NCT04939454Completed
Involvement of Skeletal Muscle Fibrocytes in sarcOpenia in Patients With Chronic ObstRuctive Pulmonary Disease
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 11 Jun 2021
- Start date
- 29 Nov 2022
- Primary completion date
- 21 Nov 2025
- Lead sponsor
- University Hospital, Bordeaux
- Diseases
- COPD
- NCT number
- NCT04939454
What you commit to
- Study type: Interventional
- Participants enrolled: 22
- From 29 Nov 2022 to the primary completion date, 21 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other concomitant respiratory pathology (e.g., asthma);
- Current systemic corticosteroid therapy;
- Presence of a concomitant muscular pathology, innate (e.g. genetic myopathy) or acquired (e.g. myositis);
Other illness
- Acute exacerbation of COPD or acute intercurrent condition (e.g. infection) ongoing or resolved within the last 48 hours
- Progressive bronchopulmonary cancer;
- Disorders of hemostasis detected on the blood sample;
Lab values
- 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;
Other
- Pregnant or breast-feeding woman;
- Patient undergoing respiratory rehabilitation;
- Refusal to participate in the study.
- Pregnancy in progress.
Who the study is looking for
- 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).
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Haut Leveque Chu de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.