Asthma
Conditions
Keywords
Asthma, Ciclesonide
Brief summary
The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. Ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks).
Interventions
DRUGCiclesonide
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Written informed consent * History of persistent bronchial asthma for at least 6 months * Good health with the exception of asthma Main
Exclusion criteria
* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids * Smoking history with ≥10 cigarette pack years * Pregnancy * Intention to become pregnant * Breast feeding * Lack of safe contraception * Previous enrolment into the current study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV1. | — |
Secondary
| Measure | Time frame |
|---|---|
| FVC | — |
| morning and evening PEF from diaries | — |
| asthma symptom score | — |
| use of rescue medication | — |
| number of patients with an asthma exacerbation | — |
| time to the first asthma exacerbation | — |
| percentage of days on which patient perceived asthma control | — |
| 8 am serum cortisol. | — |
| percentage of rescue medication-free days | — |
| percentage of asthma symptom-free days | — |
| adverse events | — |
| physical examination | — |
| vital signs | — |
| standard laboratory work-up | — |
| percentage of nocturnal awakening-free days | — |
Countries
Canada, France, Germany, Hungary, India, Italy
Outcome results
None listed