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

Sponsor: Royal Brompton & Harefield NHS Foundation Trust

NCT ID: NCT07332117

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
No Interventions (other), No intervention (other)
How long the study runs
Study runs about 7 months (dates as stated)
About the drug or intervention
No Interventions — other: No intervention · No intervention — other: No intervention
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
30
Started
2025-09-09
Last checked
2025-12

Plain English Summary

What is this study?

  • • Testing a new treatment for idiopathic pulmonary fibrosis (ipf)
  • • Clinical study - 30 participants
  • • 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 take part?

  • • Ages 18 Years and over
  • • Diagnosed with idiopathic pulmonary fibrosis (ipf)

Where?

  • • London - Royal Brompton Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

This study will be looking at the measurement of body mass composition using bioimpedance analysis (BIA) and quadriceps muscle ultrasound in patients with fibrotic lung disease who are on anti-fibrotic drugs. These anti-fibrotic drugs (nintedanib and pirfenidone) commonly cause gastrointestinal side effects such nausea, loss of appetite and diarrhoea. As a result of these side effects some patients may have a change in the amount of body fat and muscle. This change is not able to be identified using weight or body mass index (BMI). BIA machines are a quick and easy method of looking at body mass composition and require patients to have electrodes attached to their body for approximately 6 seconds. BIA machines are already in routine care for patients with other types of lung conditions. Using muscle ultrasound we will be able to measure the size of the muscle in the thigh. In addition to the use and tolerability of BIA and muscle ultrasound in this group of patients we will be also taking other measurements including mid-arm circumference and physical tests (sitting to standing, walking speed and muscle strength). We will also use questionnaires to ask about symptoms relating to quality of life, physical activity and gastrointestinal symptoms. Patients will also provide a 3-day diet diary. We will be performing all of the above tests at the beginning before patients start the anti-fibrotic drugs and then again 4 months after starting the drugs and assessing for any changes over this period of time.

Idiopathic Pulmonary Fibrosis (IPF)Progressive Pulmonary Fibrosis

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓A diagnosis of Idiopathic lung fibrosis or progressive lung fibrosis
  • ✓Newly commencing anti-fibrotic medication (either nintedanib or pirfenidone)
  • ✓Subject aged \> 18 years
  • ✓Able to willingly give consent

Who cannot take part

  • ✗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
See the full criteria
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

Where Is This Study? (1 UK site)

Royal Brompton Hospital

London SW36NP, United Kingdom

Recruiting
Site contact (verified)
Jessica Dr RajaPrincipal Investigator
Elisabetta Professor Renzonielisabetta.renzoni@nhs.net

How to Get in Touch

Jessica Dr Raja

Sponsor contact

CONTACT

07955229245 jessica.raja2@nhs.net

Elisabetta Professor Renzoni

Sponsor contact

CONTACT

elisabetta.renzoni@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2025-12