Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)

Condition(s) targeted: Asthma

Intervention: Ciclesonide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: ALTANA Pharma

Official(s) and/or principal investigator(s):
Renate Engelstaetter, PhD, Study Chair, Affiliation: ALTANA Pharma, Konstanz, Germany E-mail: info.clintrials@altanapharma.com

The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent 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 (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Official title: A Comparative Study of Inhaled Ciclesonide 200 Mcg/Day vs Fluticasone Propionate 200 Mcg/Day in Children With Asthma

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

Primary outcome: FEV1 absolute values.

Secondary outcome:

FEV1 as % of predicted

PEF from spirometry

diary based morning and evening PEF

diary based symptom score

diary based salbutamol MDI use

diurnal PEF fluctuation

drop-out rate due to asthma exacerbations

time until asthma exacerbation

number of symptom free- and rescue medication free days

number of days with asthma control

physical examination

vital signs

laboratory work-up

adverse events.

Minimum age: 4 Years. Maximum age: 15 Years. Gender(s): Both.

Criteria:

Main Inclusion Criteria: History of persistent bronchial asthma for at least 6 months FEV1 50-90% of predicted Main Exclusion Criteria: Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study History of life-threatening asthma Premature birth Current smoking Smoking history with either equal or more than 10 pack-years Pregnancy Intention to become pregnant during the course of the study Breast feeding Lack of safe contraception

ALTANA Pharma, Cities in India, India

Starting date: April 2003
Last updated: December 15, 2006