Clinical trial NCT00526344: Bronchoscopy With Bronchial Biopsies Sub-study of: Persistence of Airway Inflammation and Remodeling in Asthma Remission
Official title: Bronchoscopy and Bronchial Biopsies. Sub-study of: Characteristics of Asthma Remissions
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Asthma
Keywords: remission of asthma
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2007-09-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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,...)

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre de Recherche, Hôpital Laval
state: Quebec
Study officials:
affiliation: Hôpital Laval
name: Louis-Philippe Boulat, MD
role: PRINCIPAL_INVESTIGATOR
References: