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

Condition(s) targeted: Asthma

Intervention: Ciclesonide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: ALTANA Pharma

Official(s) and/or principal investigator(s):
Ronald Dahl, Prof., Principal Investigator, Affiliation: Aarhus University Hospital, Aarhus, Denmark

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.

Official title: Comparison of Ciclesonide (80 Mcg Once Daily in the Evening) and Fluticasone Propionate (100 Mcg Twice Daily) in Patients With Mild to Moderate Asthma

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

FEV1

time to the first asthma exacerbation.

Secondary outcome:

FVC

asthma symptom score

use of rescue medication

AQLQ(S) and EQ-5D

percentage of days on which patients perceived asthma control

percentage of nocturnal awakening-free days

percentage of rescue medication-free days

percentage of asthma symptom-free days

physical examination

vital signs

standard laboratory work-up

adverse events

number of patients with local oropharyngeal adverse events.

Minimum age: 12 Years. Maximum age: 75 Years. Gender(s): Both.

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

ALTANA Pharma, Cities in Austria, Austria

ALTANA Pharma, Cities in Canada, Canada

ALTANA Pharma, Cities in Germany, Germany

ALTANA Pharma, Cities in Poland, Poland

ALTANA Pharma, Cities in South Africa, South Africa

Starting date: November 2004
Last updated: December 15, 2006