Summary

for people ages 40-89 (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

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.

Official 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

Keywords

Persistent Cough in IPF Chronic Cough IPF Cough IPF Cough Idiopathic Pulmonary Fibrosis RVT-1601 RVT-1601 Mid Dose

Eligibility

You can join if…

Open to people ages 40-89

  • Male or female subjects age 40 through 89 years
  • Confirmed diagnosis of IPF with clinical features consistent with the current clinical practice guidelines
  • Persistent cough for at least 8 weeks that is primarily due to IPF and not responsive to anti-tussive therapy
  • Daytime cough severity score of ≥ 40 mm on a 100-mm VAS
  • 24-hour average cough count of at least 10 coughs per hour
  • Forced Vital Capacity (FVC) > 45% predicted value within 4 weeks
  • Diffusion capacity for carbon monoxide corrected for hemoglobin (DLCOc) > 30% predicted value within 4 weeks
  • Life expectancy of at least 12 months

You CAN'T join if...

  • Current or recent history of clinically significant medical condition, laboratory abnormality, or illness that could place the subject at risk or compromise the quality of the study data
  • Significant coronary artery disease (i.e., myocardial infarction within 6 months or unstable angina within 1 month)
  • Upper or lower respiratory tract infection within 4 weeks
  • Acute exacerbation of IPF within 6 months
  • Lung transplantation expected within 12 months
  • Requiring supplemental O2 > 4 litres/min to maintain peripheral arterial O2 saturation (SpO2) > 88% at rest
  • History of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 2 years
  • Current smoker (i.e., use of tobacco products within the last 3 months)
  • Current or recent history of drug or alcohol abuse within 12 months
  • Participation in any other investigational drug study within 4 weeks
  • Use of certain drugs for cough management within 4 weeks: prednisone, opiates, baclofen, gabapentin, pregabalin, thalidomide, amitriptyline, inhaled corticosteroids, or inhaled bronchodilators
  • Use of ACE inhibitors or cromolyn sodium within 4 weeks
  • Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable means of birth control during the study
  • History of hypersensitivity or intolerance to cromolyn sodium

Locations

  • University California San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • University of California Davis not yet accepting patients
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Respivant Sciences GmbH
ID
NCT03864328
Phase
Phase 2
Study Type
Interventional
Last Updated