Status:
COMPLETED
Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis
Lead Sponsor:
Nerre Therapeutics Ltd.
Collaborating Sponsors:
Pharm-Olam International
Conditions:
Cough
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40+ years
Phase:
PHASE2
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 parti...
Eligibility Criteria
Inclusion
- Key
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05185089
Start Date
August 1 2022
End Date
June 19 2024
Last Update
November 10 2025
Active Locations (37)
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1
University of Southern California
Los Angeles, California, United States, 90033
2
University of California
San Francisco, California, United States, 94143
3
National Jewish Health
Denver, Colorado, United States, 80206
4
Loyola University Chicago
Maywood, Illinois, United States, 60153