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1. Long-term safety and efficacy of tezepelumab in people with severe, uncontrolled asthma (DESTINATION): a randomised, placebo-controlled extension study

Author

Hetzel, Jorge Lima, Fiterman, Jussara, Souza Machado, Adelmir, Antila, Martti Anton, Lima, Marina Andrade, Minamoto, Suzana Erico Tanni, Blanco, Daniela Cavalet, Bezerra, Patricia Gomes de Matos, Houle, Pierre-Alain, Lemiere, Catherine, Melenka, Lyle S, Leigh, Richard, Mitchell, Patrick, Anees, Syed, Pek, Bonavuth, Chouinard, Guy, Cheema, Amarjit S, Yang, William Ho-Ching, Philteos, George, Chanez, Pascal, Bourdin, Arnaud, Devouassoux, Gilles, Taille, Camille, De Blay, Frédéric, Leroyer, Christophe, Beurnier, Antoine, Garcia, Gilles, Girodet, Pierre-Olivier, Blanc, François-Xavier, Magnan, Antoine, Wanin, Stéphanie, Just, Jocelyne, Linde, Richard, Zielen, Stefan, Förster, Karin, Geßner, Christian, Jandl, Margret, Buhl, Roland Otto, Korn, Stephanie, Kornmann, Marc Oliver, Linnhoff, Anneliese, Ludwig-Sengpiel, Andrea, Ehlers, Martin, Schmoller, Tibor, Steffen, Heiner, Hoffmann, Martin, Kirschner, Joachim, Schmidt, Olaf, Welte, Tobias, Temme, Hilke, Wand, Ori, Bar-Shai, Amir, Izbicki, Gabriel, Berkman, Neville, Fink, Gershon, Shitrit, David, Adir, Yochai, Kuna, Piotr, Rewerska, Barbara, Pisarczyk-Bogacka, Ewa, Kurbacheva, Oksana, Mikhailov, Sergey L, Vasilev, Maksim, Emelyanov, Alexander, Wali, Siraj, Albanna, Amr, van Zyl-Smit, Richard, Abdullah, Ismail, Bernhardi, David, Hoosen, Farzana, Irusen, Elvis, Kalla, Ismail, Lakha, Deepak, Mitha, Essack, Naidoo, Visvakuren, Nell, Haylene, Padayachee, Trevenesan, Reddy, Jeevren, Petrick, Friedrich, van der Walt, Eugene, Vawda, Zubar Fazal Ahmed, Park, Hae-Sim, Lee, Sang Haak, Kim, Mi-Kyeong, Park, Jung-Won, Cho, You Sook, Lee, Byung Jae, Chang, Yoon-Seok, Park, Choon-Sik, Lee, Kwan Ho, Lee, Sook Young, Yoon, HyoungKyu, Sohn, Kyoung Hee, Park, Myung Jae, Min, Kyung Hoon, Cho, Young Joo, Park, Han Ki, Lee, YongChul, Lee, Jaechun, Sheu, Chau-Chyun, Tu, Chih-Yen, Lee, Kang-Yun, Bavbek, Sevim, Gemicioglu, Bilun, Ediger, Dane, Kalkan, Ilkay Koca, Makieieva, Nataliia, Ostrovskyy, Mykola, Dytyatkovs'ka, Yevgeniya, Mostovoy, Yuriy Mykhaylovych, Lebed, Kyrylo, Yakovenko, Oleh, Adams, Atoya, Mooring, Timothy, Torres Jr, Louis, Sexton, Marvin, Thompson, Ernest, Bernstein, Jonathan A, Lisi, Paul, Chappel, Christopher M, Cole, Jeremy, Greenwald, Gary I, Jones, Conigliaro, Klein, Ryan Mitchell, Pham, David N, Spangenthal, Selwyn, Weinstein, Steven F, Windom, Hugh H, Kao, Neil L, Leong, Mila A, Mehta, Vinay, Moore, Wendy C, Bhat, Saligrama, Aish, Bassil, Meltzer, Steven M, Corren, Jonathan, Moss, Mark H, Kerwin, Edward M, Delgado, John Palsted, Lucksinger, Gregg Hudson, Thompson, Charles A, Chupp, Geoffrey, Alpizar, Sady A, Vadgama, Sanjay Virgi, Zafar, Zahid, Jacobs, Joshua S, Lugogo, NJira, Jain, Neal, Sher, Lawrence D, Andrawis, Nabil S, Fuentes, David, Boren, Eric Jason, Gonzalez, Erika G, Talreja, Neetu, Durrani, Sheharyar Sandy, Israel, Elliot, Sekhsaria, Sudhir, DeLeon, Samuel, Shukla, Mayank, Totszollosy Tarpay, Martha M, Fakih, Faisal, Hudes, Golda, Tillinghast, Jeffrey P, Korenblat, Phillip E, Shenoy, Kartik, Que, Loretta, Kureishy, Shahrukh Ahmad, Umeh, Fred Chukwuemeka, Nguyen, Vinh Nhu, Chu, Hanh Thi, Nguyen, Thuy Thi Dieu, Menzies-Gow, Andrew, Wechsler, Michael E, Brightling, Christopher E, Bednarczyk, Artur, Ponnarambil, Sandhia, Caveney, Scott, Almqvist, Gun, Gołąbek, Monika, Simonsson, Linda, Lawson, Kaitlyn, Bowen, Karin, and Colice, Gene

