Protocol Summary for 112376
| Protocol Id: | 112376 |
| Secondary Ids: |
|
| Title: | Study of salmeterol (SN408D) for adult asthma – Clinical study of salmeterol compared with Hokunalin (tulobuterol) tape – |
| Phase: | Phase 4 |
| Acronym: | |
| FDA Regulated Intervention?: | No |
| Section 801 Clinical Trial?: | |
| Delayed Posting: | |
| IND/IDE Protocol?: | no |
| Study Type: | interventional |
| Oversight Authority: |
|
| Collaborators: |
|
| Brief Summary: | To demonstrate the efficacy (non-inferiority) of Salmeterol 50mcg bid (100mcg/day), compared with Hokunalin (tulobuterol) tape 2mg once a day, in terms of improvement in pulmonary function (peak expiratory flow: PEF) in a randomized, double-blind, parallel-group comparative study in adult patients with bronchial asthma on ICS 400mcg/day of FP equivalent. |
| Detailed Description: | Primary To demonstrate the efficacy (non-inferiority) of Salmeterol 50mcg bid (100mcg/day), compared with Hokunalin (tulobuterol) tape 2mg once a day, in terms of improvement in pulmonary function (peak expiratory flow: PEF) in a randomized, double-blind, parallel-group comparative study in adult patients with bronchial asthma on ICS 400mcg/day of FP equivalent. Secondary •To evaluate the efficacy of Salmeterol , compared with Hokunalin (tulobuterol) tape in terms of asthma symptoms recorded in the asthma diary. •To evaluate the safety of Serevent compared with Hokunalin (tulobuterol) tape. |
| Record Verification Date: | September 2009 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | September 2003 |
| Study Completion Date: | February 2005 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | February 2005 |
| 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): | Parallel Assignment |
| Study Classification (Endpoint): | Safety/Efficacy Study |
| Primary Outcomes: |
|
| Secondary Outcomes: |
|
| Conditions: |
|
| Keywords: |
|
| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 15 years |
| Maximum Age: | N/A |
| Enrollment: | 367 |
| Enrollment Type: | Actual |
| Healthy Volunteers?: | No |
| 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: | No locations currently recruiting for this study. |

Click to view inclusion/exclusion criteria