Asthma
Conditions
Keywords
Asthma, Ciclesonide, Fluticasone propionate, Salmeterol
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.
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: * Clinical diagnosis of mild persistent asthma * Pre-treatment with SABAs only * FEV1 ≥80% predicted * Good health with the exception of asthma Main
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time until the first severe asthma exacerbation occurs | — |
| number of poorly controlled asthma days. | — |
Secondary
| Measure | Time frame |
|---|---|
| percentage of nocturnal awakenings due to asthma | — |
| asthma symptom score | — |
| number of inhalations of rescue medication | — |
| proportion of patients with severe asthma exacerbations | — |
| differences in morning PEF from diary | — |
| differences in FEV1 and FVC from spirometry | — |
| percentage of days with asthma control | — |
| AQLQ(S) | — |
| health economic data | — |
| vital signs | — |
| laboratory work-up | — |
| adverse events. | — |
| blood eosinophils | — |
| percentage of days with asthma symptoms | — |
Countries
Australia, Canada, Czechia, Hungary, Poland, South Africa, Spain
Outcome results
None listed