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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

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

Subjects
Pulmonary and Respiratory Medicine
Published
2023
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2. Results of a Phase 2b Trial With GB001, a Prostaglandin D2 Receptor 2 Antagonist, in Moderate to Severe Eosinophilic Asthma

Author

Mark H. Moss, Njira L. Lugogo, Mario Castro, Nicola A. Hanania, Andrea Ludwig-Sengpiel, Dinesh Saralaya, Rafal Dobek, Iñigo Ojanguren, Ivan Vyshnyvetskyy, Jean-Marie Bruey, Robin Osterhout, Cindy-ann Tompkins, Karen Dittrich, Kartik Raghupathi, Hector Ortega, Institut Català de la Salut, [Moss MH] Division of Allergy, Pulmonary and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. [Lugogo NL] Division of Pulmonary & Critical Care Medicine, University of Michigan, Ann Arbor, MI, USA. [Castro M] Division of Pulmonary, Critical Care & Sleep Medicine, University of Kansas, Kansas City, KS, USA. [Hanania NA] Section of Pulmonary & Critical Care Medicine, Baylor College of Medicine, Houston, TX, USA. [Ludwig-Sengpiel A] KLB Gesundheitsforschung Lübeck, Lübeck, Germany. [Saralaya D] NIHR PRC, Bradford Institute for Health Research, Bradford, England. [Ojanguren I] Servei de Pneumologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. CIBER de Enfermedades Respiratorias, Barcelona, Catalonia, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Pulmonary and Respiratory Medicine, Otros calificadores::/uso terapéutico [Otros calificadores], Asma - Tractament, Respiratory Tract Diseases::Bronchial Diseases::Asthma [DISEASES], Critical Care and Intensive Care Medicine, enfermedades respiratorias::enfermedades bronquiales::asma [ENFERMEDADES], Respiratory Tract Diseases::Lung Diseases::Pulmonary Eosinophilia [DISEASES], enfermedades respiratorias::enfermedades pulmonares::eosinofilia pulmonar [ENFERMEDADES], Other subheadings::/therapeutic use [Other subheadings], acciones y usos químicos::acciones farmacológicas::usos terapéuticos::fármacos del sistema respiratorio::antiasmáticos [COMPUESTOS QUÍMICOS Y DROGAS], Cardiology and Cardiovascular Medicine, Eosinofília, Medicaments antiasmàtics - Ús terapèutic, Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Respiratory System Agents::Anti-Asthmatic Agents [CHEMICALS AND DRUGS]
Abstract

Asthma; Asthma worsening; Eosinophilic asthma Asma; Empitjorament de l'asma; Asma eosinofílica Asma; Empeoramiento del asma; Asma eosinofílica Background Prostaglandin D2 receptor 2 (DP2) antagonists inhibit prostaglandin D2-induced effects, including recruitment and activation of cells driving asthma pathogenesis. However, challenges identifying target population and end points persist. Research Question What is the effect of the DP2 antagonist GB001 on asthma worsening in patients with moderate to severe eosinophilic asthma? Study Design and Methods In this phase IIb, randomized, double-blind, placebo-controlled, dose-ranging, parallel-group, multicenter study, GB001 or placebo was added to standard-of-care treatment in patients with moderate to severe asthma with a blood eosinophil count ≥ 250 cells/μL. Patients aged ≥ 18 years to < 75 years received one of four once-daily treatments (GB001 20 mg, 40 mg, or 60 mg or placebo). The primary end point was the proportion of patients who experienced asthma worsening by 24 weeks. Efficacy analyses were performed for the intention-to-treat population and safety analyses for patients who received at least one dose of study treatment. Results A total of 480 patients were treated. The ORs for asthma worsening for GB001 20 mg, 40 mg, and 60 mg vs placebo were 0.674 (95% CI, 0.398-1.142), 0.677 (95% CI, 0.399-1.149), and 0.651 (95% CI, 0.385-1.100), respectively. Analysis according to baseline blood eosinophil levels and/or fractional exhaled nitric oxide did not show greater treatment effects with higher values. Elevated liver aminotransferase levels and adverse events leading to discontinuation were more frequent for GB001 60 mg than with placebo, GB001 20 mg, and GB001 40 mg. Interpretation Although GB001 did not significantly reduce the odds of asthma worsening, reductions favoring GB001 were observed. Treatment effects were consistent regardless of high/low type 2 phenotype. The overall safety profile was acceptable, although GB001 60 mg was associated with risk of liver injury. This work was supported by GB001, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

Published
2022
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3. 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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4. Evaluation of the oral corticosteroid-sparing effect of tezepelumab in adults with oral corticosteroid-dependent asthma (SOURCE): a randomised, placebo-controlled, phase 3 study

