NCT00526019

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2007

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 6, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

3.8 years

First QC Date

September 5, 2007

Last Update Submit

February 20, 2012

Conditions

Keywords

remission of asthma

Study Arms (4)

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Louis-Philippe Boulet, MD

    Hôpital Laval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FRCPC, FCCP

Study Record Dates

First Submitted

September 5, 2007

First Posted

September 6, 2007

Study Start

September 1, 2007

Primary Completion

June 1, 2011

Study Completion

February 1, 2012

Last Updated

February 22, 2012

Record last verified: 2012-02