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

Asthma Clinical Trial

Official title:

Characteristics of Symptomatic Asthma Remissions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00526019
• Other study ID #: HL-07-20088
• Status: Completed
• Phase: N/A
• First received: September 5, 2007
• Last updated: February 20, 2012
• Start date: September 2007
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: February 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laval University