A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children (6-11 Years) With Asthma

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the efficacy of inhaled ciclesonide at three different dose levels compared with placebo with respect to pulmonary function, asthma symptoms, and use of rescue medication in children aged 6-11 years with asthma. Treatment medication will be administered as follows: ciclesonide or placebo will be inhaled once daily in the evening. The study consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study provides further data on safety and tolerability of ciclesonide.

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

Details

• Lead Sponsor: AstraZeneca; Takeda
• Collaborator: Nycomed GmbH
• Treatments: Albuterol; Ciclesonide

Criteria

Main Inclusion Criteria:

• History of asthma for at least 6 months

• Ability to show optimal use of MDI, including inhalation technique

• Lung function and reversibility within specified limits

Main Exclusion Criteria:

• Concomitant severe diseases

• Diseases which are contraindications for the use of inhaled steroids

• Two or more inpatient hospitalizations for asthma within the last year

• Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study

• Use of systemic steroids within the last 30 days prior to inclusion (depot steroids 6 weeks)

• Beginning of or change in immunotherapy within the last 6 months prior to inclusion

• Inability to follow the procedures of the study