What next?
What next?
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.
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?
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 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 our more about other research opportunities visit our research finder main page.
Aged 40 years and older
Any gender
Diagnosis of IPF
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.
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
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.
tipal@uea.ac.ukThis 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