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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

July 16, 2008

Start Date ^ICMJE

April 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

FEV1 absolute values.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00163410 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Ciclesonide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

500

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

4 Years to 15 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

India

Administrative Information

NCT ID ^ICMJE

NCT00163410

Responsible Party

Study ID Numbers ^ICMJE

BY9010/M1-205

Study Sponsor ^ICMJE

ALTANA Pharma

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Renate Engelstaetter, PhD

ALTANA Pharma, Konstanz, Germany E-mail: info.clintrials@altanapharma.com

Information Provided By

ALTANA Pharma

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP