Persistence of Airway Inflammation and Remodeling in Subj... | NCT00526019

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

NCT00526019

Sponsor

Laval University

Status

Completed

Last Update Posted

Feb 22, 2012Estimated

Enrollment

85Actual

Phase

Not provided

Conditions

Asthma

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Jun 2011Actual

Completion Date

Feb 2012Actual

First Submitted Date

Sep 5, 2007

First Submission Date that Met QC Criteria

Sep 5, 2007

First Posted Date

Sep 6, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2012

Last Update Posted Date

Feb 22, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

85Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases