NCT05185089

Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis

Official Title:

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

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

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

Disease(s) and\or Condition(s)

Cough

Idiopathic Pulmonary Fibrosis

Primary Purpose
  • TREATMENT
Intervention/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
Sponsor
  • Nerre Therapeutics Ltd.