed, Bertley, John, Bell, Alan, Cheema, Amarjit, Chouinard, Guy, Csanadi, Michael, Dhar, Anil, Dhillon, Ripple, Kanawaty, David, Kelly, Allan, Killorn, William, Landry, Daniel, Luton, Robert, Mandhane, Piushkumar, Pek, Bonavuth, Petrella, Robert, Stollery, Daniel, Wang, Chen, Chen, Meihua, Chen, Yan, Gu, Wei, Christopher Hui, Kim Ming, Li, Manxiang, Li, Shiyue, Lijun, Ma, Qin, Guangyue, Song, Weidong, Tan, Wei, Tang, Yijun, Wang, Tan, Wen, Fuqiang, Wu, Feng, Xiang, PingChao, Xiao, Zuke, Xiong, Shengdao, Yang, Jinghua, Yang, Jingping, Zhang, Caiqing, Zhang, Min, Zhang, Ping, Zhang, Wei, Zheng, Xiaohe, Zhu, Dan, Bueno, Carlos Matiz, Grimaldos, Fabio Bolivar, Arboleda, Alejandra Cañas, de Salazar, Dora Molina, Bendstrup, Elisabeth, Hilberg, Ole, Kjellerup, Carsten, Raherison, Chantal, Bonniaud, Philippe, Brun, Olivier, Chouaid, Christos, Couturaud, Francis, de Blic, Jacques, Debieuvre, Didier, Delsart, Dominique, Demaegdt, Axelle, Demoly, Pascal, Deschildre, Antoine, Egron, Carole, Falchero, Lionel, Goupil, François, Kessler, Romain, Le Roux, Pascal, Mabire, Pascal, Mahay, Guillaume, Martinez, Stéphanie, Melloni, Boris, Moreau, Laurent, Riviere, Emilie, Roux-Claudé, Pauline, Soulier, Michel, Vignal, Guillaume, Yaici, Azzedine, Bals, Robert, Aries, Sven Philip, Beck, Ekkehard, Deimling, Andreas, Feimer, Jan, Grimm-Sachs, Vera, Groth, Gesine, Herth, Felix, Hoheisel, Gerhard, Kanniess, Frank, Lienert, Thomas, Mronga, Silke, Reinhardt, Jörg, Schlenska, Christian, Stolpe, Christoph, Teber, Ishak, Timmermann, Hartmut, Ulrich, Thomas, Velling, Peter, Wehgartner-Winkler, Sabina, Welling, Juergen, Winkelmann, Ernst-Joachim, Barbetta, Carlo, Braido, Fulvio, Cardaci, Vittorio, Clini, Enrico Maria, Costantino, Maria Teresa, Cuttitta, Giuseppina, di Gioacchino, Mario, Fois, Alessandro, Foschino-Barbaro, Maria Pia, Gammeri, Enrico, Inchingolo, Riccardo, Lavorini, Federico, Molino, Antonio, Nucera, Eleonora, Patella, Vincenzo, Pesci, Alberto, Ricciardolo, Fabio, Rogliani, Paola, Sarzani, Riccardo, Vancheri, Carlo, Vincenti, Rigoletta, Endo, Takeo, Fujita, Masaki, Hara, Yu, Horiguchi, Takahiko, Hosoi, Keita, Ide, Yumiko, Inomata, Minehiko, Inoue, Koji, Inoue, Sumito, Kato, Motokazu, Kawasaki, Masayuki, Kawayama, Tomotaka, Kita, Toshiyuki, Kobayashi, Kanako, Koto, Hiroshi, Nishi, Koichi, Saito, Junpei, Shimizu, Yasuo, Shirai, Toshihiro, Sugihara, Naruhiko, Takahashi, Ken-ichi, Tashimo, Hiroyuki, Tomii, Keisuke, Yamada, Takashi, Yanai, Masaru, Rendon, Adrian, Cerino Javier, Ruth, Domínguez Peregrina, Alfredo, Fernández Corzo, Marco, Montano Gonzalez, Efraín, Ramírez-Venegas, Alejandra, Boersma, Willem, Djamin, R.S., Eijsvogel, Michiel, Franssen, Frits, Goosens, Martijn, Graat-Verboom, Lidwien, Veen, Johannes in 't, Janssen, Rob, Kuppens, Kim, van de Ven, Mario, Bakke, Per, Brunstad, Ole Petter, Einvik, Gunnar, Høines, Kristian Jong, Khusrawi, Alamdar, Oien, Torbjorn, Yoon, Ho Joo, Chang, Yoon-Seok, Cho, Young Joo, Hwang, Yong Il, Kim, Woo Jin, Koh, Young-Il, Lee, Byung-Jae, Lee, Kwan-Ho, Lee, Sang-Pyo, Lee, Yong Chul, Lim, Seong Yong, Min, Kyung Hun, Oh, Yeon-Mok, Park, Choon-Sik, Park, Hae-Sim, Park, Heung-Woo, Rhee, Chin Kook, Yoon, Hyoung-Kyu, García-Navarro, Alvar Agustí, Andújar, Rubén, Anoro, Laura, Buendía García, María, Mozo, Paloma Campo, Campos, Sergio, Casas Maldonado, Francisco, Castilla Martínez, Manuel, Cisneros Serrano, Carolina, Comeche Casanova, Lorena, Corbacho, Dolores, Campo Matías, Felix Del, Echave-Sustaeta, Jose, Corral, Gloria Francisco, Gamboa Setién, Pedro, García Clemente, Marta, Núñez, Ignacio García, García Robaina, Jose, García Salmones, Mercedes, Marín Trigo, Jose Maria, Fernandez, Marta Nuñez, Palomo, Sara Nuñez, Pérez de Llano, Luis, Pueyo Bastida, Ana, Rañó, Ana, Rodríguez González-Moro, José, Reig, Albert Roger, Velasco Garrido, José, Curiac, Dan, Lif-Tiberg, Cornelia, Luts, Anders, Råhlen, Lennart, Rustscheff, Stefan, Adams, Frances, Bradman, Drew, Broughton, Emma, Cosgrove, John, Flood-Page, Patrick, Fuller, Elizabeth, Hartley, David, Hattotuwa, Keith, Jones, Gareth, Lewis, Keir, McGarvey, Lorcan, Morice, Alyn, Pandya, Preeti, Patel, Manish, Roy, Kay, Sathyamurthy, Ramamurthy, Thiagarajan, Swaminathan, Turner, Alice, Vestbo, Jørgen, Wedzicha, Wisia, Wilkinson, Tom, Wilson, Pete, Al-Asadi, Lo’Ay, Anholm, James, Averill, Francis, Bansal, Sandeep, Baptist, Alan, Campbell, Colin, Campos, Michael A., Crook, Gretchen, DeLeon, Samuel, Eid, Alain, Epstein, Ellen, Fritz, Stephen, Harris, Hoadley, Hewitt, Mitzie, Holguin, Fernando, Hudes, Golda, Jackson, Richard, Kaufman, Alan, Kaufman, David, Klapholz, Ari, Krishna, Harshavardhan, Lee, Daria, Lin, Robert, Maselli-Caceres, Diego, Mehta, Vinay, Moy, James N., Nwokoro, Ugo, Parikh, Purvi, Parikh, Sudhir, Perrino, Frank, Ruhlmann, James, Sassoon, Catherine, Settipane, Russell A., Sousa, Daniel, Sriram, Peruvemba, Wachs, Richard, Bansal, Aruna T., Agustí, Alvar, Fageras, Malin, Alacqua, Marianna, and Reddel, Helen K.

Published
2023
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3. Frequent productive cough: Symptom burden and future exacerbation risk among patients with asthma and/or COPD in the NOVELTY study

