Status:
TERMINATED
A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF
Lead Sponsor:
Respivant Sciences GmbH
Collaborating Sponsors:
Respivant Sciences Inc.
Conditions:
Persistent Cough in IPF
Chronic Cough
Eligibility:
All Genders
40-89 years
Phase:
PHASE2
Brief 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 compl...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2020
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT03864328
Start Date
March 29 2019
End Date
June 5 2020
Last Update
June 11 2020
Active Locations (81)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
University of California Davis
Sacramento, California, United States, 95817
3
University California San Francisco
San Francisco, California, United States, 94143
4
National Jewish Health
Denver, Colorado, United States, 80206