Study of the Physiology of the Asthma of the Obese Subjects. Breathing Obesity Asthma Study (BOA)

NCT00577733 | Completed

• 1 other identifier: P061010
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Asthma; Obesity

Keywords

Pulmonary function test; Methacholine challenge; Breathing variability; Polygraphy

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  24 hours

Study Arms (2)

obese

obese

healthy volunteers

healthy volunteers

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

obese with AHR, obese without AHR and healthy non obese

You may qualify if:

• female
• age\>18 and \< 55 years
• BMI\>35 (\< 25 for healthy women)
• planned bariatric surgery

You may not qualify if:

• sleep apnea syndrome
• pregnant or breast-feeding women
• No affiliation or non beneficiary of the National Health Insurance

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Department of Physiology, Hôpital Européen Georges Pompidou

Paris, France

Location

MeSH Terms

Conditions

Asthma; Obesity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• DELCLAUX MD Christophe, PhD

  Department of Physiology, Hôpital Européen Georges Pompidou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 20, 2007
• Study Start: January 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 18, 2013

Record last verified: 2007-12

Locations

FR (1)