Chronic Obstructive Pulmonary Disease (COPD)AMI-EX-BPCONCT03153826
Determinants of Lower Limb Muscle Atrophy Induced During an Hospitalization for Exacerbation of COPD
A study testing Comparison of clinical and biological characteristics of patients in people with Chronic Obstructive Pulmonary Disease (COPD) and Exacerbation Copd, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent airway obstruction and inflammatory response of the lungs and bronchi. Episodes of exacerbations contribute to increase the severity and prognosis of the disease. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Exacerbation Copd, Muscle Atrophy
- What is being tested?
- Comparison of clinical and biological characteristics of patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2017to 15 Jan 2019
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 40 to 85 years
- COPD patients : FEV1/FVC < 70% pred
- Hospitalization for COPD exacerbation : increased respiratory symptoms over two consecutive days with at least one major symptom (dyspnea, increased sputum volume or purity) associated with another major symptom or minor symptom (sibilant, cold, sore throat or cough)
Who cannot join
- Concomitant cardiac event
- Tracheal intubation
- Chronic respiratory disease other than COPD
- Disease of locomotor apparatus, neurological or psychiatrics comorbidities
Trial locations and contacts
1 site in 1 country.
France1 site
Montpellier University Hospital Arnaud de Villeneuve Hospital
Montpellier, 34295
About this study
Official title: Determinants of Lower Limb Muscle Atrophy Induced During an Hospitalization for Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent airway obstruction and inflammatory response of the lungs and bronchi. Episodes of exacerbations contribute to increase the severity and prognosis of the disease. Muscle dysfunction (loss of strength and muscle mass) is one of comorbidities affecting 30% to 60% of patients and playing a key role in their prognosis. Indeed, several studies have shown muscle weakness during hospitalization for exacerbation of COPD by measure of maximal voluntary contraction of quadriceps (MVCQ), but the results are variable from one patient to another. Moreover, no study was interested in the change of muscle mass in patients hospitalized for an exacerbation of COPD. Several mechanisms have been mentioned but not demonstrated: systemics factors (initial amyotrophy, inflammation, oxidative stress, corticotherapy, hypoxia…) but also physical inactivity. In this context, identifying factors associated with the onset of muscle weakness during hospitalization for exacerbation of COPD is a necessary step to better understand the mechanisms and consider a personalized therapeutic approach that can improve the functional and clinical prognosis of disease.
The primary outcome is to identify the clinical and biological determinants associated with the onset of amyotrophy (Measure by ultrasound of sectional area of the Rectus Femoris, CSARF), during hospitalization for exacerbation of COPD. The secondary outcome is to identify the clinical and biological determinants associated with the onset of MVCQ decrease, during hospitalization for exacerbation of COPD.
Read more
120 patients hospitalized for exacerbation of COPD will be recruited in two hospitals (CHU Montpellier - CHU Grenoble, FRANCE). The measures of CSARF and MVCQ are carried out on the second, fifth, eighth day of hospitalization, on discharge and on the sixtieth day after hospitalization. A blood test will be performed on the second day of hospitalization to explore different markers of inflammation and oxydative stress. Moreover, to quantify the level of physical activity (number of steps), each patient will carry a pedometer throughout the duration of hospitalization.
At the end of protocol, two groups will be made from the median of CSARF : patients with a small reduction in CSARF compared to patients with a greater reduction in SSRF between the second and eighth days of hospitalization (or between the second day of hospitalization and discharge). Then clinical (comorbidities, severity disease, initial weakness, initial amyotrophy, usual physical activity before hospitalization, treatment, exacerbation number in the previous year…) and biological (markers of inflammation and oxydative stress) determinants were compared between the two groups.
Thus, the identification of the determinants associated with the onset of amyotrophy induced during exacerbation of COPD will guide research for exploration of physiopathological mechanisms of this muscular dysfunction in the exacerbation of COPD as well as to identify a personalized support.
