NCT00163397CompletedPhase 3
A Comparative Study of Inhaled Ciclesonide 160 mcg/Day vs Budesonide 400 mcg/Day in Patients With Asthma
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 120
- Locations
- 6
- Primary Endpoint
- FEV1 absolute values.
Study Overview
Brief Summary
The aim of the study is to investigate the efficacy of ciclesonide versus budesonide on lung function, symptoms and use of rescue medication in patients with asthma. Ciclesonide and budesonide will be inhaled once daily at one dose level each. The study duration consists of a baseline period (1 to 4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Exclusion Criteria
- •Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- •Concomitant COPD (i.e. 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
Outcomes
Primary Outcomes
FEV1 absolute values.
Secondary Outcomes
- AQLQ(S)
- physical examination
- vital signs
- laboratory work-up
- adverse events.
- 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
- number of symptom free- and rescue medication free days
- dropout rate due to asthma exacerbations
- time until first asthma exacerbation
- number of days with asthma control
- onset of effect
- subgroup analysis for ex/current smokers and non-smokers
Investigators
Study Sites (6)
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