Published
2023
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2. Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2): results of a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Garibaldi, Brian T., Albertson, Timothy E., Sandrock, Christian, Lee, Janet S., Looney, Mark R., Tapson, Victor F., Wiysonge, Charles Shey, Velarde, Luis Humberto Anaya, Backenroth, Daniel, Bhushanan, Jisha, Brandenburg, Börries, Cárdenas, Vicky, Chen, Bohang, Chen, Fei, Chetty, Polan, Chu, Pei-Ling, Cooper, Kimberly, Custers, Jerome, Delanghe, Hilde, Duca, Anna, Henrick, Tracy, Juraszek, Jarek, Nalpas, Catherine, Peeters, Monika, Pinheiro, Jose, Roels, Sanne, Ryser, Martin F., Salas, Jose, Santoro Matias, Samantha, Scheys, Ilse, Shetty, Pallavi, Shukarev, Georgi, Stoddard, Jeffrey, Talloen, Willem, Tran, NamPhuong, Vaissiere, Nathalie, van Son-Palmen, Elisabeth, Xu, Jiajun, Goecker, Erin A., Greninger, Alexander L., Jerome, Keith R., Roychoudhury, Pavitra, Takuva, Simbarashe G., Accini Mendoza, Jose Luis, Achtyes, Eric, Ahsan, Habibul, Alhatemi, Azhar, Allen, Nancy, Arribas, Jose R., Bahrami, Ghazaleh, Bailon, Lucia, Bajwa, Ali, Baker, Jonathan, Baron, Mira, Benet, Susana, Berdaï, Driss, Berger, Patrick, Bertoch, Todd, Bethune, Claire, Bevilacqua, Sybille, Biagioni Santos, Maria Silvia, Binnian, Ian, Bisnauthsing, Karen, Boivin, Jean-Marc, Bollen, Hilde, Bonnet, Sandrine, Borobia, Alberto M., Botelho-Nevers, Elisabeth, Bright, Phil, Britten, Vianne, Brown, Claire, Buadi, Amanda, Buntinx, Erik, Burgess, Lesley, Bush, Larry, Capeding, Maria Rosario, Carr, Quito Osuna, Carrasco Mas, Amparo, Catala, Hélène, Cathie, Katrina, Caudill, T. Shawn, Cereto Castro, Fernando, Chau, Kénora, Chavoustie, Steven, Chowdhury, Marie, Chronos, Nicolas, Cicconi, Paola, Cifuentes, Liliana, Cobo, Sara Maria, Collins, Helen, Colton, Hayley, Cuaño, Carlos Rolando G., D'Onofrio, Valentino, Dargan, Paul, Darton, Thomas, Deane, Peter, Del Pozo, Jose Luis, Derdelinckx, Inge, Desai, Amisha, Dever, Michael, Díaz-Pollán, Beatriz, DiBuono, Mark, Doust, Matthew, Duncan, Christopher, Echave-Sustaeta, Jose Maria, Eder, Frank, Ellis, Kimberly, Elzi, Stanton, Emmett, Stevan, Engelbrecht, Johannes, Evans, Mim, Farah, Theo, Felton, Timothy, Ferreira, João Pedro, Floutier, Catherine, Flume, Patrick, Ford, Stacy, Fragoso, Veronica, Freedman, Andrew, Frentiu, Emilia, Galloway, Christopher, Galtier, Florence, Garcia Diaz, Julia, García García, Irene, Garcia, Alcaide, Gardener, Zoe, Gauteul, Pascale, Geller, Steven, Gibson, Andrew, Gillet, Claudia, Girerd, Nicolas, Girodet, Pierre-Olivier, Gler, Maria Tarcela, Glover, Richard, Go, Herschel Don D., Gokani, Karishma, Gonthier, Damien, Green, Christopher, Greenberg, Richard, Griffin, Carl, Grobbelaar, Coert, Guancia, Adonis, Hakkarainen, Gloria, Harris, James, Hassman, Michael, Heimer, Deirdre, Hellstrom-Louw, Elizabeth, Herades, Yoan, Holroyd, Christopher, Hussen, Nazreen, Isidro, Marie Grace Dawn, Jackson, Yvonne, Jain, Manish, João Filho, Esaú Custódio, Johnson, Daniel, Jones, Ben, Joseph, Natasha, Jumeras, Analyn, Junquera, Patricia, Kellett-Wright, Johanna, Kennedy, Patrick, Kilgore, Paul E., Kim, Kenneth, Kimmel, Murray, Konis, George, Kutner, Mark, Lacombe, Karine, Launay, Odile, Lazarus, Rajeka, Lederman, Samuel, Lefebvre, Gigi, Lennon Collins, Katrina, Leroux-Roels, Isabel, Lim, Kenneth Wilson O., Lins, Muriel, Liu, Edward, Llewelyn, Martin, Mahomed, Akbar, Maia, Bernardo Porto, Marín-Candon, Alícia, Martínez-Gómez, Xavier, Martinot, Jean Benoit, Mazzella, Andrea, McCaughan, Frank, McCormack, Louise, McGettigan, John, Mehra, Purvi, Mejeur, Rhonda, Miller, Vicki, Mills, Anthony, Molto Marhuenda, Jose, Moodley, Prebashan, Mora-Rillo, Marta, Mothe, Beatriz, Mullan, Daniel, Munro, Alasdair, Myers, Paul, Nell, Jeremy, Newman Lobato Souza, Tamara, O'Halloran, Jane A., Ochoa Mazarro, Maria Dolores, Oliver, Abigail, Onate Gutierrez, Jose Millan, Ortega, Jessica, Oshita, Masaru, Otero Romero, Susana, Overcash, Jeffrey Scott, Owens, Daniel, Packham, Alice, Pacurar, Mihaela, Paiva de Sousa, Leonardo, Palfreeman, Adrian, Pallares, Christian José, Patel, Rahul, Patel, Suchet, Pelkey, Leslie, Peluso, Denise, Penciu, Florentina, Pinto, S. Jerry, Pounds, Kevin, Pouzar, Joe, Pragalos, Antoinette, Presti, Rachel, Price, David, Qureshi, Ehsaan, Ramalho Madruga, José Valdez, Ramesh, Mayur, Rankin, Bruce, Razat, Béatrice, Riegel Santos, Breno, Riesenberg, Robert, Riffer, Ernie, Roche, Siobhan, Rose, Katie, Rosellini, Pietro, Rossignol, Patrick, Safirstein, Beth, Salazar, Hernan, Sanchez Vallejo, Gregorio, Santhosh, Smrithi, Seco-Meseguer, Enrique, Seep, Michael, Sherry, Emma, Short, Philip, Soentjens, Patrick, Solis, Joel, Soriano Viladomiu, Alejandro, Sorli, Caroline, Spangenthal, Selwyn, Spence, Niamh, Stephenson, Elaine, Strout, Cynthia, Surowitz, Ronald, Taladua, Kristy Michelle, Tellalian, David, Thalamas, Claire, Thiriphoo, Nang, Thomas, Judith, Thomas, Nicholas, Trout, Guillermo, Urroz, Mikel, Veekmans, Bernard, Veekmans, Laurent, Villalobos, Ralph Elvi M., Warren, Sarah, Webster, Brian, White, Alexander, Williams, Gail, Williams, Hayes, Wilson, Barbara, Winston, Alan, Wiselka, Martin, Zervos, Marcus, Hardt, Karin, Vandebosch, An, Sadoff, Jerald, Le Gars, Mathieu, Truyers, Carla, Lowson, David, Van Dromme, Ilse, Vingerhoets, Johan, Kamphuis, Tobias, Scheper, Gert, Ruiz-Guiñazú, Javier, Faust, Saul N, Spinner, Christoph D, Schuitemaker, Hanneke, Van Hoof, Johan, Douoguih, Macaya, and Struyf, Frank

Published
2022
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3. Non-typeable Haemophilus influenzae–Moraxella catarrhalis vaccine for the prevention of exacerbations in chronic obstructive pulmonary disease: a multicentre, randomised, placebo-controlled, observer-blinded, proof-of-concept, phase 2b trial

Author

Brusselle, Guy, Corhay, Jean-Louis, Janssens, Eduard, Janssens, Wim, Leys, Mathias, Ferguson, Murdo, Fitzgerald, Mark, Maltais, François, Mayers, Irvin, McNeil, Shelly, Pek, Bonavuth, Bourdin, Arnaud, Boyer, Laurent, Couturaud, Francis, Dussart, Luc, Andreas, Stefan, Illies, Gabriele, Eich, Andreas, Ludwig-Sengpiel, Andrea, Watz, Henrik, Blasi, Francesco, Centanni, Stefano, Papi, Alberto, Pomari, Carlo, Echave-Sustaeta, José Maria, Llorca Martínez, Eleuterio, Narejos Pérez, Silvia, Pascual-Guardia, Sergi, Pérez Vera, Mercè, Puente-Maestu, Luis, Terns Riera, Manuel, Anderson, William, Choudhury, Gourab, De-Soyza, Anthony, Saralaya, Dinesh, Wilkinson, Tom MA, Boscia III, Joseph, Chinsky, Kenneth, Dunn, Leonard, Erb, David, Fogarty, Charles, Downey, Herman Jackson, Kerwin, Edward, Kunz, Craig, Poling, Terry, Sellman, Richard, Sigal, Barry, Southard, John, Spangenthal, Selwyn, Tannous, Ziad, Testa, Marco, Casula, Daniela, Di Maro, Gennaro, Lattanzi, Maria, Moraschini, Luca, Schoonbroodt, Sonia, Tasciotti, Annaelisa, Arora, Ashwani K, and Wilkinson, Tom M A

Published
2022
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4. Onset of effect and impact on health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms for patients with severe eosinophilic asthma treated with benralizumab (ANDHI): a randomised, controlled, phase 3b trial

Author

Pohl, Wolfgang, Voves, Robert, Deschampheleire, Maud, Louis, Renaud, Martinot, Jean-Benoit, Peché, Rudi, Chapman, Kenneth, Cheema, Amarjit, Dorscheid, Delbert, FitzGerald, J. Mark, Gagnon, Remi, Killorn, William Patrick, Olivenstein, Ronald, Philteos, George, Ramsey, Clare, Rolf, J. Douglass, Walker, Brandie, Hilberg, Ole, Skjold, Tina, Titlestad, Ingrid, Hakulinen, Auli, Kilpeläinen, Maritta, Ben Hayoun, Michèle, Bonniaud, Philippe, Bourdin, Arnaud, Chanez, Pascal, De Blay, Frédéric, Deslee, Gaëtan, Devouassoux, Gilles, Didier, Alain, Douadi, Youcef, Fry, Stéphanie, Garcia, Gilles, Girodet, Pierre-Olivier, Leroyer, Christophe, Magnan, Antoine, Mahay, Guillaume, Nocent, Cécilia, Pison, Christophe, Roux, Pauline-Marie, Taillé, Camille, Tiotiu, Juliana-Angelica, Beck, Ekkehard, Jandl, Margret, Kaehler, Christian, Kässner, Frank, Koesters, Frank, Kronsbein, Juliane, Schaum, Thomas, Schulz, Christian, Skowasch, Dirk, Taube, Christian, Welte, Tobias, de Roux, Andrés, Beghé, Bianca, Blasi, Francesco, Canonica, Giorgio Walter, Carpagnano, Giovanna, Caruso, Cristiano, Corsico, Angelo Guido, Constantino, Elio, Crimi, Nunzio, Maestrelli, Piero, Menzella, Francesco, Milanese, Manlio, Papi, Alberto, Pelaia, Girolamo, Pini, Laura, Santus, Pierachille, Savi, Eleonora, Scichilone, Nicola, Senna, Gianenrico, Spadaro, Giuseppe, Vaghi, Adriano, Gans, Steven, Hölters, Jurgen, Langeveld, B., Pieters, Willem, Staaks, G.H.A., van Veen, Ilonka, van den Berg, J.W.K., Einvik, Gunnar, Lehmann, Sverre, Ali García, Ismael, Almonacid, Carlos, Bobolea, Irina, Campo Mozo, Paloma, de Luiz, Gustavo, Domingo Ribas, Christian, Echave-Sustaeta María-Tomé, José María, García Rivero, Juan Luis, García-Cosío Piqueras, Borja, Gómez-Bastero Fernández, Ana, González Pérez, Ruperto, Henríquez Santa, Aythamy, Martínez Rivera, Carlos, Muñoz Gall, Xavier, Ramos, Jacinto, Gregorio Soto Campos, Jose, Vidal Pan, Carmen, Stenfors, Nikolai, Tunsäter, Alf, Vinge, Ines, Chaudhuri, Rekha, Harrison, Timothy, Mansur, Adel, Nasser, Shuaib, Nordstrom, Monica, Pfeffer, Paul, Saralaya, Dinesh, Short, Philip, Adlakha, Arun, Alpan, Oral, Averill, Francis, Badhwar, Anil, Bardelas, Jose, Baxter, Barbara, Bensch, George, Berger, William, Bernstein, Jonathan, Bridges, Tracy, Brimeyer, Ryan, Calhoun, William, Campbell, Edward, Cherry, William Brett, Chupp, Geoffrey, Clore, Lee, Cohn, John, Cole, Jeremy, Condemi, John, Cury, James, Davis, Benjamin, DeLeon, Samuel, Delacruz, Luis, Diaz, Joseph, Erb, David, Eziri, Emeka, Fakih, Faisal, Fiedler, Douglas, Fost, David, Fritz, Stephen, Gonzalez, Erika, Goodman, Brad, Gottlieb, Peter, Gottschlich, Gregory, Gower, Richard, Hajal, Rizan, Harris, James, Heidarian-Raissy, Hengameh, Heyder, Albrecht, Hill, David, Holguin, Fernando, Hussain, Iftikhar, Illowite, Jonathan, Jacobs, Joshua, Jarratt, Mikell, Kaiser, Harold, Kao, Neil, Kashyap, Ravindra, Kaufman, David, Kent, Edward, Kim, Kenneth, Klein, Ryan, Kraft, Monica, Kono, Ritsu, Kureishy, Shahrukh, Leflein, Jeffrey, Leong, Mila, Li, Huamin, Lin, Robert, Lugogo, Njira, Marcus, Michael, Maselli Caceres, Diego Jose, Mehta, Vinay, Mello, Curtis, Millard, Mark, Milstone, Aaron, Mohan, Arjun, Moore, Wendy, Moss, Mark, Mumneh, Nayla, O'Brien, Thomas, Ostransky, David, Palumbo, Michael, Parikh, Purvi, Parikh, Sudhir, Patel, Amit, Perez, Guido, Pleskow, Warren, Prenner, Bruce, Puppala, Dileep, Ramey, John, Reibman, Joan, Reyes, Ramon, Robinette, Emory, Rodicio, Ileana, Ryan, Stephen, Sekhsaria, Sudhir, Sigal, Barry, Sikand, Vinay, Soong, Weily, Spangenthal, Selwyn, St. John, Roy, Steven, Gary, Subramaniam, Vijay, Sumino, Kaharu, Sztejman, Eric, Tan, Ricardo A., Tanus, Tonny, Thompson, Charles, Thornblade, Carl, Villareal, Manuel, Wenzel, Sally, Zafra, Heidi, Ziedalski, Tomasz, Harrison, Tim W, Cosio, Borja G, Lugogo, Njira L, Burden, Annie, McDermott, Lawrence, Garcia Gil, Esther, and Zangrilli, James G

