Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study is designed to determine the efficacy and safety of a new long-acting beta-agonist for asthma patients (GSK159797) following dosing for 14 days.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Albuterol; Salmeterol Xinafoate

Criteria

Inclusion criteria:

• Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid

• Female subjects only using acceptable birth control method

• Non-smokers

• FEV1 between 60 and 90% predicted

• Increase in FEV1 12% or greater and 300mL and greater after salbutamol use

Exclusion criteria:

• Past or present disease conditions

• Normal screening Holter ECG

• Respiratory tract infection within 4 weeks of screening

• History of life threatening asthma

• Previous use of COA