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

February 10, 2011 updated by: Laval University

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

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.

Study Overview

Status

Withdrawn

Conditions

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,...)

Study Type

Observational

Enrollment (Anticipated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V 4G5
        • Centre de Recherche, Hôpital Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with current asthma or in remission of asthma from primary care clinics will be allowed to participate to this study. Healthy subjects will also be invited by advertisements in newspapers to volunteer for this study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
4
Healthy controls
1
Subjects with complete remission of asthma
2
Subjects with symptomatic remission of asthma
3
Subjects with asthma

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Investigators

  • Principal Investigator: Louis-Philippe Boulat, MD, Hôpital Laval

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Study Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

September 5, 2007

First Submitted That Met QC Criteria

September 5, 2007

First Posted (Estimate)

September 10, 2007

Study Record Updates

Last Update Posted (Estimate)

February 14, 2011

Last Update Submitted That Met QC Criteria

February 10, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL-07- sep-biop

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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