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1. Recombinant Alpha-1 Antitrypsin-Fc Fusion Protein INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency: A Phase 1 Study.

Author

Brantly, Mark, Kuhn, Brooks, Farah, Humam, Mahadeva, Ravi, Cole, Alexandra, Chang, Catherina, Brown, Cynthia, Campos, Michael, Lascano, Jorge, Babcock, Erin, Bhagwat, Sharvari, Boyea, Teresa, Veldstra, Carson, Andrianov, Vasily, Kalabus, James, Eckelman, Brendan, and Veale, Andrew

Subjects
alpha-1 antitrypsin deficiency, augmentation therapy, clinical trials, orphan drugs, outcomes biologic agents
Abstract

BACKGROUND: Alpha-1 antitrypsin deficiency (AATD) is characterized by low alpha-1 antitrypsin (AAT) levels, predisposing individuals to lung disease. The standard of care, plasma-derived AAT (pdAAT), is delivered as weekly infusions to maintain serum AAT concentrations ≥11µM (≈50% of those in healthy individuals). INBRX-101, a recombinant human AAT-Fc fusion protein, was designed to have a longer half-life and achieve higher AAT levels than pdAAT. METHODS: In this phase 1 dose-escalation study (N=31), adults with AATD received 1 dose (part 1) or 3 doses (part 2) of 10 (part 1), 40, 80, or 120mg/kg INBRX-101 every 3 weeks (Q3W) via intravenous infusion. The primary endpoint was safety and tolerability. Secondary endpoints were pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of INBRX-101. RESULTS: INBRX-101 was well tolerated. Most treatment-emergent adverse events were grade ≤2. In part 2 (n=18; each dose, n=6), dose-related increases in serum functional AAT (fAAT) were observed; mean fAAT levels remained above the 21 µM target for up to 4 weeks after the final dose in the 120-mg/kg cohort. Antidrug antibodies had no meaningful impact on PK or PD. INBRX-101 was detected in pulmonary epithelial lining fluid (PELF) from all patients assessed (n=11), and PELF fAAT increased after dosing. PK/PD modeling projected steady-state serum fAAT ≥21µM at 120 mg/kg Q3W (average concentration ≈43µM; trough concentration ≈28µM) and Q4W (≈34µM; ≈21µM). CONCLUSION: The favorable safety profile and ability to maintain serum fAAT levels >21µM with extended-interval dosing, support a phase 2 trial evaluating Q3W and Q4W dosing of INBRX-101.

Published
2024

11. Long-term safety and efficacy of tezacaftor–ivacaftor in individuals with cystic fibrosis aged 12 years or older who are homozygous or heterozygous for Phe508del CFTR (EXTEND): an open-label extension study

