Phase 2B study of inhaled RVT-1601 for chronic cough in idiopathic pulmonary fibrosis: a multicenter, randomized, placebo-controlled study (SCENIC Trial)
Rationale: Chronic cough remains a major and often debilitating symptom for patients with idiopathic pulmonary fibrosis (IPF). In a phase 2A study, inhaled RVT-1601 (cromolyn sodium) reduced daytime cough and 24-hour average cough counts in patients with IPF. - - Objectives: To determine the effica...
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| Hauptverfasser: | , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
January 19, 2022
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| In: |
American journal of respiratory and critical care medicine
Year: 2022, Jahrgang: 205, Heft: 9, Pages: 1084-1092 |
| ISSN: | 1535-4970 |
| DOI: | 10.1164/rccm.202106-1485OC |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1164/rccm.202106-1485OC Verlag, lizenzpflichtig, Volltext: https://www.atsjournals.org/doi/10.1164/rccm.202106-1485OC 
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| Verfasserangaben: | Fernando J. Martinez, Marlies S. Wijsenbeek, Ganesh Raghu, Kevin R. Flaherty, Toby M. Maher, Wim A. Wuyts, Michael Kreuter, Martin Kolb, Daniel C. Chambers, Charles Fogarty, Nesrin Mogulkoc, Ahmet S. Tutuncu, and Luca Richeldi |
MARC
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| 245 | 1 | 0 | |a Phase 2B study of inhaled RVT-1601 for chronic cough in idiopathic pulmonary fibrosis |b a multicenter, randomized, placebo-controlled study (SCENIC Trial) |c Fernando J. Martinez, Marlies S. Wijsenbeek, Ganesh Raghu, Kevin R. Flaherty, Toby M. Maher, Wim A. Wuyts, Michael Kreuter, Martin Kolb, Daniel C. Chambers, Charles Fogarty, Nesrin Mogulkoc, Ahmet S. Tutuncu, and Luca Richeldi |
| 246 | 3 | 3 | |a Phase two B study of inhaled RVT- sixteen hundred one for chronic cough in idiopathic pulmonary fibrosis$da multicenter, randomized, placebo-controlled study (SCENIC Trial) |
| 264 | 1 | |c January 19, 2022 | |
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| 520 | |a Rationale: Chronic cough remains a major and often debilitating symptom for patients with idiopathic pulmonary fibrosis (IPF). In a phase 2A study, inhaled RVT-1601 (cromolyn sodium) reduced daytime cough and 24-hour average cough counts in patients with IPF. - - Objectives: To determine the efficacy, safety, and optimal dose of inhaled RVT-1601 for the treatment of chronic cough in patients with IPF. - - Methods: In this multicenter, randomized, placebo-controlled phase 2B study, patients with IPF and chronic cough for ⩾8 weeks were randomized (1:1:1:1) to receive 10, 40, and 80 mg RVT-1601 three times daily or placebo for 12 weeks. The primary endpoint was change from baseline to end of treatment in log-transformed 24-hour cough count. Key secondary endpoints were change from baseline in cough severity and cough-specific quality of life. Safety was monitored throughout the study. - - Measurements and Main Results: The study was prematurely terminated owing to the impact of the coronavirus disease (COVID-19) pandemic. Overall, 108 patients (mean age 71.0 years, 62.9% males) received RVT-1601 10 mg (n = 29), 40 mg (n = 25), 80 mg (n = 27), or matching placebo (n = 27); 61.1% (n = 66) completed double-blind treatment. No statistically significant difference was observed in the least-square mean change from baseline in log-transformed 24-hour average cough count, cough severity, and cough-specific quality of life score between the RVT-1601 groups and the placebo group. The mean percentage change from baseline in 24-hour average cough count was 27.7% in the placebo group. Treatment was generally well tolerated. - - Conclusions: Treatment with inhaled RVT-1601 (10, 40, and 80 mg three times a day) did not provide benefit over placebo for the treatment of chronic cough in patients with IPF. | ||
| 650 | 4 | |a chronic cough | |
| 650 | 4 | |a cromolyn sodium | |
| 650 | 4 | |a idiopathic pulmonary fibrosis | |
| 650 | 4 | |a inhalation | |
| 650 | 4 | |a RVT-1601 | |
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| 700 | 1 | |a Raghu, Ganesh |e VerfasserIn |4 aut | |
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