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.

IPF Comfort Study
Study purpose

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?

The IPF COMFORT study will last for up to 17 weeks. It will start with a screening period of up to 4 weeks to assess your suitability for participation. After this, if you are eligible, you will start the treatment phase of the study.
Calendar
Crossover study

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 weeks12345678910111213
Screening periodTreatment period ANo study medicationTreatment period BFollow up
Study weeks

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.

Doses
Daily Diary

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
Over 40
Other checks

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 enquires@ipf-comfort-study.com

Study sites

UK

UK map
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

Study not yet started

Castle Hill Hospital
Hull University Teaching Hospitals
NHS Trust
Hull

Site active

Southampton General Hospital
University Hospital Southampton
NHS Foundation Trust
Southampton

Study not yet started

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

Ireland map
Antrim Area Hospital
Northern Health and
Social Care Trust
Antrim
Northern Ireland

Study not yet started

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
Study not yet started
Castle Hill Hospital
Hull University Teaching Hospitals
NHS Trust
Hull
Site active
Southampton General Hospital
University Hospital Southampton
NHS Foundation Trust
Southampton
Study not yet started
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
Study not yet started

Netherlands

Netherlands map
Erasmus University Medical Center
Rotterdam
Netherlands

Site active

Zuyderland Medical Center
Heerlen
Netherlands

Site active

St. Antonius Ziekenhuis
Utrecht
Netherlands

Study not yet started

Isala
Zwolle
Netherlands

Study not yet started

Site locations
Erasmus University Medical Center
Rotterdam
Netherlands
Site active
Zuyderland Medical Center
Heerlen
Netherlands
Site active
St. Antonius Ziekenhuis
Utrecht
Netherlands
Study not yet started
Isala
Zwolle
Netherlands
Study not yet started

USA

USA map
Medical University
of South Carolina
(MUSC)
Charleston
South Carolina

Study not yet started

PulmonIx Research, LLC
Greensboro
North Carolina

Study not yet started

University of Utah
Salt Lake City
Utah

Study not yet started

Vanderbilt University
Medical Center
Nashville
Tennessee

Study not yet started

Baylor University
Dallas
Texas

Study not yet started

Mayo Clinic
Rochester
Minnesota

Site active

Loyola University Chicago
Maywood
Illinois

Study not yet started

University of Michigan
Ann Arbor
Michigan

Site active

University of California
Los Angeles
California

Study not yet started

University of Virginia
Health System
Charlottesville
Virginia

Study not yet started

American Health Research
Charlotte
North Carolina

Site active

National Jewish Health
1400 Jackson Street
Denver
Colorado 80206

Site active

Temple University
Philadelphia
Pennsylvania

Study not yet started

CLS Health
Webster
Texas

Site active

Keck School of Medicine of USC
University of Southern California
Los Angeles
California

Study not yet started

Site locations
Medical University of South Carolina (MUSC)
Charleston
South Carolina
Study not yet started
Pulmonix Research, LLC
Greensboro
North Carolina
Study not yet started
American Health Research
Charlotte
North Carolina
Site active
University of Utah
Salt Lake City
Utah
Study not yet started
Vanderbilt University Medical Center
Nashville
Tennessee
Study not yet started
Mayo Clinic
Rochester
Minnesota
Site active
Loyola University Chicago
Maywood
Illinois
Study not yet started
University of Michigan
Ann Arbor
Michigan
Site active
University of California
Los Angeles
California
Study not yet started
University of Virginia Health System
Charlottesville
Virginia
Study not yet started
Baylor University
Dallas
Texas
Study not yet started
National Jewish Health
1400 Jackson Street
Denver
Colorado 80206
Site active
Temple University
Philadelphia
Pennsylvania
Study not yet started
CLS Health
Webster
Texas
Site active
Keck School of Medicine of USC
University of Southern California
Los Angeles
California
Study not yet started