Author

Gibson, Ronald L., Jr., Rowe, Steven M., Lechtzin, Noah, Ahrens, Richard C., McCoy, Karen S., Aitken, Moira, Donaldson, Scott H., McBennett, Kimberly Ann, Pilewski, Joseph M., Billings, Joanne, Milla, Carlos, Rubenstein, Ronald, Rosenbluth, Daniel Brian, Linnemann, Rachel, Powers, Michael R., Fortner, Christopher, Frederick, Carla Anne, Liou, Theodore G., Black, Philip, Wang, Janice, Colombo, John L., Berdella, Maria, Indihar, Maria Veronica, Brown, Cynthia D., Anstead, Michael, Bilodeau, Lara, Sicilian, Leonard, Jain, Manu, Tolle, James Jerome, Moffett, Kathryn, Nasr, Samya, Taylor-Cousar, Jennifer, Barto, Tara Lynn, Antos, Nicholas, Rogers, John S., Quick, Bryon, Thompson, Henry R., Sawicki, Gregory, Barnett, Bruce, Zanni, Robert L., Smith, Thomas C., Schultz, Karen D., Keating, Claire, Flume, Patrick, Omlor, Gregory J., Ashare, Alix, Voter, Karen, Mehdi, Nighat, Ortiz, Maria Gabriela Tupayachi, Gardner, Tonia E., Boas, Steven R., Messore, Barbara, Zemanick, Edith, Jain, Raksha, McCarthy, Michael, Kissner, Dana G., Patel, Kapilkumar, McNamara, John, Philley, Julie, Berlinski, Ariel, Calimano, Francisco J., Chin, Terry, Conrad, Douglas, Daines, Cori, Raissy, Hengameh H., Keens, Thomas G., Lascano, Jorge E., McWilliams, Bennie, Morrissey, Brian, Reyes, Santiago, Chittivelu, Subramanyam, Hussain, Sabiha, Stone, Arvey, Wallace, James, Klingsberg, Ross, Biller, Julie A., Bui, Stephanie, Sommerburg, Olaf, Bignamini, Elisabetta, Collura, Mirella, Biner, Reta Fischer, Moller, Alexander, Salvatore, Donatello, Belleguic, Chantal, Bentur, Lea, Efrati, Ori, Kerem, Eitan, Prais, Dario, Gallego, Esther Quintana, Barry, Peter, Livnat-Levanon, Galit, Asensi, Jose Ramon Villa, Armstrong, David Stuart, de la Cruz, Oscar Asensio, Gilchrist, Francis, Tullis, Diana Elizabeth, Quon, Bradley, Lands, Larry C., Morrison, Nancy, Lavoie, Annick, Linnane, Barry, Elidemir, Okan, Ringshausen, Felix, Kappler, Matthias, Hebestreit, Helge, Mainz, Jochen, Kiefer, Alexander, Koerner-Rettberg, Cordula, Staab, Doris, Gleiber, Wolfgang, Pressler, Tacjana, Stehling, Florian, Hector, Andreas, Sutharsan, Sivagurunathan, Naehrlich, Lutz, Fischer, Rainald, Downey, Damian, Davies, Jane Carolyn, Ketchell, Robert Ian, Carroll, Mary Patricia, Doe, Simon, MacGregor, Gordon, Nash, Edward Fairbairn, Withers, Nicholas, Peckham, Daniel Gavin, Ledson, Martin James, Kansra, Sonal, Lee, Timothy William Rayner, Delaisi, Bertrand, Rault, Gilles, Le Bihan, Jean, Hubert, Dominique, Fajac, Isabelle, Sermet-Gaudelus, Isabelle, Bakker, Marleen, Arets, Bert, De Boeck, Christiane, Chiron, Raphael, Reix, Philippe, Mainguy, Catherine, van Braeckel, Eva, Malfroot, Anne, Durieu, Isabelle, Dufeu, Nadine Desmazes, Prevotat, Anne, van der Meer, Renske, Merkus, Petrus, Weersink, E.J.M., Gomez-Aguero, Isabel Barrio, Gartner, Silvia, Jover, Amparo Sole, Fernandez, Antonio Alvarez, Cox, Desmond William, McKone, Edward F., Plant, Barry James, Selvadurai, Hiranjan, Bowler, Simon David, Wainwright, Claire Elizabeth, Smith, Daniel, Middleton, Peter Gordon, Wilson, John William, Volpi, Sonia, Colombo, Carla, Fabrizzi, Benedetta, Lucidi, Vincenzina, Cresta, Federico, Cucchiara, Salvatore, Eber, Ernst, Ellemunter, Helmut, Huttegger, Isidor, Hjelte, Lena, Krantz, Christina, Gilljam, Marita, Flume, Patrick A, Downey, Damian G, Brown, Cynthia, De Boeck, Kris, Sawicki, Gregory S, Chang, Philip, Paz-Diaz, Hildegarde, Rubin, Jaime L, Yang, Yoojung, Hu, Xingdi, Pasta, David J, Millar, Stefanie J, Campbell, Daniel, Wang, Xin, Ahluwalia, Neil, Owen, Caroline A, and Wainwright, Claire E

Published
2021
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14. Contextual Analysis of Comments in B2C Facebook Fan Pages Based on the Levenshtein Algorithm

Author

Jácome, Danny, Tapia, Freddy, Lascano, Jorge Edison, Fuertes, Walter, Kacprzyk, Janusz, Series Editor, Pal, Nikhil R., Advisory Editor, Bello Perez, Rafael, Advisory Editor, Corchado, Emilio S., Advisory Editor, Hagras, Hani, Advisory Editor, Kóczy, László T., Advisory Editor, Kreinovich, Vladik, Advisory Editor, Lin, Chin-Teng, Advisory Editor, Lu, Jie, Advisory Editor, Melin, Patricia, Advisory Editor, Nedjah, Nadia, Advisory Editor, Nguyen, Ngoc Thanh, Advisory Editor, Wang, Jun, Advisory Editor, Rocha, Álvaro, editor, Ferrás, Carlos, editor, and Paredes, Manolo, editor

