Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: GSK159797 (10, 15, and 20mcg) (Drug); salbutamol (Drug); salmeterol 50mcg (Drug); placebo (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: A Multi-Enter, Randomized, Double-Blind, Placebo-Controlled, Four-Way Incomplete Block Crossover Study to Examine Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Administration of Three Inhaled Doses (10, 15, and 20 Mcg) of GSK159797
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Mean change from baseline in trough FEV1
Secondary outcome: Mean change from baseline in trough FEV1Mean change from baseline in trough FEV1 Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Female.
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
Locations and Contacts
GSK Clinical Trials Call Center, Berlin 14057, Germany
IGSK Clinical Trials Call Center, Wiesbaden 65187, Germany
GSK Clinical Trials Call Center, Tauranga 3001, New Zealand
GSK Clinical Trials Call Center, Moscow 115446, Russian Federation
GSK Clinical Trials Call Center, Lund 22185, Sweden
GSK Clinical Trials Call Center, Manchester M23 9LT, United Kingdom
Additional Information
Starting date: March 2006
Ending date: January 2007
Last updated: November 7, 2007
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