AsthmaBOANCT00577733
Study of the Physiology of the Asthma of the Obese Subjects. Breathing Obesity Asthma Study (BOA)
An observational study of Asthma and Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Asthma is more frequent in obese women, but the mechanisms underlying the causes of this increased frequency are unknown and are different from usual asthma pathophysiology (associated with allergy). Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- How many people
- 204 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Nov 2010
- 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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: obese with AHR, obese without AHR and healthy non obese
Who may be able to join
- female
- age>18 and < 55 years
- BMI>35 (< 25 for healthy women)
- planned bariatric surgery
Who cannot join
- sleep apnea syndrome
- pregnant or breast-feeding women
- No affiliation or non beneficiary of the National Health Insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pathophysiological Study of Obesity-related Asthma
Asthma is more frequent in obese women, but the mechanisms underlying the causes of this increased frequency are unknown and are different from usual asthma pathophysiology (associated with allergy). Obesity is known to influence ventilation; our hypothesis is that the normal variability of ventilation is decreased in obese patients, and that this decrease is responsible for an increased reactivity of their airway to non specific stimuli. In this observational study, breathing variability will be studied using polygraphy (an investigation that is made in these women to detect nocturnal apneas), and airway reactivity is studied between pulmonary function tests that are made before bariatric surgery.
Read the detailed description
Background : An increase in asthma prevalence (or asthma-like symptoms) has been established in obese subjects, especially women. The aim of this pathophysiological study is to evaluate whether the modifications of respiratory mechanics due to severe obesity (Body Mass Index [BMI]>35) may explain the increase in asthma prevalence. Our hypothesis is that a decrease in variability of tidal breathing (evaluated by the coefficient of variation of Tidal volume: CVTV) (which traduces a physiological response to the increased work of breathing) associated with a decrease in the frequency of deep inhalations (FDI) (physiological sighs). The bronchodilatory and bronchoprotective roles of these deep inhalations have been demonstrated. The avoidance of deep inhalations during 10 minutes in healthy subjects is responsible for a non specific transient airway hyperresponsiveness (AHR) to methacholine. Consequently, obesity-related asthma could be due to the loss of bronchoprotective effect of deep inhalations.
Aims: The aim of this study is to evaluate whether 1) the variability of their diurnal ventilation (based on the measurement of CVTV and FDI) in three groups of women: obese with AHR, obese without AHR and healthy non obese (main objective), 2) obesity-related asthma pathophysiology is linked to atopy, and 3) obese asthmatic women have a greater decrease in ventilation variability as compared to non asthmatic obese women (secondary objectives).
Methods: The prevalence of AHR and confirmed asthma (international clinical and functional definition) are determined based on pulmonary function test (spirometry, volume determinations, arterial blood gas, measurement of the resistance of the respiratory system with evaluation of the response to deep inhalation, methacholine challenge, exhaled NO measurement, nocturnal polygraphy and oeso-gastroscopy) results obtained from 150 obese (BMI > 35). The FDI and CVTV will be determined based on the tidal volume obtained from thoracic and abdominal plethysmography inductance measurements during the polygraphy. A nocturnal polygraphy is systematically done in these women to search for a Sleep Apnea Syndrome. 30 healthy (non asthmatic, normal exhaled NO value, BMI 18.5 to 25) women will constitute a control group. The size of the groups have been calculated based on literature data concerning the FDI and CVTV.
Analysis criteria: The prevalences of asthma (or asthma-like symptoms) and AHR will be of 30% and 50% (based on a personal preliminary study), respectively. The FDI and CVTV will be compared in obese women with and without AHR and in healthy women (primary objective), and subsequently in obese asthmatic women and obese non asthmatic women. The measurement of exhaled NO and the bronchomotor effect of deep inhalation will allow the determination of underlying pathophysiology of obesity-related asthma (secondary objective).
Perspectives: If our hypothesis is verified, obesity treatment will become part of the management of asthma in women.
- Keywords
- Pulmonary function test, Methacholine challenge, Breathing variability, Polygraphy
- Medical subject headings
- Asthma, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| obese | obese | |
| healthy volunteers | healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the variability of the diurnal ventilation (based on the measurement of CVTV and FDI) in three groups of women: obese with AHR, obese without AHR and healthy non obese.
Measured: 24 hours
Secondary outcomes (1)
evaluate if the obesity-related asthma pathophysiology is linked to atopy, and if obese asthmatic women have a greater decrease in ventilation variability as compared to non asthmatic obese women
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startJan 2008
- Primary completionJun 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DELCLAUX MD Christophe, PhD, Principal investigator, Department of Physiology, Hôpital Européen Georges Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577733
- Sponsor's protocol ID
- P061010
- Acronym
- BOA
- Status last verified
- Dec 2007
- First submitted
- 19 Dec 2007
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiological Study of Obesity-related Asthma
- ClinicalTrials.gov ID
- NCT00577733
- Acronym / sponsor ID
- BOA / P061010
- Keywords
- Pulmonary function test, Methacholine challenge, Breathing variability, Polygraphy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 20 Dec 2007 (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.