Author

Wechsler, Michael E, primary, Menzies-Gow, Andrew, additional, Brightling, Christopher E, additional, Kuna, Piotr, additional, Korn, Stephanie, additional, Welte, Tobias, additional, Griffiths, Janet M, additional, Sałapa, Kinga, additional, Hellqvist, Åsa, additional, Almqvist, Gun, additional, Lal, Harbans, additional, Kaur, Primal, additional, Skärby, Tor, additional, Colice, Gene, additional, Cambursano, Victor H, additional, Fernandez, Marcelo J, additional, Scherbovsky, Fernando D, additional, Yanez, Anahi, additional, Tolcachier, Alberto J, additional, Stok, Ana M, additional, Verra, Fernando J B, additional, Forster, Karin, additional, Rolke, Mathias, additional, Ludwig-Sengpiel, Andrea, additional, Schmoller, Tibor, additional, Schmidt, Olaf, additional, Milger-Kneidinger, Katrin, additional, Hoffmann, Martin, additional, Temme, Hilke, additional, Linnhoff, Anneliese, additional, Kirschner, Joachim, additional, Rewerska, Barbara, additional, Pisarczyk-Bogacka, Ewa, additional, Haak Lee, Sang, additional, Jae Lee, Byung, additional, Park, Heung-Woo, additional, Park, Jung-Won, additional, Young Lee, Sook, additional, Sook Cho, You, additional, Ho Lee, Kwan, additional, Bavbek, Sevim, additional, Gemicioglu, Bilun, additional, Ediger, Dane, additional, Koca Kalkan, Ilkay, additional, Hanta, Ismail, additional, Yorgancioglu, Arzu, additional, DytyatkovsKa, Yevgeniya, additional, Mostovoy, Yuriy M, additional, Lebed, Kyrylo, additional, Yakovenko, Oleh, additional, Bernstein, David I, additional, Tillinghast, Jeffrey P, additional, Que, Loretta, additional, Madison, Jan, additional, Rambasek, Todd, additional, Shenoy, Kartik, additional, Thompson, Charles A, additional, Chappel, Christopher M, additional, Hudes, Golda, additional, Sorial, Ehab, additional, Kureishy, Shahrukh A, additional, Rehman, Syed M, additional, Lugogo, Njira, additional, Gonzalez, Erika G, additional, Umeh, Fred C, additional, Boren, Eric J, additional, Sigmon, Jason, additional, Ismail, Hummayun, additional, Mohan, Arjun, additional, Bansal, Sandeep, additional, and Kaelin, Thomas D, additional

Published
2022
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5. 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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6. Identification of airway mucosal type 2 inflammation by using clinical biomarkers in asthmatic patients

Author

J. Mark FitzGerald, Richard Leigh, Joel N. Kline, Stephen Lam, Matthew J. Loza, Andreas Eich, Frédéric Baribaud, Patrick Berger, P. Chanez, Philip E. Silkoff, Dave Singh, Vedrana S. Susulic, Steven G. Kelsen, Elliot S. Barnathan, Michel Laviolette, Azra Hussaini, Irina Strambu, William J. Calhoun, Andrea Ludwig-Sengpiel, Geoffrey Chupp, Mark T. Dransfield, Vibeke Backer, Pierre Olivier Girodet, and Celeste Porsbjerg

Subjects
Adult, Male, 0301 basic medicine, Adolescent, Immunology, Gene Expression, Inflammation, Respiratory Mucosa, Periostin, Nitric Oxide, Severity of Illness Index, Cell Line, Leukocyte Count, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Humans, Immunology and Allergy, CCL17, Medicine, Asthma, Interleukin-13, Chemokine CCL26, business.industry, Middle Aged, respiratory system, medicine.disease, Respiratory Function Tests, respiratory tract diseases, Eosinophils, 030104 developmental biology, 030228 respiratory system, Chemokines, CC, Exhaled nitric oxide, Population study, Female, Chemokine CCL17, CCL26, medicine.symptom, business, Airway, Cell Adhesion Molecules, Biomarkers
Abstract

