NCT05185089
Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis
PHASE2
COMPLETED
NCT05185089
INTERVENTIONAL
A Double-Blind, Randomised, Placebo Controlled, Two Period Cross-Over Study to Evaluate the Efficacy and Safety of Orvepitant in Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis
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.
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
Cough
Idiopathic Pulmonary Fibrosis
- TREATMENT
-
- Type: DRUG
- Name: Orvepitant Maleate
- Description: Orvepitant tablets 30mg or 10mg
- Arm Group Labels: Orvepitant 10mg, Orvepitant 30mg
-
- Type: DRUG
- Name: Placebo
- Description: Placebo tablets to match orvepitant 30mg and 10mg tablets
- Arm Group Labels: Placebo
- Nerre Therapeutics Ltd.