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Characterisation of Asthma in Obese Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Louis-Philippe Boulet, Laval University
ClinicalTrials.gov Identifier:
NCT00532831
First received: September 18, 2007
Last updated: February 20, 2012
Last verified: February 2012
History of Changes
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: 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

Resource links provided by NLM:

MedlinePlus related topics: Asthma Obesity
U.S. FDA Resources

Further study details as provided by Laval University:

Primary Outcome Measures:
  • Airway response to methacholine [ Time Frame: two weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • lung volumes [ Time Frame: Two weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum plasma


Enrollment: 44
Study Start Date: August 2005
Study Completion Date: July 2010
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

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: NCT00532831     History of Changes
Other Study ID Numbers: HL-Phen-OB-1243
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
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013