Asthma
Conditions
Keywords
Asthma, Ciclesonide, Fluticasone propionate
Brief summary
The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (2 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
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Written informed consent * History of bronchial asthma for at least 6 months * Pre-treatment with CFC-beclomethasone dipropionate (CFC-BDP) ≥ 1000 mcg/day or equivalent and a long-acting beta agonist (LABA) either in free or fixed combination * FEV1 ≥ 80% of predicted Main
Exclusion criteria
* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or contraindications for the use of LABAs * COPD * Smoking with ≥10 pack-years * Pregnancy * Intention to become pregnant during the course of the study * Breast feeding * Lack of safe contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of patients with candidiasis of the oropharynx or hoarseness. | — |
Secondary
| Measure | Time frame |
|---|---|
| proportion of cases of candidiasis of the oropharynx or | — |
| hoarseness at each visit Secondary variables | — |
| FEV1, FVC, PEF from spirometry | — |
| morning and evening PEF from diaries | — |
| diurnal PEF fluctuation | — |
| onset of treatment effect | — |
| percent days on which patient perceived asthma control | — |
| percent of nocturnal awakening-free days | — |
| percent of rescue medication free days | — |
| percent symptom free days | — |
| asthma symptom score | — |
| inhaled Corticosteroids Questionnaire (ICQ) | — |
| time to first asthma exacerbation | — |
| number of patients with an asthma exacerbation | — |
| AQLQ | — |
| number of patients with candidiasis of the oropharynx or hoarseness by severity | — |
| physical examination, ECG | — |
| vital sings | — |
| adverse events | — |
| standard laboratory work-up | — |
| morning serum cortisol | — |
| skin bruising. | — |
| use of rescue medication | — |
Countries
Belgium, France, Italy, Netherlands, Spain, Switzerland, United Kingdom
Outcome results
None listed