NCT00532831

Completed

Characterisation of Asthma in Obese Subjects

Laval University Source

Other study identifiers

Sponsor study identifier

HL-Phen-OB-1243

Study Type

observational

Actual enrollment (reported)

44

Locations

1 country

Sites

1

Timeline

Study Start

August 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

July 2010

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 44 participants
Study completion date: July 2010
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 18, 2007
Actual (reported)
First Posted
September 20, 2007
Actual (reported)
Study Completion
July 2010
Actual (reported)

Last Updated: February 22, 2012
Status Verified: February 2012
Last Update Submitted: February 20, 2012

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

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

Sponsors & Collaborators

Laval University
Otherlead

Study Sites (1)

Centre de Recherche, Hôpital Laval

Québec, Quebec, G1V 4G5, Canada

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: 18641097DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum plasma

MeSH Terms

Conditions

AsthmaObesity

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

Louis-Philippe Boulet, MD
Hôpital Laval
PRINCIPAL INVESTIGATOR

Enrollment

44 participants (actual enrollment reported by the registry).

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 2005

Date type not reported

This date has not been verified as actual or estimated.

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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

Contact the study team to confirm eligibility.

Signs and Symptoms

Pathological Conditions, Signs and Symptoms

Study Completion

July 2010

Actual (reported)

Last Updated

February 22, 2012

Record last verified: 2012-02

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00532831
Data provider: ClinicalTrials.gov
Source updated: 2012-02-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:26 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Obese asthmatics

Non-obese asthmatics

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations