Chronic Obstructive Pulmonary DiseaseCHAOSBOLDNCT01331070
Identification and Dynamics With Cerebral Functional Magnetic Resonance Imaging
A study testing cerebral fMRI in people with Chronic Obstructive Pulmonary Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a chronicle inflammatory disease with a non reversible diminution of the airway flow. COPD is caused most commonly from tobacco smoking, which triggers an abnormal inflammatory response in the lung. Worldwide, COPD ranked as the sixth leading cause of death in 1990. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- cerebral fMRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Mar 2013
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed patients with written consent,
- More than eighteen years old,
- Patients having a social insurance
- A previous medical examination
- Patients, half with moderate (GOLD II) and half with severe (GOLD III) COPD will be included. These patients will be clinically in a steady state situation for at least one month (no acute exacerbation). GOLD grading of COPD patients will be performed according to the American Thoracic Society.
- Informed healthy volunteer with written consent,
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- More than eighteen years old,
- Healthy volunteer having a social insurance
- A previous medical examination
- Non-smoker
- Non pathology and medicinal treatment
Who cannot join
- Long-term oxygen therapy
- Previous cerebral vascular accident
- Central neurological disease (tumor, Parkinson, etc.)
- Nobody benefiting from a particular protection: pregnant woman, minor person, major person under guardianship and under guardianship, the persons hospitalized without their consent and protected by the law, or the private persons of freedom.
- Contraindication in the functional intellectual MRI:
- Port of a biomedical device like cardiac simulator
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- Cardiac defibrillator
- Insulin pump or neurostimulating,
- Claustrophobia,
- Impossibility to remain lengthened
- Presence of cerebral vascular clips, metallic foreign body intra-ocular, not compatible cardiac valve
- Pregnancy
- Nobody benefiting from a particular protection: pregnant woman, minor person, major person under guardianship and under guardianship, the persons hospitalized without their consent and protected by the law, or the private persons of freedom.
- Contraindication in the functional intellectual MRI:
- Port of a biomedical device like cardiac simulator
- Cardiac defibrillator
- Insulin pump or neurostimulating,
- Claustrophobia,
- Impossibility to remain lengthened
- Presence of cerebral vascular clips, metallic foreign body intra-ocular, not compatible cardiac valve
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Central Control of Breathing in Patients With Chronic Obstructive Pulmonary Disease: Identification and Dynamics With Cerebral Functional Magnetic Resonance Imaging
Chronic obstructive pulmonary disease (COPD) is a chronicle inflammatory disease with a non reversible diminution of the airway flow. COPD is caused most commonly from tobacco smoking, which triggers an abnormal inflammatory response in the lung. Worldwide, COPD ranked as the sixth leading cause of death in 1990. It is projected to be the fourth leading cause of death worldwide by 2030 due to an increase in smoking rates and demographic changes in many countries. COPD is responsible for 16000 deaths per year in France, 100 000 hospitalizations per year and the health care expenditure of COPD in France is 3.5 billion of Euros. Classical markers of the disease severity, the forced expiratory volume in one second, poorly correlates with dyspnea and prognosis. Therefore, many studies focused on the control of breathing in an attempt to understand the pathophysiological mechanisms involved in the progression of the disease. Breathing control is enhanced in patients with COPD due to the progressive failure of respiratory muscles (airflow obstruction, static and dynamic hyperinflation, positive intrinsic end expiratory pressure), the ventilation/ perfusion ratio abnormalities leading to the loss of the gaz exchange efficiency. Inspiratory command depends on the medulla automatic pathway and the voluntary corticospinal command. Indirect method of breathing control estimation suggested in COPD patients an increased excitability of neurons involved in the voluntary diaphragm activation and a reduced cortical reserve. This may represent an increase risk factor for acute respiratory failure. Until now, no study reported the central breathing control with cerebral fMRI in COPD patients.