Background The Airways Disease Endotyping for Personalized Therapeutics (ADEPT) study profiled patients with mild, moderate, and severe asthma and nonatopic healthy control subjects. Objective We explored this data set to define type 2 inflammation based on airway mucosal IL-13–driven gene expression and how this related to clinically accessible biomarkers. Methods IL-13–driven gene expression was evaluated in several human cell lines. We then defined type 2 status in 25 healthy subjects, 28 patients with mild asthma, 29 patients with moderate asthma, and 26 patients with severe asthma based on airway mucosal expression of (1) CCL26 (the most differentially expressed gene), (2) periostin, or (3) a multigene IL-13 in vitro signature (IVS). Clinically accessible biomarkers included fraction of exhaled nitric oxide (Feno) values, blood eosinophil (bEOS) counts, serum CCL26 expression, and serum CCL17 expression. Results Expression of airway mucosal CCL26, periostin, and IL-13–IVS all facilitated segregation of subjects into type 2–high and type 2–low asthmatic groups, but in the ADEPT study population CCL26 expression was optimal. All subjects with high airway mucosal CCL26 expression and moderate-to-severe asthma had Feno values (≥35 ppb) and/or high bEOS counts (≥300 cells/mm 3 ) compared with a minority (36%) of subjects with low airway mucosal CCL26 expression. A combination of Feno values, bEOS counts, and serum CCL17 and CCL26 expression had 100% positive predictive value and 87% negative predictive value for airway mucosal CCL26–high status. Clinical variables did not differ between subjects with type 2–high and type 2–low status. Eosinophilic inflammation was associated with but not limited to airway mucosal type 2 gene expression. Conclusion A panel of clinical biomarkers accurately classified type 2 status based on airway mucosal CCL26, periostin, or IL-13–IVS gene expression. Use of Feno values, bEOS counts, and serum marker levels (eg, CCL26 and CCL17) in combination might allow patient selection for novel type 2 therapeutics.

Published
2017
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7. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials

Author

Fabbri, Leonardo M., Calverley, Peter M. A., Jose Luis Izquierdo Alonso, Bundschuh, Daniela S., Manja, Brose, Martinez, Fernando J., Rabe, Kf M., Study Groups Abdulla, M., Abdullah, I., Adler, M., Aguilaniu, Albert, I., Almonacid, C., Altés, A., Amaducci, S., Angrill, J., Antonana, J. M., Artner, H., Balint, B., Bantje, T. A., Barbe, F., Bateman, E., Bauchnect, E., Belda, J., Bernabeu, L., Bettendorf, A., Blagden, M., Blanquer, R., Blecher, L., Bonnaud, F., Bourbeau, J., Boyer, G. R., Brotons, C., Bruning, A. H., Bucca, C., Burns, G. E., Von Der Heydt, B. B., Caldwell, Canonica, G. W., Carter, J., Chan, V., Chapman, K. R., Chapman, G., Cheung, D., Chiner, E., Chopra, A., Clini, E., Coulet, P., Craig, B., Croonenborghs, L., Czompó, M., Dal Negro, R. W., Dapper, T., De Graaff, C. S., Ramos Pde, L., De Munck, D. R., Decramer, M., Delobbe, A., Denier, W., De Teresa, L., Dhar, A., Di Maria, G., Dupouy, J., Duschek, G., Echave, J., Esteban, C., Farmer, I. S., Flemale, A., Fletcher, P., Foden, Fouquert, L., Franz, K. H., Frognier, Gagnon, M., Garcia, Mdel M., Garelli, G., Gehling, U., Ginko, T., Glekin, B., Gooding, T., Graham, A., Greillier, P., Greses, J. V., Grillenberger, J., Gross, B., Grygier, H., Gyori, Z., Harper, Henein, S., Heredia, J. L., Hernandez, P., Hoefer, M., Hoffstein, V., Holgate, K., Holler, W., Holub, G., Homik, L., Houle, P. A., Hutter, C., Hyvernat, P., Irusen, E. M., Jackson, A., Janisty, W., Jasnot, J. Y., Joubert, J., Juhasz, G., Jullian, H., Kafe, H., Kelly, P., Kidney, J., Killian, K., Kinch, H., Kirsten, D. L., Kleinecke Pohl, U., Korlipara, K., Krige, L. P., Kroker, A., Kuipers, A. F., Labrecque, M., Larivee, P., Laskowitz, C., Le Merre, C., Lemoigne, F., Ludwig Sengpiel, A., Luengo, M., Luton, R., Macnee, W., Ali, S. M., Maltais, F., Mansur, A., Marciniuk, D., Marin, A., Martin, P., Martinot, J. B., Mazza, F., Bride, M. C., Mcdonald, B., Mckinnon, C., Mclvor, A., Mcnally, D., Mengeot, P. M., Messner, J., Moder, G., Mooney, P., Moretti, A. M., Muller, D., Murio, C., Nardini, S., Nel, A., Ochoa, Saracho Jo, D. E., Paggiaro, P., Paradis, B., Patrick, J., Peche, R., Pellicer, C., Perez, T., Perez, E., De Llano, L. A., Philteos, G., Pieters, W. R., Pigearias, B., Pohl, W., Popovic, R., Prins, M., Querfurt, H., Rajkay, K., Ras, G., Road, J., Roig, J., Roldaan, A. C., Rolke, M., Rozen, D., Sanchez Toril, F., Savani, N., Savary, L., Schiavina, M., Schiesbühl, H., Schreurs, A. J., Schröder Babo, W., Schurmann, W., Seiz, V., Sevette, C., Sharma, R., Shum, C., Damsté, H. E., Smithers, A., Soler, J. J., Steffen, H., Steinhauser, U., Sweilem, M., Tellier, G., Terol, B., Terzano, Claudio, Timar, M., Toma, G., Monserrat, P. T., Trauth, H. A., Valyon, E., Brande Van Den, Van Noord, J. A., Vaquer, J. V., Hernandez Hector, H. V., Vereecken, G., Verkindre, C., Vigh, M., Viljoen, J. J., Vincken, W., Vinkler, I., Visser, S., Volgmann, L., Vorderstrasse, W., Voves, R., Vrancken, F., Weber, H. H., Wielders, P. L., Willoughby, P., Wurtz, J., Yang, W., Zabaleta, M., Zachgo, W., Zanini, A., Zeiner, M., Michael, H., Janistyn, W., Abdulla, R., Terzano, C., Fabbri, L., Barbaro, M. P., Izquierdo, J. L., Ramos, Pde L., and Harper, Ochoa