Published
2019
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17. Anticoagulation and Antiplatelet Therapy for Prevention of Venous and Arterial Thrombotic Events in Critically Ill Patients With COVID-19: COVID-PACT

Author

Bohula, Erin A., primary, Berg, David D., additional, Lopes, Mathew S., additional, Connors, Jean M., additional, Babar, Ijlal, additional, Barnett, Christopher F., additional, Chaudhry, Sunit-Preet, additional, Chopra, Amit, additional, Ginete, Wilson, additional, Ieong, Michael H., additional, Katz, Jason N., additional, Kim, Edy Y., additional, Kuder, Julia F., additional, Mazza, Emilio, additional, McLean, Dalton, additional, Mosier, Jarrod M., additional, Moskowitz, Ari, additional, Murphy, Sabina A., additional, O’Donoghue, Michelle L., additional, Park, Jeong-Gun, additional, Prasad, Rajnish, additional, Ruff, Christian T., additional, Shahrour, Mohamad N., additional, Sinha, Shashank S., additional, Wiviott, Stephen D., additional, Van Diepen, Sean, additional, Zainea, Mark, additional, Baird-Zars, Vivian, additional, Sabatine, Marc S., additional, Morrow, David A., additional, Im, Kyung Ah, additional, Saxena, Retu, additional, Wiley, Brandon, additional, Benson, Carina, additional, Delamed, Roman, additional, Skeik, Nedaa, additional, Chopra, Ami, additional, Judson, Marc, additional, Beegle, Scott, additional, Shkolnik, Boris, additional, Tiwari, Anupama, additional, Wu, Gregory, additional, Raval, Abhijit, additional, Branch, Emerald, additional, Rischard, Franz, additional, Hypes, Cameron, additional, Bixby, Billie, additional, Bime, Christian, additional, Sundaram, Madhan, additional, Sweitzer, Nancy, additional, Sandoval, Alfredo Vazquez, additional, White, Heath, additional, Berg, Katherine, additional, Shaefi, Shahzad, additional, Donnino, Michael, additional, Carroll, Brett, additional, Ieong, Michael, additional, Ackerbauer, Kimberly, additional, Murphy, Jaime, additional, Bhatt, Ankeet, additional, Blood, Alexander, additional, Patel, Siddharth, additional, Luu, Victor, additional, Narechania, Shraddha, additional, Lorganger, Austin, additional, Plambeck, Robert, additional, Nayfeh, Ali, additional, Sanley, Michael, additional, Del Cor, Michel, additional, Hegg, AJ, additional, Nara, Winston, additional, Snyder, Michael, additional, Khan, Faisal, additional, Shawa, Imad, additional, Larned, Joshua, additional, Collado, Elias, additional, Al Faiyumi, Mohammed, additional, Mehta, Rajeev, additional, Komanapalli, Sudarshan, additional, Muppidi, Vijayadershan, additional, Desai, Mehul, additional, Flanagan, Casey, additional, Genovese, Leonard, additional, Haddad, Tariq, additional, King, Christopher, additional, Peterson, Amber, additional, Htun, Thane, additional, Pionk, Elizabeth, additional, Mouawad, Nicolas, additional, Kumar, Chintalapudi, additional, Nguyen, Kevin, additional, Mughal, Majid, additional, Malek, Ryan, additional, Parekh, Akarsh, additional, Provenzano, Christopher, additional, Ianitelli, Melissa, additional, Prentice-Gaytan, Nicole, additional, Bykowski, Adam, additional, Tait, Don, additional, Schendel, Shelley, additional, Yalamanchili, Varun, additional, Lala, Vasim, additional, Hunyadi, Victor, additional, Papolos, Alexander, additional, Kenigsberg, Benjamin, additional, Shenoy, Aarthi, additional, Stuckey, Thomas, additional, McQuaid, Douglas, additional, Mannam, Praveen, additional, McClung, Jeffrey, additional, Nilsson, Kent, additional, McKown, Andrew, additional, Wells, Jason, additional, Hotchkin, David, additional, Jacobs, Marc, additional, Strauss, Wayne, additional, Balestra, Rick, additional, Sahni, Vikram, additional, Snell, R. Jeffrey, additional, Suradi, Hussam, additional, Sungurlu, Sarah, additional, Kuppy, Jessica, additional, Gajo, Eileen, additional, Adams, Foster, additional, Shehadeh, Abbas, additional, Suleiman, Addi, additional, Nandigam, Harish, additional, Slim, Jihad, additional, Babar, Sardar Ijlal, additional, Baral, Dipti, additional, Nawaz, Talha, additional, Waheed, Syed Abdullah, additional, Roth, Randy, additional, Sitaula, Subhas, additional, Hayat, Shahid, additional, Babu, Jooby, additional, Caberto, Jason, additional, Hsu, Victor, additional, Chang, Robert, additional, Bochan, Markian, additional, Garcia-Cortes, Rafael, additional, Skopicki, Hal, additional, Chen, On, additional, Pilato, Lauren, additional, Richman, Paul, additional, Adler, Alexander, additional, Sudhindra, Praveen, additional, Beversdorf, Jamie, additional, Kashyap, Ravindra, additional, Mehta, Parth, additional, Mehrad, Borna, additional, Ataya, Ali, additional, Lascano, Jorge, additional, Brantly, Mark, additional, Austin, Adam, additional, Koman, Eduard, additional, Galski, Thomas, additional, Kumar, Vijaya, additional, Soubani, Ayman, additional, Harrison, Nicolas, additional, Reddy, Vineet, additional, and Fonkam, Audrey, additional

