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

NCT03864328 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2020-06-11

No results posted yet for this study

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

  • Persistent Cough in IPF
  • Chronic Cough
  • IPF

Interventions

DRUG

RVT-1601

Inhaled RVT-1601 administered TID via eFlow nebulizer

DRUG

Placebo

Inhaled Placebo administered TID via eFlow nebulizer

Sponsors & Collaborators

  • Respivant Sciences Inc.

    collaborator INDUSTRY

  • Respivant Sciences GmbH

    lead INDUSTRY

Principal Investigators

  • Ahmet Tutuncu, MD, PhD · Respivant Sciences Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-29
Primary Completion
2020-05-29
Completion
2020-06-05
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • Germany
  • Italy
  • Netherlands
  • New Zealand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03864328 on ClinicalTrials.gov