Published
2021
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5. Gefapixant, a P2X3 receptor antagonist, for the treatment of refractory or unexplained chronic cough: a randomised, double-blind, controlled, parallel-group, phase 2b trial

Author

Smith, Jaclyn, McGarvey, Lorcan, Birring, Surinder, Hull, James, Carr, Warner W, Goldsobel, Alan B, Gross, Gary N, Holcomb, John R, Hussain, Iftikhar, Sher, Mandel, Spangenthal, Selwyn, Storms, William, Morice, Alyn, Elkayam, David, Steven, Gary C, Krainson, James, Fakih, Faisal Alfonso, Matz, Jonathan, Brooks, Gregory Daniel, Casale, Thomas, Berman, Gary D, Condemi, John J, Greos, Leon S, Gogate, Shaila U, Sher, Ellen R, Friesen, Jason H, Schenkel, Eric J, Bernstein, David Isaac, Corren, Jonathan, Sundar, Krishna, Gotfried, Mark H, Montanaro, Anthony, Lumry, William R, Amar, Niran J, Kaplan, Michael S, Prenner, Bruce M, Murphy, Thomas R, Good, James S, Parker, Sean, Harrison, Tim, Pavord, Ian, Brightling, Christopher, Djukanovic, Ratko, McQuaid, Douglas, Denenberg, Michael, Ettinger, Neil A, Iyer, Vivek, Smith, Jaclyn A, Kitt, Michael M, Morice, Alyn H, Birring, Surinder S, McGarvey, Lorcan P, Sher, Mandel R, Li, Yu-Ping, Wu, Wen-Chi, Xu, Zhi Jin, Muccino, David R, and Ford, Anthony P

Published
2020
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7. Benralizumab for patients with mild to moderate, persistent asthma (BISE): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Chouinard, Guy, FitzGerald, J Mark, Rostami, Maryam, Oosthuizen, Jean, Pek, Bonavuth, Patel, Deepen, Houle, Pierre-Alain, Laviolette, Michel, Khattak, Sohail, Killorn, Patrick, Keller, Claus, Schenkenberger, Isabelle, Zielen, Stefan, Ballenberger, Sabine, Hoffmann, Martin, Kirschner, Joachim, Papp, Márta, Kecskés, Teréz, Póczi, Magdolna, Molnár, Lajos, Radeczky, Éva, Schlezák, Judit, Springer, Ewa, Balicka, Violetta, Kaczmarek, Jadwiga, Madra-Rogacka, Danuta, Pisarczyk-Bogacka, Ewa, Zurowska-Gebala, Malgorzata, Marczak, Maciej, Napora, Piotr, Pomiecko, Witold, Pribulova, Erika, Kurthova, Svetlana, Drugdova, Maria, Kavkova, Denisa, Frajtova, Luboslava, Golubov, Alexander, Paulinyova, Dagmar, Hasicova, Daniela, Michalickova, Miriam, Trevino, Miguel, Campbell, Charles, Wachtel, Andrew, Bleecker, Eugene, LaForce, Craig, Bernstein, David, Spangenthal, Selwyn, Kerwin, Edward, Mansfield, Lyndon, Ratner, Paul, Arora, Samir, Feldman, Gregory, Okwara, Benedict, Cruz, Humberto, Sher, Lawrence, Pedinoff, Andrew, Corder, Clinton, Ferguson, Gary T, Bleecker, Eugene R, Barker, Peter, Wu, Yanping, Jison, Maria, and Goldman, Mitchell

Published
2017
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9. Long-term safety and efficacy of tezepelumab in people with severe, uncontrolled asthma (DESTINATION): a randomised, placebo-controlled extension study

