A Study To Assess The Safety And Tolerability Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

The compound GW642444 has previously been found to be well tolerated with no significant side effects in subjects with asthma and healthy volunteers. This study will assess the safety and tolerability of GW642444 in subjects with COPD in order to obtain information to support dosing in a broader population of subjects with COPD

Official Title

A Multicentre, Randomised, Placebo-Controlled, Double-Blind, 4-Arm Parallel-Group, 2-Week Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of GW642444H (100 Administered Once Daily in the Morning Via DISKUS Dry-Powder Inhaler) Compared With SEREVENT (Salmeterol) (50mcg Administered Twice Daily Via DISKUS Dry-Powder Inhaler) and Placebo in Subjects With Moderate COPD.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

Further Details

• Primary Outcomes: Incidence of Adverse Events (AEs) reported prior to, throughout and after the 2- week treatment period as recorded by subjects on daily record cards (DRCs) and investigators (during clinic assessments).
• Secondary Outcomes: Heart Rate and Blood Pressure QTc(F)and QTc(B)values from 12-lead ECGs. FEV1 (forced expiratory volume in 1 second). Peak Flow and use of rescue medication

Study Start

September 2006

Eligibility & Criteria

• Ages Eligible for Study: 40 Years – 80 Years
• Genders Eligible for Study: Both

Inclusion criteria:

• females must be of non-childbearing potential
• moderately severe COPD

Exclusion criteria:

• Subjects with a main diagnosis of asthma
• subjects with poorly controlled COPD
• subjects with significant heart, renal, endocrine, psychiatric, immunological or neurological disease.

Total Enrolment

80 (expected)

Contact Details

• GSK Clinical Trials Call Center, Nedlands, 6009, Australia GSK Clinical Trials Call Center 1-877-379-3718
• GSK Clinical Trials Call Center, Camperdown, 2050, Australia GSK Clinical Trials Call Center 1-877-379-3718
  

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