NCT00163358
Completed
Phase 3
Efficacy of Ciclesonide and of a Fixed Combination With Fluticasone Propionate and Salmeterol Versus Placebo on Long-term Asthma Control
ConditionsAsthma
DrugsCiclesonide
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- AstraZeneca
- Enrollment
- 630
- Locations
- 1
- Primary Endpoint
- number of poorly controlled asthma days.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of mild persistent asthma
- •Pre-treatment with SABAs only
- •FEV1 ≥80% predicted
- •Good health with the exception of asthma
Exclusion Criteria
- •Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- •COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function
- •Pregnancy
- •Intention to become pregnant during the course of the study
- •Breast feeding
- •Lack of safe contraception
- •Current smokers ≥10 pack-years and ex-smokers with ≥10 pack-years
Outcomes
Primary Outcomes
number of poorly controlled asthma days.
time until the first severe asthma exacerbation occurs
Secondary Outcomes
- adverse events.
- percentage of days with asthma control
- percentage of days with asthma symptoms
- number of inhalations of rescue medication
- proportion of patients with severe asthma exacerbations
- blood eosinophils
- percentage of nocturnal awakenings due to asthma
- asthma symptom score
- differences in morning PEF from diary
- differences in FEV1 and FVC from spirometry
- AQLQ(S)
- health economic data
- vital signs
- laboratory work-up
Study Sites (1)
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