A Study To Evaluate GW685698X In Adolescent And Adult Subjects With Persistent Asthma

This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.

Official Title

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.

Conditions

Asthma

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• 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)

Study Start

November 2006

Eligibility & Criteria

• Ages Eligible for Study: 12 Years and above
• Genders Eligible for Study: Both

Inclusion criteria:

• Asthma diagnosis per NIH 2002
• Severity of Disease (a best FEV1 of 50-80% of the predicted normal)
• Reversibility of Disease (demonstrated >= 12% and 200mL reversibility of FEV1)
• Concurrent anti-asthma therapy for at least 3 months prior to Visit 1

Exclusion criteria:

• History of Life-threatening asthma and other concurrent respiratory illness
• tobacco use
• systemic, oral, parenteral, or depot corticosteroid use
• severe milk protein allergy
• positive oropharyngeal examination

Total Enrolment

648

Contact Details

Australin Locations:

• Nedlands, 6009, Australia; Recruiting
• Geelong, 3220, Australia; Recruiting
• Concord, 2139, Australia; Recruiting
• Toorak Gardens, 5065, Australia; Recruiting
• Camperdown, 2050, Australia; Recruiting
• Clayton, 3168, Australia; Recruiting
• Adelaide, 5000, Australia; Recruiting

Contact GlaxoSmithKline for more information (Please refer to this study by ClinicalTrials.gov identifier: NCT00398645)