Chronic Obstructive Pulmonary Disease (COPD)NCT07541053
Low Fat-free Mass in Prognosis of People With Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Mansoura University at 1 site in Egypt.
Trial summary
The effects of low fat-free mass in Prognosis of people with chronic obstructive pulmonary disease (COPD) as regard clinical evaluation using BODE index, GOLD ABE assessment ( Gold 2024 ) functional evaluation using spirometry and 6 min walk test and radiological evaluation by computed chest tomography. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Apr 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Group A: COPD patients with low FFM which is defined as fat-free mass refers primarily to muscle mass, especially while considering body composition and weight management. * Group B: COPD patients with normal FFM with matched age and sex to the patients group.
Who may be able to join
- Were adults aged ≥40 years with a clinical diagnosis of COPD confirmed by spirometry showing post-bronchodilator FEV₁/FVC <0.70 according to GOLD 2024 criteria
Who cannot join
- Exacerbation within the preceding month, active pulmonary infection, physical disability precluding study measurements (e.g., musculoskeletal or neurological disorders), advanced heart failure (NYHA class III-IV), malignancy or hyperthyroidism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differential Impact of Low Fat-Free Mass on Prognosis of Patients With Chronic Obstructive Pulmonary Disease (COPD)
The effects of low fat-free mass in Prognosis of people with chronic obstructive pulmonary disease (COPD) as regard clinical evaluation using BODE index, GOLD ABE assessment ( Gold 2024 ) functional evaluation using spirometry and 6 min walk test and radiological evaluation by computed chest tomography.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production and \ or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and\ or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction.
COPD is characterized by a progressive and irreversible decline in lung function. In addition, COPD is recognized as a systemic disease with significant extra pulmonary effects.
Loss of skeletal muscle mass is a well described and clinically relevant systemic consequence of COPD. Across the disease severity spectrum of COPD, the prevalence of abnormally low muscle mass (i.e. sarcopenia or cachexia) is estimated to be ∼23%.
The etiology of muscle dysfunction in COPD is complex and multifactorial. Proposed pathophysiological mechanisms include 1) disease-related factors such as systemic inflammation; 2) ageing; and 3) behavior modification, particularly less time spent physically active and more time spent sedentary.
The rate of age-related decline in skeletal muscle function is accelerated in people with COPD compared to that of otherwise healthy adults (Limpawattana et al., 2018). Additionally, loss of muscle function begins early in the disease course, with ostensible muscle dysfunction observed in people with mild COPD.
Importantly, low muscle mass is not just a systemic manifestation affecting people with COPD who are underweight, but also those who are pre-obese or obese, termed sarcopenic obesity, which is similarly associated with poor health outcomes in COPD (Machado et al., 2023). People with COPD who possess higher muscle or fat-free mass have a better quality of life and prognosis.
In addition, a significant positive association between muscle or fat-free mass and exercise tolerance in COPD has been also shown. This has led to low muscle mass being recognized as a treatable trait of COPD to help alleviate disease burden and improve clinical health outcomes.
- Keywords
- COPD, FFMI
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A: COPD patients with low FFM | Defined as fat-free mass refers primarily to muscle mass, especially while considering body composition and weight management. | |
| Group B : COPD patients with normal FFM | with normal or high FFM with matched age and sex to the patients group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat-free Mass in Chronic Obstructive Pulmonary Disease
Functional evaluation using 6 min walk test distance (meter)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Apr 2024
- Primary completion1 Oct 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 90 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MohamedAbdElmoniem, Mansoura University
- Investigators
- Mohamed Abd ElMoniem, Principal investigator, Lectruer of chest medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541053
- Sponsor's protocol ID
- MS.24.2.2706
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Impact of Low Fat-Free Mass on Prognosis of Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT07541053
- Acronym / sponsor ID
- MS.24.2.2706
- Keywords
- COPD, FFMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 21 Apr 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.
The effects of low fat-free mass in Prognosis of people with chronic obstructive pulmonary disease (COPD) as regard clinical evaluation using BODE index, GOLD ABE assessment ( Gold 2024 ) functional evaluation using spirometry and 6 min walk test and radiological evaluation by computed chest tomography.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production and \ or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and\ or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction.
COPD is characterized by a progressive and irreversible decline in lung function. In addition, COPD is recognized as a systemic disease with significant extra pulmonary effects.
Loss of skeletal muscle mass is a well described and clinically relevant systemic consequence of COPD. Across the disease severity spectrum of COPD, the prevalence of abnormally low muscle mass (i.e. sarcopenia or cachexia) is estimated to be ∼23%.
The etiology of muscle dysfunction in COPD is complex and multifactorial. Proposed pathophysiological mechanisms include 1) disease-related factors such as systemic inflammation; 2) ageing; and 3) behavior modification, particularly less time spent physically active and more time spent sedentary.
The rate of age-related decline in skeletal muscle function is accelerated in people with COPD compared to that of otherwise healthy adults (Limpawattana et al., 2018). Additionally, loss of muscle function begins early in the disease course, with ostensible muscle dysfunction observed in people with mild COPD.
Importantly, low muscle mass is not just a systemic manifestation affecting people with COPD who are underweight, but also those who are pre-obese or obese, termed sarcopenic obesity, which is similarly associated with poor health outcomes in COPD (Machado et al., 2023). People with COPD who possess higher muscle or fat-free mass have a better quality of life and prognosis.
In addition, a significant positive association between muscle or fat-free mass and exercise tolerance in COPD has been also shown. This has led to low muscle mass being recognized as a treatable trait of COPD to help alleviate disease burden and improve clinical health outcomes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: COPD patients with low FFM | – | –Defined as fat-free mass refers primarily to muscle mass, especially while considering body composition and weight management. |
| Group B : COPD patients with normal FFM | – | –with normal or high FFM with matched age and sex to the patients group. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Group A: COPD patients with low FFM which is defined as fat-free mass refers primarily to muscle mass, especially while considering body composition and weight management. * Group B: COPD patients with normal FFM with matched age and sex to the patients group.
Key inclusion criteria (1 listed)
- Were adults aged ≥40 years with a clinical diagnosis of COPD confirmed by spirometry showing post-bronchodilator FEV₁/FVC <0.70 according to GOLD 2024 criteria
Key exclusion criteria (1 listed)
- Exacerbation within the preceding month, active pulmonary infection, physical disability precluding study measurements (e.g., musculoskeletal or neurological disorders), advanced heart failure (NYHA class III-IV), malignancy or hyperthyroidism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fat-free Mass in Chronic Obstructive Pulmonary Disease
Time frame: 6 months
Functional evaluation using 6 min walk test distance (meter)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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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. This study is not recruiting at the moment.
Mohamed Abd ElMoniem principal investigator
Lectruer of chest medicine
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 Chronic Obstructive Pulmonary Disease (COPD), run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Apr 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat-free Mass in Chronic Obstructive Pulmonary Disease (time frame: 6 months). 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 21 Apr 2026.