Effectiveness of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-136)
Status and phase
Completed
Phase 3
Conditions
Asthma
Treatments
Drug: Ciclesonide
Details and patient eligibility
About
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.
Sex
All
Ages
18 to 75 years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
Main 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
19
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Data sourced from clinicaltrials.gov
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