Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00163319
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
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
Main
Exclusion Criteria
- Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or contraindications for the use of LABAs
- COPD
- Smoking with ≥10 pack-years
- Pregnancy
- Intention to become pregnant during the course of the study
- Breast feeding
- Lack of safe contraception
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method number of patients with candidiasis of the oropharynx or hoarseness.
- Secondary Outcome Measures
Name Time Method proportion of cases of candidiasis of the oropharynx or percent of rescue medication free days asthma symptom score use of rescue medication percent of nocturnal awakening-free days inhaled Corticosteroids Questionnaire (ICQ) percent days on which patient perceived asthma control percent symptom free days hoarseness at each visit Secondary variables 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 adverse events vital sings
Trial Locations
- Locations (1)
Altana Pharma/Nycomed
🇬🇧Watford, United Kingdom