Author

Benhabib, Gabriel, Ruiz, Xavier Bocca, Olmo, Ricardo del, Lisanti, Raul Eduardo, Marino, Gustavo, Mattarucco, Walter, Nogueira, Juan, Parody, Maria, Pascale, Pablo, Rodriguez, Pablo, Silva, Damian, Svetliza, Graciela, Victorio, Carlos F., Rolon, Roxana Willigs, Yañez, Anahi, Baines, Stuart, Bowler, Simon, Bremner, Peter, Bull, Sheetal, Carroll, Patrick, Chaalan, Mariam, Farah, Claude, Hammerschlag, Gary, Hancock, Kerry, Harrington, Zinta, Katsoulotos, Gregory, Kim, Joshua, Langton, David, Lee, Donald, Peters, Matthew, Prassad, Lakshman, Reddel, Helen, Sajkov, Dimitar, Santiago, Francis, Simpson, Frederick Graham, Tai, Sze, Thomas, Paul, Wark, Peter, Delfini Cançado, José Eduardo, Cunha, Thúlio, Lima, Marina, Cardoso, Alexandre Pinto, Rabahi, Marcelo, Anees, Syed, Bertley, John, Bell, Alan, Cheema, Amarjit, Chouinard, Guy, Csanadi, Michael, Dhar, Anil, Dhillon, Ripple, FitzGerald, J. Mark, Kanawaty, David, Kelly, Allan, Killorn, William, Landry, Daniel, Luton, Robert, Mandhane, Piushkumar, McIvor, Andrew, Pek, Bonavuth, Petrella, Robert, Stollery, Daniel, Chen, Meihua, Chen, Yan, Gu, Wei, Christopher Hui, Kim Ming, Li, Manxiang, Li, Shiyue, Lijun, Ma, Qin, Guangyue, Song, Weidong, Tan, Wei, Tang, Yijun, Wang, Chen, Wang, Tan, Wen, Fuqiang, Wu, Feng, Xiang, PingChao, Xiao, Zuke, Xiong, Shengdao, Yang, Jinghua, Yang, Jingping, Zhang, Caiqing, Zhang, Min, Zhang, Ping, Zhang, Wei, Zheng, Xiaohe, Zhu, Dan, Grimaldos, Fabio Bolivar, Arboleda, Alejandra Cañas, Bueno, Carlos Matiz, Molina de Salazar, Dora, Bendstrup, Elisabeth, Hilberg, Ole, Kjellerup, Carsten, Weinreich, Ulla, Bonniaud, Philippe, Brun, Olivier, Burgel, Pierre-Régis, Chouaid, Christos, Couturaud, Francis, de Blic, Jacques, Debieuvre, Didier, Delsart, Dominique, Demaegdt, Axelle, Demoly, Pascal, Deschildre, Antoine, Devouassoux, Gilles, Egron, Carole, Falchero, Lionel, Goupil, François, Kessler, Romain, Le Roux, Pascal, Mabire, Pascal, Mahay, Guillaume, Martinez, Stéphanie, Melloni, Boris, Moreau, Laurent, Raherison, Chantal, Riviere, Emilie, Roux-Claudé, Pauline, Soulier, Michel, Vignal, Guillaume, Yaici, Azzedine, Aries, Sven Philip, Bals, Robert, Beck, Ekkehard, Deimling, Andreas, Feimer, Jan, Grimm-Sachs, Vera, Groth, Gesine, Herth, Felix, Hoheisel, Gerhard, Kanniess, Frank, Lienert, Thomas, Mronga, Silke, Reinhardt, Jörg, Schlenska, Christian, Stolpe, Christoph, Teber, Ishak, Timmermann, Hartmut, Ulrich, Thomas, Velling, Peter, Wehgartner-Winkler, Sabina, Welling, Juergen, Winkelmann, Ernst-Joachim, Barbetta, Carlo, Braido, Fulvio, Cardaci, Vittorio, Clini, Enrico Maria, Costantino, Maria Teresa, Cuttitta, Giuseppina, di Gioacchino, Mario, Fois, Alessandro, Foschino-Barbaro, Maria Pia, Gammeri, Enrico, Inchingolo, Riccardo, Lavorini, Federico, Molino, Antonio, Nucera, Eleonora, Papi, Alberto, Patella, Vincenzo, Pesci, Alberto, Ricciardolo, Fabio, Rogliani, Paola, Sarzani, Riccardo, Vancheri, Carlo, Vincenti, Rigoletta, Endo, Takeo, Fujita, Masaki, Hara, Yu, Horiguchi, Takahiko, Hosoi, Keita, Ide, Yumiko, Inomata, Minehiko, Inoue, Hiromasa, Inoue, Koji, Inoue, Sumito, Kato, Motokazu, Kawasaki, Masayuki, Kawayama, Tomotaka, Kita, Toshiyuki, Kobayashi, Kanako, Koto, Hiroshi, Nishi, Koichi, Saito, Junpei, Shimizu, Yasuo, Shirai, Toshihiro, Sugihara, Naruhiko, Takahashi, Ken-ichi, Tashimo, Hiroyuki, Tomii, Keisuke, Yamada, Takashi, Yanai, Masaru, Javier, Ruth Cerino, Peregrina, Alfredo Domínguez, Corzo, Marco Fernández, Gonzalez, Efraín Montano, Ramírez-Venegas, Alejandra, Rendon, Adrian, Boersma, Willem, Djamin, R.S., Eijsvogel, Michiel, Franssen, Frits, Goosens, Martijn, Graat-Verboom, Lidwien, Veen, Johannes in 't, Janssen, Rob, Kuppens, Kim, van den Berge, Maarten, van de Ven, Mario, Brunstad, Ole Petter, Einvik, Gunnar, Høines, Kristian Jong, Khusrawi, Alamdar, Oien, Torbjorn, Chang, Yoon-Seok, Cho, Young Joo, Hwang, Yong Il, Kim, Woo Jin, Koh, Young-Il, Lee, Byung-Jae, Lee, Kwan-Ho, Lee, Sang-Pyo, Lee, Yong Chul, Lim, Seong Yong, Min, Kyung Hun, Oh, Yeon-Mok, Park, Choon-Sik, Park, Hae-Sim, Park, Heung-Woo, Rhee, Chin Kook, Yoon, Ho Joo, Yoon, Hyoung-Kyu, García-Navarro, Alvar Agusti, Andújar, Rubén, Anoro, Laura, García, María Buendía, Mozo, Paloma Campo, Campos, Sergio, Maldonado, Francisco Casas, Martínez, Manuel Castilla, Serrano, Carolina Cisneros, Casanova, Lorena Comeche, Corbacho, Dolores, Del Campo Matías, Felix, Echave-Sustaeta, Jose, Corral, Gloria Francisco, Setién, Pedro Gamboa, Clemente, Marta García, Núñez, Ignacio García, Robaina, Jose García, Salmones, Mercedes García, Marín Trigo, Jose Maria, Fernandez, Marta Nuñez, Palomo, Sara Nuñez, Rivera, José Olaguibel, Pérez de Llano, Luis, Bastida, Ana Pueyo, Rañó, Ana, González-Moro, José Rodríguez, Reig, Albert Roger, Garrido, José Velasco, Curiac, Dan, Janson, Christer, Lif-Tiberg, Cornelia, Luts, Anders, Råhlen, Lennart, Rustscheff, Stefan, Adams, Frances, Bradman, Drew, Broughton, Emma, Cosgrove, John, Flood-Page, Patrick, Fuller, Elizabeth, Harrison, Timothy, Hartley, David, Hattotuwa, Keith, Jones, Gareth, Lewis, Keir, McGarvey, Lorcan, Morice, Alyn, Pandya, Preeti, Patel, Manish, Roy, Kay, Sathyamurthy, Ramamurthy, Thiagarajan, Swaminathan, Turner, Alice, Vestbo, Jorgen, Wedzicha, Wisia, Wilkinson, Tom, Wilson, Pete, Al-Asadi, Lo’Ay, Anholm, James, Averill, Frank, Bansal, Sandeep, Baptist, Alan, Campbell, Colin, Campos, Michael A., Chipps, Bradley, Crook, Gretchen, DeLeon, Samuel, Eid, Alain, Epstein, Ellen, Fritz, Stephen, Harris, Hoadley, Hewitt, Mitzie, Holguin, Fernando, Hudes, Golda, Jackson, Richard, Kaufman, Alan, Kaufman, David, Klapholz, Ari, Krishna, Harshavardhan, Lee, Daria, Lin, Robert, Maselli-Caceres, Diego, Mehta, Vinay, Moy, James N., Nwokoro, Ugo, Parikh, Purvi, Parikh, Sudhir, Perrino, Frank, Ruhlmann, James, Sassoon, Catherine, Settipane, Russell A., Sousa, Daniel, Sriram, Peruvemba, Wachs, Richard, Hughes, Rod, Rapsomaniki, Eleni, Keen, Christina, Make, Barry J., Tomaszewski, Erin L., Müllerová, Hana, and Reddel, Helen K.

Published
2022
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4. The effect of AZD9567 vs. prednisolone on glycaemic control in patients with type 2 diabetes mellitus: Results from a phase 2a clinical trial

Author

Ambery, Philip, primary, Zajac, Grzegorz, additional, Almquist, Joachim, additional, Prothon, Susanne, additional, Astbury, Carol, additional, Brown, Mary N., additional, Nemes, Szilard, additional, Nsabimana, Joselyne, additional, Edman, Karl, additional, Öberg, Lisa, additional, Lepistö, Matti, additional, Edenro, Goran, additional, Dillmann, Inken, additional, Mitra, Suman, additional, Belfield, Graham, additional, Keen, Christina, additional, and Heise, Tim, additional

Published
2024
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6. Effects of a selective glucocorticoid receptor modulator (AZD9567) versus prednisolone in healthy volunteers: two phase 1, single-blind, randomised controlled trials

Author

Hegelund Myrbäck, Tove, Prothon, Susanne, Edman, Karl, Leander, Jacob, Hashemi, Mahdi, Dearman, Matthew, Edenro, Goran, Svanberg, Petter, Andersson, Eva-Marie, Almquist, Joachim, Ämmälä, Carina, Hendrickx, Ramon, Taib, Ziad, Johansson, Kicki A, Berggren, Anders R, Keen, Christina M, Eriksson, Ulf G, Fuhr, Rainard, and Carlsson, Björn C L

Published
2020
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7. AZD4604, An Inhaled, Selective JAK1 Inhibitor Reduces Fractional Exhaled Nitric Oxide in Patients with Mild Asthma; A Randomized, Single-Blind Phase 1 Study

Author

Jensen, Tina Jellesmark, primary, Larsson, Julia, additional, Mäenpää, Jukka, additional, Mo, John, additional, Nemes, Szilárd, additional, Riff, Camille, additional, Rojnik, Zala Jevnikar, additional, Zingmark, Pernilla, additional, Konstantinidis, Kyriakos, additional, Belvisi, Maria, additional, Keen, Christina, additional, Soto, Pablo Forte, additional, Chetty, Rajkumar, additional, Singh, Dave, additional, and Hughes, Rod, additional

Published
2024
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8. The effect of AZD9567 versus prednisolone on glycemic control in patients with Type 2 diabetes mellitus: Results from a Phase 2a clinical trial

Author

Ambery, Philip, primary, Zajac, Grzegorz, additional, Almquist, Joachim, additional, Prothon, Susanne, additional, Astbury, Carol, additional, Brown, Mary, additional, Nemes, Szilard, additional, Nsabimana, Joselyne, additional, Edman, Karl, additional, Oberg, Lisa, additional, Lepisto, Matti, additional, Endro, Goran, additional, Mitra, Suman, additional, Belfield, Graham, additional, Keen, Christina, additional, and Heise, Tim, additional

Published
2023
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9. Cluster Analyses From the Real-World NOVELTY Study: Six Clusters Across the Asthma-COPD Spectrum

