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CompletedObservational

Study to investigate longitudinal changes in breath biomarkers in idiopathic pulmonary fibrosis

Idiopathic pulmonary fibrosis (IPF) is a long-term lung condition that causes progressive scarring, making breathing harder over time. While treatments can slow this down, existing breathing tests do not always show how quickly the condition is worsening or which patients will benefit most from medication. This UK observational study tests whether analysing chemicals in exhaled breath can provide clearer answers. Participants visit a hospital clinic four times over roughly nine months. At each visit, you breathe normally into a specialised mask for about eight minutes, give a small blood sample, and fill in two short questionnaires about your symptoms. Taking part involves no changes to your current medicines and will not cure your IPF, but it could help create a gentler way to monitor the disease in the future. The trial is open to adults aged 18 and over with confirmed IPF who do not smoke.

At a glance

Status
Completed
Sponsor
Manchester University NHS Foundation Trust
Enrolment target
80
Start
09 Jul 2018
Estimated completion
30 Jun 2019

What is this study about?

Idiopathic pulmonary fibrosis (IPF) is a condition where the tissue inside the lungs becomes thick, stiff, and scarred. Over time, this scarring makes it harder for the lungs to transfer oxygen into the blood, leading to breathlessness and fatigue. Although treatments are available to help slow down lung damage, doctors currently find it difficult to predict how quickly the disease will progress in any one person or who will respond best to specific medicines.

Every time you breathe out, your breath carries tiny amounts of airborne chemicals produced by your body's cells. Scientists have found that different health conditions produce distinct chemical patterns, almost like a chemical fingerprint. In this study, researchers want to see whether analyzing these breath patterns can show how active the lung scarring is in people with IPF.

By collecting breath samples every few months, the research team hopes to learn whether breath changes can signal that the condition is advancing before severe symptoms appear. If successful, this research could lead to a quick, painless test to help doctors monitor IPF accurately and choose the right treatments earlier for each patient.

Key takeaways

  • Researchers are testing whether exhaled breath can accurately track idiopathic pulmonary fibrosis.
  • Participation involves four hospital visits over around nine months.
  • Each visit includes an 8-minute breath sample, a small blood test, and brief surveys.
  • The study involves no experimental medications; your normal treatment continues.
  • Open to non-smoking adults aged 18 and over with an established IPF diagnosis.

Who may be eligible?

You may be able to join this study if you are 18 or older and have received a formal diagnosis of idiopathic pulmonary fibrosis (IPF) from a specialist hospital respiratory team.

To make sure the breath measurements are accurate, the study cannot accept people who currently smoke. You also cannot take part if you have another major lung disease as your primary diagnosis, such as severe asthma or advanced emphysema.

In addition, anyone who has recently had a chest infection requiring treatment within the last four weeks will need to wait before participating, as short-term infections can temporarily alter the chemicals in your breath.

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. I am aged 18 or older.
  2. I have a confirmed medical diagnosis of idiopathic pulmonary fibrosis (IPF).
  3. I do not currently smoke.
  4. IPF is my main lung condition, without other major respiratory diseases.
  5. I have not had a chest infection treated in the last four weeks.
Answer every question to see your result.

What does participation involve?

Taking part in this study lasts approximately nine months and involves four hospital visits, spaced about three months apart.

At each visit, you will breathe normally into a specialised mask (called the ReCIVA device) for around eight minutes while tiny tubes collect your breath. You will also provide a small blood sample and fill out two brief questionnaires about your breathing and daily symptoms.

There are no experimental drugs in this study. You will carry on taking your normal prescribed medications, and your usual NHS care will continue as planned.

Potential risks and benefits

This study will not cure your lung condition or provide direct medical benefits to your health. However, your participation could help researchers discover better, gentler ways to monitor IPF for patients in the future. The tests carry very few risks. The breath sampling is completely non-invasive, though some people may find wearing the face mask slightly warm or strange. Having a blood sample taken can cause minor, temporary bruising. You are free to pause the breath test or leave the study at any point without it affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Wythenshawe Hospital, Manchester University NHS Foundation Trust
    City only
    Manchester, England
  • Norfolk and Norwich University Hospital NHS Foundation Trust
    City only
    Norwich, England

Common questions

Will I have to try any new experimental medicines?

No. This is an observational study, which means researchers are only collecting breath and blood samples. You will stay on your usual medicines.

What does the breath collection feel like?

It feels very similar to wearing a standard face mask. You simply sit comfortably and breathe normally for about eight minutes.

Will taking part replace my normal clinic visits?

No. This study runs alongside your normal care. You will still see your regular respiratory team as usual.

What happens if I feel uncomfortable wearing the mask?

You can ask the researcher to remove the mask and stop the test at any second. You are always in control.

Do I have to pay to take part?

No, taking part in NHS clinical research is free, and your travel expenses to the hospital visits may be reimbursed.

How to find out more

Conal Hayton

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

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