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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (1 UK site)
Royal Brompton Hospital
London SW36NP, United Kingdom
How to Get in Touch
Jessica Dr Raja
Sponsor contactCONTACT
Elisabetta Professor Renzoni
Sponsor contactCONTACT