Published
2022
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22. Cigarette smoke exposed airway epithelial cell-derived EVs promote pro-inflammatory macrophage activation in alpha-1 antitrypsin deficiency

Author

Khodayari, Nazli, primary, Oshins, Regina, additional, Mehrad, Borna, additional, Lascano, Jorge E., additional, Qiang, Xiao, additional, West, Jesse R., additional, Holliday, L. Shannon, additional, Lee, Jungnam, additional, Wiesemann, Gayle, additional, Eydgahi, Soroush, additional, and Brantly, Mark, additional

Published
2022
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27. A sense of virtual community perspective

Author

Naranjo-Zolotov, Mijail, Turel, Ofir, Oliveira, Tiago, Lascano, Jorge Edison, Information Management Research Center (MagIC) - NOVA Information Management School, NOVA Information Management School (NOVA IMS), and NOVA IMS Research and Development Center (MagIC)

Subjects
Social media, Human-Computer Interaction, Arts and Humanities (miscellaneous), SDG 3 - Good Health and Well-being, SDG 16 - Peace, Justice and Strong Institutions, Self-assertion, Social media addiction, Public unrest, Sense of virtual community, Psychology(all)
Abstract

Naranjo-Zolotov, M., Turel, O., Oliveira, T., & Lascano, J. E. (2021). Drivers of online social media addiction in the context of public unrest: A sense of virtual community perspective. Computers in Human Behavior, 121, 1-8. [106784]. https://doi.org/10.1016/j.chb.2021.106784 During periods of public unrest, people tend to increase their daily usage of social media sites, such as Facebook, Instagram, or WhatsApp, to keep themselves abreast of developments and share their opinions. Over the last trimester of 2019, there were many demonstrations of public unrest in Latin-American countries, including Ecuador, Chile, and Bolivia. These events boosted the social media use. Individuals are exposed to information that is more sensitive and engaging than what is encountered in less agitated times. For instance, images of clashes between demonstrators and police, graphic violence, fake news, and accusations become more plentiful. The increased online interaction and the engaging nature of information during extended periods of public unrest may encourage the development of social media addiction. This study explores the sense of virtual community theory and uses self-assertion as moderator to capture the drivers of online social media addiction in the context of public unrest. Results reveal that immersion has a significant association with addiction, and self-assertion moderates the relationship between influence and membership. authorsversion published

