Obesity and Asthma:a Specific Phenotype (ORPA)
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|ClinicalTrials.gov Identifier: NCT00532363|
Recruitment Status : Completed
First Posted : September 20, 2007
Last Update Posted : February 22, 2012
Clinicians frequently observed that obese women referred for severe asthma do not respond to treatment. These patients, despite the presence of wheezing, often have normal expiratory flows and normal or "borderline" airway responsiveness.
It is therefore possible that this mode of presentation reflect a pseudo-asthmatic state for which clinical definition and characteristics and optimal management remain to be determined.
The aim of this study was to study the pulmonary physiological and airway inflammatory characteristics and response to treatment of obese women considered to have clinically severe asthma in order to demonstrate that some of these patients have a phenotype that is not that of asthma.
|Condition or disease|
Twenty-five obese women (BMI over 30) and 25 non-obese women (18>BMI<25) considered to have severe asthma by their physician and requiring corticosteroids to control their asthma will have the following investigation:
- Respiratory questionnaires focussing on the nature and time-course of symptoms, asthma control criteria, medication use.
- Physical examination, including measures of BMI, waist, hips and ratio waist/hips
- Blood test for Complete Blood Count, blood glucose, total IgE levels and markers of systemic inflammation (C-Reactive Protein, fibrinogen…)
- Spirometry and bronchodilator response.
- Induced sputum analysis and Exhaled Breath Condensate pH to assess airway inflammation.
- Skin prick tests with a battery of common airborne allergens
- Measurement of lung volumes and airway resistance + MIP and MEP.
- Methacholine challenge (up to 16 mg/ml) with Borg scores for breathlessness and chest tightness.
|Study Type :||Observational|
|Actual Enrollment :||44 participants|
|Observational Model:||Case Control|
|Official Title:||Obesity-related Pseudo-asthma (ORPA): Description of a Novel Clinical Entity|
|Study Start Date :||September 2005|
|Study Completion Date :||September 2010|
Obese subjects with asthma (on inhaled corticosteroids)
Non obese asthmatics
Non obese subjects with asthma (on inhaled corticosteroids)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532363
|Centre de Recherche, Hôpital Laval|
|Québec, Quebec, Canada, G1V 4G5|
|Principal Investigator:||Louis-Philippe Boulet, MD||Hôpital Laval|