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Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis (IPF-COMFORT)

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ClinicalTrials.gov Identifier: NCT05185089
Recruitment Status : Recruiting
First Posted : January 11, 2022
Last Update Posted : August 5, 2022
Sponsor:
Collaborator:
Pharm-Olam International
Information provided by (Responsible Party):
Nerre Therapeutics Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Cough Idiopathic Pulmonary Fibrosis Drug: Orvepitant Maleate Drug: Placebo Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
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
Actual Study Start Date : August 1, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Experimental: Orvepitant 30mg
Orvepitant 30mg tablet once daily for 4 weeks
Drug: Orvepitant Maleate
Orvepitant tablets 30mg or 10mg

Experimental: Orvepitant 10mg
Orvepitant 10mg tablet once daily for 4 weeks
Drug: Orvepitant Maleate
Orvepitant tablets 30mg or 10mg

Placebo Comparator: Placebo
Placebo tablet once daily for 4 weeks
Drug: Placebo
Placebo tablets to match orvepitant 30mg and 10mg tablets




Primary Outcome Measures :
  1. Mean change from Baseline in weekly average of the daily Idiopathic Pulmonary Fibrosis Coughing Severity Scale [ Time Frame: Week 4 ]
    A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine)


Secondary Outcome Measures :
  1. Mean change from Baseline in weekly average of the early morning IPF Coughing Severity Scale [ Time Frame: Week 4 ]
    A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine)

  2. Mean change from Baseline in weekly average of the rest of the day IPF Coughing Severity Scale [ Time Frame: Week 4 ]
    A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine)

  3. Mean change from Baseline in weekly average of the daily urge to cough scale [ Time Frame: Week 4 ]
    A numerical rating scale from 0 (no urge to cough) to 10 (urge to cough as bad as you can imagine)

  4. Mean change from Baseline in weekly average of the daily cough frequency scale [ Time Frame: Week 4 ]
    A numerical rating scale from 0 (no coughing) to 10 (coughing as often as you can imagine)

  5. Mean change from Baseline in weekly average of the daily dyspnoea scale [ Time Frame: Week 4 ]
    A numerical rating scale from 0 (no shortness of breath) to 10 (shortness of breath as bad as you can imagine)

  6. Mean change from Baseline in 24-hour cough frequency [ Time Frame: Week 4 ]
    Cough frequency assessed using an ambulatory cough monitoring device

  7. Mean change from Baseline in awake cough frequency [ Time Frame: Week 4 ]
    Cough frequency assessed using an ambulatory cough monitoring device

  8. Mean change from Baseline in night-time cough frequency [ Time Frame: Week 4 ]
    Cough frequency assessed using an ambulatory cough monitoring device

  9. Mean change from Baseline in the number of coughing bouts [ Time Frame: Week 4 ]
    Cough frequency assessed using an ambulatory cough monitoring device



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Diagnosis of IPF established according to the 2018 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 ≥5.0 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 ≥5.0 and rest of the day cough scale score <5 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05185089


Contacts
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Contact: NeRRe Therapeutics Chief Medical Officer +44 (0) 1438 906960 info@nerretherapeutics.com

Locations
Show Show 29 study locations
Sponsors and Collaborators
Nerre Therapeutics Ltd.
Pharm-Olam International
Investigators
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Principal Investigator: Prof. S. Birring, MB ChB, MD Department of Respiratory Medicine, King's College Hospital, London UK
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Responsible Party: Nerre Therapeutics Ltd.
ClinicalTrials.gov Identifier: NCT05185089    
Other Study ID Numbers: ORV-PF-01
First Posted: January 11, 2022    Key Record Dates
Last Update Posted: August 5, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Cough
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action