RecruitingNot Applicable

A Pilot Study to Assess Body Mass Composition Measurement Using BIA and Muscle Ultrasound in IPF and PPF Patients on Anti-fibrotic Medications

United Kingdom30 participantsStarted 2025-09-09

Plain-language summary

To assess the impact on body mass composition from anti-fibrotic medications used in fibrotic lung disease by using BIA and muscle ultrasound

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * A diagnosis of Idiopathic pulmonary fibrosis or progressive pulmonary fibrosis * Newly commencing anti-fibrotic medication (either nintedanib or pirfenidone) * Subject aged \> 18 years * Able to willingly give consent Exclusion Criteria: * Co-morbidities currently requiring enteral feeding * Weight loss \> 10% in preceding 3-6 months * Significant musculoskeletal issues that may impact muscle mass * End of life care (expected \< 6 weeks left to live) * Previous anti-fibrotic use * Currently on \> Prednisolone 10mg daily * Presence of implantable cardioverter defibrillator (ICD) or permanent pacemaker (PPM) * Heart failure * Pregnancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recruitment of patients to study

Timeframe: For study recruitment window of 6 months

Implementation of study protocol

Timeframe: For the 6 month recruitment window

Feasibility of collection of data

Timeframe: For the the study recruitment window of 6 months

Acceptability of use of BIA and muscle ultrasound

Timeframe: To be performed at baseline visit and 4 month visit

Trial details

NCT IDNCT07332117

SponsorRoyal Brompton & Harefield NHS Foundation Trust

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-04

Contact for this trial

Jessica Dr Raja

07955229245 jessica.raja2@nhs.net

View on ClinicalTrials.gov More Idiopathic Pulmonary Fibrosis (IPF) trials