Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05185089
Other study ID # ORV-PF-01
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05984992 - The First-in-human Study of SRN-001 in Healthy Participants Phase 1
Active, not recruiting NCT04312594 - Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis Phase 2
Recruiting NCT03865927 - GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis Phase 2
Completed NCT03979430 - Early Detection of Acute Exacerbation in Patients With Idiopathic Lung Fibrosis - a Pilot Study N/A
Enrolling by invitation NCT04905693 - Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis Phase 3
Not yet recruiting NCT06241560 - A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood Phase 2
Terminated NCT04419558 - Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) Phase 3
Completed NCT03725852 - A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF) Phase 2
Terminated NCT03573505 - An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis Phase 2
Recruiting NCT04148157 - Quality of Life in IPF - Patient and Physician Perceptions
Completed NCT03222648 - Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis N/A
Not yet recruiting NCT06422884 - A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial) Phase 2
Completed NCT02257177 - RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients Phase 1/Phase 2
Completed NCT02268981 - Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF) N/A
Withdrawn NCT01524068 - A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations Phase 2
Enrolling by invitation NCT01382368 - Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients Phase 4
Completed NCT01199887 - Trial Of IW001 in Patients With Idiopathic Pulmonary Fibrosis Phase 1
Completed NCT01110694 - Prospective Observation of Fibrosis in the Lung Clinical Endpoints Study
Active, not recruiting NCT02951416 - Clinical Course of Interstitial Lung Diseases: European IPF Registry and Biobank
Terminated NCT00981747 - Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis Phase 2/Phase 3