Author

Menzies-Gow, Andrew, primary, Wechsler, Michael E, additional, Brightling, Christopher E, additional, Korn, Stephanie, additional, Corren, Jonathan, additional, Israel, Elliot, additional, Chupp, Geoffrey, additional, Bednarczyk, Artur, additional, Ponnarambil, Sandhia, additional, Caveney, Scott, additional, Almqvist, Gun, additional, Gołąbek, Monika, additional, Simonsson, Linda, additional, Lawson, Kaitlyn, additional, Bowen, Karin, additional, Colice, Gene, additional, Hetzel, Jorge Lima, additional, Fiterman, Jussara, additional, Souza Machado, Adelmir, additional, Antila, Martti Anton, additional, Lima, Marina Andrade, additional, Minamoto, Suzana Erico Tanni, additional, Blanco, Daniela Cavalet, additional, Bezerra, Patricia Gomes de Matos, additional, Houle, Pierre-Alain, additional, Lemiere, Catherine, additional, Melenka, Lyle S, additional, Leigh, Richard, additional, Mitchell, Patrick, additional, Anees, Syed, additional, Pek, Bonavuth, additional, Chouinard, Guy, additional, Cheema, Amarjit S, additional, Yang, William Ho-Ching, additional, Philteos, George, additional, Chanez, Pascal, additional, Bourdin, Arnaud, additional, Devouassoux, Gilles, additional, Taille, Camille, additional, De Blay, Frédéric, additional, Leroyer, Christophe, additional, Beurnier, Antoine, additional, Garcia, Gilles, additional, Girodet, Pierre-Olivier, additional, Blanc, François-Xavier, additional, Magnan, Antoine, additional, Wanin, Stéphanie, additional, Just, Jocelyne, additional, Linde, Richard, additional, Zielen, Stefan, additional, Förster, Karin, additional, Geßner, Christian, additional, Jandl, Margret, additional, Buhl, Roland Otto, additional, Kornmann, Marc Oliver, additional, Linnhoff, Anneliese, additional, Ludwig-Sengpiel, Andrea, additional, Ehlers, Martin, additional, Schmoller, Tibor, additional, Steffen, Heiner, additional, Hoffmann, Martin, additional, Kirschner, Joachim, additional, Schmidt, Olaf, additional, Welte, Tobias, additional, Temme, Hilke, additional, Wand, Ori, additional, Bar-Shai, Amir, additional, Izbicki, Gabriel, additional, Berkman, Neville, additional, Fink, Gershon, additional, Shitrit, David, additional, Adir, Yochai, additional, Kuna, Piotr, additional, Rewerska, Barbara, additional, Pisarczyk-Bogacka, Ewa, additional, Kurbacheva, Oksana, additional, Mikhailov, Sergey L, additional, Vasilev, Maksim, additional, Emelyanov, Alexander, additional, Wali, Siraj, additional, Albanna, Amr, additional, van Zyl-Smit, Richard, additional, Abdullah, Ismail, additional, Bernhardi, David, additional, Hoosen, Farzana, additional, Irusen, Elvis, additional, Kalla, Ismail, additional, Lakha, Deepak, additional, Mitha, Essack, additional, Naidoo, Visvakuren, additional, Nell, Haylene, additional, Padayachee, Trevenesan, additional, Reddy, Jeevren, additional, Petrick, Friedrich, additional, van der Walt, Eugene, additional, Vawda, Zubar Fazal Ahmed, additional, Park, Hae-Sim, additional, Lee, Sang Haak, additional, Kim, Mi-Kyeong, additional, Park, Jung-Won, additional, Cho, You Sook, additional, Lee, Byung Jae, additional, Chang, Yoon-Seok, additional, Park, Choon-Sik, additional, Lee, Kwan Ho, additional, Lee, Sook Young, additional, Yoon, HyoungKyu, additional, Sohn, Kyoung Hee, additional, Park, Myung Jae, additional, Min, Kyung Hoon, additional, Cho, Young Joo, additional, Park, Han Ki, additional, Lee, YongChul, additional, Lee, Jaechun, additional, Sheu, Chau-Chyun, additional, Tu, Chih-Yen, additional, Lee, Kang-Yun, additional, Bavbek, Sevim, additional, Gemicioglu, Bilun, additional, Ediger, Dane, additional, Kalkan, Ilkay Koca, additional, Makieieva, Nataliia, additional, Ostrovskyy, Mykola, additional, Dytyatkovs'ka, Yevgeniya, additional, Mostovoy, Yuriy Mykhaylovych, additional, Lebed, Kyrylo, additional, Yakovenko, Oleh, additional, Adams, Atoya, additional, Mooring, Timothy, additional, Torres Jr, Louis, additional, Sexton, Marvin, additional, Thompson, Ernest, additional, Bernstein, Jonathan A, additional, Lisi, Paul, additional, Chappel, Christopher M, additional, Cole, Jeremy, additional, Greenwald, Gary I, additional, Jones, Conigliaro, additional, Klein, Ryan Mitchell, additional, Pham, David N, additional, Spangenthal, Selwyn, additional, Weinstein, Steven F, additional, Windom, Hugh H, additional, Kao, Neil L, additional, Leong, Mila A, additional, Mehta, Vinay, additional, Moore, Wendy C, additional, Bhat, Saligrama, additional, Aish, Bassil, additional, Meltzer, Steven M, additional, Moss, Mark H, additional, Kerwin, Edward M, additional, Delgado, John Palsted, additional, Lucksinger, Gregg Hudson, additional, Thompson, Charles A, additional, Alpizar, Sady A, additional, Vadgama, Sanjay Virgi, additional, Zafar, Zahid, additional, Jacobs, Joshua S, additional, Lugogo, NJira, additional, Jain, Neal, additional, Sher, Lawrence D, additional, Andrawis, Nabil S, additional, Fuentes, David, additional, Boren, Eric Jason, additional, Gonzalez, Erika G, additional, Talreja, Neetu, additional, Durrani, Sheharyar Sandy, additional, Sekhsaria, Sudhir, additional, DeLeon, Samuel, additional, Shukla, Mayank, additional, Totszollosy Tarpay, Martha M, additional, Fakih, Faisal, additional, Hudes, Golda, additional, Tillinghast, Jeffrey P, additional, Korenblat, Phillip E, additional, Shenoy, Kartik, additional, Que, Loretta, additional, Kureishy, Shahrukh Ahmad, additional, Umeh, Fred Chukwuemeka, additional, Nguyen, Vinh Nhu, additional, Chu, Hanh Thi, additional, and Nguyen, Thuy Thi Dieu, additional

Published
2023
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10. Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2): results of a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Hardt, Karin, primary, Vandebosch, An, additional, Sadoff, Jerald, additional, Le Gars, Mathieu, additional, Truyers, Carla, additional, Lowson, David, additional, Van Dromme, Ilse, additional, Vingerhoets, Johan, additional, Kamphuis, Tobias, additional, Scheper, Gert, additional, Ruiz-Guiñazú, Javier, additional, Faust, Saul N, additional, Spinner, Christoph D, additional, Schuitemaker, Hanneke, additional, Van Hoof, Johan, additional, Douoguih, Macaya, additional, Struyf, Frank, additional, Garibaldi, Brian T., additional, Albertson, Timothy E., additional, Sandrock, Christian, additional, Lee, Janet S., additional, Looney, Mark R., additional, Tapson, Victor F., additional, Wiysonge, Charles Shey, additional, Velarde, Luis Humberto Anaya, additional, Backenroth, Daniel, additional, Bhushanan, Jisha, additional, Brandenburg, Börries, additional, Cárdenas, Vicky, additional, Chen, Bohang, additional, Chen, Fei, additional, Chetty, Polan, additional, Chu, Pei-Ling, additional, Cooper, Kimberly, additional, Custers, Jerome, additional, Delanghe, Hilde, additional, Duca, Anna, additional, Henrick, Tracy, additional, Juraszek, Jarek, additional, Nalpas, Catherine, additional, Peeters, Monika, additional, Pinheiro, Jose, additional, Roels, Sanne, additional, Ryser, Martin F., additional, Salas, Jose, additional, Santoro Matias, Samantha, additional, Scheys, Ilse, additional, Shetty, Pallavi, additional, Shukarev, Georgi, additional, Stoddard, Jeffrey, additional, Talloen, Willem, additional, Tran, NamPhuong, additional, Vaissiere, Nathalie, additional, van Son-Palmen, Elisabeth, additional, Xu, Jiajun, additional, Goecker, Erin A., additional, Greninger, Alexander L., additional, Jerome, Keith R., additional, Roychoudhury, Pavitra, additional, Takuva, Simbarashe G., additional, Accini Mendoza, Jose Luis, additional, Achtyes, Eric, additional, Ahsan, Habibul, additional, Alhatemi, Azhar, additional, Allen, Nancy, additional, Arribas, Jose R., additional, Bahrami, Ghazaleh, additional, Bailon, Lucia, additional, Bajwa, Ali, additional, Baker, Jonathan, additional, Baron, Mira, additional, Benet, Susana, additional, Berdaï, Driss, additional, Berger, Patrick, additional, Bertoch, Todd, additional, Bethune, Claire, additional, Bevilacqua, Sybille, additional, Biagioni Santos, Maria Silvia, additional, Binnian, Ian, additional, Bisnauthsing, Karen, additional, Boivin, Jean-Marc, additional, Bollen, Hilde, additional, Bonnet, Sandrine, additional, Borobia, Alberto M., additional, Botelho-Nevers, Elisabeth, additional, Bright, Phil, additional, Britten, Vianne, additional, Brown, Claire, additional, Buadi, Amanda, additional, Buntinx, Erik, additional, Burgess, Lesley, additional, Bush, Larry, additional, Capeding, Maria Rosario, additional, Carr, Quito Osuna, additional, Carrasco Mas, Amparo, additional, Catala, Hélène, additional, Cathie, Katrina, additional, Caudill, T. Shawn, additional, Cereto Castro, Fernando, additional, Chau, Kénora, additional, Chavoustie, Steven, additional, Chowdhury, Marie, additional, Chronos, Nicolas, additional, Cicconi, Paola, additional, Cifuentes, Liliana, additional, Cobo, Sara Maria, additional, Collins, Helen, additional, Colton, Hayley, additional, Cuaño, Carlos Rolando G., additional, D'Onofrio, Valentino, additional, Dargan, Paul, additional, Darton, Thomas, additional, Deane, Peter, additional, Del Pozo, Jose Luis, additional, Derdelinckx, Inge, additional, Desai, Amisha, additional, Dever, Michael, additional, Díaz-Pollán, Beatriz, additional, DiBuono, Mark, additional, Doust, Matthew, additional, Duncan, Christopher, additional, Echave-Sustaeta, Jose Maria, additional, Eder, Frank, additional, Ellis, Kimberly, additional, Elzi, Stanton, additional, Emmett, Stevan, additional, Engelbrecht, Johannes, additional, Evans, Mim, additional, Farah, Theo, additional, Felton, Timothy, additional, Ferreira, João Pedro, additional, Floutier, Catherine, additional, Flume, Patrick, additional, Ford, Stacy, additional, Fragoso, Veronica, additional, Freedman, Andrew, additional, Frentiu, Emilia, additional, Galloway, Christopher, additional, Galtier, Florence, additional, Garcia Diaz, Julia, additional, García García, Irene, additional, Garcia, Alcaide, additional, Gardener, Zoe, additional, Gauteul, Pascale, additional, Geller, Steven, additional, Gibson, Andrew, additional, Gillet, Claudia, additional, Girerd, Nicolas, additional, Girodet, Pierre-Olivier, additional, Gler, Maria Tarcela, additional, Glover, Richard, additional, Go, Herschel Don D., additional, Gokani, Karishma, additional, Gonthier, Damien, additional, Green, Christopher, additional, Greenberg, Richard, additional, Griffin, Carl, additional, Grobbelaar, Coert, additional, Guancia, Adonis, additional, Hakkarainen, Gloria, additional, Harris, James, additional, Hassman, Michael, additional, Heimer, Deirdre, additional, Hellstrom-Louw, Elizabeth, additional, Herades, Yoan, additional, Holroyd, Christopher, additional, Hussen, Nazreen, additional, Isidro, Marie Grace Dawn, additional, Jackson, Yvonne, additional, Jain, Manish, additional, João Filho, Esaú Custódio, additional, Johnson, Daniel, additional, Jones, Ben, additional, Joseph, Natasha, additional, Jumeras, Analyn, additional, Junquera, Patricia, additional, Kellett-Wright, Johanna, additional, Kennedy, Patrick, additional, Kilgore, Paul E., additional, Kim, Kenneth, additional, Kimmel, Murray, additional, Konis, George, additional, Kutner, Mark, additional, Lacombe, Karine, additional, Launay, Odile, additional, Lazarus, Rajeka, additional, Lederman, Samuel, additional, Lefebvre, Gigi, additional, Lennon Collins, Katrina, additional, Leroux-Roels, Isabel, additional, Lim, Kenneth Wilson O., additional, Lins, Muriel, additional, Liu, Edward, additional, Llewelyn, Martin, additional, Mahomed, Akbar, additional, Maia, Bernardo Porto, additional, Marín-Candon, Alícia, additional, Martínez-Gómez, Xavier, additional, Martinot, Jean Benoit, additional, Mazzella, Andrea, additional, McCaughan, Frank, additional, McCormack, Louise, additional, McGettigan, John, additional, Mehra, Purvi, additional, Mejeur, Rhonda, additional, Miller, Vicki, additional, Mills, Anthony, additional, Molto Marhuenda, Jose, additional, Moodley, Prebashan, additional, Mora-Rillo, Marta, additional, Mothe, Beatriz, additional, Mullan, Daniel, additional, Munro, Alasdair, additional, Myers, Paul, additional, Nell, Jeremy, additional, Newman Lobato Souza, Tamara, additional, O'Halloran, Jane A., additional, Ochoa Mazarro, Maria Dolores, additional, Oliver, Abigail, additional, Onate Gutierrez, Jose Millan, additional, Ortega, Jessica, additional, Oshita, Masaru, additional, Otero Romero, Susana, additional, Overcash, Jeffrey Scott, additional, Owens, Daniel, additional, Packham, Alice, additional, Pacurar, Mihaela, additional, Paiva de Sousa, Leonardo, additional, Palfreeman, Adrian, additional, Pallares, Christian José, additional, Patel, Rahul, additional, Patel, Suchet, additional, Pelkey, Leslie, additional, Peluso, Denise, additional, Penciu, Florentina, additional, Pinto, S. Jerry, additional, Pounds, Kevin, additional, Pouzar, Joe, additional, Pragalos, Antoinette, additional, Presti, Rachel, additional, Price, David, additional, Qureshi, Ehsaan, additional, Ramalho Madruga, José Valdez, additional, Ramesh, Mayur, additional, Rankin, Bruce, additional, Razat, Béatrice, additional, Riegel Santos, Breno, additional, Riesenberg, Robert, additional, Riffer, Ernie, additional, Roche, Siobhan, additional, Rose, Katie, additional, Rosellini, Pietro, additional, Rossignol, Patrick, additional, Safirstein, Beth, additional, Salazar, Hernan, additional, Sanchez Vallejo, Gregorio, additional, Santhosh, Smrithi, additional, Seco-Meseguer, Enrique, additional, Seep, Michael, additional, Sherry, Emma, additional, Short, Philip, additional, Soentjens, Patrick, additional, Solis, Joel, additional, Soriano Viladomiu, Alejandro, additional, Sorli, Caroline, additional, Spangenthal, Selwyn, additional, Spence, Niamh, additional, Stephenson, Elaine, additional, Strout, Cynthia, additional, Surowitz, Ronald, additional, Taladua, Kristy Michelle, additional, Tellalian, David, additional, Thalamas, Claire, additional, Thiriphoo, Nang, additional, Thomas, Judith, additional, Thomas, Nicholas, additional, Trout, Guillermo, additional, Urroz, Mikel, additional, Veekmans, Bernard, additional, Veekmans, Laurent, additional, Villalobos, Ralph Elvi M., additional, Warren, Sarah, additional, Webster, Brian, additional, White, Alexander, additional, Williams, Gail, additional, Williams, Hayes, additional, Wilson, Barbara, additional, Winston, Alan, additional, Wiselka, Martin, additional, and Zervos, Marcus, additional

