GSK: Protocol Summary for B2E106359

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Protocol Summary for B2E106359

Protocol Summary
Protocol Id:	B2E106359
Secondary Ids:
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
Phase:	Phase 2
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?:	no
Study Type:	interventional
Oversight Authority:	Germany: Federal Institute for Drugs and Medical Devices Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency
Collaborators:
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.
Detailed Description:
Record Verification Date:	September 2009
Status:	Completed
Why Study Stopped:
Study Start Date:	April 2006
Study Completion Date:	January 2007
Study Completion Date Type:	Actual
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose:	Treatment
Allocation:	Randomized
Masking:	Double Blind
Masked Subject:	false
Masked Caregiver:	false
Masked Investigator:	false
Masked Assessor:	false
Study Design (Assignment):	Crossover Assignment
Study Classification (Endpoint):	Safety/Efficacy Study
Primary Outcomes:	Mean change from baseline in trough FEV1 after 14 day repeat doses
Secondary Outcomes:	Mean change from baseline in trough FEV1 after a single dose Mean change from baseline in trough FEV1 after 7 days repeat dosing Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours Day 1 and Day 14
Conditions:	Pulmonary Disease, Chronic Obstructive
Keywords:	GSK159797 Asthmatic patients Efficacy Safety
Eligibility Criteria:	Click to view inclusion/exclusion 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
Gender:	Female
Minimum Age:	18 Years
Maximum Age:	70 Years
Enrollment:	54
Enrollment Type:	Actual
Healthy Volunteers?:	no
Central Contact:	US GSK Clinical Trials Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:	EU GSK Clinical Trials Call Center
Backup Central Contact Phone:	+44 (0) 20 8990 4466
Backup Central Contact Email:	GSKClinicalSupportHD@gsk.com
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	Click to view location information Germany (click to view all sites in Germany) GSK Investigational Site Berlin, Berlin, 14057; Completed; GSK Investigational Site Wiesbaden, Hessen, 65187; Completed; Netherlands (click to view all sites in Netherlands) GSK Investigational Site UTRECHT, , 3584 CJ; Completed; Russian Federation (click to view all sites in Russian Federation) GSK Investigational Site Moscow, , 115446; Completed; Sweden (click to view all sites in Sweden) GSK Investigational Site LUND, , SE-221 85; Completed; United Kingdom (click to view all sites in United Kingdom) GSK Investigational Site Manchester, , M23 9LT; Completed;

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Protocol Summary for B2E106359