Chronic Obstructive PulmonaryNCT03197909
Involvement of Plasmatic Factors in the Peripheral Muscle Dysfunction of COPD Patients - In Vitro Study
An observational study of Chronic Obstructive Pulmonary, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Chronic Obstructive Pulmonary Patients is a defined by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. Read more about this study
- Who is it for?
- Ages 35 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary
- What is being tested?
- Determination of pro-inflammatory plasma factors
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2017to 31 Jan 2019
- 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 35 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chronic Obstructive Pulmonary Patients
Who may be able to join
- 35 to 85 years old
- COPD patients: association of symtoms (breathlessness, cough, sputum) and chronic exposure to inhalated risk factors (like tobacco smoke) and a FEV1/VC ratio <70% assessed by a spirometry
- Healthy subjects: A sedentariness assessed by a Voorrips score <9.4 and/or a report of <150 min/week of moderate-to-vigorous physical activity
Who cannot join
- A recent COPD exacerbation (< 4weeks)
- The decompensation of a comorbidity
- An antioxidant supplementation or medication
- A long-term systemic corticosteroid medication
Trial locations and contacts
1 site in 1 country.
About this study
Chronic Obstructive Pulmonary Patients is a defined by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. It is associated with an atrophy of the skeletal muscle that impairs the patient's prognosis. The biological mechanisms of this muscle atrophy have not been elucidated, and the "spill-over theory" has recently emerged. Indeed, in COPD patients, the pulmonary inflammation is associated with a systemic low-grade inflammation, and the increased pro-inflamatory molelcules in the blood - which constitute the cellular micro-environement of the muscle fibre - could activate the mechanisms of the cell atrophy.
- Conditions
- Chronic Obstructive Pulmonary
- Being tested
- Determination of pro-inflammatory plasma factors
- Keywords
- COPD (Chronic Obstructive Pulmonary Patients), Atrophy, cell cultur, systemic inflammation, Catabolism
- 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.
Determination of pro-inflammatory plasma factorsOther
Determination of pro-inflammatory plasma factors at COPD patients aged from 35 to 85 years old and Healthy subjects aged from 35 to 85 years old
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Determination of pro-inflammatory plasma factors at Healthy subjects aged from 35 to 85 years old Receives: Other: Determination of pro-inflammatory plasma factors | |
| COPD patients | Determination of pro-inflammatory plasma factors at COPD patients aged from 35 to 85 years old Receives: Other: Determination of pro-inflammatory plasma factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myotube diameter of in vitro cultured myotubes
Myotube diameter of in vitro cultured myotubes from healthy subjects, exposed to the serum of healthy controls and COPD patients
Measured: 6 days
Secondary outcomes (1)
Expression and translation of markers of
Expression and translation of markers of anabolic and catabolic pathways
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start6 Jul 2017
- Primary completion31 Dec 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive PulmonaryStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maurice HAYOT, MD, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197909
- Sponsor's protocol ID
- RECHMPL17_0210
- Status last verified
- Sep 2018
- First submitted
- 21 Jun 2017
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involvement of Plasmatic Factors in the Peripheral Muscle Dysfunction of COPD Patients - In Vitro Study
- ClinicalTrials.gov ID
- NCT03197909
- Acronym / sponsor ID
- RECHMPL17_0210
- Conditions
- Chronic Obstructive Pulmonary
- Keywords
- COPD (Chronic Obstructive Pulmonary Patients), Atrophy, cell cultur, systemic inflammation, Catabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 23 Jun 2017 (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.
Chronic Obstructive Pulmonary Patients is a defined by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. It is associated with an atrophy of the skeletal muscle that impairs the patient's prognosis. The biological mechanisms of this muscle atrophy have not been elucidated, and the "spill-over theory" has recently emerged. Indeed, in COPD patients, the pulmonary inflammation is associated with a systemic low-grade inflammation, and the increased pro-inflamatory molelcules in the blood - which constitute the cellular micro-environement of the muscle fibre - could activate the mechanisms of the cell atrophy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Other: Determination of pro-inflammatory plasma factorsDetermination of pro-inflammatory plasma factors at Healthy subjects aged from 35 to 85 years old |
| COPD patients | – | Other: Determination of pro-inflammatory plasma factorsDetermination of pro-inflammatory plasma factors at COPD patients aged from 35 to 85 years old |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Obstructive Pulmonary Patients
Key inclusion criteria (3 listed)
- 35 to 85 years old
- COPD patients: association of symtoms (breathlessness, cough, sputum) and chronic exposure to inhalated risk factors (like tobacco smoke) and a FEV1/VC ratio <70% assessed by a spirometry
- Healthy subjects: A sedentariness assessed by a Voorrips score <9.4 and/or a report of <150 min/week of moderate-to-vigorous physical activity
Key exclusion criteria (4 listed)
- A recent COPD exacerbation (< 4weeks)
- The decompensation of a comorbidity
- An antioxidant supplementation or medication
- A long-term systemic corticosteroid medication
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 |
|---|---|---|
| Determination of pro-inflammatory plasma factorsDetermination of pro-inflammatory plasma factors at COPD patients aged from 35 to 85 years old and Healthy subjects aged from 35 to 85 years old | Other | COPD patients, Healthy subjects |
Primary outcome
Myotube diameter of in vitro cultured myotubes
Time frame: 6 days
Myotube diameter of in vitro cultured myotubes from healthy subjects, exposed to the serum of healthy controls and COPD patients
1 secondary outcome
Expression and translation of markers of
Time frame: 6 days
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 18 Apr 2019.
- Individual participant dataSharing planned: Undecided. NC
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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.
Maurice HAYOT, MD, PhD study director
University Hospital, Montpellier
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, run by University Hospital, Montpellier at 1 site in France.
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 3 inclusion and 4 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 18 Apr 2019. 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 France. 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?
Myotube diameter of in vitro cultured myotubes (time frame: 6 days). 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 18 Apr 2019.