Published
2022
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12. Efficacy and Safety of Glycopyrrolate/Formoterol Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Patients With COPD

Author

Martinez, Fernando J., Rabe, Klaus F., Ferguson, Gary T., Fabbri, Leonardo M., Rennard, Stephen, Feldman, Gregory J., Sethi, Sanjay, Spangenthal, Selwyn, Gottschlich, Gregory M., Rodriguez-Roisin, Roberto, Arora, Samir, Siler, Thomas M., Siddiqui, Shahid, Darken, Patrick, Fischer, Tracy, Maes, Andrea, Golden, Michael, Orevillo, Chad, and Reisner, Colin

Published
2017
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13. Non-typeable Haemophilus influenzae–Moraxella catarrhalis vaccine for the prevention of exacerbations in chronic obstructive pulmonary disease: a multicentre, randomised, placebo-controlled, observer-blinded, proof-of-concept, phase 2b trial

Author

Andreas, Stefan, primary, Testa, Marco, additional, Boyer, Laurent, additional, Brusselle, Guy, additional, Janssens, Wim, additional, Kerwin, Edward, additional, Papi, Alberto, additional, Pek, Bonavuth, additional, Puente-Maestu, Luis, additional, Saralaya, Dinesh, additional, Watz, Henrik, additional, Wilkinson, Tom M A, additional, Casula, Daniela, additional, Di Maro, Gennaro, additional, Lattanzi, Maria, additional, Moraschini, Luca, additional, Schoonbroodt, Sonia, additional, Tasciotti, Annaelisa, additional, Arora, Ashwani K, additional, Maltais, François, additional, Corhay, Jean-Louis, additional, Janssens, Eduard, additional, Leys, Mathias, additional, Ferguson, Murdo, additional, Fitzgerald, Mark, additional, Mayers, Irvin, additional, McNeil, Shelly, additional, Bourdin, Arnaud, additional, Couturaud, Francis, additional, Dussart, Luc, additional, Andreas, Stefan, additional, Illies, Gabriele, additional, Eich, Andreas, additional, Ludwig-Sengpiel, Andrea, additional, Blasi, Francesco, additional, Centanni, Stefano, additional, Pomari, Carlo, additional, Echave-Sustaeta, José Maria, additional, Llorca Martínez, Eleuterio, additional, Narejos Pérez, Silvia, additional, Pascual-Guardia, Sergi, additional, Pérez Vera, Mercè, additional, Terns Riera, Manuel, additional, Anderson, William, additional, Choudhury, Gourab, additional, De-Soyza, Anthony, additional, Wilkinson, Tom MA, additional, Boscia III, Joseph, additional, Chinsky, Kenneth, additional, Dunn, Leonard, additional, Erb, David, additional, Fogarty, Charles, additional, Downey, Herman Jackson, additional, Kunz, Craig, additional, Poling, Terry, additional, Sellman, Richard, additional, Sigal, Barry, additional, Southard, John, additional, Spangenthal, Selwyn, additional, and Tannous, Ziad, additional

Published
2022
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15. Additional file 1 of A randomized, controlled, repeat-dose study of batefenterol/fluticasone furoate compared with placebo in the treatment of COPD

Author

Crim, Courtney, Gotfried, Mark, Spangenthal, Selwyn, Watkins, Michael, Emmett, Amanda, Crawford, Catriona, Baidoo, Charlotte, and Castro-Santamaria, Ramiro

Abstract

Additional file 1: Supplementary Appendix. Study inclusion criteria and exclusion criteria. Table S1. Medications not permitted prior to Screening (Visit 1; time interval specified) and throughout the study. Table S2. Analysis of 0–4-h WM HR at Days 1, 28, and 42 using MMRM (bpm). Table S3. Analysis of Holter findings and pulse rate. Table S4. Eosinophil count over time. Table S5. Adverse events experienced by ≥1 subject.

