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

Asthma Clinical Trial

Official title:

Bronchoscopy and Bronchial Biopsies. Sub-study of: Characteristics of Asthma Remissions

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00526344
• Other study ID #: HL-07- sep-biop
• Status: Withdrawn
• Phase: N/A
• First received: September 5, 2007
• Last updated: February 10, 2011
• Start date: September 2007
• Est. completion date: March 2011

Study information

• Verified date: February 2011
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Observational

Clinical Trial 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.

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,...)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 36
• Est. completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Canada	Centre de Recherche, Hôpital Laval	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada,