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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 16, 2007 | ||||
| Last Updated Date | July 23, 2009 | ||||
| Start Date ICMJE | August 2007 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-allergen Challenge on Day 35 [ Time Frame: 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Decrease in peripheral blood eosinophils. | ||||
| Change History | Complete list of historical versions of study NCT00517634 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Peripheral blood eosinophils serum IL-5 | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects | ||||
| Official Title ICMJE | See Detailed Description | ||||
| Brief Summary | The aim of the present study is to investigate whether the effects of salmeterol in combination with fluticasone propionate on blood markers of airway inflammation are maintained after chronic dosing and whether the effect is influenced by the time of allergen challenge relative to the time of dosing. |
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| Detailed Description | A 19-week, randomized, double-blind, placebo-controlled, three-period, cross-over pilot study comparing the effect of salmeterol/fluticasone propionate 50/100mcg BID, fluticasone propionate 100mcg BID and placebo on blood markers of airway inflammation in response to allergen challenge in asthma subjects |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Asthma | ||||
| Intervention ICMJE | Drug: fluticasone propionate/salmeterol | ||||
| 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 | ||||
| Enrollment ICMJE | 23 | ||||
| Completion Date | July 2008 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00517634 | ||||
| Responsible Party | Study Director, GSK | ||||
| Study ID Numbers ICMJE | HZA109912 | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | July 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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