Status:
COMPLETED
Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00358488
Start Date
April 1 2006
End Date
January 1 2007
Last Update
October 28 2016
Active Locations (6)
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1
GSK Investigational Site
Wiesbaden, Hesse, Germany, 65187
2
GSK Investigational Site
Berlin, State of Berlin, Germany, 14057
3
GSK Investigational Site
Utrecht, Netherlands, 3584 CJ
4
GSK Investigational Site
Moscow, Russia, 115446