Involvement of Skeletal Muscle Fibrocytes in sarcOpenia in Patients With Chronic ObstRuctive Pulm… (NCT04939454) | Clinical Trial Compass
CompletedNot Applicable
Involvement of Skeletal Muscle Fibrocytes in sarcOpenia in Patients With Chronic ObstRuctive Pulmonary Disease
France22 participantsStarted 2022-11-29
Plain-language summary
Chronic obstructive pulmonary disease (COPD) is presently the third leading cause of death worldwide and is characterized by irreversible airflow limitation diagnosed by spirometry. COPD is currently considered as a systemic disease with predominantly respiratory involvement, associated with numerous comorbidities. Among these, muscle wasting, present in about one third of patients, is associated with a higher mortality (up to 10-fold, irrespective of the severity of the obstruction). Muscle wasting is classically characterized by a decrease in muscle strength and volume (sarcopenia), which can be defined by a decrease in the muscle mass measured by dual X-ray absorptiometry: Appendicular Skeletal Muscle Mass or ASM / height \< 7.0 kg/m2 in men and 5.5 kg/m2 in women. However, sarcopenia is largely underestimated in current clinical practice. Moreover, there is no specific treatment: only exercise training as part of respiratory rehabilitation has shown some efficiency. The underlying pathophysiological mechanisms are indeed poorly characterized.
Fibrocytes, cells derived from blood monocytes and able to migrate to different organs in order to play pro-fibrotic or pro-inflammatory roles, play a key role in bronchial obstruction. They are recruited in the blood of COPD patients during an acute exacerbation according to a CXCL12/CXCR4 chemotactic axis. Their role in COPD sarcopenia is currently unknown, but recent data show that they are involved in a mouse model of muscular dystrophy.
The hypothesis is that fibrocytes are involved in COPD sarcopenia.
Who can participate
Age range
40 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:
* Men or women 40 years of age or older;
* Diagnosed with COPD according to the 2018 Global Initiative for Lung Disease (GOLD) criteria:
* Smoking intoxication greater than or equal to 10 pack-years
* Bronchial obstruction on spirometry with a FEV1 to FVC ratio post-bronchodilator \< 70%.
* Available measurement of lean body mass by bioelectrical impedancemetry performed as part of routine care;
* Insured under the French social security system;
* Informed consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
The patients included will be sarcopenic and non-sarcopenic (equal numbers in each group, patients categorized according to the result of dexametry), and will be matched on sex and age (± 5 years).
Exclusion Criteria:
* Other concomitant respiratory pathology (e.g., asthma);
* Acute exacerbation of COPD or acute intercurrent condition (e.g. infection) ongoing or resolved within the last 48 hours
* Current systemic corticosteroid therapy;
* Contraindication to muscle biopsy: acquired or innate hemostasis disorders, anticoagulant therapy or double anti-platelet aggregation; contraindication to lidocaine: known hypersensitivity, patients with recurrent porphyrias;
* Presence of a concomitant muscular pathology, innate (e.g. genetic myopathy) or acquired (e.g. myositis);
* Progressive bronchopulmonary cancer;
* Pregnant or breast-feeding woman;
* Patient…
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
1
Fibrocytes density (number/mm2) in quadricipital biopsies of sarcopenic patients versus non-sarcopenic patients