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

This study has been withdrawn prior to enrollment.
(No funding, study not done)
Sponsor:
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT00526344
First received: September 5, 2007
Last updated: February 10, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Bronchoscopy and Bronchial Biopsies. Sub-study of: Characteristics of Asthma Remissions

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Laval University:

Biospecimen Retention:   Samples With DNA

Tissue (bronchial biopsies)


Estimated Enrollment: 36
Study Start Date: September 2007
Estimated Study Completion Date: March 2011
Groups/Cohorts
1
Subjects with complete remission of asthma
2
Subjects with symptomatic remission of asthma
3
Subjects with asthma
4
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,...)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526344

Locations
Canada, Quebec
Centre de Recherche, Hôpital Laval
Québec, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
Investigators
Principal Investigator: Louis-Philippe Boulat, MD Hôpital Laval
  More Information

No publications provided

Responsible Party: Louis-Philippe Boulet, Laval Hospital
ClinicalTrials.gov Identifier: NCT00526344     History of Changes
Other Study ID Numbers: HL-07- sep-biop
Study First Received: September 5, 2007
Last Updated: February 10, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Laval University:
remission of asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013