Subjects
Chronic bronchitis, medicine.drug_class, glucocorticosteroids, Placebo, exacerbations, Bronchodilator, medicine, COPD, humans, Roflumilast, Intention-to-treat analysis, business.industry, Body weight, chronic bronchitis, emphysema, inflammation, lung function, phosphodiesterase 4 inhibitor, PDE4, General Medicine, Tiotropium bromide, medicine.disease, respiratory tract diseases, Anesthesia, Salmeterol, business, medicine.drug
Abstract

Summary Background Patients with chronic obstructive pulmonary disease (COPD) have few options for treatment. The efficacy and safety of the phosphodiesterase-4 inhibitor roflumilast have been investigated in studies of patients with moderate-to-severe COPD, but not in those concomitantly treated with longacting inhaled bronchodilators. The effect of roflumilast on lung function in patients with COPD that is moderate to severe who are already being treated with salmeterol or tiotropium was investigated. Methods In two double-blind, multicentre studies done in an outpatient setting, after a 4-week run-in, patients older than 40 years with moderate-to-severe COPD were randomly assigned to oral roflumilast 500 μg or placebo once a day for 24 weeks, in addition to salmeterol (M2-127 study) or tiotropium (M2-128 study). The primary endpoint was change in prebronchodilator forced expiratory volume in 1 s (FEV 1 ). Analysis was by intention to treat. The studies are registered with ClinicalTrials.gov, number NCT00313209 for M2-127, and NCT00424268 for M2-128. Findings In the salmeterol plus roflumilast trial, 466 patients were assigned to and treated with roflumilast and 467 with placebo; in the tiotropium plus roflumilast trial, 371 patients were assigned to and treated with roflumilast and 372 with placebo. Compared with placebo, roflumilast consistently improved mean prebronchodilator FEV 1 by 49 mL (p 1 was noted in both groups. Furthermore, roflumilast had beneficial effects on other lung function measurements and on selected patient-reported outcomes in both groups. Nausea, diarrhoea, weight loss, and, to a lesser extent, headache were more frequent in patients in the roflumilast groups. These adverse events were associated with increased patient withdrawal. Interpretation Roflumilast improves lung function in patients with COPD treated with salmeterol or tiotropium, and could become an important treatment for these patients. Funding Nycomed.

Published
2009
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8. Identification of airway mucosal type 2 inflammation by using clinical biomarkers in asthmatic patients

Author

Silkoff, Philip E., primary, Laviolette, Michel, additional, Singh, Dave, additional, FitzGerald, J. Mark, additional, Kelsen, Steven, additional, Backer, Vibeke, additional, Porsbjerg, Celeste M., additional, Girodet, Pierre-Olivier, additional, Berger, Patrick, additional, Kline, Joel N., additional, Chupp, Geoffrey, additional, Susulic, Vedrana S., additional, Barnathan, Elliot S., additional, Baribaud, Frédéric, additional, Loza, Matthew J., additional, Strambu, I., additional, Lam, S., additional, Eich, A., additional, Ludwig-Sengpiel, A., additional, Leigh, R., additional, Dransfield, M., additional, Calhoun, W., additional, Hussaini, A., additional, and Chanez, P., additional

Published
2017
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