Author

Hughes, Rod, primary, Rapsomaniki, Eleni, additional, Bansal, Aruna T., additional, Vestbo, Jørgen, additional, Price, David, additional, Agustí, Alvar, additional, Beasley, Richard, additional, Fageras, Malin, additional, Alacqua, Marianna, additional, Papi, Alberto, additional, Müllerová, Hana, additional, Reddel, Helen K., additional, Olmo, Ricardo del, additional, Anderson, Gary, additional, Reddel, Helen, additional, Rabahi, Marcelo, additional, McIvor, Andrew, additional, Sadatsafavi, Mohsen, additional, Weinreich, Ulla, additional, Burgel, Pierre-Régis, additional, Devouassoux, Gilles, additional, Inoue, Hiromasa, additional, Rendon, Adrián, additional, van den Berge, Maarten, additional, García-Navarro, Alvar Agusti, additional, Faner, Rosa, additional, Olaguibel Rivera, José, additional, Janson, Christer, additional, Bilińska-Izydorczyk, Magdalena, additional, Fagerås, Malin, additional, Fihn-Wikander, Titti, additional, Franzén, Stefan, additional, Keen, Christina, additional, Ostridge, Kristoffer, additional, Chalmers, James, additional, Harrison, Timothy, additional, Pavord, Ian, additional, Azim, Adnan, additional, Belton, Laura, additional, Blé, Francois-Xavier, additional, Erhard, Clement, additional, Gairy, Kerry, additional, Hughes, Rod, additional, Lassi, Glenda, additional, Scott, Ian Christopher, additional, Chipps, Bradley, additional, Christenson, Stephanie, additional, Make, Barry, additional, Tomaszewski, Erin, additional, Benhabib, Gabriel, additional, Ruiz, Xavier Bocca, additional, Lisanti, Raul Eduardo, additional, Marino, Gustavo, additional, Mattarucco, Walter, additional, Nogueira, Juan, additional, Parody, Maria, additional, Pascale, Pablo, additional, Rodriguez, Pablo, additional, Silva, Damian, additional, Svetliza, Graciela, additional, Victorio, Carlos F., additional, Rolon, Roxana Willigs, additional, Yañez, Anahi, additional, Baines, Stuart, additional, Bowler, Simon, additional, Bremner, Peter, additional, Bull, Sheetal, additional, Carroll, Patrick, additional, Chaalan, Mariam, additional, Farah, Claude, additional, Hammerschlag, Gary, additional, Hancock, Kerry, additional, Harrington, Zinta, additional, Katsoulotos, Gregory, additional, Kim, Joshua, additional, Langton, David, additional, Lee, Donald, additional, Peters, Matthew, additional, Prassad, Lakshman, additional, Sajkov, Dimitar, additional, Santiago, Francis, additional, Simpson, Frederick Graham, additional, Tai, Sze, additional, Thomas, Paul, additional, Wark, Peter, additional, Cançado, José Eduardo Delfini, additional, Cunha, Thúlio, additional, Lima, Marina, additional, Cardoso, Alexandre Pinto, additional, FitzGerald, J. Mark, additional, Anees, Syed, additional, Bertley, John, additional, Bell, Alan, additional, Cheema, Amarjit, additional, Chouinard, Guy, additional, Csanadi, Michael, additional, Dhar, Anil, additional, Dhillon, Ripple, additional, Kanawaty, David, additional, Kelly, Allan, additional, Killorn, William, additional, Landry, Daniel, additional, Luton, Robert, additional, Mandhane, Piushkumar, additional, Pek, Bonavuth, additional, Petrella, Robert, additional, Stollery, Daniel, additional, Wang, Chen, additional, Chen, Meihua, additional, Chen, Yan, additional, Gu, Wei, additional, Christopher Hui, Kim Ming, additional, Li, Manxiang, additional, Li, Shiyue, additional, Lijun, Ma, additional, Qin, Guangyue, additional, Song, Weidong, additional, Tan, Wei, additional, Tang, Yijun, additional, Wang, Tan, additional, Wen, Fuqiang, additional, Wu, Feng, additional, Xiang, PingChao, additional, Xiao, Zuke, additional, Xiong, Shengdao, additional, Yang, Jinghua, additional, Yang, Jingping, additional, Zhang, Caiqing, additional, Zhang, Min, additional, Zhang, Ping, additional, Zhang, Wei, additional, Zheng, Xiaohe, additional, Zhu, Dan, additional, Bueno, Carlos Matiz, additional, Grimaldos, Fabio Bolivar, additional, Arboleda, Alejandra Cañas, additional, de Salazar, Dora Molina, additional, Bendstrup, Elisabeth, additional, Hilberg, Ole, additional, Kjellerup, Carsten, additional, Raherison, Chantal, additional, Bonniaud, Philippe, additional, Brun, Olivier, additional, Chouaid, Christos, additional, Couturaud, Francis, additional, de Blic, Jacques, additional, Debieuvre, Didier, additional, Delsart, Dominique, additional, Demaegdt, Axelle, additional, Demoly, Pascal, additional, Deschildre, Antoine, additional, Egron, Carole, additional, Falchero, Lionel, additional, Goupil, François, additional, Kessler, Romain, additional, Le Roux, Pascal, additional, Mabire, Pascal, additional, Mahay, Guillaume, additional, Martinez, Stéphanie, additional, Melloni, Boris, additional, Moreau, Laurent, additional, Riviere, Emilie, additional, Roux-Claudé, Pauline, additional, Soulier, Michel, additional, Vignal, Guillaume, additional, Yaici, Azzedine, additional, Bals, Robert, additional, Aries, Sven Philip, additional, Beck, Ekkehard, additional, Deimling, Andreas, additional, Feimer, Jan, additional, Grimm-Sachs, Vera, additional, Groth, Gesine, additional, Herth, Felix, additional, Hoheisel, Gerhard, additional, Kanniess, Frank, additional, Lienert, Thomas, additional, Mronga, Silke, additional, Reinhardt, Jörg, additional, Schlenska, Christian, additional, Stolpe, Christoph, additional, Teber, Ishak, additional, Timmermann, Hartmut, additional, Ulrich, Thomas, additional, Velling, Peter, additional, Wehgartner-Winkler, Sabina, additional, Welling, Juergen, additional, Winkelmann, Ernst-Joachim, additional, Barbetta, Carlo, additional, Braido, Fulvio, additional, Cardaci, Vittorio, additional, Clini, Enrico Maria, additional, Costantino, Maria Teresa, additional, Cuttitta, Giuseppina, additional, di Gioacchino, Mario, additional, Fois, Alessandro, additional, Foschino-Barbaro, Maria Pia, additional, Gammeri, Enrico, additional, Inchingolo, Riccardo, additional, Lavorini, Federico, additional, Molino, Antonio, additional, Nucera, Eleonora, additional, Patella, Vincenzo, additional, Pesci, Alberto, additional, Ricciardolo, Fabio, additional, Rogliani, Paola, additional, Sarzani, Riccardo, additional, Vancheri, Carlo, additional, Vincenti, Rigoletta, additional, Endo, Takeo, additional, Fujita, Masaki, additional, Hara, Yu, additional, Horiguchi, Takahiko, additional, Hosoi, Keita, additional, Ide, Yumiko, additional, Inomata, Minehiko, additional, Inoue, Koji, additional, Inoue, Sumito, additional, Kato, Motokazu, additional, Kawasaki, Masayuki, additional, Kawayama, Tomotaka, additional, Kita, Toshiyuki, additional, Kobayashi, Kanako, additional, Koto, Hiroshi, additional, Nishi, Koichi, additional, Saito, Junpei, additional, Shimizu, Yasuo, additional, Shirai, Toshihiro, additional, Sugihara, Naruhiko, additional, Takahashi, Ken-ichi, additional, Tashimo, Hiroyuki, additional, Tomii, Keisuke, additional, Yamada, Takashi, additional, Yanai, Masaru, additional, Rendon, Adrian, additional, Cerino Javier, Ruth, additional, Domínguez Peregrina, Alfredo, additional, Fernández Corzo, Marco, additional, Montano Gonzalez, Efraín, additional, Ramírez-Venegas, Alejandra, additional, Boersma, Willem, additional, Djamin, R.S., additional, Eijsvogel, Michiel, additional, Franssen, Frits, additional, Goosens, Martijn, additional, Graat-Verboom, Lidwien, additional, Veen, Johannes in 't, additional, Janssen, Rob, additional, Kuppens, Kim, additional, van de Ven, Mario, additional, Bakke, Per, additional, Brunstad, Ole Petter, additional, Einvik, Gunnar, additional, Høines, Kristian Jong, additional, Khusrawi, Alamdar, additional, Oien, Torbjorn, additional, Yoon, Ho Joo, additional, Chang, Yoon-Seok, additional, Cho, Young Joo, additional, Hwang, Yong Il, additional, Kim, Woo Jin, additional, Koh, Young-Il, additional, Lee, Byung-Jae, additional, Lee, Kwan-Ho, additional, Lee, Sang-Pyo, additional, Lee, Yong Chul, additional, Lim, Seong Yong, additional, Min, Kyung Hun, additional, Oh, Yeon-Mok, additional, Park, Choon-Sik, additional, Park, Hae-Sim, additional, Park, Heung-Woo, additional, Rhee, Chin Kook, additional, Yoon, Hyoung-Kyu, additional, García-Navarro, Alvar Agustí, additional, Andújar, Rubén, additional, Anoro, Laura, additional, Buendía García, María, additional, Mozo, Paloma Campo, additional, Campos, Sergio, additional, Casas Maldonado, Francisco, additional, Castilla Martínez, Manuel, additional, Cisneros Serrano, Carolina, additional, Comeche Casanova, Lorena, additional, Corbacho, Dolores, additional, Campo Matías, Felix Del, additional, Echave-Sustaeta, Jose, additional, Corral, Gloria Francisco, additional, Gamboa Setién, Pedro, additional, García Clemente, Marta, additional, Núñez, Ignacio García, additional, García Robaina, Jose, additional, García Salmones, Mercedes, additional, Marín Trigo, Jose Maria, additional, Fernandez, Marta Nuñez, additional, Palomo, Sara Nuñez, additional, Pérez de Llano, Luis, additional, Pueyo Bastida, Ana, additional, Rañó, Ana, additional, Rodríguez González-Moro, José, additional, Reig, Albert Roger, additional, Velasco Garrido, José, additional, Curiac, Dan, additional, Lif-Tiberg, Cornelia, additional, Luts, Anders, additional, Råhlen, Lennart, additional, Rustscheff, Stefan, additional, Adams, Frances, additional, Bradman, Drew, additional, Broughton, Emma, additional, Cosgrove, John, additional, Flood-Page, Patrick, additional, Fuller, Elizabeth, additional, Hartley, David, additional, Hattotuwa, Keith, additional, Jones, Gareth, additional, Lewis, Keir, additional, McGarvey, Lorcan, additional, Morice, Alyn, additional, Pandya, Preeti, additional, Patel, Manish, additional, Roy, Kay, additional, Sathyamurthy, Ramamurthy, additional, Thiagarajan, Swaminathan, additional, Turner, Alice, additional, Wedzicha, Wisia, additional, Wilkinson, Tom, additional, Wilson, Pete, additional, Al-Asadi, Lo’Ay, additional, Anholm, James, additional, Averill, Francis, additional, Bansal, Sandeep, additional, Baptist, Alan, additional, Campbell, Colin, additional, Campos, Michael A., additional, Crook, Gretchen, additional, DeLeon, Samuel, additional, Eid, Alain, additional, Epstein, Ellen, additional, Fritz, Stephen, additional, Harris, Hoadley, additional, Hewitt, Mitzie, additional, Holguin, Fernando, additional, Hudes, Golda, additional, Jackson, Richard, additional, Kaufman, Alan, additional, Kaufman, David, additional, Klapholz, Ari, additional, Krishna, Harshavardhan, additional, Lee, Daria, additional, Lin, Robert, additional, Maselli-Caceres, Diego, additional, Mehta, Vinay, additional, Moy, James N., additional, Nwokoro, Ugo, additional, Parikh, Purvi, additional, Parikh, Sudhir, additional, Perrino, Frank, additional, Ruhlmann, James, additional, Sassoon, Catherine, additional, Settipane, Russell A., additional, Sousa, Daniel, additional, Sriram, Peruvemba, additional, and Wachs, Richard, additional

Published
2023
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11. AZD9567 versus prednisolone in patients with active rheumatoid arthritis: A phase IIa, randomized, double‐blind, efficacy, and safety study.

