Obesity and Asthma:a Specific Phenotype (ORPA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Louis-Philippe Boulet, Laval University
ClinicalTrials.gov Identifier:
NCT00532363
First received: September 18, 2007
Last updated: February 20, 2012
Last verified: February 2012
  Purpose

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
Obesity
Asthma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Obesity-related Pseudo-asthma (ORPA): Description of a Novel Clinical Entity

Resource links provided by NLM:


Further study details as provided by Laval University:

Biospecimen Retention:   Samples Without DNA

Serum plasma


Enrollment: 44
Study Start Date: September 2005
Study Completion Date: September 2010
Groups/Cohorts
Obese asthmatics
Obese subjects with asthma (on inhaled corticosteroids)
Non obese asthmatics
Non obese subjects with asthma (on inhaled corticosteroids)

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532363

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

No publications provided by Laval University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Louis-Philippe Boulet, MD, FRCPC, FCCP, Laval University
ClinicalTrials.gov Identifier: NCT00532363     History of Changes
Other Study ID Numbers: HL-ORPA-1171
Study First Received: September 18, 2007
Last Updated: February 20, 2012
Health Authority: Canada: Canadian Institutes of Health Research

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

ClinicalTrials.gov processed this record on October 20, 2014