Characterisation of Asthma in Obese Subjects

NCT00532831 | Completed

• 1 other identifier: HL-Phen-OB-1243
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma; Obesity

Outcome Measures

Primary Outcomes (1)

• Airway response to methacholine

  two weeks

Secondary Outcomes (1)

• lung volumes

  Two weeks

Study Arms (2)

Obese asthmatics

Obese subjects with asthma (on inhaled bd only)

Non-obese asthmatics

Non-obese subjects with asthma(on inhaled bd only)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

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.

  PMID: 18641097 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum plasma

MeSH Terms

Conditions

Asthma; Obesity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: August 1, 2005
• Study Completion: July 1, 2010
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

CA (1)