NCT00163423CompletedPhase 3
Comparison of Ciclesonide (80 mcg Once Daily in the Evening) and Fluticasone Propionate (100 mcg Twice Daily) in Patients With Mild to Moderate Asthma
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 480
- Locations
- 51
- Primary Endpoint
- FEV1
Study Overview
Brief Summary
The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, time to first asthma exacerbation, asthma symptoms, use of rescue medication, and quality of life in patients with mild to moderate asthma. Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 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
- 12 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Main Inclusion Criteria:
- •Outpatients
- •Written informed consent
- •History of bronchial asthma for at least 6 months
- •Good health with the exception of asthma
- •Treated with inhaled steroids with a maximum daily constant dosage of 250 mcg fluticasone propionate or equivalent
- •FEV1 80 - 105% of predicted
Exclusion Criteria
- •Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- •COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
- •Current smoking with more than 10 pack-years
- •Previous smoking with more than 10 pack-years
- •Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 2 times
- •Pregnancy
- •Intention to become pregnant during the course of the study
- •Breast feeding
- •Lack of safe contraception
Outcomes
Primary Outcomes
FEV1
time to the first asthma exacerbation.
Secondary Outcomes
- adverse events
- number of patients with local oropharyngeal adverse events.
- asthma symptom score
- AQLQ(S) and EQ-5D
- percentage of rescue medication-free days
- physical examination
- FVC
- use of rescue medication
- vital signs
- percentage of days on which patients perceived asthma control
- percentage of nocturnal awakening-free days
- percentage of asthma symptom-free days
- standard laboratory work-up
Investigators
Study Sites (51)
Loading locations...
Similar Trials
Completed
Phase 3
Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)AsthmaNCT00163462AstraZeneca750
Completed
Phase 3
Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)AsthmaNCT00163410AstraZeneca500
Completed
Phase 3
Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)AsthmaNCT00163332AstraZeneca30
Completed
Phase 3
Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)AsthmaNCT00163319AstraZeneca500
Completed
Phase 3
Effects of Inhaled Ciclesonide Versus Fluticasone Propionate Versus Placebo on Lower Leg Growth in Prepubertal Children With Mild Persistent Asthma (6 to 12 y) (BY9010/M1-208)AsthmaNCT00163371AstraZeneca28