A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of GW685698X 200 mcg Twice Daily, GW685698X 200 mcg and 400 mcg Once Daily in the Morning, and GW685698X 200 mcg and 400 mcg Once Daily in the Evening Compared With Placebo for 8 Weeks in Adolescent and Adult Subjects (12 Years of Age and Older) With Persistent Asthma
Overview
- Phase
- Phase 2
- Intervention
- GW685698X 200mcg,GW685698X 200mcg and 400mcg
- Conditions
- Asthma
- Sponsor
- GlaxoSmithKline
- Enrollment
- 648
- Locations
- 1
- Primary Endpoint
- The primary efficacy measure will be mean change from baseline at Week 8 (last assessment on treatment using last observation carried forward) in tough (AM or PM pre-dose and pre-rescue bronchodilator) forced expiratory volume in one second (FEV1)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.
Detailed Description
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of GW685698X 200mcg Twice Daily, GW685698X 200mcg and 400mcg Once Daily in the Morning, and GW685698X 200mcg and 400mcg Once Daily in the Evening Compared with Placebo for 8 Weeks in Adolescent and Adult Subjects (12 Years of Age and Older) with Persistent Asthma.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm 1
Intervention: GW685698X 200mcg,GW685698X 200mcg and 400mcg
Outcomes
Primary Outcomes
The primary efficacy measure will be mean change from baseline at Week 8 (last assessment on treatment using last observation carried forward) in tough (AM or PM pre-dose and pre-rescue bronchodilator) forced expiratory volume in one second (FEV1)