Chronic Obstructive Pulmonary DiseaseNCT02284932
Muscle Atrophy In Patients With Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease, run by Laval University at 1 site in Canada.
Trial summary
Limb muscle dysfunction, characterized by atrophy and weakness, is amongst the most troublesome systemic consequences of chronic obstructive pulmonary disease (COPD) leading to poor functional status and premature mortality. Read more about this study
- Who is it for?
- Ages 55 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- No specific intervention for this study
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Sep 2018
- How long will I take part?
- 6 Weeks
- 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 55 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with COPD
Who may be able to join
- male
- COPD with an FEV1 of under 60% of predicted
- non-smoker
- between 55 and 75 years old
Who cannot join
- all inflammatory disease (HIV, cancer, renal and cardiac deficiency)
- hormonal dysregulation
- inferior limb pathology
- neuromuscular pathology
- history of tobacco or alcool abuse
- oxygen dependent
- recent exacerbation (2 months) of the symptoms of COPD
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5
About this study
Limb muscle dysfunction, characterized by atrophy and weakness, is amongst the most troublesome systemic consequences of chronic obstructive pulmonary disease (COPD) leading to poor functional status and premature mortality.
One prevailing hypothesis stipulates that the deterioration in muscle structure and function during COPD results from a spillover of inflammatory mediators from the lungs to the systemic circulation and then to the muscles.
Read the detailed description
The investigators objective is to investigate the impact of COPD on key signaling pathways involved in the muscle atrophy. Moderate to severe COPD patients (FEV1 under 60% of predicted) and healthy controls will be recruited. All of the investigators patients will undergo a thorough baseline assessment in pulmonary capacity, muscle force and body composition. Blood sampling and biopsy of the quadriceps will be done. Key proteins of signaling intramuscular pathways involved in protein synthesis and degradation will be measured in the quadriceps.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- No specific intervention for this study
- Keywords
- COPD, atrophy, muscle
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No specific intervention for this studyOther
No specific intervention for this study
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Group : COPD patients No specific intervention for this study Receives: Other: No specific intervention for this study | |
| Healthy controls | Group : healthy volunteers No specific intervention for this study Receives: Other: No specific intervention for this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of protein degradation in muscles of wasted COPD patients
Measured: At baseline (COPD in a stable state of the disease)
Secondary outcomes (1)
Increase of protein synthesis in muscles of wasted COPD patients
Measured: At baseline (COPD in a stable state of the disease)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startSep 2011
- Primary completionSep 2017 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Laval 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Annie Dubé, Laval University
- Investigators
- François Maltais, MD, PhD, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284932
- Sponsor's protocol ID
- COPD-20739
- Status last verified
- Sep 2016
- First submitted
- 8 Oct 2014
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Atrophy In Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02284932
- Acronym / sponsor ID
- COPD-20739
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, atrophy, muscle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2011
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 6 Nov 2014 (estimated)
- 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.
Limb muscle dysfunction, characterized by atrophy and weakness, is amongst the most troublesome systemic consequences of chronic obstructive pulmonary disease (COPD) leading to poor functional status and premature mortality.
One prevailing hypothesis stipulates that the deterioration in muscle structure and function during COPD results from a spillover of inflammatory mediators from the lungs to the systemic circulation and then to the muscles.
Detailed description
The investigators objective is to investigate the impact of COPD on key signaling pathways involved in the muscle atrophy. Moderate to severe COPD patients (FEV1 under 60% of predicted) and healthy controls will be recruited. All of the investigators patients will undergo a thorough baseline assessment in pulmonary capacity, muscle force and body composition. Blood sampling and biopsy of the quadriceps will be done. Key proteins of signaling intramuscular pathways involved in protein synthesis and degradation will be measured in the quadriceps.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | Other: No specific intervention for this studyGroup : COPD patients No specific intervention for this study |
| Healthy controls | – | Other: No specific intervention for this studyGroup : healthy volunteers No specific intervention for this study |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD
Key inclusion criteria (4 listed)
- male
- COPD with an FEV1 of under 60% of predicted
- non-smoker
- between 55 and 75 years old
Key exclusion criteria (7 listed)
- all inflammatory disease (HIV, cancer, renal and cardiac deficiency)
- hormonal dysregulation
- inferior limb pathology
- neuromuscular pathology
- history of tobacco or alcool abuse
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 specific intervention for this studyNo specific intervention for this study | Other | COPD patients, Healthy controls |
Primary outcome
Decrease of protein degradation in muscles of wasted COPD patients
Time frame: At baseline (COPD in a stable state of the disease)
1 secondary outcome
Increase of protein synthesis in muscles of wasted COPD patients
Time frame: At baseline (COPD in a stable state of the disease)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
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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.
François Maltais, MD, PhD principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
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, run by Laval University at 1 site in Canada.
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 7 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: status not confirmed, as of the sponsor's last update on 8 Sep 2016. 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 Canada. 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?
Results are not available in the source record.
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?
Decrease of protein degradation in muscles of wasted COPD patients (time frame: At baseline (COPD in a stable state of the disease)). 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 8 Sep 2016.