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)

This study has been completed.

First Received on September 12, 2005. Last Updated on July 16, 2008 History of Changes

Sponsor:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00163371

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Ciclesonide	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Fluticasone Ciclesonide

U.S. FDA Resources

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	28
Study Start Date:	September 2005

Eligibility

Ages Eligible for Study:	6 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163371

Locations

Denmark
Altana Pharma/Nycomed
Kolding, Denmark, 6000

Sponsors and Collaborators

ALTANA Pharma

Investigators

Principal Investigator:

Søren Pedersen, Prof.

University of Odense, Kolding, Denmark

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00163371 History of Changes
Other Study ID Numbers:	BY9010/M1-208
Study First Received:	September 12, 2005
Last Updated:	July 16, 2008
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by ALTANA Pharma:

Asthma
Ciclesonide
Child
Fluticasone propionate

HPA-axis
Pediatric
Linear growth rate

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Ciclesonide

Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012