Characterisation of Asthma in Obese Subjects - Full Text View

Sponsored by:	Laval University
Information provided by:	Laval University
ClinicalTrials.gov Identifier:	NCT00532831

Purpose

Our hypothesis:

Obese subjects with a physician's made diagnosis of asthma have a poorer asthma control than asthmatics with normal weight, less variability of peak expiratory flows (PEF) and bronchodilator response,increased induced sputum and systemic markers of inflammation and an increased prevalence of atopy.

Obese subjects have an increased incidence of co-morbidities such as rhinosinusitis, gastroesophageal reflux and sleep apnea syndrome.

This study aims to determine if, in comparison with asthmatics with a normal weight, paired for age and sex, obese subjects with asthma (all not using anti-inflammatory agents) show:

A more uncontrolled asthma, increased health care use and poorer quality of life
A reduced response to bronchodilators and diurnal variability of expiratory flows
More marked airway inflammation and evidences of a systemic inflammatory response
An increased prevalence of co-morbidities which can influence the report of respiratory symptoms or the severity of the disease, such as esophageal reflux symptoms, upper airway disease (rhinitis) and sleep apnea syndrome or other sleep disorder.

Condition
Asthma Obesity

MedlinePlus related topics: Asthma Obesity

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional
Official Title:	Characterisation of Asthma in Obese Subjects. Relationships Between Asthma and Obesity, Potential Mechanisms by Which Obesity Can Contribute to Asthma and Modify Treatment Responses

Further study details as provided by Laval University:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

serum plasma

Enrollment:	44
Study Start Date:	August 2005
Estimated Study Completion Date:	January 2008

Groups/Cohorts
Obese asthmatics Obese subjects with asthma (on inhaled bd only)
Non-obese asthmatics Non-obese subjects with asthma(on inhaled bd only)

Detailed Description:

Questionnaires on respiratory symptoms, health care use, quality of life, medication and asthma control will be administered and a thoracic examination performed.

Spirometry and bronchodilator response, blood tests for inflammatory parameters, pH measurements in exhaled air condensate and sputum induction will be performed. Peak expiratory flows will be measured and recorded on a diary card during one week.

On the second visit, measures of lung volumes and a methacholine challenge will be performed.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects wiil be selected from the Hospital asthma primary care clinic and from advertisements in newspapers. Their will be offered to participate to the study

Criteria

Inclusion Criteria:

aged 18 and over.
in good health apart from asthma or obesity as determined by history and physical examination (no other condition which 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 asthma and have received a bronchodilator prescription in the last year.

Exclusion Criteria:

Use of asthma medications other than bronchodilators
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532831

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

Publications indexed to this study:

Lessard A, Turcotte H, Cormier Y, Boulet LP. Obesity and asthma: a specific phenotype? Chest. 2008 Aug;134(2):317-23. Epub 2008 Jul 18.

Responsible Party:	Laval Hospital ( Louis-Philippe Boulet )
Study ID Numbers:	HL-Phen-OB-1243
Study First Received:	September 18, 2007
Last Updated:	December 4, 2007
ClinicalTrials.gov Identifier:	NCT00532831
Health Authority:	Canada: Canadian Institutes of Health Research

Study placed in the following topic categories:

Obesity
Asthma
Overweight
Body Weight
Signs and Symptoms
Lung Diseases, Obstructive
Hypersensitivity

Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Nutrition Disorders
Overnutrition
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009