drugset / Trial / NCT03864328

A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF

NCT03864328 ↗

Phase 2 Terminated 108 enrolled Respivant Sciences GmbH
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Idiopathic pulmonary fibrosis (IPF) is a rare, progressive life-threatening disease that is characterized by exertional dyspnea and persistent dry cough. Cough in IPF is both a presenting and a complicating clinical feature, which affects approximately three quarters of IPF cases. It is often a debilitating symptom that adversely affects quality of life (QoL) and is usually refractory to medical therapy. Inhaled RVT-1601 (formerly, PA101B), a new inhalation formulation of cromolyn sodium delivered via the eFlow® Closed System (CS) nebulizer, is being evaluated in this Phase 2b study for the treatment of persistent cough in patients with IPF.

Timeline

Start
2019-03-29
Primary completion
2020-05-29
Completion
2020-06-05

Outcome

Outcome not reported

Stopped: “COVID-19 Pandemic”

Drugs

EvaluationDrugModalityDoseRoute
Subject RVT-1601 Unknown — Inhaled