All studies
CompletedNot ApplicableInterventional

Pilot trial of omeprazole in idiopathic pulmonary fibrosis (PPIPF Study)

Idiopathic pulmonary fibrosis (IPF) causes progressive scarring in the lungs, often leading to shortness of breath and a persistent, dry cough. Doctors know that acid reflux—where tiny amounts of stomach acid travel up towards the throat and lungs—is very common in people with IPF and may make their cough much worse. This trial is looking at whether omeprazole, a widely used tablet that stops stomach acid production, can help calm this cough. Researchers in Newcastle upon Tyne are comparing omeprazole against a placebo (dummy pill) in adults aged 40 to 85 with IPF. Participants take a capsule twice daily before food for 90 days and attend six hospital visits for simple breathing checks and cough monitoring. The goal is to see if reducing acid provides meaningful relief, which could lead to larger trials and better symptom support.

At a glance

Status
Completed
Phase
Not Applicable
Sponsor
The Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Enrolment target
40
Start
01 Feb 2014
Estimated completion
30 Sep 2016

What is this study about?

Idiopathic pulmonary fibrosis (IPF) is a lung condition where normal, healthy lung tissue gradually becomes thick and scarred. Over time, this scarring makes it harder for the lungs to take in oxygen, causing breathlessness and a relentless cough. This cough can be exhausting and difficult to treat with standard medicines, significantly affecting a person's quality of life.

In recent years, researchers noticed that many people with IPF also experience acid reflux. Reflux happens when acidic digestive juices leak upwards from the stomach into the food pipe. Even tiny, microscopic droplets of this acid can accidentally enter the airways, irritating the delicate lung tissue and triggering frequent coughing fits.

Omeprazole is an established, gentle medicine that blocks stomach acid production. It has been used safely by millions of people for indigestion. In this study, doctors want to see if switching off stomach acid with omeprazole can calm lung irritation and ease coughing in people with IPF. Because this is a pilot study, it aims to gather early evidence to show whether a larger, nationwide trial should take place.

Key takeaways

  • Tests whether the common heartburn drug omeprazole can soothe chronic coughing in IPF.
  • Participants take a capsule twice a day for 90 days (either omeprazole or a dummy pill).
  • Involves six hospital visits at the Royal Victoria Infirmary in Newcastle upon Tyne.
  • Open to adults aged 40 to 85 with a confirmed diagnosis of IPF.
  • Participation is voluntary, low-risk, and you can withdraw at any point.

Who may be eligible?

This study is designed for adults aged between 40 and 85 who have a confirmed diagnosis of idiopathic pulmonary fibrosis (IPF) agreed by a specialist lung team. Participants must have an ongoing cough, with or without breathlessness during daily activities, alongside typical signs of IPF on chest scans and lung tests.

People who already take acid-reducing tablets (such as omeprazole, lansoprazole, or similar medicines) may still be able to join. However, you might be asked to safely stop taking them for a short time before the study starts. This will only happen if your GP and study doctors agree it is safe for you, and it ensures the trial tests the medicine fairly.

You cannot take part if you have certain severe stomach conditions that strictly require continuous acid medicine, such as Zollinger-Ellison syndrome or a recent history of stomach bleeding.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 40 and 85 years old?
  2. Have you been diagnosed with idiopathic pulmonary fibrosis (IPF)?
  3. Do you have a persistent, troublesome cough?
  4. Are you able to travel to Newcastle for six clinic appointments over three months?
  5. Are you willing to pause your current indigestion tablets if your GP agrees it is safe?
Answer every question to see your result.

What does participation involve?

Taking part in this study lasts for about three months (90 days). You will be randomly placed into one of two groups by a computer. One group takes a 20 mg omeprazole capsule twice a day before meals, while the other group takes a matching placebo (dummy) capsule. Neither you nor your study doctor will know which one you are taking until the study ends.

You will need to attend six appointments at the Royal Victoria Infirmary in Newcastle upon Tyne. During these visits, the team will check your breathing using routine, non-invasive lung function tests and monitor your cough using safe recording equipment. There are no painful or invasive procedures involved, and the team will closely monitor your wellbeing throughout.

Potential risks and benefits

You might not personally benefit from taking part, especially if you receive the placebo capsule. However, your involvement will help doctors understand how to better treat distressing coughs in people with IPF in the future. The risks of joining are very low. The breathing tests and cough monitors are completely safe and routinely used in clinics. Omeprazole has been used worldwide for decades and serious side effects are extremely rare. You are free to leave the trial at any time without giving a reason, and choosing to withdraw will never affect your usual NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • 4th Floor William Leech Building
    City only
    Newcastle Upon Tyne, England

Common questions

What is a placebo?

A placebo is a dummy pill that looks and tastes identical to the real medicine but contains no active ingredients. It helps researchers prove whether any improvements are truly caused by the drug.

Will I know if I am taking omeprazole or the dummy pill?

No. This is a double-blind study, which means neither you nor your study team will know which capsule you have until the trial is finished. In a medical emergency, the doctors can quickly find out.

What if I already take indigestion tablets?

You might still be able to join. Your GP and the study team will check if it is safe for you to take a brief, supervised break from your current heartburn tablets before the trial begins.

Does omeprazole cure IPF?

No, omeprazole does not cure IPF or reverse existing lung scars. The goal of this study is simply to see if reducing stomach acid can reduce coughing and improve everyday comfort.

Do I have to pay to take part?

No, the study medication and all trial tests are provided free of charge through the research team and funding from the British Lung Foundation.

How to find out more

Prosenjit Dutta

Always speak to your GP or specialist before deciding to take part in a study.

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