TY - JOUR
T1 - Phase 2B Study of Inhaled RVT-1601 for Chronic Cough in Idiopathic Pulmonary Fibrosis: A Multicenter, Randomized, Placebo-controlled Study (SCENIC Trial)
AU - Martinez, Fernando J.
AU - Wijsenbeek, Marlies S.
AU - Raghu, Ganesh
AU - Flaherty, Kevin R.
AU - Maher, Toby M.
AU - Wuyts, Wim A.
AU - Kreuter, Michael
AU - Kolb, Martin
AU - Chambers, Daniel C.
AU - Fogarty, Charles
AU - Mogulkoc, Nesrin
AU - Tutuncu, Ahmet S.
AU - Richeldi, Luca
PY - 2022
Y1 - 2022
N2 - Abstract
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.
Keywords: cromolyn sodium; idiopathic pulmonary fibrosis; chronic cough; inhalation; RVT-1601
AB - Abstract
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.
Keywords: cromolyn sodium; idiopathic pulmonary fibrosis; chronic cough; inhalation; RVT-1601
KW - Idiopathic Pulmonary Fibrosis
KW - Idiopathic Pulmonary Fibrosis
UR - http://hdl.handle.net/10807/203749
U2 - 10.1164/rccm.202106-1485OC
DO - 10.1164/rccm.202106-1485OC
M3 - Article
SN - 1073-449X
VL - 205
SP - 1084
EP - 1092
JO - American Journal of Respiratory and Critical Care Medicine
JF - American Journal of Respiratory and Critical Care Medicine
ER -