Author

van Laar, Jacob M., Lei, Alejhandra, Safy‐Khan, Mary, Almquist, Joachim, Belfield, Graham, Edman, Karl, Öberg, Lisa, Angermann, Bastian R., Dillmann, Inken, Berntsson, Pia, Etal, Damla, Dainty, Ian, Astbury, Carol, Belvisi, Maria G., Nemes, Szilárd, Platt, Adam, Prothon, Susanne, Samuelsson, Sara, Svanberg, Petter, and Keen, Christina

Subjects
PREDNISOLONE, ABATACEPT, RHEUMATOID arthritis, MINERALOCORTICOID receptors, WATER-electrolyte balance (Physiology), GLUCOCORTICOID receptors
Abstract

Oral corticosteroid use is limited by side effects, some caused by off‐target actions on the mineralocorticoid receptor that disrupt electrolyte balance. AZD9567 is a selective, nonsteroidal glucocorticoid receptor modulator. The efficacy, safety, and tolerability of AZD9567 and prednisolone were assessed in a phase IIa study. Anti‐inflammatory mechanism of action was also evaluated in vitro in monocytes from healthy donors. In this randomized, double‐blind, parallel‐group, multicenter study, patients with active rheumatoid arthritis were randomized 1:1 to AZD9567 40 mg or prednisolone 20 mg once daily orally for 14 days. The primary end point was change from baseline in DAS28‐CRP at day 15. Secondary end points included components of DAS28‐CRP, American College of Rheumatology (ACR) response criteria (ACR20, ACR50, and ACR70), and safety end points, including serum electrolytes. Overall, 21 patients were randomized to AZD9567 (n = 11) or prednisolone (n = 10), and all completed the study. As anticipated, AZD9567 had a similar efficacy profile to prednisolone, with no clinically meaningful (i.e., >1.0) difference in change from baseline to day 15 in DAS28‐CRP between AZD9567 and prednisolone (least‐squares mean difference: 0.47, 95% confidence interval: −0.49 to 1.43). Similar results were observed for the secondary efficacy end points. In vitro transcriptomic analysis showed that anti‐inflammatory responses were similar for AZD9567, prednisolone, and dexamethasone. Unlike prednisolone, AZD9567 had no effect on the serum sodium:potassium ratio. The safety profile was not different from that of prednisolone. Larger studies of longer duration are required to determine whether AZD9567 40 mg may in the future be an alternative to prednisolone in patients with inflammatory disease. [ABSTRACT FROM AUTHOR]

Published
2023
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12. Frequent productive cough: Symptom burden and future exacerbation risk among patients with asthma and/or COPD in the NOVELTY study

Author

Hughes, Rod, primary, Rapsomaniki, Eleni, additional, Janson, Christer, additional, Keen, Christina, additional, Make, Barry J., additional, Burgel, Pierre-Régis, additional, Tomaszewski, Erin L., additional, Müllerová, Hana, additional, Reddel, Helen K., additional, Benhabib, Gabriel, additional, Ruiz, Xavier Bocca, additional, Olmo, Ricardo del, additional, Lisanti, Raul Eduardo, additional, Marino, Gustavo, additional, Mattarucco, Walter, additional, Nogueira, Juan, additional, Parody, Maria, additional, Pascale, Pablo, additional, Rodriguez, Pablo, additional, Silva, Damian, additional, Svetliza, Graciela, additional, Victorio, Carlos F., additional, Rolon, Roxana Willigs, additional, Yañez, Anahi, additional, Baines, Stuart, additional, Bowler, Simon, additional, Bremner, Peter, additional, Bull, Sheetal, additional, Carroll, Patrick, additional, Chaalan, Mariam, additional, Farah, Claude, additional, Hammerschlag, Gary, additional, Hancock, Kerry, additional, Harrington, Zinta, additional, Katsoulotos, Gregory, additional, Kim, Joshua, additional, Langton, David, additional, Lee, Donald, additional, Peters, Matthew, additional, Prassad, Lakshman, additional, Reddel, Helen, additional, Sajkov, Dimitar, additional, Santiago, Francis, additional, Simpson, Frederick Graham, additional, Tai, Sze, additional, Thomas, Paul, additional, Wark, Peter, additional, Delfini Cançado, José Eduardo, additional, Cunha, Thúlio, additional, Lima, Marina, additional, Cardoso, Alexandre Pinto, additional, Rabahi, Marcelo, additional, Anees, Syed, additional, Bertley, John, additional, Bell, Alan, additional, Cheema, Amarjit, additional, Chouinard, Guy, additional, Csanadi, Michael, additional, Dhar, Anil, additional, Dhillon, Ripple, additional, FitzGerald, J. Mark, additional, Kanawaty, David, additional, Kelly, Allan, additional, Killorn, William, additional, Landry, Daniel, additional, Luton, Robert, additional, Mandhane, Piushkumar, additional, McIvor, Andrew, additional, Pek, Bonavuth, additional, Petrella, Robert, additional, Stollery, Daniel, additional, Chen, Meihua, additional, Chen, Yan, additional, Gu, Wei, additional, Christopher Hui, Kim Ming, additional, Li, Manxiang, additional, Li, Shiyue, additional, Lijun, Ma, additional, Qin, Guangyue, additional, Song, Weidong, additional, Tan, Wei, additional, Tang, Yijun, additional, Wang, Chen, additional, Wang, Tan, additional, Wen, Fuqiang, additional, Wu, Feng, additional, Xiang, PingChao, additional, Xiao, Zuke, additional, Xiong, Shengdao, additional, Yang, Jinghua, additional, Yang, Jingping, additional, Zhang, Caiqing, additional, Zhang, Min, additional, Zhang, Ping, additional, Zhang, Wei, additional, Zheng, Xiaohe, additional, Zhu, Dan, additional, Grimaldos, Fabio Bolivar, additional, Arboleda, Alejandra Cañas, additional, Bueno, Carlos Matiz, additional, Molina de Salazar, Dora, additional, Bendstrup, Elisabeth, additional, Hilberg, Ole, additional, Kjellerup, Carsten, additional, Weinreich, Ulla, additional, Bonniaud, Philippe, additional, Brun, Olivier, additional, Chouaid, Christos, additional, Couturaud, Francis, additional, de Blic, Jacques, additional, Debieuvre, Didier, additional, Delsart, Dominique, additional, Demaegdt, Axelle, additional, Demoly, Pascal, additional, Deschildre, Antoine, additional, Devouassoux, Gilles, additional, Egron, Carole, additional, Falchero, Lionel, additional, Goupil, François, additional, Kessler, Romain, additional, Le Roux, Pascal, additional, Mabire, Pascal, additional, Mahay, Guillaume, additional, Martinez, Stéphanie, additional, Melloni, Boris, additional, Moreau, Laurent, additional, Raherison, Chantal, additional, Riviere, Emilie, additional, Roux-Claudé, Pauline, additional, Soulier, Michel, additional, Vignal, Guillaume, additional, Yaici, Azzedine, additional, Aries, Sven Philip, additional, Bals, Robert, additional, Beck, Ekkehard, additional, Deimling, Andreas, additional, Feimer, Jan, additional, Grimm-Sachs, Vera, additional, Groth, Gesine, additional, Herth, Felix, additional, Hoheisel, Gerhard, additional, Kanniess, Frank, additional, Lienert, Thomas, additional, Mronga, Silke, additional, Reinhardt, Jörg, additional, Schlenska, Christian, additional, Stolpe, Christoph, additional, Teber, Ishak, additional, Timmermann, Hartmut, additional, Ulrich, Thomas, additional, Velling, Peter, additional, Wehgartner-Winkler, Sabina, additional, Welling, Juergen, additional, Winkelmann, Ernst-Joachim, additional, Barbetta, Carlo, additional, Braido, Fulvio, additional, Cardaci, Vittorio, additional, Clini, Enrico Maria, additional, Costantino, Maria Teresa, additional, Cuttitta, Giuseppina, additional, di Gioacchino, Mario, additional, Fois, Alessandro, additional, Foschino-Barbaro, Maria Pia, additional, Gammeri, Enrico, additional, Inchingolo, Riccardo, additional, Lavorini, Federico, additional, Molino, Antonio, additional, Nucera, Eleonora, additional, Papi, Alberto, additional, Patella, Vincenzo, additional, Pesci, Alberto, additional, Ricciardolo, Fabio, additional, Rogliani, Paola, additional, Sarzani, Riccardo, additional, Vancheri, Carlo, additional, Vincenti, Rigoletta, additional, Endo, Takeo, additional, Fujita, Masaki, additional, Hara, Yu, additional, Horiguchi, Takahiko, additional, Hosoi, Keita, additional, Ide, Yumiko, additional, Inomata, Minehiko, additional, Inoue, Hiromasa, additional, Inoue, Koji, additional, Inoue, Sumito, additional, Kato, Motokazu, additional, Kawasaki, Masayuki, additional, Kawayama, Tomotaka, additional, Kita, Toshiyuki, additional, Kobayashi, Kanako, additional, Koto, Hiroshi, additional, Nishi, Koichi, additional, Saito, Junpei, additional, Shimizu, Yasuo, additional, Shirai, Toshihiro, additional, Sugihara, Naruhiko, additional, Takahashi, Ken-ichi, additional, Tashimo, Hiroyuki, additional, Tomii, Keisuke, additional, Yamada, Takashi, additional, Yanai, Masaru, additional, Javier, Ruth Cerino, additional, Peregrina, Alfredo Domínguez, additional, Corzo, Marco Fernández, additional, Gonzalez, Efraín Montano, additional, Ramírez-Venegas, Alejandra, additional, Rendon, Adrian, additional, Boersma, Willem, additional, Djamin, R.S., additional, Eijsvogel, Michiel, additional, Franssen, Frits, additional, Goosens, Martijn, additional, Graat-Verboom, Lidwien, additional, Veen, Johannes in 't, additional, Janssen, Rob, additional, Kuppens, Kim, additional, van den Berge, Maarten, additional, van de Ven, Mario, additional, Brunstad, Ole Petter, additional, Einvik, Gunnar, additional, Høines, Kristian Jong, additional, Khusrawi, Alamdar, additional, Oien, Torbjorn, additional, Chang, Yoon-Seok, additional, Cho, Young Joo, additional, Hwang, Yong Il, additional, Kim, Woo Jin, additional, Koh, Young-Il, additional, Lee, Byung-Jae, additional, Lee, Kwan-Ho, additional, Lee, Sang-Pyo, additional, Lee, Yong Chul, additional, Lim, Seong Yong, additional, Min, Kyung Hun, additional, Oh, Yeon-Mok, additional, Park, Choon-Sik, additional, Park, Hae-Sim, additional, Park, Heung-Woo, additional, Rhee, Chin Kook, additional, Yoon, Ho Joo, additional, Yoon, Hyoung-Kyu, additional, García-Navarro, Alvar Agusti, additional, Andújar, Rubén, additional, Anoro, Laura, additional, García, María Buendía, additional, Mozo, Paloma Campo, additional, Campos, Sergio, additional, Maldonado, Francisco Casas, additional, Martínez, Manuel Castilla, additional, Serrano, Carolina Cisneros, additional, Casanova, Lorena Comeche, additional, Corbacho, Dolores, additional, Del Campo Matías, Felix, additional, Echave-Sustaeta, Jose, additional, Corral, Gloria Francisco, additional, Setién, Pedro Gamboa, additional, Clemente, Marta García, additional, Núñez, Ignacio García, additional, Robaina, Jose García, additional, Salmones, Mercedes García, additional, Marín Trigo, Jose Maria, additional, Fernandez, Marta Nuñez, additional, Palomo, Sara Nuñez, additional, Rivera, José Olaguibel, additional, Pérez de Llano, Luis, additional, Bastida, Ana Pueyo, additional, Rañó, Ana, additional, González-Moro, José Rodríguez, additional, Reig, Albert Roger, additional, Garrido, José Velasco, additional, Curiac, Dan, additional, Lif-Tiberg, Cornelia, additional, Luts, Anders, additional, Råhlen, Lennart, additional, Rustscheff, Stefan, additional, Adams, Frances, additional, Bradman, Drew, additional, Broughton, Emma, additional, Cosgrove, John, additional, Flood-Page, Patrick, additional, Fuller, Elizabeth, additional, Harrison, Timothy, additional, Hartley, David, additional, Hattotuwa, Keith, additional, Jones, Gareth, additional, Lewis, Keir, additional, McGarvey, Lorcan, additional, Morice, Alyn, additional, Pandya, Preeti, additional, Patel, Manish, additional, Roy, Kay, additional, Sathyamurthy, Ramamurthy, additional, Thiagarajan, Swaminathan, additional, Turner, Alice, additional, Vestbo, Jorgen, additional, Wedzicha, Wisia, additional, Wilkinson, Tom, additional, Wilson, Pete, additional, Al-Asadi, Lo’Ay, additional, Anholm, James, additional, Averill, Frank, additional, Bansal, Sandeep, additional, Baptist, Alan, additional, Campbell, Colin, additional, Campos, Michael A., additional, Chipps, Bradley, additional, Crook, Gretchen, additional, DeLeon, Samuel, additional, Eid, Alain, additional, Epstein, Ellen, additional, Fritz, Stephen, additional, Harris, Hoadley, additional, Hewitt, Mitzie, additional, Holguin, Fernando, additional, Hudes, Golda, additional, Jackson, Richard, additional, Kaufman, Alan, additional, Kaufman, David, additional, Klapholz, Ari, additional, Krishna, Harshavardhan, additional, Lee, Daria, additional, Lin, Robert, additional, Maselli-Caceres, Diego, additional, Mehta, Vinay, additional, Moy, James N., additional, Nwokoro, Ugo, additional, Parikh, Purvi, additional, Parikh, Sudhir, additional, Perrino, Frank, additional, Ruhlmann, James, additional, Sassoon, Catherine, additional, Settipane, Russell A., additional, Sousa, Daniel, additional, Sriram, Peruvemba, additional, and Wachs, Richard, additional

