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.
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.
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.
There are many different types of research. These studies might ask participants to test different treatments, devices, or complete questionnaires. Some studies may not require any involvement from people affected by PF, but instead look at cells in a lab environment, animal models, or utilise computer modelling.
A study involving people can be:
- Interventional – participants are given an active treatment decided by researchers. This could be a change in medication or lifestyle (e.g. exercise, diet, complementary wellbeing therapy, or symptom management). These are commonly known as clinical trials.
- Observational – participants are assessed for specific changes over time, but researchers do not alter their standard treatment or care (e.g. questionnaires to understand the impact of symptom, or patient registries that track trends in how disease affects people or the services that are provided).
There are 3 main phases of clinical trials:
- Phase 1 is the earliest stage of research, where there is often a focus on understanding if the treatment is safe or if it causes any side effects.
- Phase 2 still focuses on safety and side effects, but also tries to find out more about what is the best dose.
- Phase 3 often compares the new treatment to existing treatments or lookalike medications.
As drugs or interventions move into the different phases, the number of people taking part will increase. Not all studies will make it to the later phases, especially if the intervention is not found to be safe or effective in phase 1 and 2.
The recruitment aim is the number of people that researcher want to take part in the research study.
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 research 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 out more about other research opportunities visit our research finder main page.
Diagnosis of IPF
A cough for more than 8 weeks
Aged above 40
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
This page is a summary which 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.
enquires@ipf-comfort-study.comThis study is supported by
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