Effectiveness of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-136)
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00163384
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method FEV1 absolute values.
- Secondary Outcome Measures
Name Time Method FEV1 as percent of predicted FVC PEF absolute values morning and evening PEF from diary diurnal PEF fluctuation asthma symptom score from diary use of rescue medication from diary dropout rate due to asthma exacerbations number of days with asthma control number of symptom free- and rescue medication free days onset of effect subgroup analysis for ex/current smokers and non-smokers AQLQ(S). time until first asthma exacerbation
Trial Locations
- Locations (1)
Altana Pharma/Nycomed
🇰🇷Seoul, Korea, Republic of