Published
2022
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13. AZD5634, an inhaled ENaC inhibitor, in healthy subjects and patients with cystic fibrosis

Author

Kristensson, Cecilia, primary, Åstrand, Annika, additional, Donaldson, Scott, additional, Goldwater, Ron, additional, Abdulai, Raolat, additional, Patel, Naimish, additional, Gardiner, Philip, additional, Tehler, Ulrika, additional, Mercier, Anne-Kristina, additional, Olsson, Marita, additional, Ersdal, Eva, additional, Mäenpää, Jukka, additional, Bramer, Tobias, additional, Malmgren, Anna, additional, Bennett, William, additional, and Keen, Christina, additional

Published
2022
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14. Frequent productive cough : Symptom burden and future exacerbation risk among patients with asthma and/or COPD in the NOVELTY study

Author

Hughes, Rod, Rapsomaniki, Eleni, Janson, Christer, Keen, Christina, Make, Barry J., Burgel, Pierre-Regis, Tomaszewski, Erin L., Mullerova, Hana, Reddel, Helen K., Hughes, Rod, Rapsomaniki, Eleni, Janson, Christer, Keen, Christina, Make, Barry J., Burgel, Pierre-Regis, Tomaszewski, Erin L., Mullerova, Hana, and Reddel, Helen K.

Abstract

Introduction: Persistent cough with sputum production is an important clinical trait in chronic obstructive pulmonary disease (COPD). We defined "frequent productive cough" based on 2 questions from the St George's Respiratory Questionnaire (SGRQ) and sought to determine its occurrence and associated outcomes in patients with physician-assigned asthma and/or COPD from the NOVELTY study. Methods: Frequent productive cough was defined as cough and sputum production most or several days/week for the past 3 months (scoring >= 3 for both SGRQ questions). Relationships with baseline disease characteristics and exacerbations over 12 months' follow-up were examined using logistic regression. Results: Baseline SGRQ data were available for 7125 patients, of whom 31.3% had frequent productive cough. It was more common in asthma + COPD (38.8%) and COPD (38.1%) than asthma (25.0%), increasing with physician-assessed severity, and in current versus former and never smokers. Patient-reported symptomatic worsening was more common in patients with versus without frequent productive cough. Reduced post-bronchodilator FEV1 (odds ratio [OR] per 10% decrement 1.14 [95% confidence interval 1.11-1.16]) and history of pollutant exposure at home/work (OR 1.50 [1.33-1.69]) were associated with frequent productive cough in all diagnoses. Patients with baseline frequent productive cough were more likely to have >= 1 exacerbation over the subsequent 12 months (OR 1.71 [1.52-1.93]), including exacerbations requiring hospital admission and those treated with oral corticosteroids. Conclusions: Frequent productive cough represents an important indicator of adverse clinical outcomes across asthma and/or COPD. Research into the underlying pathologic mechanisms is required to support targeted therapy development.

Published
2022
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15. Response

Author

Usmani, Omar S., primary, Han, MeiLan K., additional, Kaminsky, David A., additional, Hogg, James, additional, Hjoberg, Josephine, additional, Patel, Naimish, additional, Hardin, Megan, additional, Keen, Christina, additional, Rennard, Stephen, additional, Blé, François-Xavier, additional, and Brown, Mary N., additional

Published
2022
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18. Characterisation of pharmacokinetics, safety and tolerability in a first‐in‐human study for AZD8154, a novel inhaled selective PI3Kγδ dual inhibitor targeting airway inflammatory disease

Author

Sadiq, Muhammad Waqas, primary, Asimus, Sara, additional, Belvisi, Maria G., additional, Brailsford, Wayne, additional, Fransson, Rebecca, additional, Fuhr, Rainard, additional, Hagberg, Anette, additional, Hashemi, Mahdi, additional, Jellesmark Jensen, Tina, additional, Jonsson, Julia, additional, Keen, Christina, additional, Körnicke, Thomas, additional, Kristensson, Cecilia, additional, Mäenpää, Jukka, additional, Necander, Sofia, additional, Nemes, Szilárd, additional, and Betts, Joanne, additional

Published
2021
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19. Seven Pillars of Small Airways Disease in Asthma and COPD

Author

Usmani, Omar S., primary, Han, MeiLan K., additional, Kaminsky, David A., additional, Hogg, James, additional, Hjoberg, Josephine, additional, Patel, Naimish, additional, Hardin, Megan, additional, Keen, Christina, additional, Rennard, Stephen, additional, Blé, François-Xavier, additional, and Brown, Mary N., additional

Published
2021
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20. Validation of a diagnosis-agnostic symptom questionnaire for asthma and/or COPD

Author

Karlsson, Niklas, Atkinson, Mark J., Müllerová, Hana, Alacqua, Marianna, Keen, Christina, Hughes, Rod, Janson, Christer, Make, Barry, Price, David, Reddel, Helen K., Karlsson, Niklas, Atkinson, Mark J., Müllerová, Hana, Alacqua, Marianna, Keen, Christina, Hughes, Rod, Janson, Christer, Make, Barry, Price, David, and Reddel, Helen K.

