Chronic Obstructive Pulmonary DiseaseNCT02903043
Expression of miR-204 and Consequences on Capillarization in Limb Muscles of Patients With COPD
An observational study of Chronic Obstructive Pulmonary Disease, run by Laval University at 1 site in Canada.
Trial summary
Limb muscle dysfunction, characterized by loss of capillaries, 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 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to Feb 2018
- How long will I take part?
- 1 Day
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with COPD
Who may be able to join
- COPD (FEV1/FVC < 0.70)
- Healthy subjects: no evidence of airways obstruction (FEV1/FVC > 0.70 and FEV1 > 0.80 predicted)
- Smoking history > 10 pack-years
- Ex-smoker >6 months
Who cannot join
- Chronic hypoxemia and/or hypercapnia (PaO2 < 60 mmHg or SpO2 < 88% at rest and/or PaCO2 > 45 mmHg)
- Recent exacerbation or oral corticosteroids (< 2 months)
- Recent cancer (< 3 years)
- Diabetes
- Myopathy, neuromuscular, neurological or articular diseases
- Kidney disease
Show all 10Show fewer
- Other respiratory diseases
- Unstable cardiac disease
- Physical activity score > 9 in the Voorips questionnaire
- BMI > 30
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, G1V 4G5
About this study
Official title: Expression of miR-204 and Consequences on Capillarization in Limb Muscles of Patients With Chronic Obstructive Pulmonary Disease
Limb muscle dysfunction, characterized by loss of capillaries, 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 modification in the expression of miR-204 leads to change the regulation of angiogenesis in vastus lateralis of patients with COPD when compared to controls.
Read the detailed description
The investigators objective is to investigate the impact of COPD on key signaling pathways involved in the muscle angiogenesis. Mild to severe COPD patients and healthy controls will be recruited. All of the investigators patients will undergo a thorough baseline assessment in pulmonary capacity and body composition. Blood sampling and biopsy of the quadriceps will be done. Key proteins and microRNAs of signaling intramuscular pathways involved in angiogenesis will be measured in the quadriceps.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- MicroRNAs, Angiogenesis, Skeletal muscle, COPD
- 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 |
|---|---|---|
| COPD patients | Quadriceps biopsies will be done. No drug administration. | |
| Healthy controls | Quadriceps biopsies will be done. No drug administration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
miR-204 in limb muscles in patients with COPD
i)To measure miR-204 level in the quadriceps of patients with COPD in comparison to controls.
ii) To study possible involvement of miR-204 on pathways regulating angiogenesis and on muscle microcirculation in these individuals.
Measured: At baseline (COPD patients in a stable state of the disease)
Secondary outcomes (1)
microRNAs in limb muscles of patients with COPD
- To measure microRNAs levels in the quadriceps of patients with COPD in comparison to controls. ii) To study possible involvement of these microRNAs on pathways regulating myogenesis, angiogenesis and on muscle microcirculation in these individuals.
Measured: At baseline (COPD patients 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 posted16 Sep 2016 (estimated)
- Study startFeb 2013
- Primary completionApr 2015
- Study completionFeb 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
- 100 participants (estimated)
- Target duration
- 1 Day
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, Study director, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903043
- Sponsor's protocol ID
- MIR-20895
- Status last verified
- May 2017
- First submitted
- 9 Apr 2015
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of miR-204 and Consequences on Capillarization in Limb Muscles of Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02903043
- Acronym / sponsor ID
- MIR-20895
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- MicroRNAs, Angiogenesis, Skeletal muscle, COPD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Feb 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Feb 2018 (estimated)
- First posted
- 16 Sep 2016 (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 loss of capillaries, 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 modification in the expression of miR-204 leads to change the regulation of angiogenesis in vastus lateralis of patients with COPD when compared to controls.
Detailed description
The investigators objective is to investigate the impact of COPD on key signaling pathways involved in the muscle angiogenesis. Mild to severe COPD patients and healthy controls will be recruited. All of the investigators patients will undergo a thorough baseline assessment in pulmonary capacity and body composition. Blood sampling and biopsy of the quadriceps will be done. Key proteins and microRNAs of signaling intramuscular pathways involved in angiogenesis will be measured in the quadriceps.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | –Quadriceps biopsies will be done. No drug administration. |
| Healthy controls | – | –Quadriceps biopsies will be done. No drug administration. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD
Key inclusion criteria (4 listed)
- COPD (FEV1/FVC < 0.70)
- Healthy subjects: no evidence of airways obstruction (FEV1/FVC > 0.70 and FEV1 > 0.80 predicted)
- Smoking history > 10 pack-years
- Ex-smoker >6 months
Key exclusion criteria (10 listed)
- Chronic hypoxemia and/or hypercapnia (PaO2 < 60 mmHg or SpO2 < 88% at rest and/or PaCO2 > 45 mmHg)
- Recent exacerbation or oral corticosteroids (< 2 months)
- Recent cancer (< 3 years)
- Diabetes
- Myopathy, neuromuscular, neurological or articular diseases
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
miR-204 in limb muscles in patients with COPD
Time frame: At baseline (COPD patients in a stable state of the disease)
i)To measure miR-204 level in the quadriceps of patients with COPD in comparison to controls. ii) To study possible involvement of miR-204 on pathways regulating angiogenesis and on muscle microcirculation in these individuals.
1 secondary outcome
microRNAs in limb muscles of patients with COPD
Time frame: At baseline (COPD patients 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 10 May 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Obstructive Pulmonary Disease
RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Recruiting
Comprehensive Maintenance Program: a Health Haven for COPD in Lleida.The NAPOLEON Project.
COPD - Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation
Recruiting
Study on Impact of Maximal Strength Training in Patients With COPD
Chronic Obstructive Pulmonary Disease
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 study director
Laval University
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 10 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 10 May 2017. 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?
miR-204 in limb muscles in patients with COPD (time frame: At baseline (COPD patients 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 10 May 2017.