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

Characteristics of Symptomatic Asthma Remissions

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00526019

Enrollment

Registered

2007-09-06

Start date

2007-09-30

Completion date

2012-02-29

Last updated

2012-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

remission of asthma

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)

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Outcome results