RVT1601-CC-04: RVT-1601 treatment in IPF patients with chronic cough
Research type
Research Study
Full title
Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial
IRAS ID
260487
Contact name
Toby Maher
Contact email
Sponsor organisation
Respivant Sciences Inc.
Eudract number
2018-004447-23
Duration of Study in the UK
1 years, 4 months, 18 days
Research summary
Idiopathic pulmonary fibrosis (IPF) is a disease that causes scarring in the lungs that leads to shortness of breath and a persistent cough. Cough can be a debilitating symptom of IPF and is difficult to treat. This research study will test the effectiveness and safety of the study drug, RVT-1601, in participants with persistent cough due to IPF.
RVT-1601 is an inhaled form of cromolyn sodium that is delivered into the lungs using a nebuliser. Previous studies have shown that RVT-1601 may inhibit inflammatory mediators that contribute to cough and fibrosis progression. Three doses of RVT-1601 will be tested in this study, 10 mg, 40 mg, and 80 mg.
This study will be conducted in 2 parts. Part 1 will compare the 3 doses of RVT-1601 to placebo over a 12-week period. Placebo is an inactive substance that is taken in the same manner as RVT-1601 and is used in research studies such as this one. In Part 2, all participants will receive 80 mg of RVT-1601 for an additional 12 weeks. Part 2 will begin immediately after a participant finishes Part 1 of the study. A participant will be eligible to participate in Part 2 of the study only after completion of Part 1.Approximately 180 participants from approximately 9 countries will participate in this research study.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
19/EM/0101
Date of REC Opinion
20 May 2019
REC opinion
Further Information Favourable Opinion