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Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
40 Years and Over
Gender
All
More Inclusion & Exclusion Criteria
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
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 2
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Nerre Therapeutics Ltd.
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Prof. S. Birring, MB ChB, MD
Principal Investigator Affiliation
Department of Respiratory Medicine, King's College Hospital, London UK
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Recruiting
Countries
Netherlands, United Kingdom, United States
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Cough, Idiopathic Pulmonary Fibrosis
Additional Details
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.
Arms & Interventions
Arms
Experimental: Orvepitant 30mg
Orvepitant 30mg tablet once daily for 4 weeks
Experimental: Orvepitant 10mg
Orvepitant 10mg tablet once daily for 4 weeks
Placebo Comparator: Placebo
Placebo tablet once daily for 4 weeks
Interventions
Drug: - Orvepitant Maleate
Orvepitant tablets 30mg or 10mg
Drug: - Placebo
Placebo tablets to match orvepitant 30mg and 10mg tablets
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
University of Southern California, Los Angeles, California
