Status:
COMPLETED
A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children (6-11 Years) With Asthma
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Nycomed GmbH
Conditions:
Asthma
Eligibility:
All Genders
6-11 years
Phase:
PHASE3
Brief 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 res...
Detailed Description
The drug being tested is called ciclesonide. This study looked at the safety and efficacy of inhaled ciclesonide in children with asthma. The study enrolled 1080 patients. Participants were randomly ...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
1080 Patients enrolled
Trial Details
Trial ID
NCT00384189
Start Date
September 1 2006
End Date
August 1 2008
Last Update
February 1 2017
Active Locations (122)
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1
Altana Pharma/Nycomed
Plovdiv, Bulgaria, 4000
2
Altana Pharma/Nycomed
Plovdiv, Bulgaria, 4002
3
Altana Pharma/Nycomed
Rousse, Bulgaria, 7004
4
Altana Pharma/Nycomed
Sofia, Bulgaria, 1431