Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis
NCT ID: NCT05185089
Last Updated: 2025-11-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2022-08-01
2024-06-19
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Orvepitant 30mg
Orvepitant 30mg tablet once daily for 4 weeks
Orvepitant Maleate
Orvepitant tablets 30mg or 10mg
Orvepitant 10mg
Orvepitant 10mg tablet once daily for 4 weeks
Orvepitant Maleate
Orvepitant tablets 30mg or 10mg
Placebo
Placebo tablet once daily for 4 weeks
Placebo
Placebo tablets to match orvepitant 30mg and 10mg tablets
Interventions
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Orvepitant Maleate
Orvepitant tablets 30mg or 10mg
Placebo
Placebo tablets to match orvepitant 30mg and 10mg tablets
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
40 Years
ALL
No
Sponsors
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Nerre Therapeutics Ltd.
INDUSTRY
Pharm-Olam International
INDUSTRY
Responsible Party
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Principal Investigators
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Prof. S. Birring, MB ChB, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Respiratory Medicine, King's College Hospital, London UK
Locations
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University of Southern California
Los Angeles, California, United States
University of California
San Francisco, California, United States
National Jewish Health
Denver, Colorado, United States
Loyola University Chicago
Maywood, Illinois, United States
Jadestone Clinical Research, LLC
Silver Spring, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
American Health Research
Charlotte, North Carolina, United States
PulmonIx, LLC
Greensboro, North Carolina, United States
Temple University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor University
Dallas, Texas, United States
Clear Lake Health
Webster, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Zuyderland Medical Centre
Heerlen, , Netherlands
Sint Antonius Hospital
Nieuwegein, , Netherlands
Erasmus University Medical Centre
Rotterdam, , Netherlands
Isala Ziekenhuis
Zwolle, , Netherlands
Royal Berkshire Hospital
Reading, Berkshire, United Kingdom
Castle Hill Hospital
Cottingham, Hull, United Kingdom
MAC Clinical Research
Prescot, Merseyside, United Kingdom
Antrim Area Hospital
Antrim, Northern Ireland, United Kingdom
Altnagelvin Area Hospital
Londonderry, Northern Ireland, United Kingdom
Churchill Hospital
Headington, Oxford, United Kingdom
Perth Royal Infirmary
Perth, Perth and Kinross, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom
MAC Clinical Research
Barnsley, South Yorkshire, United Kingdom
MAC Clinical Research
Leeds, West Yorkshire, United Kingdom
Heartlands Hospital
Birmingham, , United Kingdom
Royal Papworth Hospital
Cambridge, , United Kingdom
Royal Devon and Exeter Hospital
Exeter, , United Kingdom
Guy's Hospital
London, , United Kingdom
MAC Clinical Research
Manchester, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ORV-PF-01
Identifier Type: -
Identifier Source: org_study_id