Published
2021

28. A Randomized Clinical Trial of Antimicrobial Duration for Cystic Fibrosis Pulmonary Exacerbation Treatment

Author

Goss, Christopher H., primary, Heltshe, Sonya L., additional, West, Natalie E., additional, Skalland, Michelle, additional, Sanders, Don B., additional, Jain, Raksha, additional, Barto, Tara L., additional, Fogarty, Barbra, additional, Marshall, Bruce C., additional, VanDevanter, Donald R., additional, Flume, Patrick A., additional, Omlor, Gregory, additional, Bourne, Brenda, additional, Roberts, Dion, additional, Roberts, Vicki, additional, Nasr, Samya, additional, Kruse, Dawn, additional, Linnemann, Rachel, additional, Hailemichael, Tsion, additional, Forseen, Caralee, additional, Stapp, Heidi, additional, West, Natalie, additional, Patel, S., additional, Claudio, A., additional, Lysinger, Jerimiah, additional, Harmala, Amy, additional, Solomon, George, additional, Kersh, Latona, additional, Miller, Karen, additional, Durham, Dixie, additional, Uluer, Ahmet, additional, Fowler, Robert, additional, Frederick, Carla, additional, Caci, Nadine, additional, Teneback, Charlotte, additional, Sweet, Julie, additional, Parkins, Michael, additional, Smith, Clare, additional, Goralski, Jennifer, additional, Haywood, Kelsey, additional, Flume, Patrick, additional, Brailsford, Caroline, additional, Albon, Dana, additional, Aderholt, Christie, additional, McBennett, Kimberly, additional, Schaefer, Cindy, additional, Patel, Alpa, additional, Hunt, April, additional, Schumacher, Lauren, additional, Polenakovik, Hari, additional, Clark, Linda, additional, Nick, Jerry, additional, Poch, Katie, additional, Kissner, Dana, additional, Cahill, James, additional, Lascano, Jorge, additional, Silverman, Erin, additional, McArdle, John, additional, Champagne, Alison, additional, Vender, Robert, additional, Allwein, Lisa, additional, Cohen, Lance, additional, Barton, Norma (Jean), additional, Barto, Tara, additional, Patel, Ami, additional, Brown, Cynthia, additional, Vorhees, Nia, additional, Crosser, Michael, additional, Scott, Lawrence, additional, Ashare, Alix, additional, Rodgers, Barbara, additional, Zanni, Robert, additional, Koval, Lisa, additional, Braun, Andrew, additional, Stevens, Sophia Chiron, additional, Ortiz, Maria Tupayachi, additional, Graham, Patricia, additional, Biller, Julie, additional, Hubertz, Erin, additional, Moffett, Kathryn, additional, Clark, Tammy, additional, Griffith, Rebecca, additional, Martinez, Nancy, additional, Hussain, Sabiha, additional, Chen, Fei, additional, Egan, Marie, additional, Guzman, Catalina, additional, Wang, Janice, additional, Espinal, Aileen, additional, Walker, Patricia, additional, Kukral, Anne, additional, DiMango, Emily, additional, Francis, Sarah Fracasso, additional, Milla, Carlos, additional, Dunn, Colleen, additional, Chittivelu, Subramanyam, additional, Scott, Ashley, additional, Dorgan, Daniel, additional, Ng, Sharon, additional, Pilewski, Joseph, additional, Lanzo, Rose, additional, Chaudary, Nauman, additional, Hayden, Ryan, additional, Scofield, Steven, additional, Johnson, Barb, additional, Morrissey, Brian, additional, Robinson, Brandt, additional, Conrad, Douglas, additional, Mielke, Jenna, additional, Aitken, Moira, additional, Sanlors, Chami, additional, Nayak, Ravi, additional, Branch, Freda, additional, Rosenbluth, Daniel, additional, Siegel, Molly, additional, Ghimire, Anil, additional, Forell, Mary, additional, Daines, Cori, additional, Varela, Monica, additional, Couch, Leslie, additional, Hibbard, Rebekah, additional, Dozor, Allen, additional, Ramirez, Armando, additional, Ortega, Victor, additional, Kennedy, Kathryn, additional, Fish, David, additional, and Longtine, Karen, additional

Published
2021
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29. Testing the effects of combining azithromycin with inhaled tobramycin for P. aeruginosa in cystic fibrosis: a randomised, controlled clinical trial

Author

Nichols, David P, primary, Singh, Pradeep K, additional, Baines, Arthur, additional, Caverly, Lindsay J, additional, Chmiel, James F, additional, GIbson, Ronald L, additional, Lascano, Jorge, additional, Morgan, Sarah J, additional, Retsch-Bogart, George, additional, Saiman, Lisa, additional, Sadeghi, Hossein, additional, Billings, Joanne L, additional, Heltshe, Sonya L, additional, Kirby, Shannon, additional, Kong, Ada, additional, Nick, Jerry A, additional, and Mayer-Hamblett, Nicole, additional

