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Sponsors and Collaborators: |
Sanofi-Aventis ALTANA Pharma |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00270348 |
The primary objective is to determine if CIC 50 mg/day or 200 mg/day (ex-valve) administered once daily in the morning is non-inferior to placebo with respect to growth velocity in children with mild persistent asthma following a 12-month treatment period
The secondary objective is to investigate changes in growth in terms of bone age (wrist X-ray), and maintenance of asthma control and safety with ciclesonide
Condition | Intervention | Phase |
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Asthma |
Drug: ciclesonide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Phase III, Multicenter, Double-Blind, Placebo Controlled, Non-Inferiority Study Assessing the Effects of Ciclesonide Metered Dose Inhaler 50 Mg/Day and 200 Mg/Day (Ex-Valve) Administered Once Daily on Growth in Children With Mild Persistent Asthma |
Estimated Enrollment: | 450 |
Study Start Date: | December 2000 |
Estimated Study Completion Date: | September 2004 |
Ages Eligible for Study: | 5 Years to 102 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | LTS6159, XRP1526B - 343 |
Study First Received: | December 22, 2005 |
Last Updated: | December 27, 2005 |
ClinicalTrials.gov Identifier: | NCT00270348 |
Health Authority: | United States: Food and Drug Administration |
Asthma Safety Pediatrics |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Ciclesonide |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Immune System Diseases Bronchial Diseases Therapeutic Uses Anti-Allergic Agents Pharmacologic Actions |