Idiopathic Pulmonary Fibrosis Clinical Trial
— IPF-COMFORTOfficial 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
Verified date | February 2024 |
Source | Nerre Therapeutics Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Nerre Therapeutics Ltd. | Pharm-Olam International |
United States, Netherlands, United Kingdom,
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 |
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