Status:
COMPLETED
Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
4-11 years
Phase:
PHASE3
Brief 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 ad...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00163293
Start Date
January 1 2005
End Date
April 1 2010
Last Update
April 26 2017
Active Locations (7)
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1
Altana Pharma/Nycomed
Calgary, Canada, T2T5C7
2
Altana Pharma/Nycomed
Fleurimont, Canada, J1H 5M4
3
Altana Pharma/Nycomed
London, Canada, N6C 4Y7
4
Altana Pharma/Nycomed
London,ON, Canada, N6A1V2