Published
2020
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16. Onset of effect and impact on health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms for patients with severe eosinophilic asthma treated with benralizumab (ANDHI): a randomised, controlled, phase 3b trial

Author

Harrison, Tim W, primary, Chanez, Pascal, additional, Menzella, Francesco, additional, Canonica, Giorgio Walter, additional, Louis, Renaud, additional, Cosio, Borja G, additional, Lugogo, Njira L, additional, Mohan, Arjun, additional, Burden, Annie, additional, McDermott, Lawrence, additional, Garcia Gil, Esther, additional, Zangrilli, James G, additional, Pohl, Wolfgang, additional, Voves, Robert, additional, Deschampheleire, Maud, additional, Martinot, Jean-Benoit, additional, Peché, Rudi, additional, Chapman, Kenneth, additional, Cheema, Amarjit, additional, Dorscheid, Delbert, additional, FitzGerald, J. Mark, additional, Gagnon, Remi, additional, Killorn, William Patrick, additional, Olivenstein, Ronald, additional, Philteos, George, additional, Ramsey, Clare, additional, Rolf, J. Douglass, additional, Walker, Brandie, additional, Hilberg, Ole, additional, Skjold, Tina, additional, Titlestad, Ingrid, additional, Hakulinen, Auli, additional, Kilpeläinen, Maritta, additional, Ben Hayoun, Michèle, additional, Bonniaud, Philippe, additional, Bourdin, Arnaud, additional, De Blay, Frédéric, additional, Deslee, Gaëtan, additional, Devouassoux, Gilles, additional, Didier, Alain, additional, Douadi, Youcef, additional, Fry, Stéphanie, additional, Garcia, Gilles, additional, Girodet, Pierre-Olivier, additional, Leroyer, Christophe, additional, Magnan, Antoine, additional, Mahay, Guillaume, additional, Nocent, Cécilia, additional, Pison, Christophe, additional, Roux, Pauline-Marie, additional, Taillé, Camille, additional, Tiotiu, Juliana-Angelica, additional, Beck, Ekkehard, additional, Jandl, Margret, additional, Kaehler, Christian, additional, Kässner, Frank, additional, Koesters, Frank, additional, Kronsbein, Juliane, additional, Schaum, Thomas, additional, Schulz, Christian, additional, Skowasch, Dirk, additional, Taube, Christian, additional, Welte, Tobias, additional, de Roux, Andrés, additional, Beghé, Bianca, additional, Blasi, Francesco, additional, Carpagnano, Giovanna, additional, Caruso, Cristiano, additional, Corsico, Angelo Guido, additional, Constantino, Elio, additional, Crimi, Nunzio, additional, Maestrelli, Piero, additional, Milanese, Manlio, additional, Papi, Alberto, additional, Pelaia, Girolamo, additional, Pini, Laura, additional, Santus, Pierachille, additional, Savi, Eleonora, additional, Scichilone, Nicola, additional, Senna, Gianenrico, additional, Spadaro, Giuseppe, additional, Vaghi, Adriano, additional, Gans, Steven, additional, Hölters, Jurgen, additional, Langeveld, B., additional, Pieters, Willem, additional, Staaks, G.H.A., additional, van Veen, Ilonka, additional, van den Berg, J.W.K., additional, Einvik, Gunnar, additional, Lehmann, Sverre, additional, Ali García, Ismael, additional, Almonacid, Carlos, additional, Bobolea, Irina, additional, Campo Mozo, Paloma, additional, de Luiz, Gustavo, additional, Domingo Ribas, Christian, additional, Echave-Sustaeta María-Tomé, José María, additional, García Rivero, Juan Luis, additional, García-Cosío Piqueras, Borja, additional, Gómez-Bastero Fernández, Ana, additional, González Pérez, Ruperto, additional, Henríquez Santa, Aythamy, additional, Martínez Rivera, Carlos, additional, Muñoz Gall, Xavier, additional, Ramos, Jacinto, additional, Gregorio Soto Campos, Jose, additional, Vidal Pan, Carmen, additional, Stenfors, Nikolai, additional, Tunsäter, Alf, additional, Vinge, Ines, additional, Chaudhuri, Rekha, additional, Harrison, Timothy, additional, Mansur, Adel, additional, Nasser, Shuaib, additional, Nordstrom, Monica, additional, Pfeffer, Paul, additional, Saralaya, Dinesh, additional, Short, Philip, additional, Adlakha, Arun, additional, Alpan, Oral, additional, Averill, Francis, additional, Badhwar, Anil, additional, Bardelas, Jose, additional, Baxter, Barbara, additional, Bensch, George, additional, Berger, William, additional, Bernstein, Jonathan, additional, Bridges, Tracy, additional, Brimeyer, Ryan, additional, Calhoun, William, additional, Campbell, Edward, additional, Cherry, William Brett, additional, Chupp, Geoffrey, additional, Clore, Lee, additional, Cohn, John, additional, Cole, Jeremy, additional, Condemi, John, additional, Cury, James, additional, Davis, Benjamin, additional, DeLeon, Samuel, additional, Delacruz, Luis, additional, Diaz, Joseph, additional, Erb, David, additional, Eziri, Emeka, additional, Fakih, Faisal, additional, Fiedler, Douglas, additional, Fost, David, additional, Fritz, Stephen, additional, Gonzalez, Erika, additional, Goodman, Brad, additional, Gottlieb, Peter, additional, Gottschlich, Gregory, additional, Gower, Richard, additional, Hajal, Rizan, additional, Harris, James, additional, Heidarian-Raissy, Hengameh, additional, Heyder, Albrecht, additional, Hill, David, additional, Holguin, Fernando, additional, Hussain, Iftikhar, additional, Illowite, Jonathan, additional, Jacobs, Joshua, additional, Jarratt, Mikell, additional, Kaiser, Harold, additional, Kao, Neil, additional, Kashyap, Ravindra, additional, Kaufman, David, additional, Kent, Edward, additional, Kim, Kenneth, additional, Klein, Ryan, additional, Kraft, Monica, additional, Kono, Ritsu, additional, Kureishy, Shahrukh, additional, Leflein, Jeffrey, additional, Leong, Mila, additional, Li, Huamin, additional, Lin, Robert, additional, Lugogo, Njira, additional, Marcus, Michael, additional, Maselli Caceres, Diego Jose, additional, Mehta, Vinay, additional, Mello, Curtis, additional, Millard, Mark, additional, Milstone, Aaron, additional, Moore, Wendy, additional, Moss, Mark, additional, Mumneh, Nayla, additional, O'Brien, Thomas, additional, Ostransky, David, additional, Palumbo, Michael, additional, Parikh, Purvi, additional, Parikh, Sudhir, additional, Patel, Amit, additional, Perez, Guido, additional, Pleskow, Warren, additional, Prenner, Bruce, additional, Puppala, Dileep, additional, Ramey, John, additional, Reibman, Joan, additional, Reyes, Ramon, additional, Robinette, Emory, additional, Rodicio, Ileana, additional, Ryan, Stephen, additional, Sekhsaria, Sudhir, additional, Sigal, Barry, additional, Sikand, Vinay, additional, Soong, Weily, additional, Spangenthal, Selwyn, additional, St. John, Roy, additional, Steven, Gary, additional, Subramaniam, Vijay, additional, Sumino, Kaharu, additional, Sztejman, Eric, additional, Tan, Ricardo A., additional, Tanus, Tonny, additional, Thompson, Charles, additional, Thornblade, Carl, additional, Villareal, Manuel, additional, Wenzel, Sally, additional, Zafra, Heidi, additional, and Ziedalski, Tomasz, additional

Published
2021
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18. Treatment of Persistent Cough in Subjects with Idiopathic Pulmonary Fibrosis (IPF) with Gefapixant, a P2X3 Antagonist, in a Randomized, Placebo-Controlled Clinical Trial.

Author

Martinez, Fernando J., Afzal, Amna Sadaf, Smith, Jaclyn A., Ford, Anthony P., Li, Jerry Jing, Li, Yuping, Kitt, Michael M., the Chronic Cough in IPF Study Group, Hussain, Iftikhar, Sher, Mandel, Spangenthal, Selwyn, Fakih, Faisal, Gotfried, Mark, Flaherty, Kevin, Lancaster, Lisa, Horton, Maureen, Kaner, Robert, Patel, Kapil, Scholand, Mary Beth, and Sussman, Robert

Subjects
COUGH, IDIOPATHIC pulmonary fibrosis, CLINICAL trials
Abstract

Introduction: Chronic cough is a highly problematic symptom for patients with idiopathic pulmonary fibrosis (IPF); limited therapeutic options are available. We evaluated gefapixant, a P2X3 receptor antagonist, for the treatment of chronic cough in IPF. Methods: This randomized, double-blind, placebo-controlled, crossover study included subjects with IPF. Sequence A included gefapixant 50 mg BID (period 1; 14 days) followed by placebo (period 2; 14 days); sequence B had the opposite sequence of treatments. This regimen was specified in a protocol amendment that modified the original active treatment regimen of gefapixant 50 mg BID for 10 days and 150 mg BID for 4 days. Patients randomized to the original treatment regimen were excluded from efficacy analyses but included in safety assessments. The primary efficacy endpoint was change from baseline in awake cough frequency (coughs/hour) from periods 1 and 2 combined. Adverse events (AEs) were monitored throughout the study. Results: A total of 51 subjects were randomized, 44 of whom were randomized to treatment sequences evaluated in the primary efficacy analysis (i.e., 22 subjects in sequence A and 22 subjects in sequence B); seven subjects received the treatment assigned before the protocol amendment and were excluded from efficacy analyses. The change from baseline in awake cough frequency from periods 1 and 2 combined (mixed model for repeated measures analysis) did not demonstrate a significant reduction versus placebo in cough at day 14 (p = 0.90); in a post hoc analysis of log-transformed data p value for reduction versus placebo at day 14 was 0.07. The most common AEs were related to taste (dysgeusia and ageusia). Conclusions: Gefapixant was generally well tolerated but was not associated with a significant improvement in chronic cough in subjects with IPF as defined by the primary endpoint in this study. Trial Registration: NCT02502097. [ABSTRACT FROM AUTHOR]

