Chronic Cough in Idiopathic Pulmonary Fibrosis: The Same Difference?

• Published in: American journal of respiratory and critical care medicine Vol. 205; no. 9; pp. 985 - 986
• Main Author: Morice, Alyn H
• Format: Journal Article
• Language: English
• Published: United States American Thoracic Society 01.05.2022
• Subjects: Chronic Disease; Clinical trials; Cough - etiology; Double-Blind Method; Humans; Idiopathic Pulmonary Fibrosis - complications; Medical treatment; Placebo effect; Pulmonary fibrosis
• ISSN: 1073-449X; 1535-4970
• DOI: 10.1164/rccm.202201-0083ED

Morice discusses the study of Martinez and colleagues in which they present a multicenter, randomized, placebo-controlled phase 2B study of PA-101 (now renamed RVT-1601) in patients with idiopathic pulmonary fibrosis (IPF) and chronic cough (the SCENIC (A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF) trial). The premature termination of the study severely limited its power, which was at the limits of feasibility even with the planned 180 subjects in a four-way parallel group study. Any treatment effects may have been swamped by the placebo response. Placebo response is well described in studies of neurogenic conditions such as cough, pain, and migraine. Chronic cough phase 2 studies usually report an approximately 30% effect, but such studies are usually performed in centers treating patients with cough who have become accustomed to negative therapeutic trials. In SCENIC, patients were recruited who were naive to cough therapy for their disease.