Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca; Takeda
• Treatments: Ciclesonide

Criteria

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