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

Idiopathic Pulmonary Fibrosis Clinical Trial

— IPF-COMFORT  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05185089
• Other study ID #: ORV-PF-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 1, 2022
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Nerre Therapeutics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 88
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

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

Related Conditions & MeSH terms

• Chronic Cough
• Cough
• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Orvepitant Maleate
Orvepitant tablets 30mg or 10mg
• Placebo
Placebo tablets to match orvepitant 30mg and 10mg tablets

Locations

Country	Name	City	State
Netherlands	Zuyderland Medical Centre	Heerlen
Netherlands	Sint Antonius Hospital	Nieuwegein
Netherlands	Erasmus University Medical Centre	Rotterdam
Netherlands	Isala Ziekenhuis	Zwolle
United Kingdom	Antrim Area Hospital	Antrim	Northern Ireland
United Kingdom	MAC Clinical Research	Barnsley	South Yorkshire
United Kingdom	Heartlands Hospital	Birmingham
United Kingdom	Royal Papworth Hospital	Cambridge
United Kingdom	Castle Hill Hospital	Cottingham	Hull
United Kingdom	Altnagelvin Area Hospital	Derry	Northern Ireland
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh	Scotland
United Kingdom	Royal Devon and Exeter Hospital	Exeter
United Kingdom	Churchill Hospital	Headington	Oxford
United Kingdom	MAC Clinical Research	Leeds	West Yorkshire
United Kingdom	Guy's Hospital	London
United Kingdom	MAC Clinical Research	Manchester
United Kingdom	Nottingham City Hospital	Nottingham
United Kingdom	Perth Royal Infirmary	Perth	Perth And Kinross
United Kingdom	MAC Clinical Research	Prescot	Merseyside
United Kingdom	Royal Berkshire Hospital	Reading	Berkshire
United Kingdom	Southampton General Hospital	Southampton
United States	University of Michigan	Ann Arbor	Michigan
United States	Medical University of South Carolina	Charleston	South Carolina
United States	American Health Research	Charlotte	North Carolina
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Baylor University	Dallas	Texas
United States	National Jewish Health	Denver	Colorado
United States	PulmonIx, LLC	Greensboro	North Carolina
United States	University of Southern California	Los Angeles	California
United States	Loyola University Chicago	Maywood	Illinois
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Temple University	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Utah	Salt Lake City	Utah
United States	University of California	San Francisco	California
United States	Jadestone Clinical Research, LLC	Silver Spring	Maryland
United States	Clear Lake Health	Webster	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Nerre Therapeutics Ltd.	Pharm-Olam International

Countries where clinical trial is conducted

United States,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from Baseline in weekly average of the daily Idiopathic Pulmonary Fibrosis Coughing Severity Scale	A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine)	Week 4
Secondary	Mean change from Baseline in weekly average of the early morning IPF Coughing Severity Scale	A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine)	Week 4
Secondary	Mean change from Baseline in weekly average of the rest of the day IPF Coughing Severity Scale	A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine)	Week 4
Secondary	Mean change from Baseline in weekly average of the daily urge to cough scale	A numerical rating scale from 0 (no urge to cough) to 10 (urge to cough as bad as you can imagine)	Week 4
Secondary	Mean change from Baseline in weekly average of the daily cough frequency scale	A numerical rating scale from 0 (no coughing) to 10 (coughing as often as you can imagine)	Week 4
Secondary	Mean change from Baseline in weekly average of the daily dyspnoea scale	A numerical rating scale from 0 (no shortness of breath) to 10 (shortness of breath as bad as you can imagine)	Week 4
Secondary	Mean change from Baseline in 24-hour cough frequency	Cough frequency assessed using an ambulatory cough monitoring device	Week 4
Secondary	Mean change from Baseline in awake cough frequency	Cough frequency assessed using an ambulatory cough monitoring device	Week 4
Secondary	Mean change from Baseline in night-time cough frequency	Cough frequency assessed using an ambulatory cough monitoring device	Week 4
Secondary	Mean change from Baseline in the number of coughing bouts	Cough frequency assessed using an ambulatory cough monitoring device	Week 4