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a chronicle inflammatory disease with a non reversible diminution of the airway flow. COPD is caused most commonly from tobacco smoking, which triggers an abnormal inflammatory response in the lung. Worldwide, COPD ranked as the sixth leading cause of death in 1990. It is projected to be the fourth leading cause of death worldwide by 2030 due to an increase in smoking rates and demographic changes in many countries. COPD is responsible for 16000 deaths per year in France, 100 000 hospitalizations per year and the health care expenditure of COPD in France is 3.5 billion of Euros. Classical markers of the disease severity, the forced expiratory volume in one second, poorly correlates with dyspnea and prognosis. Therefore, many studies focused on the control of breathing in an attempt to understand the pathophysiological mechanisms involved in the progression of the disease. Breathing control is enhanced in patients with COPD due to the progressive failure of respiratory muscles (airflow obstruction, static and dynamic hyperinflation, positive intrinsic end expiratory pressure), the ventilation/ perfusion ratio abnormalities leading to the loss of the gaz exchange efficiency. Inspiratory command depends on the medulla automatic pathway and the voluntary corticospinal command. Indirect method of breathing control estimation suggested in COPD patients an increased excitability of neurons involved in the voluntary diaphragm activation and a reduced cortical reserve. This may represent an increase risk factor for acute respiratory failure. Until now, no study reported the central breathing control with cerebral fMRI in COPD patients. This pilot study also aims in estimating if the absence or diminution of the cortical reserve is a marker of disease severity. In addition correlations will be performed between activated neuronal signals with fMRI and ventilatory flow output recordings (chaotic analysis).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- cerebral fMRI
- Keywords
- Chronic obstructive pulmonary disease (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.
cerebral fMRIOther
Also called the central breathing control with cerebral fMRI
the central breathing control with cerebral fMRI in COPD patients
cerebral fMRIOther
Also called the central breathing control with cerebral fMRI
the central breathing control with cerebral fMRI in Accepts Healthy Volunteers
| Study group | Role | What they receive |
|---|---|---|
| PATIENT | Experimental | Patients, half with moderate (GOLD II) and half with severe (GOLD III) COPD Receives: Other: cerebral fMRI |
| Accepts Healthy Volunteers | Other | Control arm with the same intervention Receives: Other: cerebral fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central ventilatory control
Evaluation of the central ventilatory control at the patients COPD during the application of an inspiratory resistance.
Measured: 1 month
Secondary outcomes (2)
Evaluation of the neuronal activation
Evaluation of the neuronal activation bulbo-pontique and corticospinal during the application of an inspiratory resistance.
Measured: 1 month
Chaotic analysis
The correlations will be performed between activated neuronal signals with fMRI and ventilatory flow output recordings (chaotic analysis).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2012
- Study completionMar 2013
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 Assistance Publique - Hôpitaux de ParisThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence MANGIN, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331070
- Sponsor's protocol ID
- P100136
- Other IDs
- AOM10010
- Acronym
- CHAOSBOLD
- Status last verified
- Aug 2013
- First submitted
- 4 Apr 2011
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Control of Breathing in Patients With Chronic Obstructive Pulmonary Disease: Identification and Dynamics With Cerebral Functional Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT01331070
- Acronym / sponsor ID
- CHAOSBOLD / P100136
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease (COPD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 7 Apr 2011 (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.
