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

Primary Purpose

Cough, Idiopathic Pulmonary Fibrosis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Orvepitant Maleate
Placebo
Sponsored by
Nerre Therapeutics Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cough

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern CaliforniaRecruiting
  • University of CaliforniaRecruiting
  • National Jewish HealthRecruiting
  • Loyola University ChicagoRecruiting
  • University of MichiganRecruiting
  • Mayo ClinicRecruiting
  • American Health ResearchRecruiting
  • PulmonIx, LLCRecruiting
  • Temple UniversityRecruiting
  • Medical University of South CarolinaRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • Baylor UniversityRecruiting
  • Clear Lake HealthRecruiting
  • University of UtahRecruiting
  • University of Virginia Health SystemRecruiting
  • Zuyderland Medical CentreRecruiting
  • Sint Antonius HospitalRecruiting
  • Erasmus University Medical CentreRecruiting
  • Isala ZiekenhuisRecruiting
  • Royal Berkshire HospitalRecruiting
  • Castle Hill HospitalRecruiting
  • MAC Clinical ResearchRecruiting
  • Antrim Area HospitalRecruiting
  • Altnagelvin Area HospitalRecruiting
  • Churchill HospitalRecruiting
  • Royal Infirmary of EdinburghRecruiting
  • MAC Clinical ResearchRecruiting
  • MAC Clinical ResearchRecruiting
  • Heartlands Hospital
  • Royal Devon and Exeter HospitalRecruiting
  • Guy's HospitalRecruiting
  • MAC Clinical ResearchRecruiting
  • Southampton General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Orvepitant 30mg

Orvepitant 10mg

Placebo

Arm Description

Orvepitant 30mg tablet once daily for 4 weeks

Orvepitant 10mg tablet once daily for 4 weeks

Placebo tablet once daily for 4 weeks

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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)
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)
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)
Mean change from Baseline in 24-hour cough frequency
Cough frequency assessed using an ambulatory cough monitoring device
Mean change from Baseline in awake cough frequency
Cough frequency assessed using an ambulatory cough monitoring device
Mean change from Baseline in night-time cough frequency
Cough frequency assessed using an ambulatory cough monitoring device
Mean change from Baseline in the number of coughing bouts
Cough frequency assessed using an ambulatory cough monitoring device

Full Information

First Posted
December 23, 2021
Last Updated
July 10, 2023
Sponsor
Nerre Therapeutics Ltd.
Collaborators
Pharm-Olam International
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1. Study Identification

Unique Protocol Identification Number
NCT05185089
Brief Title
Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis
Acronym
IPF-COMFORT
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nerre Therapeutics Ltd.
Collaborators
Pharm-Olam International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough, Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Orvepitant 30mg
Arm Type
Experimental
Arm Description
Orvepitant 30mg tablet once daily for 4 weeks
Arm Title
Orvepitant 10mg
Arm Type
Experimental
Arm Description
Orvepitant 10mg tablet once daily for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet once daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Orvepitant Maleate
Intervention Description
Orvepitant tablets 30mg or 10mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets to match orvepitant 30mg and 10mg tablets
Primary Outcome Measure Information:
Title
Mean change from Baseline in weekly average of the daily Idiopathic Pulmonary Fibrosis Coughing Severity Scale
Description
A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine)
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Mean change from Baseline in weekly average of the early morning IPF Coughing Severity Scale
Description
A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine)
Time Frame
Week 4
Title
Mean change from Baseline in weekly average of the rest of the day IPF Coughing Severity Scale
Description
A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine)
Time Frame
Week 4
Title
Mean change from Baseline in weekly average of the daily urge to cough scale
Description
A numerical rating scale from 0 (no urge to cough) to 10 (urge to cough as bad as you can imagine)
Time Frame
Week 4
Title
Mean change from Baseline in weekly average of the daily cough frequency scale
Description
A numerical rating scale from 0 (no coughing) to 10 (coughing as often as you can imagine)
Time Frame
Week 4
Title
Mean change from Baseline in weekly average of the daily dyspnoea scale
Description
A numerical rating scale from 0 (no shortness of breath) to 10 (shortness of breath as bad as you can imagine)
Time Frame
Week 4
Title
Mean change from Baseline in 24-hour cough frequency
Description
Cough frequency assessed using an ambulatory cough monitoring device
Time Frame
Week 4
Title
Mean change from Baseline in awake cough frequency
Description
Cough frequency assessed using an ambulatory cough monitoring device
Time Frame
Week 4
Title
Mean change from Baseline in night-time cough frequency
Description
Cough frequency assessed using an ambulatory cough monitoring device
Time Frame
Week 4
Title
Mean change from Baseline in the number of coughing bouts
Description
Cough frequency assessed using an ambulatory cough monitoring device
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
NeRRe Therapeutics Chief Medical Officer
Phone
+44 (0) 1438 906960
Email
info@nerretherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. S. Birring, MB ChB, MD
Organizational Affiliation
Department of Respiratory Medicine, King's College Hospital, London UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toby Maher
Facility Name
University of California
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Golden
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Swigris
Facility Name
Loyola University Chicago
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Dilling
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Sheth
First Name & Middle Initial & Last Name & Degree
Courtney Graft
Email
ccgraft@med.umich.edu
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivek Iyer
Facility Name
American Health Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selwyn Spangenthal
Facility Name
PulmonIx, LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murali Ramaswamy
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Parag Desai
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29424
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Whelan
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Lancaster
Facility Name
Baylor University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yolanda Mageto
Facility Name
Clear Lake Health
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regina Pillai
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Beth Scholand
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Numaan Malik
Facility Name
Zuyderland Medical Centre
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rémy Mostard
Facility Name
Sint Antonius Hospital
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcel Veltkamp
Facility Name
Erasmus University Medical Centre
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlies Wijsenbeek - Lourens
Facility Name
Isala Ziekenhuis
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Walen
Facility Name
Royal Berkshire Hospital
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faisal Kamal
Facility Name
Castle Hill Hospital
City
Cottingham
State/Province
Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Hart
Facility Name
MAC Clinical Research
City
Prescot
State/Province
Merseyside
ZIP/Postal Code
L34 1BH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Worthington
Facility Name
Antrim Area Hospital
City
Antrim
State/Province
Northern Ireland
ZIP/Postal Code
BT41 2RL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Minnis
Facility Name
Altnagelvin Area Hospital
City
Derry
State/Province
Northern Ireland
ZIP/Postal Code
BT47 6SB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nazia Chaudhuri
Facility Name
Churchill Hospital
City
Headington
State/Province
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Saunders
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikhil Hirani
Facility Name
MAC Clinical Research
City
Barnsley
State/Province
South Yorkshire
ZIP/Postal Code
S75 3DL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Evans
Facility Name
MAC Clinical Research
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS10 1DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malathy Munisamy
Facility Name
Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gareth Walters
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Gibbons
Facility Name
Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex West
Facility Name
MAC Clinical Research
City
Manchester
ZIP/Postal Code
M13 9NQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aliya Asher
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Fletcher

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis

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