Abstract

Background he Respiratory Symptoms Questionnaire (RSQ) is a novel, 4-item patient-reported diagnosis-agnostic tool designed to assess the frequency of respiratory symptoms and their impact on activity, without specifying a particular diagnosis. Our objective was to examine its validity in patients with asthma and/or chronic obstructive pulmonary disease (COPD).Methods Baseline data were randomly sampled from patients who completed the RSQ in the NOVELTY study (NCT02760329). The total sample (N=1530) comprised three randomly selected samples (N=510 each) from each physician-assigned diagnostic group (asthma, asthma+COPD, COPD). The internal consistency and structural validity of the RSQ were evaluated using exploratory and confirmatory factor analyses; psychometric performance was observed using Classical Test Theory and Item Response Theory analyses.Results For the total sample, the mean RSQ score was 5.6 (sd 4.3; range: 0–16). Irrespective of diagnosis, the internal consistency of items was uniformly adequate (Cronbach's alphas range: 0.76–0.80). All items had high factor loadings, and structural characteristics of the measure were invariant across groups. Using the total sample, RSQ items informatively covered the theta score range of –2.0 to 2.8, with discrimination coefficients for individual items being high-to-very high (1.7–2.6). Strong convergent correlations were observed between the RSQ and St George's Respiratory Questionnaire (SGRQ; 0.77, p<0.001).Conclusions he RSQ is a valid, brief, patient-reported tool for assessing respiratory symptoms in patients across the whole spectrum of asthma and/or COPD, rather than using different questionnaires for each diagnosis. It can be used for monitoring respiratory symptoms in clinical practice, clinical trials and real-world studies.

Published
2021
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21. Characterisation of pharmacokinetics, safety and tolerability in a first‐in‐human study for AZD8154, a novel inhaled selective PI3Kγδ dual inhibitor targeting airway inflammatory disease.

Author

Sadiq, Muhammad Waqas, Asimus, Sara, Belvisi, Maria G., Brailsford, Wayne, Fransson, Rebecca, Fuhr, Rainard, Hagberg, Anette, Hashemi, Mahdi, Jellesmark Jensen, Tina, Jonsson, Julia, Keen, Christina, Körnicke, Thomas, Kristensson, Cecilia, Mäenpää, Jukka, Necander, Sofia, Nemes, Szilárd, and Betts, Joanne

Subjects
PHOSPHATIDYLINOSITOL 3-kinases, PHARMACOKINETICS, LUNGS, RESPIRATORY diseases
Abstract

Aims: This 3‐part, randomised, phase 1 first‐in‐human study (NCT03436316) investigated the safety, tolerability and pharmacokinetics (PK) of AZD8154, a dual phosphoinositide 3‐kinase (PI3K) γδ inhibitor developed as a novel inhaled anti‐inflammatory treatment for respiratory disease. Methods: Healthy men, and women of nonchildbearing potential, were enrolled to receive single and multiple ascending inhaled doses of AZD8154 in parts 1 and 3 of the study, respectively, while part 2 characterised the systemic PK after a single intravenous (IV) dose. In part 1, participants received 0.1–7.7 mg AZD8154 in 6 cohorts. In part 2, participants were given 0.15 mg AZD8154 as an IV infusion. In part 3, AZD8154 was given in 3 cohorts of 0.6, 1.8 and 3.1 mg, with a single dose on Day 1 followed by repeated once‐daily doses on Days 4–12. Results: In total, 78 volunteers were randomised. All single inhaled, single IV and multiple inhaled doses were shown to be well tolerated without any safety concerns. A population PK model, using nonlinear mixed‐effect modelling, was developed to describe the PK of AZD8154. The terminal mean half‐life of AZD8154 was 18.0–32.0 hours. The geometric mean of the absolute pulmonary bioavailability of AZD8154 via the inhaled route was 94.1%. Conclusion: AZD8154 demonstrated an acceptable safety profile, with no reports of serious adverse events and no clinically significant drug‐associated safety concerns reported in healthy volunteers. AZD8154 demonstrated prolonged lung retention and a half‐life supporting once‐daily dosing. [ABSTRACT FROM AUTHOR]

Published
2022
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24. Prospective observational study in patients with obstructive lung disease : NOVELTY design

Author

Reddel, Helen K, Gerhardsson de Verdier, Maria, Agustí, Alvar, Anderson, Gary, Beasley, Richard, Bel, Elisabeth H, Janson, Christer, Make, Barry, Martin, Richard J, Pavord, Ian, Price, David, Keen, Christina, Gardev, Asparuh, Rennard, Stephen, Sveréus, Alecka, Bansal, Aruna T, Brannman, Lance, Karlsson, Niklas, Nuevo, Javier, Nyberg, Fredrik, Young, Simon S, Vestbo, Jørgen, Reddel, Helen K, Gerhardsson de Verdier, Maria, Agustí, Alvar, Anderson, Gary, Beasley, Richard, Bel, Elisabeth H, Janson, Christer, Make, Barry, Martin, Richard J, Pavord, Ian, Price, David, Keen, Christina, Gardev, Asparuh, Rennard, Stephen, Sveréus, Alecka, Bansal, Aruna T, Brannman, Lance, Karlsson, Niklas, Nuevo, Javier, Nyberg, Fredrik, Young, Simon S, and Vestbo, Jørgen

Abstract

Asthma and chronic obstructive pulmonary disease (COPD) have overlapping clinical features and share pathobiological mechanisms but are often considered distinct disorders. Prospective, observational studies across asthma, COPD and asthma-COPD overlap are limited. NOVELTY is a global, prospective observational 3-year study enrolling ∼12 000 patients ≥12 years of age from primary and specialist clinical practices in 19 countries (ClinicalTrials.gov identifier: NCT02760329). NOVELTY's primary objectives are to describe patient characteristics, treatment patterns and disease burden over time, and to identify phenotypes and molecular endotypes associated with differential outcomes over time in patients with a diagnosis/suspected diagnosis of asthma and/or COPD. NOVELTY aims to recruit real-world patients, unlike clinical studies with restrictive inclusion/exclusion criteria. Data collected at yearly intervals include clinical assessments, spirometry, biospecimens, patient-reported outcomes (PROs) and healthcare utilisation (HCU). PROs and HCU will also be collected 3-monthly via internet/telephone. Data will be used to identify phenotypes and endotypes associated with different trajectories for symptom burden, clinical progression or remission and HCU. Results may allow patient classification across obstructive lung disease by clinical outcomes and biomarker profile, rather than by conventional diagnostic labels and severity categories. NOVELTY will provide a rich data source on obstructive lung disease, to help improve patient outcomes and aid novel drug development.

Published
2019
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25. Reducing the variability of DLCO measurements in clinical trials

Author

Hagberg, Anette, primary, Betts, Joanne, additional, Kristensson, Cecilia, additional, Mo, John, additional, Asimus, Sara, additional, Sadiq, Muhammad Waqas, additional, Koernicke, Thomas, additional, Fuhr, Rainard, additional, Brailsford, Wayne, additional, Keen, Christina, additional, and Mäenpää, Jukka, additional

Published
2019
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26. Safety, tolerability and pharmacokinetics (PK) of AZD8154 (a selective PI3K?d inhibitor) after single ascending inhaled doses in healthy volunteers

Author

Sadiq, Muhammad Waqas, primary, Asimus, Sara, additional, Kristensson, Cecilia, additional, Hagberg, Anette, additional, Mäenpää, Jukka, additional, Valastro, Barbara, additional, Fuhr, Rainard, additional, Koernicke, Thomas, additional, Keen, Christina, additional, Brailsford, Wayne, additional, and Betts, Joanne, additional

Published
2019
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27. Asthma: moving toward a global children's charter

Author

Lenney, Warren, primary, Adachi, Yuichi, additional, Bush, Andrew, additional, Fischer, Gilberto B, additional, Hong, Jianguo, additional, Ostrem, Anders, additional, Pedersen, Soren, additional, Sly, Peter D, additional, Szefler, Stanley J, additional, Tilak, Raj, additional, Zar, Heather J, additional, Akinbami, Lara J, additional, Blake, Kathryn V, additional, Cabana, Michael, additional, Cicutto, Lisa C, additional, Custovic, Adnan, additional, Doull, Iolo, additional, Fitzgerald, Dominic A, additional, Fletcher, Monica, additional, Grigg, Jonathan, additional, Hughes, Rod, additional, Keen, Christina, additional, Leather, David A, additional, Lemanske, Rob F, additional, Lenney, Warren, additional, Garcia-Marcos, Louis, additional, Mazyck, Donna J, additional, Rubin, Bruce K, additional, Sheikh, Aziz, additional, Shen, Kunling, additional, Sly, Peter, additional, Stein, Renato T, additional, Stout, James W, additional, Subbarao, Padmaja, additional, Winders, Tonya, additional, and Williams, Sian, additional

Published
2019
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28. Prospective observational study in patients with obstructive lung disease: NOVELTY design

Author

Reddel, Helen K., primary, Gerhardsson de Verdier, Maria, additional, Agustí, Alvar, additional, Anderson, Gary, additional, Beasley, Richard, additional, Bel, Elisabeth H., additional, Janson, Christer, additional, Make, Barry, additional, Martin, Richard J., additional, Pavord, Ian, additional, Price, David, additional, Keen, Christina, additional, Gardev, Asparuh, additional, Rennard, Stephen, additional, Sveréus, Alecka, additional, Bansal, Aruna T., additional, Brannman, Lance, additional, Karlsson, Niklas, additional, Nuevo, Javier, additional, Nyberg, Fredrik, additional, Young, Simon S., additional, and Vestbo, Jørgen, additional

Published
2019
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29. Additional file 1: Table S1. of The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given â as neededâ in mild asthma: study protocols for two randomised controlled trials

Author

O’Byrne, Paul, J. FitzGerald, Nanshan Zhong, Bateman, Eric, Barnes, Peter, Keen, Christina, Almqvist, Gun, Pemberton, Kristine, Jorup, Carin, Ivanov, Stefan, and Reddel, Helen

Abstract

Oversight Authorities for SYGMA1 and SYGMA2. (DOCX 20 kb)

Published
2017
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30. Additional file 2: of The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given â as neededâ in mild asthma: study protocols for two randomised controlled trials

Author

O’Byrne, Paul, J. FitzGerald, Nanshan Zhong, Bateman, Eric, Barnes, Peter, Keen, Christina, Almqvist, Gun, Pemberton, Kristine, Jorup, Carin, Ivanov, Stefan, and Reddel, Helen

Abstract

SPIRIT Checklist for SYGMA1 and SYGMA2. (DOCX 52 kb)

Published
2017
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32. Inhaled Combined Budesonide–Formoterol as Needed in Mild Asthma

Author

O’Byrne, Paul M., primary, FitzGerald, J. Mark, additional, Bateman, Eric D., additional, Barnes, Peter J., additional, Zhong, Nanshan, additional, Keen, Christina, additional, Jorup, Carin, additional, Lamarca, Rosa, additional, Ivanov, Stefan, additional, and Reddel, Helen K., additional

