Effects of Inhaled Ciclesonide Versus Fluticasone Propionate Versus Placebo on Lower Leg Growth in Prepubertal Children With Mild Persistent Asthma (6 to 12 y) (BY9010/M1-208) - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

July 16, 2008

Start Date ^ICMJE

September 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

growth velocity of the right lower leg as measured by knemometry.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00163371 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

HPA-axis function
weight and height
lung function from spirometry
asthma symptom score, use of rescue medication from diary
adverse events
vital signs, including blood pressure, pulse rate
physical examination
laboratory investigation.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Effects of Inhaled Ciclesonide Versus Fluticasone Propionate Versus Placebo on Lower Leg Growth in Prepubertal Children With Mild Persistent Asthma (6 to 12 y) (BY9010/M1-208)

Official Title ^ICMJE

Effect of Ciclesonide (320 Mcg/Day) vs Fluticasone Propionate (375 Mcg/Day) vs. Placebo on Short-Term Linear Growth Rate and HPA-Axis Function in Prepubertal Children With Mild Asthma

Brief Summary

The aim of the study is to compare the effects of ciclesonide inhaled at one dose level twice daily versus fluticasone propionate inhaled at one dose level twice daily versus placebo, on short-term lower leg growth in prepubertal children with mild persistent asthma. The study duration consists of a baseline period (2 weeks), a treatment period (2 weeks for each treatment), and a wash-out period (2 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, Crossover 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

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Main Inclusion Criteria:

Written informed consent by the patient's parent(s) or legal guardian(s) and by the patient, if capable
Prepubertal stage
Good health with the exception of asthma
History of asthma for at least 6 months
Currently using rescue medication only

Main Exclusion Criteria:

Childbearing potential (beyond menarche)
Concurrent diseases or conditions which may subsequently affect growth
COPD or relevant lung diseases causing alternating impairment in lung function
Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
History of life-threatening asthma
Current smoking

Gender

Both

Ages

6 Years to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00163371

Responsible Party

Study ID Numbers ^ICMJE

BY9010/M1-208

Study Sponsor ^ICMJE

ALTANA Pharma

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Søren Pedersen, Prof.

University of Odense, Kolding, Denmark

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