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Neurokinin-1 Receptor Antagonist
Orvepitant for Chronic Cough in IPF (IPF-COMFORT Trial)
Phase 2
Waitlist Available
Led By Prof. S. Birring, MB ChB, MD
Research Sponsored by Nerre Therapeutics Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of IPF established according to the 2018 or 2022 joint ATS/ERS/JRS/ALAT Clinical Practice Guideline
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4
Awards & highlights
IPF-COMFORT Trial Summary
This trial is testing a new drug to see if it can help lessen coughing in patients with IPF.
Who is the study for?
This trial is for patients with Idiopathic Pulmonary Fibrosis (IPF) who have a persistent cough not relieved by other treatments. Participants must meet specific criteria, including having an oxygen saturation of ≥90%, life expectancy over 12 months, and certain lung function test results. Smokers or recent quitters (<6 months), those with productive coughs due to other lung issues, or recent respiratory infections are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of Orvepitant Maleate in reducing cough in IPF patients compared to a placebo. It's a cross-over study where participants will receive both the drug and placebo at different times, allowing researchers to observe changes in cough severity.See study design
What are the potential side effects?
While specific side effects for Orvepitant are not listed here, common side effects for new medications can include nausea, headache, dizziness, fatigue, and potential allergic reactions. The exact side effects will be monitored throughout the trial.
IPF-COMFORT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis of IPF follows the 2018 or 2022 guidelines.
IPF-COMFORT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change from Baseline in weekly average of the daily Idiopathic Pulmonary Fibrosis Coughing Severity Scale
Secondary outcome measures
Mean change from Baseline in 24-hour cough frequency
Mean change from Baseline in awake cough frequency
Mean change from Baseline in night-time cough frequency
+6 moreSide effects data
From 2019 Phase 2 trial • 315 Patients • NCT0299382216%
Fatigue
10%
Viral upper respiratory tract infection
9%
Headache
6%
Dizziness
6%
Oropharyngeal pain
6%
Upper respiratory tract infection
5%
Paraesthesia
5%
Urinary tract infection
5%
Back pain
5%
Arthralgia
3%
Somnolence
3%
Nausea
1%
Hypertension
1%
Bradycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Orvepitant 10mg
Orvepitant 20mg
Orvepitant 30mg
Placebo
IPF-COMFORT Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Orvepitant 30mgExperimental Treatment1 Intervention
Orvepitant 30mg tablet once daily for 4 weeks
Group II: Orvepitant 10mgExperimental Treatment1 Intervention
Orvepitant 10mg tablet once daily for 4 weeks
Group III: PlaceboPlacebo Group1 Intervention
Placebo tablet once daily for 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Orvepitant Maleate
2017
Completed Phase 2
~320
Find a Location
Who is running the clinical trial?
Nerre Therapeutics Ltd.Lead Sponsor
7 Previous Clinical Trials
618 Total Patients Enrolled
Pharm-Olam InternationalIndustry Sponsor
7 Previous Clinical Trials
2,223 Total Patients Enrolled
Prof. S. Birring, MB ChB, MDPrincipal InvestigatorDepartment of Respiratory Medicine, King's College Hospital, London UK
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- More than half of my lungs show emphysema on a detailed lung scan.My morning cough score is 5 or more, but less than 5 the rest of the day.Your lung function test showed that your body can transfer oxygen properly.I have a cough from IPF that hasn't improved with treatment for at least 8 weeks.Your coughing is very severe, with an average score of 5 or more on the coughing severity scale.My diagnosis of IPF follows the 2018 or 2022 guidelines.Your lung function test shows a specific ratio of air flow that is normal.I have not had a respiratory infection in the last 8 weeks.My lung condition worsened less than 8 weeks ago.I have a cough mostly with mucus due to lung conditions like chronic bronchitis.I am currently smoking or quit less than 6 months ago.You are expected to live for at least 12 more months.Your blood oxygen level is at least 90% when you are breathing normally.
Research Study Groups:
This trial has the following groups:- Group 1: Orvepitant 30mg
- Group 2: Orvepitant 10mg
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Orvepitant Maleate a safe medication for human use?
"Orvepitant Maleate's safety was given a score of 2. Although there is some evidence backing its safety, Phase 2 trials lack data pertaining to the medication's efficacy."
Answered by AI
How many different offices are handling this clinical trial?
"There are a total of 21 study sites for this research project. Three of which are located in Charlotte, Tennessee; Nashville, Colorado; and Denver, Michigan. The remaining 18 clinical trial sites are located across the United States."
Answered by AI
Does this research project still have room for new participants?
"That is correct. The trial, which was originally posted on 8/1/2022 and last updated on 10/30/2022, is currently looking for 88 participants at 18 locations around the country."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
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