NCT00532363

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2007

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

First QC Date

September 18, 2007

Last Update Submit

February 20, 2012

Conditions

Study Arms (2)

Obese asthmatics

Obese subjects with asthma (on inhaled corticosteroids)

Non obese asthmatics

Non obese subjects with asthma (on inhaled corticosteroids)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche, Hôpital Laval

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

  • Lessard A, Turcotte H, Cormier Y, Boulet LP. Obesity and asthma: a specific phenotype? Chest. 2008 Aug;134(2):317-323. doi: 10.1378/chest.07-2959. Epub 2008 Jul 18.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum plasma

MeSH Terms

Conditions

ObesityAsthma

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Louis-Philippe Boulet, MD

    Hôpital Laval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FRCPC, FCCP

Study Record Dates

First Submitted

September 18, 2007

First Posted

September 20, 2007

Study Start

September 1, 2005

Study Completion

September 1, 2010

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations