Asthma
Conditions
Keywords
Asthma, Ciclesonide, Budesonide
Brief summary
The aim of the study is to investigate the efficacy of ciclesonide versus budesonide on lung function, symptoms and use of rescue medication in patients with asthma. Ciclesonide and budesonide will be inhaled once daily at one dose level each. The study duration consists of a baseline period (1 to 4 weeks) and a treatment period (12 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
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * During the last 4 weeks prior to baseline, treatment with an inhaled steroid (dosage: up to 250 mcg fluticasone propionate or equivalent) * FEV1 80 - 105% of predicted * Healthy with the exception of asthma * Written informed consent has been obtained * Outpatients * Patients who have a history of persistent bronchial asthma for at least 6 months Main
Exclusion criteria
* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids * Concomitant COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function * An asthma exacerbation or an infection of the lower airways prior to entry into the baseline period * Pregnancy * Intention to become pregnant during the course of the study * Breast feeding * Lack of safe contraception * Patient is current smoker with 10 or more pack-years * Patient is ex-smoker with 10 or more pack-years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV1 absolute values. | — |
Secondary
| Measure | Time frame |
|---|---|
| number of symptom free- and rescue medication free days | — |
| dropout rate due to asthma exacerbations | — |
| time until first asthma exacerbation | — |
| asthma symptom score from diary | — |
| FEV1 as percent of predicted | — |
| FVC | — |
| PEF absolute values | — |
| morning and evening PEF from diary | — |
| use of rescue medication from diary | — |
| number of days with asthma control | — |
| onset of effect | — |
| subgroup analysis for ex/current smokers and non-smokers | — |
| AQLQ(S) | — |
| physical examination | — |
| vital signs | — |
| laboratory work-up | — |
| adverse events. | — |
| diurnal PEF fluctuation | — |
Countries
Malaysia, Taiwan
Outcome results
None listed