- Being tested
- Comparison of clinical and biological characteristics of patients
- Keywords
- COPD Exacerbation, Muscle atrophy, Inflammation, Oxidative stress
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Muscular Atrophy, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of clinical and biological characteristics of patientsOther
Comparison of clinical and biological characteristics of patients with less variation in muscle mass (evaluated by CSARF) compared to patients with greater variation during an hospitalization for COPD exacerbation
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Not described Receives: Other: Comparison of clinical and biological characteristics of patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of clinical and biological characteristics of patients
Comparison of clinical and biological characteristics of patients with less variation in muscle mass (evaluated by CSARF) compared to patients with greater variation during an hospitalization for COPD exacerbation
Measured: Second day after hospitalization and discharge
Comparison of clinical and biological characteristics of patients
Comparison of clinical and biological characteristics of patients with less variation in muscle mass (evaluated by CSARF) compared to patients with greater variation during an hospitalization for COPD exacerbation
Measured: Fifth day after hospitalization and discharge
Comparison of clinical and biological characteristics of patients
Comparison of clinical and biological characteristics of patients with less variation in muscle mass (evaluated by CSARF) compared to patients with greater variation during an hospitalization for COPD exacerbation
Measured: Eigth day after hospitalization and discharge
Secondary outcomes (1)
Comparison of clinical and biological characteristics
Comparison of clinical and biological characteristics of patients with less variation in maximal voluntary contraction of quadriceps (MVCQ) compared to patients with greater variation during an hospitalization for COPD exacerbation
Measured: Second, fifth, and eighth day after hospitalization and discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start10 May 2017
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Why it stopped: Lack of patient recruitment
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 University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153826
- Sponsor's protocol ID
- 9774
- Acronym
- AMI-EX-BPCO
- Status last verified
- Dec 2021
- First submitted
- 5 May 2017
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Lower Limb Muscle Atrophy Induced During an Hospitalization for Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT03153826
- Acronym / sponsor ID
- AMI-EX-BPCO / 9774
- Keywords
- COPD Exacerbation, Muscle atrophy, Inflammation, Oxidative stress
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patient recruitment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 15 May 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 Disease (COPD) is characterized by persistent airway obstruction and inflammatory response of the lungs and bronchi. Episodes of exacerbations contribute to increase the severity and prognosis of the disease. Muscle dysfunction (loss of strength and muscle mass) is one of comorbidities affecting 30% to 60% of patients and playing a key role in their prognosis. Indeed, several studies have shown muscle weakness during hospitalization for exacerbation of COPD by measure of maximal voluntary contraction of quadriceps (MVCQ), but the results are variable from one patient to another. Moreover, no study was interested in the change of muscle mass in patients hospitalized for an exacerbation of COPD. Several mechanisms have been mentioned but not demonstrated: systemics factors (initial amyotrophy, inflammation, oxidative stress, corticotherapy, hypoxia…) but also physical inactivity. In this context, identifying factors associated with the onset of muscle weakness during hospitalization for exacerbation of COPD is a necessary step to better understand the mechanisms and consider a personalized therapeutic approach that can improve the functional and clinical prognosis of disease.
The primary outcome is to identify the clinical and biological determinants associated with the onset of amyotrophy (Measure by ultrasound of sectional area of the Rectus Femoris, CSARF), during hospitalization for exacerbation of COPD. The secondary outcome is to identify the clinical and biological determinants associated with the onset of MVCQ decrease, during hospitalization for exacerbation of COPD.
120 patients hospitalized for exacerbation of COPD will be recruited in two hospitals (CHU Montpellier - CHU Grenoble, FRANCE). The measures of CSARF and MVCQ are carried out on the second, fifth, eighth day of hospitalization, on discharge and on the sixtieth day after hospitalization. A blood test will be performed on the second day of hospitalization to explore different markers of inflammation and oxydative stress. Moreover, to quantify the level of physical activity (number of steps), each patient will carry a pedometer throughout the duration of hospitalization.
At the end of protocol, two groups will be made from the median of CSARF : patients with a small reduction in CSARF compared to patients with a greater reduction in SSRF between the second and eighth days of hospitalization (or between the second day of hospitalization and discharge). Then clinical (comorbidities, severity disease, initial weakness, initial amyotrophy, usual physical activity before hospitalization, treatment, exacerbation number in the previous year…) and biological (markers of inflammation and oxydative stress) determinants were compared between the two groups.
Thus, the identification of the determinants associated with the onset of amyotrophy induced during exacerbation of COPD will guide research for exploration of physiopathological mechanisms of this muscular dysfunction in the exacerbation of COPD as well as to identify a personalized support.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Other: Comparison of clinical and biological characteristics of patients |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 40 to 85 years
- COPD patients : FEV1/FVC < 70% pred
- Hospitalization for COPD exacerbation : increased respiratory symptoms over two consecutive days with at least one major symptom (dyspnea, increased sputum volume or purity) associated with another major symptom or minor symptom (sibilant, cold, sore throat or cough)
Key exclusion criteria (4 listed)
- Concomitant cardiac event
- Tracheal intubation
- Chronic respiratory disease other than COPD
- Disease of locomotor apparatus, neurological or psychiatrics comorbidities
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 |
|---|---|---|
| Comparison of clinical and biological characteristics of patientsComparison of clinical and biological characteristics of patients with less variation in muscle mass (evaluated by CSARF) compared to patients with greater variation during an hospitalization for COPD exacerbation | Other | Patients |
Primary outcome
Comparison of clinical and biological characteristics of patients
Time frame: Second day after hospitalization and discharge
Comparison of clinical and biological characteristics of patients with less variation in muscle mass (evaluated by CSARF) compared to patients with greater variation during an hospitalization for COPD exacerbation
Comparison of clinical and biological characteristics of patients
Time frame: Fifth day after hospitalization and discharge
Comparison of clinical and biological characteristics of patients with less variation in muscle mass (evaluated by CSARF) compared to patients with greater variation during an hospitalization for COPD exacerbation
Comparison of clinical and biological characteristics of patients
Time frame: Eigth day after hospitalization and discharge
Comparison of clinical and biological characteristics of patients with less variation in muscle mass (evaluated by CSARF) compared to patients with greater variation during an hospitalization for COPD exacerbation
1 secondary outcome
Comparison of clinical and biological characteristics
Time frame: Second, fifth, and eighth day after hospitalization and discharge
Results and safety
The study was stopped early (reason given: Lack of patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of clinical and biological characteristics of patients in people with Chronic Obstructive Pulmonary Disease (COPD) and Exacerbation Copd, 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: stopped early, as of the sponsor's last update on 21 Dec 2021. 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 patient recruitment). 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?
Comparison of clinical and biological characteristics of patients (time frame: Second day after hospitalization and discharge). The study lists 3 primary outcomes in all. 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 Dec 2021.