Published
2018
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34. Next generation glucocorticoid receptor modulators

Author

Edman, Karl, primary, Belfield, Graham, additional, Dearman, Matthew, additional, Edenro, Goran, additional, Geschwindner, Stefan, additional, Hegelund-Myrback, Tove, additional, Hemmerling, Martin, additional, Hendrickx, Ramon, additional, Keen, Christina, additional, Karrman-Mardh, Carina, additional, Lepisto, Matti, additional, Mitra, Suman, additional, Monkley, Susan, additional, Prothon, Susanne, additional, Ripa, Lena, additional, Steele, John, additional, Vaarala, Outi, additional, Wissler, Lisa, additional, and Oberg, Lisa, additional

Published
2018
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35. Assessment Of US Electronic Medical Records To Guide Feasibility And Design Of The Novelty Study

Author

Reddel, Helen, De Verdier, Maria Gerhardsson, Agusti, Alvar, Beasley, Richard, Bel, Elisabeth H., Hiller, Josh, Janson, Christer, Kamauu, Aaron W. C., Make, Barry J., Martin, Richard J., Pavord, Ian, Price, David, Wong, Diana, Keen, Christina, Gardev, Asparuh D., Rennard, Stephen I., Svereus, Alecka, Bansal, Aruna T., Brannman, Lance, Karlsson, Niklas, Nuevo, Javier, Nyberg, Fredrik, Wang, Xia, Young, Simon, Vestbo, Jorgen, Reddel, Helen, De Verdier, Maria Gerhardsson, Agusti, Alvar, Beasley, Richard, Bel, Elisabeth H., Hiller, Josh, Janson, Christer, Kamauu, Aaron W. C., Make, Barry J., Martin, Richard J., Pavord, Ian, Price, David, Wong, Diana, Keen, Christina, Gardev, Asparuh D., Rennard, Stephen I., Svereus, Alecka, Bansal, Aruna T., Brannman, Lance, Karlsson, Niklas, Nuevo, Javier, Nyberg, Fredrik, Wang, Xia, Young, Simon, and Vestbo, Jorgen

Published
2017

36. Suitability of australian electronic medical records to guide the design of the novelty study

Author

Reddel, Helen K., De Verdier, Maria Gerhardsson, Agusti, Alvar, Beasley, Richard, Bel, Elisabeth H., Hiller, Josh, Janson, Christer, Make, Barry, Martin, Richard J., Pavord, Ian, Postma, Dirkje, Price, David, Wong, Diana, Keen, Christina, Gardev, Asparuh, Rennard, Stephen, Svereus, Alecka, Bansal, Aruna T., Brannman, Lance, Karlsson, Niklas, Nuevo, Javier, Nyberg, Fredrik, Wang, Xia, Young, Simon, Vestbo, Jörgen, Reddel, Helen K., De Verdier, Maria Gerhardsson, Agusti, Alvar, Beasley, Richard, Bel, Elisabeth H., Hiller, Josh, Janson, Christer, Make, Barry, Martin, Richard J., Pavord, Ian, Postma, Dirkje, Price, David, Wong, Diana, Keen, Christina, Gardev, Asparuh, Rennard, Stephen, Svereus, Alecka, Bansal, Aruna T., Brannman, Lance, Karlsson, Niklas, Nuevo, Javier, Nyberg, Fredrik, Wang, Xia, Young, Simon, and Vestbo, Jörgen

Published
2017
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37. The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given ‘as needed’ in mild asthma: study protocols for two randomised controlled trials

Author

O’Byrne, Paul M., primary, FitzGerald, J. Mark, additional, Zhong, Nanshan, additional, Bateman, Eric, additional, Barnes, Peter J., additional, Keen, Christina, additional, Almqvist, Gun, additional, Pemberton, Kristine, additional, Jorup, Carin, additional, Ivanov, Stefan, additional, and Reddel, Helen K., additional

Published
2017
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38. Asthma: moving toward a global children's charter

Author

Adachi, Yuichi, Akinbami, Lara J, Blake, Kathryn V, Bush, Andrew, Cabana, Michael, Cicutto, Lisa C, Custovic, Adnan, Doull, Iolo, Fischer, Gilberto B, Fitzgerald, Dominic A, Fletcher, Monica, Grigg, Jonathan, Hong, Jianguo, Hughes, Rod, Keen, Christina, Leather, David A, Lemanske, Rob F, Lenney, Warren, Garcia-Marcos, Louis, Mazyck, Donna J, Ostrem, Anders, Pedersen, Soren, Rubin, Bruce K, Sheikh, Aziz, Shen, Kunling, Sly, Peter, Stein, Renato T, Stout, James W, Subbarao, Padmaja, Szefler, Stanley J, Tilak, Raj, Winders, Tonya, Williams, Sian, Zar, Heather J, and Sly, Peter D

Published
2019
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39. The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given 'as needed' in mild asthma: study protocols for two randomised controlled trials.

Author

O'Byrne, Paul M., FitzGerald, J. Mark, Nanshan Zhong, Bateman, Eric, Barnes, Peter J., Keen, Christina, Almqvist, Gun, Pemberton, Kristine, Jorup, Carin, Ivanov, Stefan, Reddel, Helen K., and Zhong, Nanshan

Subjects
ASTHMA treatment, BUDESONIDE, FORMOTEROL, DRUG efficacy, HEALTH programs, THERAPEUTICS, DRUG therapy for asthma, COMPARATIVE studies, RESEARCH methodology, MEDICAL cooperation, RESEARCH protocols, RESEARCH, STATISTICAL sampling, SAMPLE size (Statistics), EVALUATION research, RANDOMIZED controlled trials, BLIND experiment
Abstract

Background: In many patients with mild asthma, the low frequency of symptoms and the episodic nature of exacerbations make adherence to regular maintenance treatment difficult. This often leads to over-reliance on short-acting β2-agonist (SABA) reliever medication and under-treatment of the underlying inflammation, with poor control of asthma symptoms and increased risk of exacerbations. The use of budesonide/formoterol 'as needed' in response to symptoms may represent an alternative treatment option for patients with mild asthma.Methods/design: The SYmbicort Given as needed in Mild Asthma (SYGMA) programme consists of two 52-week, double-blind, randomised, multicentre, parallel-group, phase 3 trials of patients aged 12 years and older with a clinical diagnosis of asthma for at least 6 months, who would qualify for treatment with regular inhaled corticosteroids (ICS). SYGMA1 aims to recruit 3750 patients who will be randomised to placebo twice daily (bid) plus as-needed budesonide/formoterol 160/4.5 μg, placebo bid plus as-needed terbutaline 0.4 mg, or budesonide 200 μg bid plus as-needed terbutaline 0.4 mg. The primary objective is to demonstrate the superiority of as-needed budesonide/formoterol over as-needed terbutaline for asthma control, as measured by well-controlled asthma weeks; a secondary objective is to establish the noninferiority of as-needed budesonide/formoterol versus maintenance budesonide plus as-needed terbutaline using the same outcome measure. SYGMA2 aims to recruit 4114 patients who will be randomised to placebo bid plus as-needed budesonide/formoterol 160/4.5 μg, or budesonide 200 μg bid plus as-needed terbutaline 0.4 mg. The primary objective is to demonstrate the noninferiority of as-needed budesonide/formoterol over budesonide bid plus as-needed terbutaline as measured by the annualised severe exacerbation rate. In both studies, use of all blinded study inhalers will be recorded electronically using Turbuhaler® Usage Monitors.Discussion: Given the known risks of mild asthma, and known poor adherence with regular inhaled corticosteroids, the results of the SYGMA programme will help to determine the efficacy and safety of as-needed budesonide/formoterol therapy in mild asthma. Patient recruitment is complete, and completion of the phase 3 studies is planned in 2017.Trial Registration: ClinicalTrials.gov identifiers: NCT02149199 SYGMA1 and NCT02224157 SYGMA2. Registered on 16 May 2014 and 19 August 2014, respectively. [ABSTRACT FROM AUTHOR]

Published
2017
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40. Supplementation With Fatty Acids Influences the Airway Nitric Oxide and Inflammatory Markers in Patients With Cystic Fibrosis

Author

Keen, Christina, Olin, Anna-Carin, Eriksson, Susanne, Ekman, Anna, Lindblad, Anders, Basu, Samar, Beermann, Christopher, Strandvik, Birgitta, Keen, Christina, Olin, Anna-Carin, Eriksson, Susanne, Ekman, Anna, Lindblad, Anders, Basu, Samar, Beermann, Christopher, and Strandvik, Birgitta

Abstract

Objectives: To obtain a balance in the fatty acid (FA) metabolism is important for the inflammatory response and of special importance in cystic fibrosis (CF), which is characterized by impaired FA metabolism, chronic inflammation, and infection in the airways. Nitric oxide (NO) has antimicrobial properties and low nasal (nNO) and exhaled NO (FENO), commonly reported in CF that may affect bacterial status. The present study investigates the effect of different FA blends on nNO and FENO and immunological markers in patients with CF. Patients and Methods: Forty-three patients with CF and "severe" mutations were consecutively enrolled in a randomized double-blind placebo-controlled study with 3 FA blends containing mainly n-3 or n-6 FA or saturated FA acting as placebo. FENO, nNO, serum phospholipid concentrations of FA, and biomarkers of inflammation were measured before and after 3 months of supplementation. Results: Thirty-five patients in clinically stable condition completed the study. The serum phospholipid FA pattern changed significantly in all 3 groups. An increase of the n-6FA, arachidonic acid, was associated with a decrease of FENO and nNO. The inflammatory biomarkers, erythrocyte sedimentation rate, and interleukin-8 decreased after supplementation with n-3 FA and erythrocyte sedimentation rate increased after supplementation with n-6 FA. Conclusions: This small pilot study indicated that the composition of dietary n-3 and n-6 FA influenced the inflammatory markers in CF. FENO and nNO were influenced by changes in the arachidonic acid concentration, supporting previous studies suggesting that both the lipid abnormality and the colonization with Pseudomonas influenced NO in the airways.

Published
2010
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43. Inhaled Combined Budesonide-Formoterol as Needed in Mild Asthma.

Author

O'Byrne, Paul M., FitzGerald, J. Mark, Bateman, Eric D., Barnes, Peter J., Zhong, Nanshan, Keen, Christina, Jorup, Carin, Lamarca, Rosa, Ivanov, Stefan, and Reddel, Helen K.

