Protocol Summary for 112202
| Protocol Id: | 112202 |
| Secondary Ids: |
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| Title: | A Multi-Centre, Randomized, Double Blind Cross-over study to assess the non-inferiority of GW685698X 200mcg Once Daily and 100mcg Twice Daily in Adult and Adolescent Patients with Asthma |
| Phase: | phase 2 |
| Acronym: | |
| FDA Regulated Intervention?: | Yes |
| Section 801 Clinical Trial?: | Yes |
| Delayed Posting: | No |
| IND/IDE Protocol?: | yes |
| IND/IDE Grantor: | CDER |
| IND/IDE Number: | 70,297 |
| IND/IDE Serial Number: | 0061 |
| Has Expanded Access?: | no |
| Study Type: | Interventional |
| Oversight Authority: |
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| Brief Summary: | The purpose of this study is to compare once and twice daily GW685698 in asthma |
| Detailed Description: | |
| Record Verification Date: | |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | October 2008 |
| Study Completion Date: | March 2009 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | March 2009 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | treatment |
| Allocation: | Randomized |
| Masking: | Double Blind |
| Masked Subject: | yes |
| Masked Caregiver: | no |
| Masked Investigator: | yes |
| Masked Assessor: | no |
| Study Design (Assignment): | Crossover Assignment |
| Study Classification (Endpoint): | Safety/Efficacy Study |
| Primary Outcomes: |
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| Conditions: |
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| Keywords: |
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| Eligibility Criteria: | 
Click to view inclusion/exclusion criteria
Key Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 12 Year |
| Maximum Age: | |
| Enrollment: | 190 |
| Enrollment Type: | Actual |
| Healthy Volunteers?: | none |
| Central Contact: | US GSK Clinical Trials Call Center |
| Central Contact Phone: | 877-379-3718 |
| Central Contact Email: | GSKClinicalSupportHD@gsk.com |
| Backup Central Contact: | EU GSK Clinical Trials Call Center |
| Backup Central Contact Phone: | +44 (0) 20 8990 4466 |
| Backup Central Contact Email: | GSKClinicalSupportHD@gsk.com |
| Overall Study Official: | GSK Clinical Trials |
| Overall Study Official Affiliation: | GlaxoSmithKline |
| Overall Study Official Role: | Study Director |
| Responsible Party Name/Official Title: | Cheri Hudson; Clinical Disclosure Advisor |
| Responsible Party Organization: | GSK Clinical Disclosure |
| Location and Contact Information: |
Click to view location
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