IPF COMFORT Study
A clinical trial for patients with chronic cough caused by idiopathic pulmonary fibrosis (IPF)
What is the IPF COMFORT study?
The IPF COMFORT Study is a clinical research study in patients with coughing attributed to 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.
The purpose of the IPF COMFORT Study is to see if the investigational study drug reduces the severity and burden of coughing in people with IPF compared to placebo. A placebo looks exactly like the investigational study drug but contains no active medicine. The study will also test the safety of the investigational drug and how it is absorbed and used within the body.
What does the study involve?
This is a crossover study which means you will take both the investigational study drug and placebo at different times during the trial. You will take each of them for 4 weeks, separated by a 3-week period with no treatment (called the wash-out).
| Study weeks | |||||||||||||
| Up to 4 weeks | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 |
| Screening period | Treatment period A | No study medication | Treatment period B | Follow up | |||||||||
There are two different doses of study drug being tested. You won’t know which dose you are taking, and neither will you know whether you take placebo or the investigational drug first.
The study medication is taken as a tablet once daily.
You will be asked to complete a daily diary on a device like a smart phone throughout most of the study, and will need to wear a cough monitor, which records how often you cough over a 24-hour period on three separate occasions.
You will need to have a number of other routine tests during the study, many of which you may have experienced before.
Is the study right for me?
If you are interested in joining the IPF COMFORT Study you must:
- Be aged 40 years or older
- Have been diagnosed with IPF
- Have had a troublesome cough as one of your IPF symptoms that has lasted for at least 8 weeks, and which has not improved with other treatments
There are other checks to complete before you can join the study. These are to determine if you are right for the study and whether the study is right for you.
If you are interested in taking part review the study sites below to see if there is one in your location, or email enquiries@ipf-comfort-study.com
Study sites
UK
Guy's Hospital
Guy's & St Thomas'
NHS Foundation Trust
London
Site active
Royal Devon and Exeter Hospital
Royal Devon & Exeter
NHS Foundation Trust
Exeter
Site active
Churchill Hospital
Oxford University Hospitals
NHS Foundation Trust
Oxford
Site active
Castle Hill Hospital
Hull University Teaching Hospitals
NHS Trust
Hull
Site active
Southampton General Hospital
University Hospital Southampton
NHS Foundation Trust
Southampton
Site Active
MAC Clinical Research
Prescot
Liverpool
Site active
MAC Clinical Research
Barnsley
South Yorkshire
Site active
MAC Clinical Research
Stourton
Leeds
Site active
MAC Clinical Research
Manchester
Site active
Royal Infirmary of Edinburgh
Lothian Health Board
Edinburgh
Study not yet started
Altnagelvin Area Hospital
Western Health and
Social Care Trust
Londonderry
Northern Ireland
Site active
Royal Berkshire Hospital
Royal Berkshire Hospital NHS
Foundation Trust
Reading
Site active
Heartlands Hospital
University Hospitals Birmingham
NHS Foundation Trust
Birmingham
Study not yet started
Antrim Area Hospital
Northern Health and
Social Care Trust
Antrim
Northern Ireland
Site active
| Site locations |
| Guy's Hospital Guy's & St Thomas' NHS Foundation Trust London Site active |
| Royal Devon and Exeter Hospital Royal Devon & Exeter NHS Foundation Trust Exeter Site active |
| Churchill Hospital Oxford University Hospitals NHS Foundation Trust Oxford Site active |
| Castle Hill Hospital Hull University Teaching Hospitals NHS Trust Hull Site active |
| Southampton General Hospital University Hospital Southampton NHS Foundation Trust Southampton Site active |
| MAC Clinical Research Prescot Liverpool Site active |
| MAC Clinical Research Barnsley South Yorkshire Site active |
| MAC Clinical Research Stourton Leeds Site active |
| MAC Clinical Research Manchester Site active |
| North Tyneside General Hospital Northumbria Healthcare NHS Foundation Trust North Shields Study not yet started |
| Antrim Area Hospital Northern Health and Social Care Trust Antrim Northern Ireland Site active |
| Royal Infirmary of Edinburgh Lothian Health Board Edinburgh Study not yet started |
| Altnagelvin Area Hospital Western Health and Social Care Trust Londonderry Northern Ireland Site active |
| Royal Berkshire Hospital Royal Berkshire Hospital NHS Foundation Trust Reading Site active |
| Heartlands Hospital University Hospitals Birmingham NHS Foundation Trust Birmingham Study not yet started |
Netherlands
Erasmus University Medical Center
Rotterdam
Netherlands
Site active
Zuyderland Medical Center
Heerlen
Netherlands
Site active
St. Antonius Ziekenhuis
Utrecht
Netherlands
Site active
Isala
Zwolle
Netherlands
Site active
| Site locations |
| Erasmus University Medical Center Rotterdam Netherlands Site active |
| Zuyderland Medical Center Heerlen Netherlands Site active |
| St. Antonius Ziekenhuis Utrecht Netherlands Site active |
| Isala Zwolle Netherlands Site active |
USA
Medical University
of South Carolina
(MUSC)
Charleston
South Carolina
Site active
PulmonIx Research, LLC
Greensboro
North Carolina
Site active
University of Utah
Salt Lake City
Utah
Site active
Vanderbilt University
Medical Center
Nashville
Tennessee
Study not yet started
Baylor University
Dallas
Texas
Site active
Mayo Clinic
Rochester
Minnesota
Site active
Loyola University Chicago
Maywood
Illinois
Site active
University of Michigan
Ann Arbor
Michigan
Site active
University of California
Los Angeles
California
Site active
University of Virginia
Health System
Charlottesville
Virginia
Site active
American Health Research
Charlotte
North Carolina
Site active
National Jewish Health
1400 Jackson Street
Denver
Colorado 80206
Site active
Temple University
Philadelphia
Pennsylvania
Site active
CLS Health
Webster
Texas
Site active
Keck School of Medicine of USC
University of Southern California
Los Angeles
California
Site active
| Site locations |
| Medical University of South Carolina (MUSC) Charleston South Carolina Site active |
| Pulmonix Research, LLC Greensboro North Carolina Site active |
| American Health Research Charlotte North Carolina Site active |
| University of Utah Salt Lake City Utah Site active |
| Vanderbilt University Medical Center Nashville Tennessee Site active |
| Mayo Clinic Rochester Minnesota Site active |
| Loyola University Chicago Maywood Illinois Site active |
| University of Michigan Ann Arbor Michigan Site active |
| University of California Los Angeles California Site active |
| University of Virginia Health System Charlottesville Virginia Site active |
| Baylor University Dallas Texas Site active |
| National Jewish Health 1400 Jackson Street Denver Colorado 80206 Site active |
| Temple University Philadelphia Pennsylvania Site active |
| CLS Health Webster Texas Site active |
| Keck School of Medicine of USC University of Southern California Los Angeles California Site active |
