Chronic Obstructive Pulmonary DiseaseOXYPHENNCT02532426
Influence of Chronic Hypoxia on Oxidative Phenotype in Patients With Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
In addition to chronic airflow obstruction, patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from skeletal muscle dysfunction which is a prominent and disabling feature and also an independent determinant of survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Muscle biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2012to 30 Sep 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients with chronic hypoxemia and with normoxemia
Who may be able to join
- Diagnosis of COPD confirmed according to GOLD score.
- Hypoxemia group: resting arterial paO2 <55 mmHg.
- Normoxemia group : resting arterial paO2 > 67 mmHg
Who cannot join
- Unstable cardiorespiratory status (acute respiratory failure)
- Oxygen treatment started
- Inclusion in a pulmonary rehabilitation program in the last 6 months
- Anticoagulant treatment
Trial locations and contacts
1 site in 1 country.
About this study
In addition to chronic airflow obstruction, patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from skeletal muscle dysfunction which is a prominent and disabling feature and also an independent determinant of survival. Muscular impairment involves loss of muscle oxidative phenotype (OXPHEN: a slow-to-fast shift in fibre types and reduced oxidative capacity). Since hypoxia obviously is a key feature of COPD, the aim of this study is to elucidate the role of hypoxia in loss of muscle OXPHEN.
Thus, OXPHEN and expression levels of its key regulators will be determined in the baseline biopsies for association with the degree of hypoxemia. In addition, expression levels of the key OXPHEN regulators will be measured in pre/post exercise biopsies.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Muscle biopsy
- Keywords
- Chronic Obstructive Pulmonary Disease, Muscle biopsy, Chronic hypoxia, OXYPHEN, Oxydative phenotype, Exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle biopsyProcedure or surgery
The biopsy is performed on the vastus lateralis muscle at rest and 2 hours after an acute exercise, with a local anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients with chronic hypoxemia | COPD patients with chronic and severe arterial hypoxemia at rest (paO2<55mmHg). Receives: Procedure: Muscle biopsy | |
| COPD patients with normoxia | COPD patients with normoxia at rest (paO2>67mmHg), matched for age, sex, bronchial obstruction and lean mass. Receives: Procedure: Muscle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of expression of muscle messenger ribonucleic acid (mRNA) of HIF-1α and PGC-1α
Comparison of expression levels of Hypoxia-inducible Factors (HIF-1α) and Peroxisome proliferator-activated receptor gamma, coactivator 1 alpha (PGC-1α), two OXYPHEN regulators, in muscle biopsy, between COPD patients with chronic hypoxemia and those with normoxemia
Measured: Day 1
Secondary outcomes (4)
Type I muscle fibers
It is an indicator of the muscle phenotype (with a muscle biopsy). It used to compared the muscle phenotype in the 2 groups of patients. It is a percentage.
Measured: Day 1
Oxidative enzyme capacity
It is an other indicator of the muscle phenotype (with a muscle biopsy). It used to compared the muscle phenotype in the 2 groups of patients.
Measured: Day 1
Level of expression of muscle mRNA of HIF-1α after acute exercise
Comparison of response to acute exercise for expression level of HIF-1α (an OXYPHEN regulator) in muscle biopsy between the 2 groups.
Measured: Day 1
Level of expression of muscle mRNA of PGC-1α after acute exercise
Comparison of response to acute exercise for expression level of PGC-1α (an OXYPHEN regulator) in muscle biopsy between the 2 groups.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study start18 May 2012
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Why it stopped: Lack of inclusion
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 Centre Hospitalier Universitaire de Saint EtienneThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- SYNAPSE assocation
- Responsible party
- Sponsor
- Investigators
- COSTES Frédéric, MD PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532426
- Sponsor's protocol ID
- 1108100
- Other IDs
- 2011-A00856-35
- Acronym
- OXYPHEN
- Status last verified
- Oct 2017
- First submitted
- 21 Aug 2015
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Chronic Hypoxia on Oxidative Phenotype in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02532426
- Acronym / sponsor ID
- OXYPHEN / 1108100
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Muscle biopsy, Chronic hypoxia, OXYPHEN, Oxydative phenotype, Exercise
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of inclusion
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- SYNAPSE assocation
- Study start
- 18 May 2012 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 25 Aug 2015 (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.
In addition to chronic airflow obstruction, patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from skeletal muscle dysfunction which is a prominent and disabling feature and also an independent determinant of survival. Muscular impairment involves loss of muscle oxidative phenotype (OXPHEN: a slow-to-fast shift in fibre types and reduced oxidative capacity). Since hypoxia obviously is a key feature of COPD, the aim of this study is to elucidate the role of hypoxia in loss of muscle OXPHEN.
Thus, OXPHEN and expression levels of its key regulators will be determined in the baseline biopsies for association with the degree of hypoxemia. In addition, expression levels of the key OXPHEN regulators will be measured in pre/post exercise biopsies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients with chronic hypoxemia | – | Procedure: Muscle biopsyCOPD patients with chronic and severe arterial hypoxemia at rest (paO2<55mmHg). |
| COPD patients with normoxia | – | Procedure: Muscle biopsyCOPD patients with normoxia at rest (paO2>67mmHg), matched for age, sex, bronchial obstruction and lean mass. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients with chronic hypoxemia and with normoxemia
Key inclusion criteria (3 listed)
- Diagnosis of COPD confirmed according to GOLD score.
- Hypoxemia group: resting arterial paO2 <55 mmHg.
- Normoxemia group : resting arterial paO2 > 67 mmHg
Key exclusion criteria (4 listed)
- Unstable cardiorespiratory status (acute respiratory failure)
- Oxygen treatment started
- Inclusion in a pulmonary rehabilitation program in the last 6 months
- Anticoagulant treatment
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 |
|---|---|---|
| Muscle biopsyThe biopsy is performed on the vastus lateralis muscle at rest and 2 hours after an acute exercise, with a local anesthesia. | Procedure or surgery | COPD patients with chronic hypoxemia, COPD patients with normoxia |
Primary outcome
Level of expression of muscle messenger ribonucleic acid (mRNA) of HIF-1α and PGC-1α
Time frame: Day 1
Comparison of expression levels of Hypoxia-inducible Factors (HIF-1α) and Peroxisome proliferator-activated receptor gamma, coactivator 1 alpha (PGC-1α), two OXYPHEN regulators, in muscle biopsy, between COPD patients with chronic hypoxemia and those with normoxemia
4 secondary outcomes
Type I muscle fibers
Time frame: Day 1
Oxidative enzyme capacity
Time frame: Day 1
Level of expression of muscle mRNA of HIF-1α after acute exercise
Time frame: Day 1
Level of expression of muscle mRNA of PGC-1α after acute exercise
Time frame: Day 1
Results and safety
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Individual participant dataSharing planned: No
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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.
COSTES Frédéric, MD PhD principal investigator
CHU de Saint-Etienne
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 Centre Hospitalier Universitaire de Saint Etienne 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: stopped early, as of the sponsor's last update on 19 Oct 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 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 was stopped early (reason given: Lack of inclusion). 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?
Level of expression of muscle messenger ribonucleic acid (mRNA) of HIF-1α and PGC-1α (time frame: Day 1). 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 19 Oct 2017.