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Sponsored by: |
ALTANA Pharma |
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Information provided by: | ALTANA Pharma |
ClinicalTrials.gov Identifier: | NCT00163371 |
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 |
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Asthma |
Drug: Ciclesonide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 28 |
Study Start Date: | September 2005 |
Ages Eligible for Study: | 6 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Study ID Numbers: | BY9010/M1-208 |
Study First Received: | September 12, 2005 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00163371 History of Changes |
Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
Asthma Ciclesonide Child Fluticasone propionate |
HPA-axis Pediatric Linear growth rate |
Anti-Inflammatory Agents Bronchial Diseases Ciclesonide Asthma Anti-Asthmatic Agents Anti-Allergic Agents Lung Diseases, Obstructive Hypersensitivity |
Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Fluticasone Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Bronchial Diseases Immune System Diseases Ciclesonide Physiological Effects of Drugs Anti-Asthmatic Agents Asthma Anti-Allergic Agents Pharmacologic Actions Lung Diseases, Obstructive |
Hypersensitivity Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Hypersensitivity, Immediate Fluticasone Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents Respiratory Hypersensitivity |