Persistence of Airway Inflammation and Remodeling in Subjects With Symptomatic or Complete Asthma Remission

NCT ID: NCT00526019

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 85 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2012-02-29

Brief Summary

This study aims at determining the patterns of asthma remission, the prevalence of these different patterns, the various factors associated with such remissions and possible recurrences of asthma, in order to determine the mechanisms involved in these processes.

The investigators therefore want to document these specificities in 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 (% induced sputum eosinophils)

Secondary Outcome Measures:

• Perception of induced respiratory symptoms
• Airway response to methacholine and AMP, and perception scores
• Diurnal variation in Peak Expiratory Flows
• Profile of regulatory T cells in the peripheral blood
• Changes in these parameters over time (baseline, 6 months, 1 and 2 years)

Conditions

Asthma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Complete remission of their asthma

Subjects in complete remission of their asthma Subjects in complete remission of their asthma: absence of respiratory symptoms, no rescue asthma medication need and an optimal pulmonary function and normal PC20 methacholine (\>16 mg/ml) for more than two years (with no current treatment).

No interventions assigned to this group

Symptomatic remission ofasthma

Subjects in symptomatic remission of their asthma (No asthma symptoms in the last 2 years, no asthma medication, PC20 methacholine \<16 mg/ml)

No interventions assigned to this group

Current asthma (mild asthma)

Subjects with current asthma (Mild asthma)

No interventions assigned to this group

Healthy controls

Healthy controls

No interventions assigned to this group

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Louis-Philippe Boulet

MD, FRCPC, FCCP

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louis-Philippe Boulet, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Laval

Other Identifiers

HL-07-20088

Identifier Type: -

Identifier Source: org_study_id