Idiopathic Pulmonary Fibrosis (IPF)AF-BMCNCT07332117
A Pilot Study to Assess Body Mass Composition Measurement Using BIA and Muscle Ultrasound in IPF and PPF Patients on Anti-fibrotic Medications
An observational study of Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
To assess the impact on body mass composition from anti-fibrotic medications used in fibrotic lung disease by using BIA and muscle ultrasound Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Sep 2025to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients being newly commenced on anti-fibrotic medication as part of their clinical care (either nintedanib or pirfenidone)
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Presence of implantable cardioverter defibrillator (ICD) or permanent pacemaker (PPM)
- Heart failure
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elisabetta Professor Renzoni contact
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Brompton Hospital
London, SW36NP
Jessica Dr Raja, 07955229245, jessica.raja2@nhs.net
Elisabetta Professor Renzoni, elisabetta.renzoni@nhs.net
About this study
To assess the impact on body mass composition from anti-fibrotic medications used in fibrotic lung disease by using BIA and muscle ultrasound
Read the detailed description
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.
- Being tested
- No Interventions, No intervention
- Keywords
- bioimpedance analysis, muscle ultrasound, body composition
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
No intervention
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients to be commenced on anti-fibrotics | Patients with either idiopathic pulmonary fibrosis or progressive pulmonary fibrosis planned to commenced anti-fibrotic medication (either pirfenidone or nintedanib) will be recruited. Receives: Other: No Interventions; Other: No intervention | |
| Control group | We will also recruit 20 controls with predominantly fibrotic lung disease. Only those with extent of disease > 20% on HRCT as determined by PI and CI will be included. These are patients who in the opinion of the treating physician may require anti-fibrotic treatment in the future, but are not planned to start anti-fibrotic medications over the subsequent 4 months and have not previously been on anti-fibrotic medications. Receives: Other: No Interventions; Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment of patients to study
Measured by number of patients consenting/number of patients contacted and rationale for declining
Measured: For study recruitment window of 6 months
Implementation of study protocol
Number of patients attending both visits (baseline and 4 months) and rationale for dropout
Measured: For the 6 month recruitment window
Feasibility of collection of data
Collection of data from BIA (skeletal muscle index (SMI), phase angle (PhA) and fat free mass index (FFMI)) and muscle ultrasound (Anterior-posterior diameter of rectus femoris and cross sectional area of rectus femoris)
Measured: For the the study recruitment window of 6 months
Acceptability of use of BIA and muscle ultrasound
Likert scale on use of BIA and muscle ultrasound
Measured: To be performed at baseline visit and 4 month visit
Secondary outcomes (10)
Bioelectrical impedance analysis (BIA)
Messurements taken with BIA include fat-free mass index (FFMI) kg/m2, phase angle (PhA) and skeletal muscle mass (SMM)
Measured: Performed at baseline visit and at 4 month visit
Five times sit to stand (5TST)
Time taken from moving from sitting to standing position for 5 repetitions will be recorded (seconds)
Measured: To be performed at baseline visit and at 4 month visit
Four metre gait speed (4MGS)
Time taken to complete a 4 metre distance walking will be recorded and repeated 3 times (seconds)
Measured: To be performed at baseline visit and 4 month visit
Questionnaires assessing gastrointestinal symptoms
- Gastrointestinal symptom rating scale (GSRS) to quantify the severity and impact of gastrointestinal symptoms
- Visual analogue scale (VAS) for loss of appetite, nausea and diarrhoea
- Past 1 week, how many bowel movements per day
Measured: To be performed at baseline visit and at 4 month visit
Questionnaires assessing respiratory symptoms and quality of life
- The King's brief interstitial lung disease questionnaire (K-BILD) - a widely validated ILD-specific quality of life questionnaire
Measured: To be performed at baseline visit and at 4 month visit
Questionnaire to assess levels of physical activity
- International physical activity questionnaire (IPAQ)
Measured: To be performed at baseline visit and at 4 month visit
Muscle strength
Isometric quadriceps testing - patient seated on a treatment table with hips flexed approximately 85 degrees, thigh is secured to treatment table with one velcro strap placed across thighs, strap attached to patient's ankle and instructed to push their leg forward. This is repeated 3 times with the best reading recorded in kilograms (kg)
Measured: Performed at baseline visit and 4 month visit
Height
Height - will be taken from the most recent lung function test (within the previous 12 months) in metres (m)
Measured: To be performed at baseline
Body weight
Body weight - measured with low clothes and without shoes in kilograms (kg)
Measured: Performed at baseline visit and 4 month visit
Quadriceps ultrasound
Using phillips (Lumify) linear transducer (C12-4) measurements will be taken by placing the probe perpendicular to the long axis of the the thigh three-fifths of thr distance from the anterior superior iliac spine to the superior patellar border. The average of 3 measurements will be taken of both the anterior-posterior (AP) (cm) and the cross-sectional area of rectus femoris (RFcsa) (cm2). Due to limitations with available software, images will be sent to ImageJ software to determine RFcsa.
Measured: To be performed at baseline visit and 4 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start9 Sep 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332117
- Sponsor's protocol ID
- IRAS ID: 358410
- Acronym
- AF-BMC
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Identifiable individual participant data will not be shared with other researchers, however de-identified study results will be submitted to journals for publication.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess Body Mass Composition Measurement Using BIA and Muscle Ultrasound in IPF and PPF Patients on Anti-fibrotic Medications
- ClinicalTrials.gov ID
- NCT07332117
- Acronym / sponsor ID
- AF-BMC / IRAS ID: 358410
- Keywords
- bioimpedance analysis, muscle ultrasound, body composition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the impact on body mass composition from anti-fibrotic medications used in fibrotic lung disease by using BIA and muscle ultrasound
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients to be commenced on anti-fibrotics | – | Other: No Interventions, Other: No interventionPatients with either idiopathic pulmonary fibrosis or progressive pulmonary fibrosis planned to commenced anti-fibrotic medication (either pirfenidone or nintedanib) will be recruited. |
| Control group | – | Other: No Interventions, Other: No interventionWe will also recruit 20 controls with predominantly fibrotic lung disease. Only those with extent of disease > 20% on HRCT as determined by PI and CI will be included. These are patients who in the opinion of the treating physician may require anti-fibrotic treatment in the future, but are not planned to start anti-fibrotic medications over the subsequent 4 months and have not previously been on anti-fibrotic medications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being newly commenced on anti-fibrotic medication as part of their clinical care (either nintedanib or pirfenidone)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionsNo intervention | Other | Control group, Patients to be commenced on anti-fibrotics |
| No interventionNo intervention | Other | Control group, Patients to be commenced on anti-fibrotics |
Primary outcome
Recruitment of patients to study
Time frame: For study recruitment window of 6 months
Measured by number of patients consenting/number of patients contacted and rationale for declining
Implementation of study protocol
Time frame: For the 6 month recruitment window
Number of patients attending both visits (baseline and 4 months) and rationale for dropout
Feasibility of collection of data
Time frame: For the the study recruitment window of 6 months
Collection of data from BIA (skeletal muscle index (SMI), phase angle (PhA) and fat free mass index (FFMI)) and muscle ultrasound (Anterior-posterior diameter of rectus femoris and cross sectional area of rectus femoris)
Acceptability of use of BIA and muscle ultrasound
Time frame: To be performed at baseline visit and 4 month visit
Likert scale on use of BIA and muscle ultrasound
10 secondary outcomes
Bioelectrical impedance analysis (BIA)
Time frame: Performed at baseline visit and at 4 month visit
Five times sit to stand (5TST)
Time frame: To be performed at baseline visit and at 4 month visit
Four metre gait speed (4MGS)
Time frame: To be performed at baseline visit and 4 month visit
Questionnaires assessing gastrointestinal symptoms
Time frame: To be performed at baseline visit and at 4 month visit
Questionnaires assessing respiratory symptoms and quality of life
Time frame: To be performed at baseline visit and at 4 month visit
Questionnaire to assess levels of physical activity
Time frame: To be performed at baseline visit and at 4 month visit
Muscle strength
Time frame: Performed at baseline visit and 4 month visit
Height
Time frame: To be performed at baseline
Body weight
Time frame: Performed at baseline visit and 4 month visit
Quadriceps ultrasound
Time frame: To be performed at baseline visit and 4 month visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No. Identifiable individual participant data will not be shared with other researchers, however de-identified study results will be submitted to journals for publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elisabetta Professor Renzoni contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Dr Raja (07955229245, jessica.raja2@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment of patients to study (time frame: For study recruitment window of 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.