Published
2021
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19. Non-typeable Haemophilus influenzae–Moraxella catarrhalisvaccine for the prevention of exacerbations in chronic obstructive pulmonary disease: a multicentre, randomised, placebo-controlled, observer-blinded, proof-of-concept, phase 2b trial

Author

Andreas, Stefan, Testa, Marco, Boyer, Laurent, Brusselle, Guy, Janssens, Wim, Kerwin, Edward, Papi, Alberto, Pek, Bonavuth, Puente-Maestu, Luis, Saralaya, Dinesh, Watz, Henrik, Wilkinson, Tom M A, Casula, Daniela, Di Maro, Gennaro, Lattanzi, Maria, Moraschini, Luca, Schoonbroodt, Sonia, Tasciotti, Annaelisa, Arora, Ashwani K, Maltais, François, Brusselle, Guy, Corhay, Jean-Louis, Janssens, Eduard, Janssens, Wim, Leys, Mathias, Ferguson, Murdo, Fitzgerald, Mark, Maltais, François, Mayers, Irvin, McNeil, Shelly, Pek, Bonavuth, Bourdin, Arnaud, Boyer, Laurent, Couturaud, Francis, Dussart, Luc, Andreas, Stefan, Illies, Gabriele, Eich, Andreas, Ludwig-Sengpiel, Andrea, Watz, Henrik, Blasi, Francesco, Centanni, Stefano, Papi, Alberto, Pomari, Carlo, Echave-Sustaeta, José Maria, Llorca Martínez, Eleuterio, Narejos Pérez, Silvia, Pascual-Guardia, Sergi, Pérez Vera, Mercè, Puente-Maestu, Luis, Terns Riera, Manuel, Anderson, William, Choudhury, Gourab, De-Soyza, Anthony, Saralaya, Dinesh, Wilkinson, Tom MA, Boscia III, Joseph, Chinsky, Kenneth, Dunn, Leonard, Erb, David, Fogarty, Charles, Downey, Herman Jackson, Kerwin, Edward, Kunz, Craig, Poling, Terry, Sellman, Richard, Sigal, Barry, Southard, John, Spangenthal, Selwyn, Tannous, Ziad, Testa, Marco, Casula, Daniela, Di Maro, Gennaro, Lattanzi, Maria, Moraschini, Luca, Schoonbroodt, Sonia, Tasciotti, Annaelisa, and Arora, Ashwani K

Abstract

Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are associated with changes in the sputum microbiome, including an increased prevalence of pathogenic bacteria. Vaccination against the most frequent bacteria identified in AECOPD might reduce exacerbation frequency. We assessed the efficacy, safety, and immunogenicity of a candidate vaccine containing surface proteins from non-typeable Haemophilus influenzae(NTHi) and Moraxella catarrhalis(Mcat) in patients with COPD.

Published
2022
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21. Additional file 1: of A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension™ Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease

Author

Reisner, Colin, Fabbri, Leonardo, Kerwin, Edward, Fogarty, Charles, Spangenthal, Selwyn, Rabe, Klaus, Ferguson, Gary, Martinez, Fernando, Donohue, James, Darken, Patrick, Rose, Earl St., Orevillo, Chad, Strom, Shannon, Fischer, Tracy, Golden, Michael, and Sarvajna Dwivedi

Abstract

Study design; Additional Fig. 1. Study design schematic; Additional Fig. 2. Mean change from baseline in PEFR over time by treatment on Day 7 (mITT population); Additional Fig. 3. Mean change from baseline FVC over time by treatment on Day 7 (mITT population); Additional Table 1. Secondary efficacy endpoints: Days 1 and 7 – FF 9.6 μg and FF 7.2 μg comparisons (mITT population). (DOCX 466 kb)

Published
2017
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22. Randomized study of the effects of Aerochamber Plus ® Flow-Vu ® on the efficacy, pharmacokinetics and safety of glycopyrronium/formoterol fumarate dihydrate metered dose inhaler in patients with chronic obstructive pulmonary disease

Author

Fakih, Faisal, primary, Spangenthal, Selwyn, additional, Sigal, Barry, additional, Darken, Patrick, additional, Maes, Andrea, additional, Siddiqui, Shahid, additional, Gillen, Michael, additional, Reisner, Colin, additional, and Martin, Ubaldo J., additional

Published
2018
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23. Additional file 1: Figure S1. of Dose-response to inhaled glycopyrrolate delivered with a novel Co-Suspensionâ ˘ Delivery Technology metered dose inhaler (MDI) in patients with moderate-to-severe COPD

Author

Fabbri, Leonardo, Kerwin, Edward, Spangenthal, Selwyn, Ferguson, Gary, Rodriguez-Roisin, Roberto, Pearle, James, Sethi, Sanjay, Orevillo, Chad, Darken, Patrick, Rose, Earl St., Fischer, Tracy, Golden, Michael, Sarvajna Dwivedi, and Reisner, Colin

Subjects
respiratory system, circulatory and respiratory physiology, respiratory tract diseases
Abstract

Adjusted change from baseline in FEV1 over time on Day 14 (mITT population). Figure S2. LSM difference in FEV1 AUC0â 12 on Day 14, vs placebo MDI (mITT population). (DOCX 437 kb)

Published
2016
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24. Erratum to: A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension™ Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease

Author

Reisner, Colin, primary, Fabbri, Leonardo M., additional, Kerwin, Edward M., additional, Fogarty, Charles, additional, Spangenthal, Selwyn, additional, Rabe, Klaus F., additional, Ferguson, Gary T., additional, Martinez, Fernando J., additional, Donohue, James F., additional, Darken, Patrick, additional, St. Rose, Earl, additional, Orevillo, Chad, additional, Strom, Shannon, additional, Fischer, Tracy, additional, Golden, Michael, additional, and Dwivedi, Sarvajna, additional

Published
2017
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25. Benralizumab for patients with mild to moderate, persistent asthma (BISE): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Ferguson, Gary T, primary, FitzGerald, J Mark, additional, Bleecker, Eugene R, additional, Laviolette, Michel, additional, Bernstein, David, additional, LaForce, Craig, additional, Mansfield, Lyndon, additional, Barker, Peter, additional, Wu, Yanping, additional, Jison, Maria, additional, Goldman, Mitchell, additional, Chouinard, Guy, additional, Rostami, Maryam, additional, Oosthuizen, Jean, additional, Pek, Bonavuth, additional, Patel, Deepen, additional, Houle, Pierre-Alain, additional, Khattak, Sohail, additional, Killorn, Patrick, additional, Keller, Claus, additional, Schenkenberger, Isabelle, additional, Zielen, Stefan, additional, Ballenberger, Sabine, additional, Hoffmann, Martin, additional, Kirschner, Joachim, additional, Papp, Márta, additional, Kecskés, Teréz, additional, Póczi, Magdolna, additional, Molnár, Lajos, additional, Radeczky, Éva, additional, Schlezák, Judit, additional, Springer, Ewa, additional, Balicka, Violetta, additional, Kaczmarek, Jadwiga, additional, Madra-Rogacka, Danuta, additional, Pisarczyk-Bogacka, Ewa, additional, Zurowska-Gebala, Malgorzata, additional, Marczak, Maciej, additional, Napora, Piotr, additional, Pomiecko, Witold, additional, Pribulova, Erika, additional, Kurthova, Svetlana, additional, Drugdova, Maria, additional, Kavkova, Denisa, additional, Frajtova, Luboslava, additional, Golubov, Alexander, additional, Paulinyova, Dagmar, additional, Hasicova, Daniela, additional, Michalickova, Miriam, additional, Trevino, Miguel, additional, Campbell, Charles, additional, Wachtel, Andrew, additional, Bleecker, Eugene, additional, Spangenthal, Selwyn, additional, Kerwin, Edward, additional, Ratner, Paul, additional, Arora, Samir, additional, Feldman, Gregory, additional, Okwara, Benedict, additional, Cruz, Humberto, additional, Sher, Lawrence, additional, Pedinoff, Andrew, additional, and Corder, Clinton, additional

Published
2017
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26. A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension™ Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease

Author

Reisner, Colin, primary, Fabbri, Leonardo M., additional, Kerwin, Edward M., additional, Fogarty, Charles, additional, Spangenthal, Selwyn, additional, Rabe, Klaus F., additional, Ferguson, Gary T., additional, Martinez, Fernando J., additional, Donohue, James F., additional, Darken, Patrick, additional, St. Rose, Earl, additional, Orevillo, Chad, additional, Strom, Shannon, additional, Fischer, Tracy, additional, Golden, Michael, additional, and Dwivedi, Sarvajna, additional

