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