Asthma
Conditions
Keywords
Asthma, Ciclesonide, Fluticasone propionate
Brief summary
The aim of the study is to investigate the effect of ciclesonide versus fluticasone propionate versus placebo on airway hyperresponsiveness and on the hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five treatment periods (9 days each), and a washout period between treatments (4 to 12 weeks). The study will provide further data on safety and tolerability of ciclesonide.
Interventions
DRUGCiclesonide
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Patients who have had a history of bronchial asthma for at least 6 months * FEV1 \>60% of predicted for at least 24 h * Patients who are hyperresponsive to methacholine and to AMP * Patients who are in good health with the exception of asthma Main
Exclusion criteria
* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids * Patients suffering from COPD and/or other relevant lung diseases except asthma * Current smokers and ex-smokers both with ≥10 pack years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC(0-24h)/24 h of serum cortisol level | — |
| 24 h urinary cortisol excretion adjusted for creatinine. | — |
Secondary
| Measure | Time frame |
|---|---|
| PC20FEV1 to AMP | — |
| lung function (FEV1, FVC) | — |
| 8 am measurement of bone formation markers | — |
| safety and tolerability. | — |
| pharmacokinetics | — |
| PC20FEV1 to methacholine | — |
Countries
Belgium
Outcome results
None listed