Trials / Terminated
TerminatedNCT03864328
A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 108 (actual)
- Sponsor
- Respivant Sciences GmbH · Industry
- Sex
- All
- Age
- 40 Years – 89 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RVT-1601 | Inhaled RVT-1601 administered TID via eFlow nebulizer |
| DRUG | Placebo | Inhaled Placebo administered TID via eFlow nebulizer |
Timeline
- Start date
- 2019-03-29
- Primary completion
- 2020-05-29
- Completion
- 2020-06-05
- First posted
- 2019-03-06
- Last updated
- 2020-06-11
Locations
81 sites across 11 countries: United States, Australia, Belgium, Canada, Czechia, Germany, Italy, Netherlands, New Zealand, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03864328. Inclusion in this directory is not an endorsement.