Relative Potency of Inhaled Corticosteroids

Asthma Clinical Trial

Official title:

Relative Potency of Inhaled Corticosteroids: Validation of a Clinical Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292838
• Other study ID #: RP#01-1929
• Status: Completed
• Phase: Phase 4
• First received: February 14, 2006
• Last updated: July 19, 2011
• Start date: January 2001
• Est. completion date: February 2007

Study information

• Verified date: July 2011
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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:

1. Recent asthma or COPD exacerbation (as judged by the clinician) due to respiratory infection within the last month

2. Relevant seasonal allergen exposure within 4 weeks or within the course of the study

3. Treatment with prednisone or antibiotics or hospitalisation within the past 6 weeks

4. Other respiratory diseases

5. Women who are pregnant or unwilling to use appropriate contraception during the study

6. Unable to withhold short-acting ß-agonist treatment for 6 hours before visit

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• fluticasone 25, 50, 100, 200 mcg

Locations

Country	Name	City	State
Canada	Firestone Institute for Respiratory Health, St. Joseph's Healthcare	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	GlaxoSmithKline

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sputum eosinophils
Secondary	Exhaled nitric oxide, FEV1, FEF25-75%