
Chronic cough remains a major and often debilitating symptom for idiopathic pulmonary fibrosis (IPF) patients. In a phase 2A study, inhaled RVT-1601 (cromolyn sodium) reduced daytime cough and 24-hour average cough counts in patients with IPF. The study determines the efficacy, safety, and optimal dose of inhaled RVT-1601 for the treatment of chronic cough in patients with IPF. 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 changed from baseline to end of treatment in log-transformed 24-hour cough count. Safety was monitored throughout the study. Unfortunately, the study was prematurely terminated due to the coronavirus disease (COVID-19) pandemic. Therefore, treatment with inhaled RVT-1601 (10, 40, and 80 mg three times a day) did not benefit over placebo for treating chronic cough in patients with IPF.
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