Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis
- Conditions
- CoughIdiopathic Pulmonary Fibrosis
- Interventions
- Drug: Placebo
- Registration Number
- NCT05185089
- Lead Sponsor
- Nerre Therapeutics Ltd.
- Brief Summary
ORV-PF-01 is a two way, placebo controlled, cross-over study, to evaluate the effect of two doses of orvepitant on cough in patients with IPF.
- Detailed Description
The study will be a multi-center, double-blind, randomised, placebo-controlled 2-period cross-over study in subjects with chronic cough due to idiopathic pulmonary fibrosis (IPF).
Subjects will participate in one of two cohorts (Cohort 1 and Cohort 2). Cohort 1 will evaluate a 30 mg orvepitant dose and Cohort 2 the 10 mg dose. Within each cohort, subjects will be randomised to receive either orvepitant or placebo in the first treatment period (Treatment Period A) followed by the alternate treatment in Treatment Period B. There will be a wash-out period of 3 weeks between the two treatment periods. Subjects will be randomised 1:1 to each of the two treatment orders and 1:1 to each cohort.
Subjects will enter a screening period of between 14 and 28 days to determine eligibility. Eligible subjects will be randomised at the Baseline visit and will participate in two identical 28 day treatment periods with the wash-out period between them. There will be a total of 8 visits including the Screening, Baseline and final Follow-up visits.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Diagnosis of IPF established according to the 2018 or 2022 joint ATS/ERS/JRS/ALAT Clinical Practice Guideline
- FEV1/FVC ratio ≥0.65 at the screening visit
- Haemoglobin-corrected diffusion capacity of carbon monoxide (Hb-corrected DLCO) ≥25% within 12 months of the screening visit
- Arterial oxygen saturation on room air or oxygen ≥90% at Screening
- Life expectancy of at least 12 months
- Cough that is attributed to IPF, which has not responded to anti-tussive treatment, and which has been present for at least 8 weeks prior to Screening
- Mean daily IPF Coughing Severity Scale score ≥5 (after rounding) during the second week of the baseline assessment period
Key
- Recent respiratory tract infection (<8 weeks prior to Screening)
- Recent acute exacerbation of IPF (<8 weeks prior to Screening)
- Current smokers or ex-smokers with <6 months' abstinence prior to Screening
- Emphysema ≥50% on high-resolution computed tomography, or the extent of emphysema is greater than the extent of fibrosis according to the reported results of the most recent scan
- Mean early morning cough scale score ≥5 and rest of the day cough scale score <5 (after rounding) during the second week of the baseline assessment period (assessed at Visit 2)
- Cough that is predominantly productive in nature and attributable to lung pathology such as chronic bronchitis or bronchiectasis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Orvepitant 30mg Orvepitant Maleate Orvepitant 30mg tablet once daily for 4 weeks Orvepitant 10mg Orvepitant Maleate Orvepitant 10mg tablet once daily for 4 weeks Placebo Placebo Placebo tablet once daily for 4 weeks
- Primary Outcome Measures
Name Time Method Mean change from Baseline in weekly average of the daily Idiopathic Pulmonary Fibrosis Coughing Severity Scale Week 4 A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine)
- Secondary Outcome Measures
Name Time Method Mean change from Baseline in 24-hour cough frequency Week 4 Cough frequency assessed using an ambulatory cough monitoring device
Mean change from Baseline in night-time cough frequency Week 4 Cough frequency assessed using an ambulatory cough monitoring device
Mean change from Baseline in the number of coughing bouts Week 4 Cough frequency assessed using an ambulatory cough monitoring device
Mean change from Baseline in weekly average of the early morning IPF Coughing Severity Scale Week 4 A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine)
Mean change from Baseline in weekly average of the daily cough frequency scale Week 4 A numerical rating scale from 0 (no coughing) to 10 (coughing as often as you can imagine)
Mean change from Baseline in weekly average of the rest of the day IPF Coughing Severity Scale Week 4 A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine)
Mean change from Baseline in weekly average of the daily urge to cough scale Week 4 A numerical rating scale from 0 (no urge to cough) to 10 (urge to cough as bad as you can imagine)
Mean change from Baseline in awake cough frequency Week 4 Cough frequency assessed using an ambulatory cough monitoring device
Mean change from Baseline in weekly average of the daily dyspnoea scale Week 4 A numerical rating scale from 0 (no shortness of breath) to 10 (shortness of breath as bad as you can imagine)
Related Research Topics
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Trial Locations
- Locations (34)
University of Southern California
🇺🇸Los Angeles, California, United States
University of California
🇺🇸San Francisco, California, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Loyola University Chicago
🇺🇸Maywood, Illinois, United States
Jadestone Clinical Research, LLC
🇺🇸Silver Spring, Maryland, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
American Health Research
🇺🇸Charlotte, North Carolina, United States
PulmonIx, LLC
🇺🇸Greensboro, North Carolina, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Scroll for more (24 remaining)University of Southern California🇺🇸Los Angeles, California, United States