IPF COMFORT: A clinical trial investigating the effects of orvepitant on IPF cough

Upcoming study
Expected to open June 2022
This study is currently recruiting
Expected to close February 2024
This study is closed
This study closed in February 2024
We will update this page with study results when available.
Information on study results are included below
This study closed in February 2024

What next?

The IPF COMFORT study is now closed to recruitment. More than 65% of people taking part in the study from around the world were from the UK. This page will be updated once the study has finished and the results become available.

Original listing:

What next?

The IPF COMFORT study is now closed to recruitment. More than 65% of people taking part in the study from around the world were from the UK. This page will be updated once the study has finished and the results become available.

Original listing:

About this study

Many patients diagnosed with idiopathic pulmonary fibrosis experience a troublesome cough.  Treatment options are limited and clinical trials investigating better options are needed.

The IPF COMFORT study is investigating whether a study drug called orvepitant can reduce the burden  of cough in people diagnosed with IPF.

The cough in IPF may be caused by the airways becoming oversensitive. The investigational drug being tested in the study may reduce this over-sensitivity.

 – 

What is involved?

The study involves taking a both a study drug (orvepitant) and a placebo tablet (tablets that look like orvepitant but contain no active drug) at different times during the trial. There are two treatment periods of 4 weeks each (with a three-week gap in between when no medication will be taken). The study medication is taken as a tablet once a day.

You would need to visit the hospital 6 times, which includes initial checks to assess if you are able to take part. You would have medical assessments, including blood tests, and be asked to wear a cough monitor for a 24-hr period on 3 separate occasions during the study. There is a daily diary to complete on a device like a smart phone throughout most of the study.

Summary of involvement

17 weeks participation

Taking a drug

Medical assessments

Wearing a cough monitor

Completing surveys

Can I take part?

You may be able to take part if you have a diagnosis of IPF, are aged 40 years and above, and have had a troublesome cough for at least 8 weeks, for which there is no other obvious cause.

Unfortunately, you will not be able to take part in this study if you do not have a diagnosis of IPF, if a measurement of your lung function (FEV1/FVC ratio) is less than 65%, or you are a current smoker/ ex-smoker with less then 6 months abstinence.

In research studies, there are lots of different reasons why you may or may not be able to take part. These are known as inclusion and exclusion criteria (see list below). Only the clinical trial team will be able to fully determine whether you are able to take part in the study. You can withdraw at any point.

If you are not able to take part in this research study, there may be other opportunities for you to take part in different studies.

To find our more about other research opportunities visit our research finder main page.

You may be able to join this study if all of these apply:

Diagnosis of IPF

A cough for more than 8 weeks

Aged above 40

You will not be able to join the study of any of the following applies:

You do not have a diagnosis of IPF

Your cough is likely to be due to something other than IPF

A measurement of your lung function (known as FEV1/FVC) is less than 65%

Current smokers or ex-smokers with <6 months' abstinence

What difference could taking part make?

Taking part in this clinical trial will help researchers to identify the potential effects of orvepitant on the burden of a chronic cough. The study will help to gain greater understanding of the medication and if it has the potential to help people affected by IPF.

Taking part in research has the potential to make a difference for people who have IPF now and for future generations.

Where does the study take place?

Study locations

Liverpool

Manchester

Leeds

Barnsley

Hull

Oxford

London

Southampton

Exeter

Antrim

Edinburgh

Londonderry

Reading

Birmingham

Perth

Nottingham

Cambridge

The study will be recruiting patients at multiple sites in the UK.

Check the study website here for all currently recruiting sites. Patients who do not live locally to these sites may also be able to take part as travel expenses will be reimbursed.

How to take part

Speak to your clinical team or email enquires@ipf-comfort-study.com to find out more.

Further information

The summary on this page provides information about an opportunity to participate in research. More detailed information about the study can be found via the following the links and through contacting the research team.

If you have any questions about this research study, please speak to your medical team and contact the researchers directly via:

enquires@ipf-comfort-study.com

This study is supported by

NeRRe therapeutics
Study ID number:
NCT05185089

APF does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators.

Every effort is made to keep these details up to date. If you are aware of any inaccuracies, please email research@actionpf.org