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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00526019
First Posted: September 6, 2007
Last Update Posted: February 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Louis-Philippe Boulet, Laval University
  Purpose

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.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Characteristics of Symptomatic Asthma Remissions

Further study details as provided by Louis-Philippe Boulet, Laval University:

Biospecimen Retention:   Samples Without DNA
Serum

Enrollment: 85
Study Start Date: September 2007
Study Completion Date: February 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).
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)
Current asthma (mild asthma)
Subjects with current asthma (Mild asthma)
Healthy controls
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)
  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects wiil be offered to volunteer from advertisements in newspaper. Subjects with asthma or in remission of asthma from primary care clinics will be offered to participate.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526019


Sponsors and Collaborators
Laval University
Investigators
Principal Investigator: Louis-Philippe Boulet, MD Hôpital Laval
  More Information

Responsible Party: Louis-Philippe Boulet, MD, FRCPC, FCCP, Laval University
ClinicalTrials.gov Identifier: NCT00526019     History of Changes
Other Study ID Numbers: HL-07-20088
First Submitted: September 5, 2007
First Posted: September 6, 2007
Last Update Posted: February 22, 2012
Last Verified: February 2012

Keywords provided by Louis-Philippe Boulet, Laval University:
remission of asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases