A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children (6-11 years) with Asthma - RAINBOW
Study identifier:BY9010/M1-209
ClinicalTrials.gov identifier:NCT00384189
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children with Asthma
Medical condition
asthma
Phase
Phase 3
Healthy volunteers
No
Study drug
Ciclesonide, Placebo, Salbutamol
Sex
All
Actual Enrollment
1080
Study type
Interventional
Age
6 Years - 11 Years
Date
Study Start Date: 01 Sept 2006
Primary Completion Date: 01 Aug 2007
Study Completion Date: 01 Aug 2008
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Nycomed GmbH
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Ciclesonide 40 µg Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. | Drug: Ciclesonide inhaled Ciclesonide Drug: Placebo Ciclesonide placebo-matching inhaler Drug: Salbutamol Salbutamol inhalation powder |
| Active Comparator: Ciclesonide 80 µg Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. | Drug: Ciclesonide inhaled Ciclesonide Drug: Placebo Ciclesonide placebo-matching inhaler Drug: Salbutamol Salbutamol inhalation powder |
| Active Comparator: Ciclesonide 160 µg Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. | Drug: Ciclesonide inhaled Ciclesonide Drug: Placebo Ciclesonide placebo-matching inhaler Drug: Salbutamol Salbutamol inhalation powder |
| Placebo Comparator: Placebo Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. | Drug: Placebo Ciclesonide placebo-matching inhaler Drug: Salbutamol Salbutamol inhalation powder |
Contacts
Investigators
Principal Investigator
AstraZeneca AstraZeneca
AstraZeneca
