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Characterisation of Asthma in Obese Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00532831
First Posted: September 20, 2007
Last Update Posted: February 22, 2012
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.
Information provided by (Responsible Party):
Louis-Philippe Boulet, Laval University
  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

Further study details as provided by Louis-Philippe Boulet, Laval University:

Primary Outcome Measures:
  • Airway response to methacholine [ Time Frame: two weeks ]

Secondary Outcome Measures:
  • lung volumes [ Time Frame: Two weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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 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
First Submitted: September 18, 2007
First Posted: September 20, 2007
Last Update Posted: February 22, 2012
Last Verified: February 2012

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