Relative Potency of Inhaled Corticosteroids

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

fluticasone 25, 50, 100, 200 mcg

About this trial

This is an interventional treatment trial for Asthma focused on measuring Eosinophilic bronchitis with asthma, Eosinophilic bronchitis without asthma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

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

Outcomes

Primary Outcome Measures

Sputum eosinophils

Secondary Outcome Measures

Exhaled nitric oxide, FEV1, FEF25-75%

Full Information

NCT ID

NCT00292838

First Posted

February 14, 2006

Last Updated

July 19, 2011

Sponsor

St. Joseph's Healthcare Hamilton

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00292838

Brief Title

Relative Potency of Inhaled Corticosteroids

Official Title

Relative Potency of Inhaled Corticosteroids: Validation of a Clinical Model

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

January 2001 (undefined)

Primary Completion Date

February 2007 (Actual)

Study Completion Date

February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

St. Joseph's Healthcare Hamilton

Collaborators

GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma, Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Eosinophilic bronchitis with asthma, Eosinophilic bronchitis without asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

fluticasone 25, 50, 100, 200 mcg

Primary Outcome Measure Information:

Title

Sputum eosinophils

Secondary Outcome Measure Information:

Title

Exhaled nitric oxide, FEV1, FEF25-75%

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frederick E Hargreave, MD

Organizational Affiliation

McMaster University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Asthma, Chronic Obstructive Pulmonary Disease (COPD)

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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