Published
2017
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27. Efficacy and safety of twice-daily glycopyrrolate in patients with stable, symptomatic COPD with moderate-to-severe airflow limitation: the GEM1 study

Author

LaForce,Craig F., Feldman,Gregory, Spangenthal,Selwyn, Eckert,Joerg H., Henley,Michelle, Patalano,Francesco, D’Andrea,Peter, Khanna,Vivek, LaForce,Craig F., Feldman,Gregory, Spangenthal,Selwyn, Eckert,Joerg H., Henley,Michelle, Patalano,Francesco, D’Andrea,Peter, and Khanna,Vivek

Abstract

Craig LaForce,1 Gregory Feldman,2 Selwyn Spangenthal,3 Joerg H Eckert,4 Michelle Henley,5 Francesco Patalano,4 Peter D’Andrea5 1North Carolina Clinical Research, Raleigh, NC, USA; 2South Carolina Pharmaceutical Research, Spartanburg, SC, USA; 3American Health Research, Charlotte, NC, USA; 4Novartis Pharma AG, Basel, Switzerland; 5Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA Background: The purpose of this study was to confirm the efficacy and safety of twice-daily glycopyrrolate 15.6 µg, a long-acting muscarinic antagonist, in patients with stable, symptomatic, chronic obstructive pulmonary disease (COPD) with moderate-to-severe airflow limitation.Methods: The GEM1 study was a 12-week, multicenter, double-blind, parallel-group, placebo-controlled study that randomized patients with stable, symptomatic COPD with moderate-to-severe airflow limitation to twice-daily glycopyrrolate 15.6 µg or placebo (1:1) via the Neohaler® device. The primary objective was to demonstrate superiority of glycopyrrolate versus placebo in terms of forced expiratory volume in 1 second area under the curve between 0 and 12 hours post morning dose at week 12. Other outcomes included additional spirometric end points, transition dyspnea index, St George’s Respiratory Questionnaire, COPD Assessment Test, rescue medication use, and symptoms reported by patients via electronic diary. Safety was also assessed during the study.Results: Of the 441 patients randomized (glycopyrrolate, n=222; placebo, n=219), 96% of patients completed the planned treatment phase. Glycopyrrolate demonstrated statistically significant (P<0.001) improvements in lung function versus placebo. Glycopyrrolate showed statistically significant improvement in the transition dyspnea index focal score, St George’s Respiratory Questionnaire total score, COPD Assessment Test score, rescue medication use, and daily total symptom score versus placebo at w

Published
2016

28. Dose-response to inhaled glycopyrrolate delivered with a novel Co-Suspension™ Delivery Technology metered dose inhaler (MDI) in patients with moderate-to-severe COPD

Author

Fabbri, Leonardo M., primary, Kerwin, Edward M., additional, Spangenthal, Selwyn, additional, Ferguson, Gary T., additional, Rodriguez-Roisin, Roberto, additional, Pearle, James, additional, Sethi, Sanjay, additional, Orevillo, Chad, additional, Darken, Patrick, additional, St. Rose, Earl, additional, Fischer, Tracy, additional, Golden, Michael, additional, Dwivedi, Sarvajna, additional, and Reisner, Colin, additional

Published
2016
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32. Once-daily indacaterol 75 µg in moderate- to-severe COPD: results of a Phase IV study assessing time until patients’ perceived onset of effect

Author

Siler,Thomas M, LaForce,Craig F, Kianifard,Farid, Williams,James, Spangenthal,Selwyn, Siler,Thomas M, LaForce,Craig F, Kianifard,Farid, Williams,James, and Spangenthal,Selwyn

Abstract

Thomas M Siler,1 Craig F LaForce,2 Farid Kianifard,3 James Williams,3 Selwyn Spangenthal4 1Midwest Chest Consultants, St Charles, MO, USA; 2North Carolina Clinical Research, Raleigh, NC, USA; 3Novartis Pharmaceuticals, East Hanover, NJ, USA; 4Charlotte Lung and Health Center, Charlotte, NC, USA Background: Indacaterol 75 µg once daily is a long-acting β2 agonist approved for maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD). The purpose of this study was to evaluate patients' perception of onset of effect with a single dose. Methods: In this double-blind, crossover, Phase IV study, 40 patients were randomized to receive a single dose of indacaterol 75 µg or placebo via a dry powder inhaler device. The primary variable was time until patient’s perception of onset of effect, using a simple self-administered (nonvalidated) questionnaire that patients answered at nine protocol-specified time points. Exploratory variables included change in forced expiratory volume in 1 second (FEV1) and change in percent predicted FEV1 from predose to postdose (determined 60–75 minutes postdose). Results: The least-squares mean time to patient’s perception of onset of effect was 25.4 minutes and 23.9 minutes for indacaterol and placebo, respectively. There was no significant effect for treatment, period, or sequence on the time to patient's perception. In addition, no statistically significant differences between treatments were observed for patient's global satisfaction with onset of effect and global expectation of treatment adherence. For the exploratory variable change in FEV1 from predose to postdose, indacaterol showed superiority over placebo with a clinically relevant least-squares mean treatment difference of 0.12 L (P<0.0001). There was little or no association between patient’s perception of time to onset of effect and change in

Published
2014

36. Novel Combination Of Glycopyrrolate And Formoterol MDI (GFF-MDI) Provides Superior Bronchodilation Compared To Its Components Administered Alone, Tiotropium DPI, And Formoterol DPI In A Randomized, Double-Blind, Placebo-Controlled Phase 2b Study In Patients With COPD

Author

Reisner, Colin, primary, Fogarty, Charles, additional, Spangenthal, Selwyn, additional, Dunn, Leonard, additional, Kerwin, Edward M., additional, Quinn, Dean, additional, Seale, J P., additional, Thomas, Mervyn, additional, St. Rose, Earl, additional, and Orevillo, Chadwick J., additional

Published
2011
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40. Efficacy and Safety of Glycopyrrolate/Formoterol Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Patients With COPD.

Author

Martinez, Fernando J, Rabe, Klaus F, Ferguson, Gary T, Fabbri, Leonardo M, Rennard, Stephen, Feldman, Gregory J, Sethi, Sanjay, Spangenthal, Selwyn, Gottschlich, Gregory M, Rodriguez-Roisin, Roberto, Arora, Samir, Siler, Thomas M, Siddiqui, Shahid, Darken, Patrick, Fischer, Tracy, Maes, Andrea, Golden, Michael, Orevillo, Chad, and Reisner, Colin

Subjects
THERAPEUTIC use of glucocorticoids, PREDNISONE, BUDESONIDE, BRONCHODILATOR agents, COMBINATION drug therapy, COMPARATIVE studies, OBSTRUCTIVE lung diseases, RESEARCH methodology, MEDICAL cooperation, RESEARCH, RESPIRATORY measurements, RESPIRATORY therapy equipment, SUSPENSIONS (Chemistry), EVALUATION research, RANDOMIZED controlled trials, VITAL capacity (Respiration), BLIND experiment, MUSCARINIC antagonists, INHALATION administration, GLYCOPYRROLATE, THERAPEUTICS
Abstract

Background: Long-acting muscarinic antagonist (LAMA)/long-acting β2-agonist (LABA) combinations are a treatment option for patients with COPD who continue to have symptoms despite treatment with a LAMA or a LABA alone. The Efficacy and Safety of PT003, PT005, and PT001 in Subjects with Moderate-to-Very Severe COPD (PINNACLE-1) (NCT01854645) and the Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects with Moderate-to-Very Severe COPD (PINNACLE-2) (NCT01854658) trials investigated the efficacy and safety of a novel glycopyrrolate [GP]/formoterol [FF] 18/9.6-μg (GFF) metered dose inhaler (MDI) formulated using the Co-Suspension Delivery Technology in patients with moderate-to-very severe COPD.Methods: These two phase III trials took place over 24 weeks and were randomized, double blind, and placebo controlled; 2,103 and 1,615 patients (40-80 years of age), respectively, were randomized. Patients received GFF MDI, GP MDI 18 μg, FF MDI 9.6 μg, or placebo MDI (all twice daily), or tiotropium 18 μg dry powder inhaler (once daily in PINNACLE-1 only [open-label active comparator]). Efficacy and safety were assessed.Results: At week 24, differences in change from baseline in the morning predose trough FEV1 for GFF MDI vs placebo MDI, GP MDI, and FF MDI were 150 mL, 59 mL, and 64 mL in PINNACLE-1 (all P < .0001) and 103 mL, 54 mL, and 56 mL in PINNACLE-2 (all P < .001), respectively. There were no significant safety findings (incidence of adverse events was similar between treatment arms).Conclusions: We conclude that GFF MDI 18/9.6 μg demonstrated superiority over placebo and monocomponent MDIs and was well tolerated, thus providing an additional treatment option for patients with moderate-to-very severe COPD.Trial Registry: ClinicalTrials.gov; No.: NCT01854645 and No. NCT01854658; URL: www.clinicaltrials.gov. [ABSTRACT FROM AUTHOR]

Published
2016
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