Relative Potency of Inhaled Corticosteroids

St. Joseph's Healthcare Hamilton

Status and phase: Completed; Phase 4

Conditions: Asthma; Chronic Obstructive Pulmonary Disease (COPD)

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00292838

RP#01-1929

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind