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

Royal Brompton & Harefield NHS Foundation Trust

Status: Enrolling

Conditions: Progressive Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis (IPF)

Treatments: Other: No Interventions; Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT07332117

IRAS ID: 358410

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

Patients to be commenced on anti-fibrotics

Description:

Patients with either idiopathic pulmonary fibrosis or progressive pulmonary fibrosis planned to commenced anti-fibrotic medication (either pirfenidone or nintedanib) will be recruited.

Treatment:

Other: No intervention

Other: No Interventions

Control group

Description:

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.

Treatment:

Other: No intervention

Other: No Interventions