Chronic obstructive pulmonary disease (COPD) is a chronicle inflammatory disease with a non reversible diminution of the airway flow. COPD is caused most commonly from tobacco smoking, which triggers an abnormal inflammatory response in the lung. Worldwide, COPD ranked as the sixth leading cause of death in 1990. It is projected to be the fourth leading cause of death worldwide by 2030 due to an increase in smoking rates and demographic changes in many countries. COPD is responsible for 16000 deaths per year in France, 100 000 hospitalizations per year and the health care expenditure of COPD in France is 3.5 billion of Euros. Classical markers of the disease severity, the forced expiratory volume in one second, poorly correlates with dyspnea and prognosis. Therefore, many studies focused on the control of breathing in an attempt to understand the pathophysiological mechanisms involved in the progression of the disease. Breathing control is enhanced in patients with COPD due to the progressive failure of respiratory muscles (airflow obstruction, static and dynamic hyperinflation, positive intrinsic end expiratory pressure), the ventilation/ perfusion ratio abnormalities leading to the loss of the gaz exchange efficiency. Inspiratory command depends on the medulla automatic pathway and the voluntary corticospinal command. Indirect method of breathing control estimation suggested in COPD patients an increased excitability of neurons involved in the voluntary diaphragm activation and a reduced cortical reserve. This may represent an increase risk factor for acute respiratory failure. Until now, no study reported the central breathing control with cerebral fMRI in COPD patients.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a chronicle inflammatory disease with a non reversible diminution of the airway flow. COPD is caused most commonly from tobacco smoking, which triggers an abnormal inflammatory response in the lung. Worldwide, COPD ranked as the sixth leading cause of death in 1990. It is projected to be the fourth leading cause of death worldwide by 2030 due to an increase in smoking rates and demographic changes in many countries. COPD is responsible for 16000 deaths per year in France, 100 000 hospitalizations per year and the health care expenditure of COPD in France is 3.5 billion of Euros. Classical markers of the disease severity, the forced expiratory volume in one second, poorly correlates with dyspnea and prognosis. Therefore, many studies focused on the control of breathing in an attempt to understand the pathophysiological mechanisms involved in the progression of the disease. Breathing control is enhanced in patients with COPD due to the progressive failure of respiratory muscles (airflow obstruction, static and dynamic hyperinflation, positive intrinsic end expiratory pressure), the ventilation/ perfusion ratio abnormalities leading to the loss of the gaz exchange efficiency. Inspiratory command depends on the medulla automatic pathway and the voluntary corticospinal command. Indirect method of breathing control estimation suggested in COPD patients an increased excitability of neurons involved in the voluntary diaphragm activation and a reduced cortical reserve. This may represent an increase risk factor for acute respiratory failure. Until now, no study reported the central breathing control with cerebral fMRI in COPD patients. This pilot study also aims in estimating if the absence or diminution of the cortical reserve is a marker of disease severity. In addition correlations will be performed between activated neuronal signals with fMRI and ventilatory flow output recordings (chaotic analysis).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PATIENT | Experimental | Other: cerebral fMRIPatients, half with moderate (GOLD II) and half with severe (GOLD III) COPD |
| Accepts Healthy Volunteers | Other | Other: cerebral fMRIControl arm with the same intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Informed patients with written consent,
- More than eighteen years old,
- Patients having a social insurance
- A previous medical examination
- Patients, half with moderate (GOLD II) and half with severe (GOLD III) COPD will be included. These patients will be clinically in a steady state situation for at least one month (no acute exacerbation). GOLD grading of COPD patients will be performed according to the American Thoracic Society.
Key exclusion criteria (21 listed)
- Long-term oxygen therapy
- Previous cerebral vascular accident
- Central neurological disease (tumor, Parkinson, etc.)
- Nobody benefiting from a particular protection: pregnant woman, minor person, major person under guardianship and under guardianship, the persons hospitalized without their consent and protected by the law, or the private persons of freedom.
- Contraindication in the functional intellectual MRI:
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 |
|---|---|---|
| cerebral fMRIAlso: the central breathing control with cerebral fMRIthe central breathing control with cerebral fMRI in COPD patients | Other | PATIENT |
| cerebral fMRIAlso: the central breathing control with cerebral fMRIthe central breathing control with cerebral fMRI in Accepts Healthy Volunteers | Other | Accepts Healthy Volunteers |
Primary outcome
Central ventilatory control
Time frame: 1 month
Evaluation of the central ventilatory control at the patients COPD during the application of an inspiratory resistance.
2 secondary outcomes
Evaluation of the neuronal activation
Time frame: 1 month
Chaotic analysis
Time frame: 1 month
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 14 Aug 2013.
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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.
Laurence MANGIN, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cerebral fMRI in people with Chronic Obstructive Pulmonary Disease, run by Assistance Publique - Hôpitaux de Paris 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 11 inclusion and 21 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 14 Aug 2013. 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?
Central ventilatory control (time frame: 1 month). 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 14 Aug 2013.