Published
2021
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32. Long-term safety and efficacy of tezacaftor–ivacaftor in individuals with cystic fibrosis aged 12 years or older who are homozygous or heterozygous for Phe508del CFTR (EXTEND): an open-label extension study

Author

Flume, Patrick A, primary, Biner, Reta Fischer, additional, Downey, Damian G, additional, Brown, Cynthia, additional, Jain, Manu, additional, Fischer, Rainald, additional, De Boeck, Kris, additional, Sawicki, Gregory S, additional, Chang, Philip, additional, Paz-Diaz, Hildegarde, additional, Rubin, Jaime L, additional, Yang, Yoojung, additional, Hu, Xingdi, additional, Pasta, David J, additional, Millar, Stefanie J, additional, Campbell, Daniel, additional, Wang, Xin, additional, Ahluwalia, Neil, additional, Owen, Caroline A, additional, Wainwright, Claire E, additional, Gibson, Ronald L., additional, Rowe, Steven M., additional, Lechtzin, Noah, additional, Ahrens, Richard C., additional, McCoy, Karen S., additional, Aitken, Moira, additional, Donaldson, Scott H., additional, McBennett, Kimberly Ann, additional, Pilewski, Joseph M., additional, Billings, Joanne, additional, Milla, Carlos, additional, Rubenstein, Ronald, additional, Rosenbluth, Daniel Brian, additional, Linnemann, Rachel, additional, Powers, Michael R., additional, Fortner, Christopher, additional, Frederick, Carla Anne, additional, Liou, Theodore G., additional, Black, Philip, additional, Wang, Janice, additional, Colombo, John L., additional, Berdella, Maria, additional, Indihar, Maria Veronica, additional, Brown, Cynthia D., additional, Anstead, Michael, additional, Bilodeau, Lara, additional, Sicilian, Leonard, additional, Tolle, James Jerome, additional, Moffett, Kathryn, additional, Nasr, Samya, additional, Taylor-Cousar, Jennifer, additional, Barto, Tara Lynn, additional, Antos, Nicholas, additional, Rogers, John S., additional, Quick, Bryon, additional, Thompson, Henry R., additional, Sawicki, Gregory, additional, Barnett, Bruce, additional, Zanni, Robert L., additional, Smith, Thomas C., additional, Schultz, Karen D., additional, Keating, Claire, additional, Flume, Patrick, additional, Omlor, Gregory J., additional, Ashare, Alix, additional, Voter, Karen, additional, Mehdi, Nighat, additional, Ortiz, Maria Gabriela Tupayachi, additional, Gardner, Tonia E., additional, Boas, Steven R., additional, Messore, Barbara, additional, Zemanick, Edith, additional, Jain, Raksha, additional, McCarthy, Michael, additional, Kissner, Dana G., additional, Patel, Kapilkumar, additional, McNamara, John, additional, Philley, Julie, additional, Berlinski, Ariel, additional, Calimano, Francisco J., additional, Chin, Terry, additional, Conrad, Douglas, additional, Daines, Cori, additional, Raissy, Hengameh H., additional, Keens, Thomas G., additional, Lascano, Jorge E., additional, McWilliams, Bennie, additional, Morrissey, Brian, additional, Reyes, Santiago, additional, Chittivelu, Subramanyam, additional, Hussain, Sabiha, additional, Stone, Arvey, additional, Wallace, James, additional, Klingsberg, Ross, additional, Biller, Julie