TIPAL: Treating People With Idiopathic Pulmonary Fibrosis (IPF) With the Addition of Lansoprazole

Upcoming study
Expected to open June 2021
This study is currently recruiting
Expected to close August 2024
This study is closed
This study closed in August 2024
We will update this page with study results when available.
Information on study results are included below
This study closed in August 2024

What next?

Original listing:

What next?

Original listing:

About this study

People affected by idiopathic pulmonary fibrosis (IPF) currently have limited treatment options to slow the progression of disease. New research studies are needed to gain valuable knowledge about potentially better treatment options.

People with IPF often have acid reflux, which is thought to result in stomach acid potentially reaching the lungs and causing damage. The production of stomach acid can be stopped by medicines called proton pump inhibitors (PPIs), which can then reduce the symptoms of acid reflux.

The aim of the TIPAL study is to see if IPF progresses at a slower rate when taking PPIs.

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What is involved?

You will be assigned to one of two groups. One group in the study will be given a drug called lansoprazole, whereas the other group will be given a placebo. A placebo does not contain any active ingredients of the study drug.

At the beginning of the study, you will be asked to start complete weekly breathing tests at home using equipment that will be provided to you. For those who have a cough, an additional measurement using a device will count the number of times you cough in a 24 hour period.

The researchers will ask you to complete questionnaires about your coughing, IPF, sleep habits and other general health questions.

Depending on which group you are in, either the drug or the placebo will be given twice a day for 12 months. At the end of the study you will have the same tests and questionnaires that you were asked to complete at the beginning of the study.

Summary of involvement

Taking Lansoprazole or a placebo twice per day

Completing questionnaires

Weekly breathing tests at home

Cough device measurement for 24 hours (only applicable to those who have a cough)

Can I take part?

You may be able to take part if you have a diagnosis of IPF, are 40 years or older and are not currently receiving treatment with proton pump inhibitors for acid reflux.

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:

Aged 40 years and older

Any gender

Diagnosis of IPF

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

Use of another proton pump inhibitor medication or prokinetic drugs

Patients with a respiratory tract infection within 4 weeks of the initial assessment

Other significant respiratory disease

Patients with an FEV1/FVC<0.7

Known allergy to proton pump inhibitors

Females who are able to childbear or breastfeeding

Receiving long-term oxygen therapy

What difference could taking part make?

Taking part in the TIPAL study will help researchers to determine if patients with IPF should take PPIs. This will help researchers to understand the potential effects of the new drug and how it impacts the body. The study will help to see if it has the potential to help people with 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

37 UK hospitals

How to take part

Please speak to your healthcare team about the study.

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:

tipal@uea.ac.uk

This study is supported by

Norwich Clinical Trials Unit
Study ID number:
NCT04965298

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