Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: Ciclesonide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00163423

BY9010/M1-142

Details and patient eligibility

About

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.

Sex

All

Ages

12 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Main 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