Asthma is more frequent in obese women, but the mechanisms underlying the causes of this increased frequency are unknown and are different from usual asthma pathophysiology (associated with allergy). Obesity is known to influence ventilation; our hypothesis is that the normal variability of ventilation is decreased in obese patients, and that this decrease is responsible for an increased reactivity of their airway to non specific stimuli. In this observational study, breathing variability will be studied using polygraphy (an investigation that is made in these women to detect nocturnal apneas), and airway reactivity is studied between pulmonary function tests that are made before bariatric surgery.
Detailed description
Background : An increase in asthma prevalence (or asthma-like symptoms) has been established in obese subjects, especially women. The aim of this pathophysiological study is to evaluate whether the modifications of respiratory mechanics due to severe obesity (Body Mass Index [BMI]>35) may explain the increase in asthma prevalence. Our hypothesis is that a decrease in variability of tidal breathing (evaluated by the coefficient of variation of Tidal volume: CVTV) (which traduces a physiological response to the increased work of breathing) associated with a decrease in the frequency of deep inhalations (FDI) (physiological sighs). The bronchodilatory and bronchoprotective roles of these deep inhalations have been demonstrated. The avoidance of deep inhalations during 10 minutes in healthy subjects is responsible for a non specific transient airway hyperresponsiveness (AHR) to methacholine. Consequently, obesity-related asthma could be due to the loss of bronchoprotective effect of deep inhalations.
Aims: The aim of this study is to evaluate whether 1) the variability of their diurnal ventilation (based on the measurement of CVTV and FDI) in three groups of women: obese with AHR, obese without AHR and healthy non obese (main objective), 2) obesity-related asthma pathophysiology is linked to atopy, and 3) obese asthmatic women have a greater decrease in ventilation variability as compared to non asthmatic obese women (secondary objectives).
Methods: The prevalence of AHR and confirmed asthma (international clinical and functional definition) are determined based on pulmonary function test (spirometry, volume determinations, arterial blood gas, measurement of the resistance of the respiratory system with evaluation of the response to deep inhalation, methacholine challenge, exhaled NO measurement, nocturnal polygraphy and oeso-gastroscopy) results obtained from 150 obese (BMI > 35). The FDI and CVTV will be determined based on the tidal volume obtained from thoracic and abdominal plethysmography inductance measurements during the polygraphy. A nocturnal polygraphy is systematically done in these women to search for a Sleep Apnea Syndrome. 30 healthy (non asthmatic, normal exhaled NO value, BMI 18.5 to 25) women will constitute a control group. The size of the groups have been calculated based on literature data concerning the FDI and CVTV.
Analysis criteria: The prevalences of asthma (or asthma-like symptoms) and AHR will be of 30% and 50% (based on a personal preliminary study), respectively. The FDI and CVTV will be compared in obese women with and without AHR and in healthy women (primary objective), and subsequently in obese asthmatic women and obese non asthmatic women. The measurement of exhaled NO and the bronchomotor effect of deep inhalation will allow the determination of underlying pathophysiology of obesity-related asthma (secondary objective).
Perspectives: If our hypothesis is verified, obesity treatment will become part of the management of asthma in women.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese | – | –obese |
| healthy volunteers | – | –healthy volunteers |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- obese with AHR, obese without AHR and healthy non obese
Key inclusion criteria (4 listed)
- female
- age>18 and < 55 years
- BMI>35 (< 25 for healthy women)
- planned bariatric surgery
Key exclusion criteria (3 listed)
- sleep apnea syndrome
- pregnant or breast-feeding women
- No affiliation or non beneficiary of the National Health Insurance
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
compare the variability of the diurnal ventilation (based on the measurement of CVTV and FDI) in three groups of women: obese with AHR, obese without AHR and healthy non obese.
Time frame: 24 hours
1 secondary outcome
evaluate if the obesity-related asthma pathophysiology is linked to atopy, and if obese asthmatic women have a greater decrease in ventilation variability as compared to non asthmatic obese women
Time frame: 24 hours
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 Sep 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.
DELCLAUX MD Christophe, PhD principal investigator
Department of Physiology, Hôpital Européen Georges Pompidou
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 Asthma and Obesity, 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 4 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: finished, as of the sponsor's last update on 18 Sep 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?
compare the variability of the diurnal ventilation (based on the measurement of CVTV and FDI) in three groups of women: obese with AHR, obese without AHR and healthy non obese. (time frame: 24 hours). 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 Sep 2013.