A., additional, Bui, Stephanie, additional, Sommerburg, Olaf, additional, Bignamini, Elisabetta, additional, Collura, Mirella, additional, Moller, Alexander, additional, Salvatore, Donatello, additional, Belleguic, Chantal, additional, Bentur, Lea, additional, Efrati, Ori, additional, Kerem, Eitan, additional, Prais, Dario, additional, Gallego, Esther Quintana, additional, Barry, Peter, additional, Livnat-Levanon, Galit, additional, Asensi, Jose Ramon Villa, additional, Armstrong, David Stuart, additional, de la Cruz, Oscar Asensio, additional, Gilchrist, Francis, additional, Tullis, Diana Elizabeth, additional, Quon, Bradley, additional, Lands, Larry C., additional, Morrison, Nancy, additional, Lavoie, Annick, additional, Linnane, Barry, additional, Elidemir, Okan, additional, Ringshausen, Felix, additional, Kappler, Matthias, additional, Hebestreit, Helge, additional, Mainz, Jochen, additional, Kiefer, Alexander, additional, Koerner-Rettberg, Cordula, additional, Staab, Doris, additional, Gleiber, Wolfgang, additional, Pressler, Tacjana, additional, Stehling, Florian, additional, Hector, Andreas, additional, Sutharsan, Sivagurunathan, additional, Naehrlich, Lutz, additional, Downey, Damian, additional, Davies, Jane Carolyn, additional, Ketchell, Robert Ian, additional, Carroll, Mary Patricia, additional, Doe, Simon, additional, MacGregor, Gordon, additional, Nash, Edward Fairbairn, additional, Withers, Nicholas, additional, Peckham, Daniel Gavin, additional, Ledson, Martin James, additional, Kansra, Sonal, additional, Lee, Timothy William Rayner, additional, Delaisi, Bertrand, additional, Rault, Gilles, additional, Le Bihan, Jean, additional, Hubert, Dominique, additional, Fajac, Isabelle, additional, Sermet-Gaudelus, Isabelle, additional, Bakker, Marleen, additional, Arets, Bert, additional, De Boeck, Christiane, additional, Chiron, Raphael, additional, Reix, Philippe, additional, Mainguy, Catherine, additional, van Braeckel, Eva, additional, Malfroot, Anne, additional, Durieu, Isabelle, additional, Dufeu, Nadine Desmazes, additional, Prevotat, Anne, additional, van der Meer, Renske, additional, Merkus, Petrus, additional, Weersink, E.J.M., additional, Gomez-Aguero, Isabel Barrio, additional, Gartner, Silvia, additional, Jover, Amparo Sole, additional, Fernandez, Antonio Alvarez, additional, Cox, Desmond William, additional, McKone, Edward F., additional, Plant, Barry James, additional, Selvadurai, Hiranjan, additional, Bowler, Simon David, additional, Wainwright, Claire Elizabeth, additional, Smith, Daniel, additional, Middleton, Peter Gordon, additional, Wilson, John William, additional, Volpi, Sonia, additional, Colombo, Carla, additional, Fabrizzi, Benedetta, additional, Lucidi, Vincenzina, additional, Cresta, Federico, additional, Cucchiara, Salvatore, additional, Eber, Ernst, additional, Ellemunter, Helmut, additional, Huttegger, Isidor, additional, Hjelte, Lena, additional, Krantz, Christina, additional, and Gilljam, Marita, additional

