Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Disease, Chronic Obstructive
Intervention: GSK159797 (10, 15, and 20mcg) (Drug); salbutamol (Drug); salmeterol 50mcg (Drug); placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, 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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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 Investigational Site, Berlin 14057, Germany
GSK Investigational Site, Utrecht 3584 CJ, Netherlands
GSK Investigational Site, Moscow 115446, Russian Federation
GSK Investigational Site, Lund SE-221 85, Sweden
GSK Investigational Site, Manchester M23 9LT, United Kingdom
GSK Investigational Site, Wiesbaden, Hessen 65187, Germany
Additional Information
Starting date: April 2006
Last updated: November 7, 2013
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