Asthma
Conditions
Keywords
Asthma, Ciclesonide, Budesonide
Brief summary
This trial will compare the effectiveness of one dose of ciclesonide against one dose of budesonide in patients with asthma. The aim of the present trial is to compare the efficacy of ciclesonide versus budesonide on pulmonary function, symptoms and use of rescue medication in patients with asthma. The onset of action and the safety and tolerability of ciclesonide in comparison to budesonide will also be investigated.
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 (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 |
|---|---|
| FVC | — |
| PEF absolute values | — |
| morning and evening PEF from diary | — |
| diurnal PEF fluctuation | — |
| asthma symptom score from diary | — |
| use of rescue medication from diary | — |
| FEV1 as percent of predicted | — |
| dropout rate due to asthma exacerbations | — |
| time until first asthma exacerbation | — |
| number of days with asthma control | — |
| onset of effect | — |
| subgroup analysis for ex/current smokers and non-smokers | — |
| AQLQ(S). | — |
| number of symptom free- and rescue medication free days | — |
Countries
South Korea
Outcome results
None listed