Published
2021
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33. Testing the effects of combining azithromycin with inhaled tobramycin for in cystic fibrosis: a randomised, controlled clinical trial.

Author

Nichols, David P., Singh, Pradeep K., Baines, Arthur, Caverly, Lindsay J., Chmiel, James F., GIbson, Ronald L., Lascano, Jorge, Morgan, Sarah J., Retsch-Bogart, George, Saiman, Lisa, Sadeghi, Hossein, Billings, Joanne L., Heltshe, Sonya L., Kirby, Shannon, Kong, Ada, Nick, Jerry A., Mayer-Hamblett, Nicole, and TEACH Study Group

Subjects
ANTIBIOTICS, RESEARCH, TOBRAMYCIN, RESEARCH methodology, EVALUATION research, CYSTIC fibrosis, COMPARATIVE studies, RANDOMIZED controlled trials, PSEUDOMONAS diseases, FORCED expiratory volume, RESEARCH funding, INHALATION administration, PSEUDOMONAS, AZITHROMYCIN, LONGITUDINAL method, DISEASE complications
Abstract

Rationale: Inhaled tobramycin and oral azithromycin are common chronic therapies in people with cystic fibrosis and Pseudomonas aeruginosa airway infection. Some studies have shown that azithromycin can reduce the ability of tobramycin to kill P. aeruginosa. This trial was done to test the effects of combining azithromycin with inhaled tobramycin on clinical and microbiological outcomes in people already using inhaled tobramycin. We theorised that those randomised to placebo (no azithromycin) would have greater improvement in forced expiratory volume in one second (FEV1) and greater reduction in P. aeruginosa sputum in response to tobramycin.Methods: A 6-week prospective, randomised, placebo-controlled, double-blind trial testing oral azithromycin versus placebo combined with clinically prescribed inhaled tobramycin in individuals with cystic fibrosis and P. aeruginosa airway infection.Results: Over a 6-week period, including 4 weeks of inhaled tobramycin, the relative change in FEV1 did not statistically significantly differ between groups (azithromycin (n=56) minus placebo (n=52) difference: 3.44%; 95% CI: -0.48 to 7.35; p=0.085). Differences in secondary clinical outcomes, including patient-reported symptom scores, weight and need for additional antibiotics, did not significantly differ. Among the 29 azithromycin and 35 placebo participants providing paired sputum samples, the 6-week change in P. aeruginosa density differed in favour of the placebo group (difference: 0.75 log10 CFU/mL; 95% CI: 0.03 to 1.47; p=0.043).Conclusions: Despite having greater reduction in P. aeruginosa density in participants able to provide sputum samples, participants randomised to placebo with inhaled tobramycin did not experience significantly greater improvements in lung function or other clinical outcomes compared with those randomised to azithromycin with tobramycin. [ABSTRACT FROM AUTHOR]

Published
2022
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36. Oral cysteamine as an adjunct treatment in cystic fibrosis pulmonary exacerbations: An exploratory randomized clinical trial

Author

Devereux, Graham, primary, Wrolstad, Danielle, additional, Bourke, Stephen J., additional, Daines, Cori L., additional, Doe, Simon, additional, Dougherty, Ryan, additional, Franco, Rose, additional, Innes, Alastair, additional, Kopp, Benjamin T., additional, Lascano, Jorge, additional, Layish, Daniel, additional, MacGregor, Gordon, additional, Murray, Lorna, additional, Peckham, Daniel, additional, Lucidi, Vincenzina, additional, Lovie, Emma, additional, Robertson, Jennifer, additional, Fraser-Pitt, Douglas J., additional, and O'Neil, Deborah A., additional

Published
2020
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46. Testing the effects of combining azithromycin with inhaled tobramycin for P. aeruginosain cystic fibrosis: a randomised, controlled clinical trial

Author

Nichols, David P, Singh, Pradeep K, Baines, Arthur, Caverly, Lindsay J, Chmiel, James F, GIbson, Ronald L, Lascano, Jorge, Morgan, Sarah J, Retsch-Bogart, George, Saiman, Lisa, Sadeghi, Hossein, Billings, Joanne L, Heltshe, Sonya L, Kirby, Shannon, Kong, Ada, Nick, Jerry A, and Mayer-Hamblett, Nicole

Abstract

RationaleInhaled tobramycin and oral azithromycin are common chronic therapies in people with cystic fibrosis and Pseudomonas aeruginosaairway infection. Some studies have shown that azithromycin can reduce the ability of tobramycin to kill P. aeruginosa. This trial was done to test the effects of combining azithromycin with inhaled tobramycin on clinical and microbiological outcomes in people already using inhaled tobramycin. We theorised that those randomised to placebo (no azithromycin) would have greater improvement in forced expiratory volume in one second (FEV1) and greater reduction in P. aeruginosasputum in response to tobramycin.MethodsA 6-week prospective, randomised, placebo-controlled, double-blind trial testing oral azithromycin versus placebo combined with clinically prescribed inhaled tobramycin in individuals with cystic fibrosis and P. aeruginosaairway infection.ResultsOver a 6-week period, including 4 weeks of inhaled tobramycin, the relative change in FEV1did not statistically significantly differ between groups (azithromycin (n=56) minus placebo (n=52) difference: 3.44%; 95% CI: −0.48 to 7.35; p=0.085). Differences in secondary clinical outcomes, including patient-reported symptom scores, weight and need for additional antibiotics, did not significantly differ. Among the 29 azithromycin and 35 placebo participants providing paired sputum samples, the 6-week change in P. aeruginosadensity differed in favour of the placebo group (difference: 0.75 log10CFU/mL; 95% CI: 0.03 to 1.47; p=0.043).ConclusionsDespite having greater reduction in P. aeruginosadensity in participants able to provide sputum samples, participants randomised to placebo with inhaled tobramycin did not experience significantly greater improvements in lung function or other clinical outcomes compared with those randomised to azithromycin with tobramycin.

Published
2022
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