Bronchoscopy With Bronchial Biopsies Sub-study of: Persistence of Airway Inflammation and Remodeling in Asthma Remission

NCT ID: NCT00526344

Last Updated: 2011-02-14

Basic Information

• Recruitment Status: WITHDRAWN
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2011-03-31

Brief Summary

This study aims at determining the patterns of asthma remission, the prevalence of these different patterns and the various factors associated with such remissions and possible recurrences of asthma, in order to determine the mechanisms involved in these processes.

We therefore want to document these specificities in studying biopsies of subjects in complete remission of their asthma and those in only symptomatic remission of their asthma, in comparison with mildly symptomatic asthmatic subjects and healthy controls.

Detailed Description

Primary Outcome Measures :

Airway inflammation and remodeling: in bronchial biopsies

Secondary Outcome Measures:

Comparisons of bronchial biopsy features between groups:

• Bronchial epithelial morphology
• Bronchial mucosa (smooth muscle, reticular basement membrane, submucosal gland,...)

Conditions

Asthma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

1

Subjects with complete remission of asthma

No interventions assigned to this group

2

Subjects with symptomatic remission of asthma

No interventions assigned to this group

3

Subjects with asthma

No interventions assigned to this group

4

Healthy controls

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• In remission of their asthma: absence of respiratory symptoms, no rescue asthma medication need and (for complete remission) an optimal pulmonary function (FEV1 > 90%) and normal PC20 methacholine for more than two years (with no current treatment).
• With a proven past history of asthma from medical files (reversible airway obstruction (> 12% FEV1 after bronchodilator or 20% by other means) proven by spirometry, PEF measures or methacholine challenge according to current criteria + previous symptoms and asthma medication use), having no more asthma symptoms and not having used asthma medication for more than 2 years.
• Agree to sign the consent form.
• No other condition that could interfere with the study measurements.

Exclusion Criteria

• Subjects using inhaled or oral anti-inflammatory agents.
• FEV1 < 1.2 L.
• Unable to adhere to the protocol requirements.
• Other current respiratory disease
• Upper or lower respiratory tract infection or use of antibiotics < 1 month.
• Use of oral corticosteroids within the last 3 months.
• Signs or symptoms of progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Laval Hospital

Principal Investigators

Louis-Philippe Boulat, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Laval

Locations

Centre de Recherche, Hôpital Laval

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

HL-07- sep-biop

Identifier Type: -

Identifier Source: org_study_id