Obesity and Asthma:a Specific Phenotype (ORPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00532363
Recruitment Status : Completed
First Posted : September 20, 2007
Last Update Posted : February 22, 2012
Information provided by (Responsible Party):
Louis-Philippe Boulet, Laval University

Brief Summary:

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
Obesity Asthma

Detailed Description:

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
Time Perspective: Cross-Sectional
Official Title: Obesity-related Pseudo-asthma (ORPA): Description of a Novel Clinical Entity
Study Start Date : September 2005
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Obese asthmatics
Obese subjects with asthma (on inhaled corticosteroids)
Non obese asthmatics
Non obese subjects with asthma (on inhaled corticosteroids)

Biospecimen Retention:   Samples Without DNA
Serum plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be selected from advertisements in newspapers and from the hospital primary care asthma clinic and will be offered to participate to the study.

Inclusion Criteria:

  • Will be women aged 18 years and over
  • Will be in good health apart from asthma or obesity as determined by history and physical examination (No other condition that could influence the proposed tests).
  • All will be non smokers or ex-smokers for more than six months with a smoking history of no more than 10 pack- years (i.e., one pack per day or its equivalent for 10 years.)
  • Subjects will have a physician's made diagnosis of severe asthma and treated with corticosteroids.

Exclusion Criteria:

  • Subjects who are, in the opinion of the investigator, mentally or legally incapacitated thus preventing informed consent from being obtained.
  • Subjects having a co-existing illness that precludes them from the trial.
  • Pregnancy or lactation
  • Contraindication to the prednisone treatment.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00532363

Canada, Quebec
Centre de Recherche, Hôpital Laval
Québec, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
Principal Investigator: Louis-Philippe Boulet, MD Hôpital Laval

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Louis-Philippe Boulet, MD, FRCPC, FCCP, Laval University Identifier: NCT00532363     History of Changes
Other Study ID Numbers: HL-ORPA-1171
First Posted: September 20, 2007    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases