A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Persistent Asthma.

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: GW685698X 200mcg,GW685698X 200mcg and 400mcg

• Registration Number: NCT00398645
• Lead Sponsor: GlaxoSmithKline

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.

Study Timeline

• Study First Submitted: 2006-11-09
• Study First Submitted QC: 2006-11-10
• Study First Posted: 2006-11-14
• Study Start: 2006-11-15
• Primary Completion: 2007-08-01
• Study Completion: 2007-08-30
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-18
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 648

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	GW685698X 200mcg,GW685698X 200mcg and 400mcg	-

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇦 Vinnitsa, Ukraine