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| Tracking Information | |||||||||
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| First Received Date ICMJE | March 18, 2008 | ||||||||
| Last Updated Date | March 24, 2009 | ||||||||
| Start Date ICMJE | November 2002 | ||||||||
| Primary Completion Date | September 2004 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change from Baseline in % predicted Forced Expiratory Volume in 1 second [ Time Frame: Week 2, 4 and 8, then at week 12 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00642161 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | New Version Pulmicort Turbuhaler USA Children | ||||||||
| Official Title ICMJE | A Placebo-Controlled Comparison of the Efficacy, Safety and Pharmacokinetics of the Current US Version of Pulmicort (Budesonide) Turbuhaler and the New Version of Pulmicort Turbuhaler in Asthmatic Children and Adolescents. | ||||||||
| Brief Summary | A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in children and adolescents who have asthma. In addition the study evaluated the functionality of the new inhaler at the end of its intended life. |
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| Detailed Description | |||||||||
| Study Phase | Phase III | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Asthma | ||||||||
| Intervention ICMJE | Drug: budesonide | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 430 | ||||||||
| Completion Date | September 2004 | ||||||||
| Primary Completion Date | September 2004 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 6 Years to 17 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | |||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00642161 | ||||||||
| Responsible Party | Lars-Göran Carlsson | ||||||||
| Study ID Numbers ICMJE | SD-004-0726, D5254C00726 | ||||||||
| Study Sponsor ICMJE | AstraZeneca | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||||||
| Verification Date | March 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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