Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)
Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)
The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of
 the number of asthma exacerbations in children with mild persistent asthma. Treatment
 medication will be administered as follows: ciclesonide will be inhaled once daily, using one
 of the two dose levels versus placebo together with other corticosteroids used as
 intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a
 treatment period (12 months). The study will provide further data on safety and tolerability
 of ciclesonide.
The drug being tested in this study is called ciclesonide. Ciclesonide is being tested to
 treat children who have mild asthma.

 The study enrolled 240 patients. Participants were randomly assigned (by chance, like
 flipping a coin) to one of the three treatment groups-which remained undisclosed to the
 patient and study doctor during the study (unless there was an urgent medical need):

 -  Ciclesonide 100 µg

 -  Ciclesonide 200 µg

 -  Placebo (dummy inactive inhalation) - this is a metered-dose inhaler that looks like the
 study drug but has no active ingredient.

 All participants were asked to take two puffs from a metered-dose inhaler once daily, in the
 evening, for up to 12 months.

 This multi-center trial was conducted in Canada, Hungary and South Africa. The overall time
 to participate in this study was 12 months preceded by a baseline washout period of 3 to 4
 weeks. Participants made multiple visits to the clinic including a safety follow-up visit
 within 30 days of the last treatment.
Main Inclusion Criteria:

 -  Outpatients

 -  Symptoms consistent with the diagnosis of asthma for at least 12 months

 -  Forced Expiratory Volume in one Second (FEV) at least 80% of predicted

 -  Participants who have a history of reversible airway obstruction

 -  Good health with the exception of asthma

 Main Exclusion Criteria:

 -  History of life-threatening asthma

 -  A hospitalization for asthma within the last 3 months, or more than two
 hospitalizations for asthma within the last year

 -  Concomitant severe diseases or diseases which are contraindications for the use of
 inhaled steroids

 -  Participants suffering from relevant lung diseases causing alternating impairment in
 lung function (e.g. chronic bronchitis or emphysema)

 -  Prematurely born children (<36 weeks of gestation)

 -  Smokers

 -  Pregnancy (or intention to become pregnant during the course of the trial), breast
 feeding or lack of safe contraception by female of child-bearing potential