Obstructive Chronic BronchoPneumopathy (OCBP)OBALPANCT01885247
4-10 Week Observational Study Comparing 3 Management Strategies for Obstructive Chronic BronchoPneumopathy (OCBP) in Common Clinical Practice
An observational study of Obstructive Chronic BronchoPneumopathy (OCBP), run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The management of patients with Obstructive Chronic BronchoPneumopathy (OCBP) is based on a progression of therapeutic options and on a sensitization to physical activity. For these patients selected on OCBP stage 2, the treatment options include Long Acting Beta-Agonist Bronchodilator (LABA) or Long Acting Muscarinic… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Obstructive Chronic BronchoPneumopathy (OCBP)
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Dec 2016
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Obstructive Chronic BronchoPneumopathy (OCBP) stage ≥ 2
Who may be able to join
- Patients with Obstructive Chronic BronchoPneumopathy stage ≥ 2.
- Patients under treatment with LABA or LAMA or LABA+LAMA since at least 1 month.
- VEMS/CVF<70%
- VEMS<80%
- Patients without regular physical activity and without physical activity program since 1 year.
Who cannot join
- Patients under treatment with LABA + inhaled Corticoids.
- Contraindication to physical activity.
- Patients with previous history of respiratory exacerbations.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Lyon, 69004
Gilles DEVOUASSOUX, MD
About this study
The management of patients with Obstructive Chronic BronchoPneumopathy (OCBP) is based on a progression of therapeutic options and on a sensitization to physical activity.
For these patients selected on OCBP stage 2, the treatment options include Long Acting Beta-Agonist Bronchodilator (LABA) or Long Acting Muscarinic Antagonist Anticholinergic (LAMA) or both (LAMA+LABA).
The purpose of this study is to observe in common clinical practice the benefit of physical activity on quality of life, dyspnoea and walking distance for these patients under treatment (LABA and/or LAMA) and to determine whether these 3 medical strategies (LABA/LAMA/LABA+LAMA) benefit from physical activity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life after 4 to 10 weeks of physical activity program
Evaluation of quality of life by specific questionnaires (VQ11, RICCI Test) and by specific parameters such as: spirometry, dyspnea, Body Mass Index (BMI), 6 minute Stepper Test (TS6), Body mass index, airflow Obstruction, Dyspnea and Exercise tolerance (BODE), O2 maximal Volume (VO2max) or Electrocardiogram (ECG).
Measured: Visit 1 before physical activity program and Visit 2 after 4 to 10 weeks of physical activity program
Secondary outcomes (3)
Medical Research Council dyspnea scale (grade degree 0 to 4)activity
Grade Degree of breathlessness related to activities (o to 4) :
0 : Not troubled by breathlessness except on strenuous exercise
- : Short of breath when hurrying or walking up a slight hill
- : Walks slower than contemporaries on level ground because of breathlessness, or has to stop for breath when walking at own pace
- : Stops for breath after walking about 100m or after a few minutes on level ground
- : Too breathless to leave the house, or breathless when dressing or undressing
Measured: Grade degree of dyspnea will be evaluated one time before and after the physical activity program an expected average of 10 weeks.
6 Minute Walking Test (6MWT) (unit : meter)
The original purpose of the six minute walk was to test exercise tolerance in chronic respiratory disease and heart failure. The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Measured: 6MWT will be realized one time before and after the physical activity program an expected average of 10 weeks.
Actimetry by accelerometer (unit : number of body movement)
Actimetry by accelerometer to assess physical activity. Technically, an accelerometer consists of a device with a piezoelectric sensor that registers physical activity via body movement (acceleration) produced during a limited period of time.
Measured: Accelerometer will be installed one time before and after the physical activity program an expected average of 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Chronic BronchoPneumopathy (OCBP)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Gilles Devouassoux, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885247
- Sponsor's protocol ID
- 2012-746
- Acronym
- OBALPA
- Status last verified
- May 2016
- First submitted
- 27 May 2013
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4-10 Week Observational Study Comparing 3 Management Strategies for Obstructive Chronic BronchoPneumopathy (OCBP) in Common Clinical Practice
- ClinicalTrials.gov ID
- NCT01885247
- Acronym / sponsor ID
- OBALPA / 2012-746
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jun 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 24 Jun 2013 (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.
The management of patients with Obstructive Chronic BronchoPneumopathy (OCBP) is based on a progression of therapeutic options and on a sensitization to physical activity.
For these patients selected on OCBP stage 2, the treatment options include Long Acting Beta-Agonist Bronchodilator (LABA) or Long Acting Muscarinic Antagonist Anticholinergic (LAMA) or both (LAMA+LABA).
The purpose of this study is to observe in common clinical practice the benefit of physical activity on quality of life, dyspnoea and walking distance for these patients under treatment (LABA and/or LAMA) and to determine whether these 3 medical strategies (LABA/LAMA/LABA+LAMA) benefit from physical activity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Obstructive Chronic BronchoPneumopathy (OCBP) stage ≥ 2
Key inclusion criteria (5 listed)
- Patients with Obstructive Chronic BronchoPneumopathy stage ≥ 2.
- Patients under treatment with LABA or LAMA or LABA+LAMA since at least 1 month.
- VEMS/CVF<70%
- VEMS<80%
- Patients without regular physical activity and without physical activity program since 1 year.
Key exclusion criteria (3 listed)
- Patients under treatment with LABA + inhaled Corticoids.
- Contraindication to physical activity.
- Patients with previous history of respiratory exacerbations.
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
Change in quality of life after 4 to 10 weeks of physical activity program
Time frame: Visit 1 before physical activity program and Visit 2 after 4 to 10 weeks of physical activity program
Evaluation of quality of life by specific questionnaires (VQ11, RICCI Test) and by specific parameters such as: spirometry, dyspnea, Body Mass Index (BMI), 6 minute Stepper Test (TS6), Body mass index, airflow Obstruction, Dyspnea and Exercise tolerance (BODE), O2 maximal Volume (VO2max) or Electrocardiogram (ECG).
3 secondary outcomes
Medical Research Council dyspnea scale (grade degree 0 to 4)activity
Time frame: Grade degree of dyspnea will be evaluated one time before and after the physical activity program an expected average of 10 weeks.
6 Minute Walking Test (6MWT) (unit : meter)
Time frame: 6MWT will be realized one time before and after the physical activity program an expected average of 10 weeks.
Actimetry by accelerometer (unit : number of body movement)
Time frame: Accelerometer will be installed one time before and after the physical activity program an expected average of 10 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
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.
Gilles Devouassoux, MD principal investigator
Hospices Civils de Lyon
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 Obstructive Chronic BronchoPneumopathy (OCBP), run by Hospices Civils de Lyon 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 5 inclusion and 3 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 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gilles DEVOUASSOUX, MD, PhD (33 4.26.73.29.47, gilles.devouassoux@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life after 4 to 10 weeks of physical activity program (time frame: Visit 1 before physical activity program and Visit 2 after 4 to 10 weeks of physical activity program). 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 2016.