Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)

Condition(s) targeted: Asthma

Intervention: Ciclesonide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: ALTANA Pharma

Official(s) and/or principal investigator(s):
Søren Pedersen, Prof., Principal Investigator, Affiliation: Odense University Hospital, Kolding, Denmark

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 once daily, using one of the two dose levels; 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: Comparison of Ciclesonide (80 Mcg or 160 Mcg Once Daily in the Evening) and Fluticasone Propionate (100 Mcg Twice Daily in the Morning and Evening) in Pediatric Asthma Patients

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

Primary outcome:

FEV1 absolute values

PD20FEV1 from methacholine challenge.

Secondary outcome:

FEV1 as % of predicted

PEF from spirometry

morning and evening PEF from diary

asthma symptom score from diary

salbutamol MDI use from diary

diurnal PEF fluctuation from diary

dropout rate due to asthma exacerbations and time to the first asthma exacerbation

percentage of asthma symptom-free days, rescue medication-free days, nocturnal awakening free days and days on which patients perceived asthma control

onset of effect assessed by morning PEF, asthma total symptom score and use of rescue medication

interview administered PAQLQ(S), self-administered PACQLQ

physical examination and vital signs

laboratory investigation

AEs

HPA-axis function assessed by free cortisol concentration in 24 hour-urine samples.

Minimum age: 6 Years. Maximum age: 11 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

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