NCT00292838

Brief Summary

To investigate the validity of a clinical model to determine the relative potency of different preparations of inhaled corticosteroids used for the treatment of asthma or of eosinophilic bronchitis without asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 asthma

Timeline
Completed

Started Jan 2001

Longer than P75 for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

6.1 years

First QC Date

February 14, 2006

Last Update Submit

July 19, 2011

Conditions

AsthmaChronic Obstructive Pulmonary Disease (COPD)

Keywords

Eosinophilic bronchitis with asthmaEosinophilic bronchitis without asthma

Outcome Measures

Primary Outcomes (1)

  • Sputum eosinophils

Secondary Outcomes (1)

  • Exhaled nitric oxide, FEV1, FEF25-75%

Interventions

fluticasone 25, 50, 100, 200 mcgDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sputum eosinophilia \>3%
  • Adults age 18-70 years
  • History of episodic wheeze, chest tightness, dyspnea or cough within the last 12 months.
  • FEV1 ≥ 60% predicted
  • Steroid naive or on not more than 500 µg a day of beclomethasone or equivalent.
  • Able to give written informed consent

You may not qualify if:

  • Recent asthma or COPD exacerbation (as judged by the clinician) due to respiratory infection within the last month
  • Relevant seasonal allergen exposure within 4 weeks or within the course of the study
  • Treatment with prednisone or antibiotics or hospitalisation within the past 6 weeks
  • Other respiratory diseases
  • Women who are pregnant or unwilling to use appropriate contraception during the study
  • Unable to withhold short-acting ß-agonist treatment for 6 hours before visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Firestone Institute for Respiratory Health, St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Frederick E Hargreave, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2006

First Posted

February 16, 2006

Study Start

January 1, 2001

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations

CA(1)