Phase 2
N=80
Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis
Cough · Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT05185089 ↗Enrolled (actual)
80
Serious AEs
4.5%
Results posted
Nov 2025
Primary outcome: Primary: Mean Change From Baseline in Weekly Average of the Daily Idiopathic Pulmonary Fibrosis Coughing Severity Scale (IPF CSS) — -0.69; -0.66; -0.26; -0.85 Points — p=0.989
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Orvepitant Maleate (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Nerre Therapeutics Ltd.
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Weekly Average of the Daily Idiopathic Pulmonary Fibrosis Coughing Severity Scale (IPF CSS) |
-0.69; -0.66; -0.26; -0.85 | 0.989 |
| SECONDARY Mean Change From Baseline in Weekly Average of the Early Morning IPF Coughing Severity Scale |
-0.57; -0.51; -0.49; -1.08 | 0.872 |
| SECONDARY Mean Change From Baseline in Weekly Average of the Rest of the Day IPF Coughing Severity Scale |
-0.62; -0.62; -0.44; -0.80 | 0.991 |
| SECONDARY Mean Change From Baseline in Weekly Average of the Daily Urge to Cough Scale |
-0.46; -0.63; -0.30; -0.76 | 0.639 |
| SECONDARY Mean Change From Baseline in Weekly Average of the Daily Cough Frequency Scale |
-0.20; -0.15; -0.06; -0.29 | 0.650 |
| SECONDARY Mean Change From Baseline in Weekly Average of the Daily Dyspnoea Scale |
-0.26; -0.22; 0.00; -0.44 | 0.856 |
| SECONDARY Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score |
1.07; 1.27; 0.14; 1.60 | 0.678 |
| SECONDARY Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Physical Domain Score |
0.18; 0.26; 0.06; 0.36 | 0.633 |
| SECONDARY Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Psychological Domain Score |
0.57; 0.47; 0.12; 0.63 | 0.732 |
| SECONDARY Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Social Domain Score |
0.32; 0.54; -0.03; 0.60 | 0.318 |
| SECONDARY Mean Change From Baseline in 24-hour Cough Frequency |
0.93; 1.00; 0.84; 0.87 | 0.438 |
| SECONDARY Mean Change From Baseline in Awake Cough Frequency |
0.95; 1.03; 0.84; 0.87 | 0.449 |
| SECONDARY Mean Change From Baseline in Night-time Cough Frequency |
0.79; 0.90; 0.87; 0.85 | 0.400 |
| SECONDARY Mean Change From Baseline in the Number of Coughing Bouts |
0.91; 1.00; 0.82; 0.88 | 0.287 |
| SECONDARY Mean Change From Baseline in the Number of Coughs Per Bout |
0.91; 0.92; 0.98; 0.89 | 0.765 |
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.
Eligibility Criteria
Key Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05185089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.