Asthma
Conditions
Keywords
Asthma, Ciclesonide, Fluticasone propionate
Brief summary
The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, time to first asthma exacerbation, asthma symptoms, use of rescue medication, and quality of life in patients with mild to moderate asthma. Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.
Interventions
DRUGCiclesonide
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Outpatients * Written informed consent * History of bronchial asthma for at least 6 months * Good health with the exception of asthma * Treated with inhaled steroids with a maximum daily constant dosage of 250 mcg fluticasone propionate or equivalent * FEV1 80 - 105% of predicted Main
Exclusion criteria
* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids * COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function * Current smoking with more than 10 pack-years * Previous smoking with more than 10 pack-years * Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 2 times * Pregnancy * Intention to become pregnant during the course of the study * Breast feeding * Lack of safe contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV1 | — |
| time to the first asthma exacerbation. | — |
Secondary
| Measure | Time frame |
|---|---|
| use of rescue medication | — |
| AQLQ(S) and EQ-5D | — |
| percentage of days on which patients perceived asthma control | — |
| percentage of nocturnal awakening-free days | — |
| percentage of rescue medication-free days | — |
| FVC | — |
| physical examination | — |
| vital signs | — |
| standard laboratory work-up | — |
| adverse events | — |
| number of patients with local oropharyngeal adverse events. | — |
| percentage of asthma symptom-free days | — |
| asthma symptom score | — |
Countries
Austria, Canada, Germany, Poland, South Africa
Outcome results
None listed