Subjects
*DRUG therapy for asthma, *BRONCHODILATOR agents, *DRUG therapy, *COMBINATION drug therapy, *COMPARATIVE studies, *DRUGS, *DRUG administration, *GLUCOCORTICOIDS, *RESEARCH methodology, *MEDICAL cooperation, *PATIENT compliance, *RESEARCH, *STATISTICAL sampling, *EVALUATION research, *RANDOMIZED controlled trials, *VITAL capacity (Respiration), *BLIND experiment, *TERBUTALINE, *BUDESONIDE, *INHALATION administration
Abstract

Background: In patients with mild asthma, as-needed use of an inhaled glucocorticoid plus a fast-acting β2-agonist may be an alternative to conventional treatment strategies.Methods: We conducted a 52-week, double-blind trial involving patients 12 years of age or older with mild asthma. Patients were randomly assigned to one of three regimens: twice-daily placebo plus terbutaline (0.5 mg) used as needed (terbutaline group), twice-daily placebo plus budesonide-formoterol (200 μg of budesonide and 6 μg of formoterol) used as needed (budesonide-formoterol group), or twice-daily budesonide (200 μg) plus terbutaline used as needed (budesonide maintenance group). The primary objective was to investigate the superiority of as-needed budesonide-formoterol to as-needed terbutaline with regard to electronically recorded weeks with well-controlled asthma.Results: A total of 3849 patients underwent randomization, and 3836 (1277 in the terbutaline group, 1277 in the budesonide-formoterol group, and 1282 in the budesonide maintenance group) were included in the full analysis and safety data sets. With respect to the mean percentage of weeks with well-controlled asthma per patient, budesonide-formoterol was superior to terbutaline (34.4% vs. 31.1% of weeks; odds ratio, 1.14; 95% confidence interval [CI], 1.00 to 1.30; P=0.046) but inferior to budesonide maintenance therapy (34.4% and 44.4%, respectively; odds ratio, 0.64; 95% CI, 0.57 to 0.73). The annual rate of severe exacerbations was 0.20 with terbutaline, 0.07 with budesonide-formoterol, and 0.09 with budesonide maintenance therapy; the rate ratio was 0.36 (95% CI, 0.27 to 0.49) for budesonide-formoterol versus terbutaline and 0.83 (95% CI, 0.59 to 1.16) for budesonide-formoterol versus budesonide maintenance therapy. The rate of adherence in the budesonide maintenance group was 78.9%. The median metered daily dose of inhaled glucocorticoid in the budesonide-formoterol group (57 μg) was 17% of the dose in the budesonide maintenance group (340 μg).Conclusions: In patients with mild asthma, as-needed budesonide-formoterol provided superior asthma-symptom control to as-needed terbutaline, assessed according to electronically recorded weeks with well-controlled asthma, but was inferior to budesonide maintenance therapy. Exacerbation rates with the two budesonide-containing regimens were similar and were lower than the rate with terbutaline. Budesonide-formoterol used as needed resulted in substantially lower glucocorticoid exposure than budesonide maintenance therapy. (Funded by AstraZeneca; SYGMA 1 ClinicalTrials.gov number, NCT02149199 .). [ABSTRACT FROM AUTHOR]

Published
2018
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44. AZD9567 versus prednisolone in patients with active rheumatoid arthritis: A phase IIa, randomized, double-blind, efficacy, and safety study.

Author

van Laar JM, Lei A, Safy-Khan M, Almquist J, Belfield G, Edman K, Öberg L, Angermann BR, Dillmann I, Berntsson P, Etal D, Dainty I, Astbury C, Belvisi MG, Nemes S, Platt A, Prothon S, Samuelsson S, Svanberg P, and Keen C

Subjects
Humans, Prednisolone adverse effects, Treatment Outcome, Anti-Inflammatory Agents therapeutic use, Double-Blind Method, Methotrexate therapeutic use, Antirheumatic Agents therapeutic use, Arthritis, Rheumatoid drug therapy
Abstract

Oral corticosteroid use is limited by side effects, some caused by off-target actions on the mineralocorticoid receptor that disrupt electrolyte balance. AZD9567 is a selective, nonsteroidal glucocorticoid receptor modulator. The efficacy, safety, and tolerability of AZD9567 and prednisolone were assessed in a phase IIa study. Anti-inflammatory mechanism of action was also evaluated in vitro in monocytes from healthy donors. In this randomized, double-blind, parallel-group, multicenter study, patients with active rheumatoid arthritis were randomized 1:1 to AZD9567 40 mg or prednisolone 20 mg once daily orally for 14 days. The primary end point was change from baseline in DAS28-CRP at day 15. Secondary end points included components of DAS28-CRP, American College of Rheumatology (ACR) response criteria (ACR20, ACR50, and ACR70), and safety end points, including serum electrolytes. Overall, 21 patients were randomized to AZD9567 (n = 11) or prednisolone (n = 10), and all completed the study. As anticipated, AZD9567 had a similar efficacy profile to prednisolone, with no clinically meaningful (i.e., >1.0) difference in change from baseline to day 15 in DAS28-CRP between AZD9567 and prednisolone (least-squares mean difference: 0.47, 95% confidence interval: -0.49 to 1.43). Similar results were observed for the secondary efficacy end points. In vitro transcriptomic analysis showed that anti-inflammatory responses were similar for AZD9567, prednisolone, and dexamethasone. Unlike prednisolone, AZD9567 had no effect on the serum sodium:potassium ratio. The safety profile was not different from that of prednisolone. Larger studies of longer duration are required to determine whether AZD9567 40 mg may in the future be an alternative to prednisolone in patients with inflammatory disease., (© 2023 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)

Published
2023
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45. Validation of a diagnosis-agnostic symptom questionnaire for asthma and/or COPD.

Author

Karlsson N, Atkinson MJ, Müllerová H, Alacqua M, Keen C, Hughes R, Janson C, Make B, Price D, and Reddel HK

Abstract

Background: The Respiratory Symptoms Questionnaire (RSQ) is a novel, four-item patient-reported diagnosis-agnostic tool designed to assess the frequency of respiratory symptoms and their impact on activity, without specifying a particular diagnosis. Our objective was to examine its validity in patients with asthma and/or chronic obstructive pulmonary disease (COPD)., Methods: Baseline data were randomly sampled from patients who completed the RSQ in the NOVELTY study (ClinicalTrials.gov: NCT02760329). The total sample (n=1530) comprised three randomly selected samples (n=510 each) from each physician-assigned diagnostic group (asthma, asthma+COPD and COPD). The internal consistency and structural validity of the RSQ were evaluated using exploratory and confirmatory factor analyses; psychometric performance was observed using Classical Test Theory and Item Response Theory analyses., Results: For the total sample, the mean±sd RSQ score was 5.6±4.3 (range 0-16). Irrespective of diagnosis, the internal consistency of items was uniformly adequate (Cronbach's α=0.76-0.80). All items had high factor loadings and structural characteristics of the measure were invariant across groups. Using the total sample, RSQ items informatively covered the θ score range of -2.0 to 2.8, with discrimination coefficients for individual items being high to very high (1.7-2.6). Strong convergent correlations were observed between the RSQ and the St George's Respiratory Questionnaire (0.77, p<0.001)., Conclusions: The RSQ is a valid, brief, patient-reported tool for assessing respiratory symptoms in patients across the whole spectrum of asthma and/or COPD, rather than using different questionnaires for each diagnosis. It can be used for monitoring respiratory symptoms in clinical practice, clinical trials and real-world studies., Competing Interests: Conflict of interest: N. Karlsson is an employee of AstraZeneca. Conflict of interest: M.J. Atkinson reports payment as an independent consultant to Evidera for activities contracted by AstraZeneca associated with the psychometric evaluation of the Respiratory Symptoms Questionnaire; he has provided analytic direction and unbiased interpretation of the RSQ findings. Conflict of interest: H. Müllerová is an employee of AstraZeneca. Conflict of interest: M. Alacqua is an employee of AstraZeneca. Conflict of interest: C. Keen is an employee of AstraZeneca. Conflict of interest: R. Hughes is an employee of AstraZeneca. Conflict of interest: C. Janson reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis and Teva Pharmaceuticals, outside the submitted work. Conflict of interest: B. Make reports grants (with funds provided to, and controlled by, National Jewish Health) from AstraZeneca, GlaxoSmithKline, National Heart, Lung, and Blood Institute, Pearl Research and Sunovion; personal fees from Takeda and Third Pole; nonfinancial support from AstraZeneca, Circassia, GlaxoSmithKline, Phillips, Shire, Spiration, Sunovion and Third Pole; and other support from Academy Continued Health Care Learning, American College of Chest Physicians, AstraZeneca, Boehringer Ingelheim, Catamount Medical, Circassia, Eastern Pulmonary Society, Eastern VA Medical Center, GlaxoSmithKline, Hybrid Communications, Medscape, Mount Sinai Medical Center, National Jewish Health, Novartis, Phillips, Projects in Knowledge, Science 24/7, Shire, Sunovion, Theravance, Ultimate Medical Academy, Verona, WebMD and Wolters Kluwer Health, all outside the submitted work. Conflict of interest: D. Price received funding for the conduct of this study from AstraZeneca and discloses board membership with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mundipharma, Mylan, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals and Thermofisher; consultancy agreements with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mundipharma, Mylan, Novartis, Pfizer, Teva Pharmaceuticals and Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mundipharma, Mylan, Novartis, Pfizer, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance and the UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mundipharma, Mylan, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme and Teva Pharmaceuticals; payment for the development of educational materials from Mundipharma and Novartis; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis and Thermofisher; funding for patient enrolment or completion of research from Novartis; stock/stock options from AKL Research and Development Ltd, which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp, which develops adherence monitoring technology; is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. Conflict of interest: H.K. Reddel reports that this study is funded by AstraZeneca. She received reimbursement from AstraZeneca for time spent working on the study but not for manuscript preparation. She also reports advisory boards for AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis and Sanofi-Genzyme; data and safety monitoring boards for AstraZeneca, GlaxoSmithKline, Merck and Novartis; honoraria from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Teva Pharmaceuticals for independent medical educational presentations; and independent research funding from AstraZeneca, GlaxoSmithKline and Novartis, all outside the submitted work., (Copyright ©ERS 2021.)

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2021
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