NCT00163319CompletedPhase 3
Comparison of Inhaled Ciclesonide (640 mcg/Day) and Fluticasone Propionate (1000 mcg/Day) in Patients With Moderate and Severe Persistent Asthma
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 500
- Locations
- 89
- Primary Endpoint
- number of patients with candidiasis of the oropharynx or hoarseness.
Study Overview
Brief Summary
The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (2 weeks) and a treatment period (24 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:
- •Written informed consent
- •History of bronchial asthma for at least 6 months
- •Pre-treatment with CFC-beclomethasone dipropionate (CFC-BDP) ≥ 1000 mcg/day or equivalent and a long-acting beta agonist (LABA) either in free or fixed combination
- •FEV1 ≥ 80% of predicted
Exclusion Criteria
- •Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or contraindications for the use of LABAs
- •Smoking with ≥10 pack-years
- •Pregnancy
- •Intention to become pregnant during the course of the study
- •Breast feeding
- •Lack of safe contraception
Outcomes
Primary Outcomes
number of patients with candidiasis of the oropharynx or hoarseness.
Secondary Outcomes
- asthma symptom score
- use of rescue medication
- hoarseness at each visit Secondary variables
- adverse events
- proportion of cases of candidiasis of the oropharynx or
- percent of rescue medication free days
- percent of nocturnal awakening-free days
- inhaled Corticosteroids Questionnaire (ICQ)
- percent days on which patient perceived asthma control
- percent symptom free days
- diurnal PEF fluctuation
- number of patients with an asthma exacerbation
- physical examination, ECG
- skin bruising.
- FEV1, FVC, PEF from spirometry
- number of patients with candidiasis of the oropharynx or hoarseness by severity
- standard laboratory work-up
- morning serum cortisol
- morning and evening PEF from diaries
- onset of treatment effect
- time to first asthma exacerbation
- AQLQ
- vital sings
Investigators
Study Sites (89)
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