Effects of Ciclesonide MDI 50mg/Day and 200mg/Day (Ex-Valve) Once-Daily on Growth in Children With Mild Persistent Asthma

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00270348
First received: December 22, 2005
Last updated: December 27, 2005
Last verified: December 2005

December 22, 2005
December 27, 2005
December 2000
Not Provided
Subject’s height measured w. standard stadiometry techniques. 4 acceptable serial measurements taken at each visit on same equipment by a qualified technician.Median of 4 measurements used the subject’s stadiometer height data
Same as current
Complete list of historical versions of study NCT00270348 on ClinicalTrials.gov Archive Site
Blinded assessment of bone age according to Greulich and Pyle radiographic atlas with wrist X-rays. Subjects monitored for AEs and any events occurring during study. Pulmonary function tests performed to measure FEV1 in liters and % of predicted FEV1
Same as current
Not Provided
Not Provided
 
Effects of Ciclesonide MDI 50mg/Day and 200mg/Day (Ex-Valve) Once-Daily on Growth in Children With Mild Persistent Asthma
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Asthma
Drug: ciclesonide
Not Provided
Skoner DP, Maspero J, Banerji D; Ciclesonide Pediatric Growth Study Group. Assessment of the long-term safety of inhaled ciclesonide on growth in children with asthma. Pediatrics. 2008 Jan;121(1):e1-14. Epub 2007 Dec 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
September 2004
Not Provided

Inclusion Criteria:

  • Females between 5 and 7.5 years and male between 5 and 8.5 years of age with normal heights, a history of mild persistent asthma for at least 3 months prior to visit 1, a forced expiratory volume in one second (FEV1) of ³80% of predicted following at least a 4-hour albuterol withhold, and treated with non-corticosteroid asthma medications on an as-needed or daily basis, or with low doses of inhaled corticosteroids (ICSs) for at least one month prior to Visit 1. Subjects were to be no greater than Stage 1 in the Tanner classification of sexual maturity, and they had to be able to demonstrate effective use of the MDI devices and perform reproducible pulmonary function test.

Exclusion Criteria:

  • Subjects with a history of life-threatening asthma, severe respiratory impairment, history of abnormal growth, concurrent disease or condition which may substantially affect growth, previous requirement for daily or alternate day oral corticosteroids (OCS) treatment for ³60 days within the 2 years of Visit 3 and/or any use of OCS within 30 days prior to Visit 1 or during the run-in period, previous treatment with moderate or high doses of inhaled corticosteroid during the 30 days prior to Visit 1
Both
5 Years to 102 Months
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00270348
LTS6159, XRP1526B - 343
Not Provided
Not Provided
Sanofi
Takeda
Not Provided
Sanofi
December 2005

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