Efficacy and Safety of Ciclesonide Administered With or Without Different Spacers in Patients With Asthma (12 to 75 y) (BY9010/M1-145)
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00163436
- Lead Sponsor
- AstraZeneca
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method FEV1.
- Secondary Outcome Measures
Name Time Method vital signs 8 am serum cortisol. physical examination morning and evening PEF from diaries asthma symptom score use of rescue medication percentage of nocturnal awakening-free days percentage of rescue medication-free days adverse events time to the first asthma exacerbation FVC number of patients with an asthma exacerbation percentage of days on which patient perceived asthma control percentage of asthma symptom-free days standard laboratory work-up
Trial Locations
- Locations (1)
Altana Pharma/Nycomed
🇮🇹Verona, Italy