A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF
- Conditions
- Persistent Cough in IPFChronic CoughIPF
- Interventions
- Drug: Placebo
- Registration Number
- NCT03864328
- Lead Sponsor
- Respivant Sciences GmbH
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 108
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RVT-1601 Low Dose RVT-1601 - RVT-1601 Mid Dose RVT-1601 - Placebo Placebo - RVT-1601 High Dose RVT-1601 -
- Primary Outcome Measures
Name Time Method Change in 24-hour average cough count 12 weeks Objective cough count monitoring performed using a digital recording device.
- Secondary Outcome Measures
Name Time Method Change in cough severity 12 weeks Cough severity assessed using Visual Analog Scale (VAS), a single-item questionnaire using 100-point scale ranging from 0 (no cough) to 100 (extremely severe cough).
Change in cough-specific QoL 12 weeks Cough-specific QoL assessed using Leicester Cough Questionnaire (LCQ), a 19-item questionnaire designed to measure impact of cough in three domains (physical, psychological and social), each domain ranging from 1 to 7 and LCQ total score ranging from 3 to 21, with the higher scores corresponding with better QoL.
Trial Locations
- Locations (81)
University of Alabama
🇺🇸Birmingham, Alabama, United States
University of California Davis
🇺🇸Sacramento, California, United States
University California San Francisco
🇺🇸San Francisco, California, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Ascension Medical Group / St. Vincent's Lung Institute
🇺🇸Jacksonville, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Tampa General Hospital / Uni of South Florida
🇺🇸Tampa, Florida, United States
Loyola University
🇺🇸Maywood, Illinois, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States
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