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

This study is currently recruiting participants.
Verified by Laval University, June 2008

Sponsored by: Laval University
Information provided by: Laval University
ClinicalTrials.gov Identifier: NCT00526344
  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
Remission of Asthma
Asthma

MedlinePlus related topics:   Asthma   

U.S. FDA Resources

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

Further study details as provided by Laval University:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Tissue (bronchial biopsies)


Estimated Enrollment:   36
Study Start Date:   September 2007
Estimated Study Completion Date:   September 2009

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 offered to participate to this study. Subjects with current asthma or in remission of asthma and 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     Recruiting
      Québec, Quebec, Canada, G1V 4G5
      Contact: Hélène Turcotte, MSc     418-656-8711 ext 5393     helene.turcotte@crhl.ulaval.ca    
      Principal Investigator: Louis-Philippe Boulet, MD            

Sponsors and Collaborators
Laval University

Investigators
Principal Investigator:     Louis-Philippe Boulat, MD     Hôpital Laval    
  More Information


Responsible Party:   Laval Hospital ( Louis-Philippe Boulet )
Study ID Numbers:   HL-07- sep-biop
First Received:   September 5, 2007
Last Updated:   June 10, 2008
ClinicalTrials.gov Identifier:   NCT00526344
Health Authority:   Canada: Canadian Institutes of Health Research

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity
Inflammation

Additional relevant MeSH terms:
Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on October 16, 2008




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