Study HZA106827: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics

Condition(s) targeted: Asthma

Intervention: Fluticasone furoate/Vilanterol Inhalation Powder (Drug); Fluticasone Furoate Inhalation Powder (Drug); Placebo Inhaltion Powder (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718

The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder and fluticasone furoate inhalation powder both administered once daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 12 week treatment period.

Official title: HZA106827: A Randomised, Double-blind, Placebo-controlled (With Rescue Medication), Parallel Group Multicentre Study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder Alone in the Treatment of Persistent Asthma in Adults and Adolescents

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Change in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 in all subjects

Weighted mean serial FEV1 over 0-24 hours post-dose calculated in a subset of subjects performing serial FEV1

Secondary outcome:

Change in the percentage of rescue-free 24-hour periods

Change in the percentage of symptom-free 24-hour periods

Change in total AQLQ (+12) score

Number of withdrawals due to lack of efficacy

Clinic Visit, 12-hour FEV1 in the subset of subjects performing serial FEV1 assesments

Weighted mean serial FEV1over 0-24 hours post dose in the subset of subjects performing serial FEV1 assessment

Weighted mean serial FEV1over 0-4 hours post dose in the subset of subjects performing serial FEV1 assessment

Time to onset of bronchodilator effect (the timepoint when FEV1 first exceeded 12.0% and 200mL increase over baseline) in the subset of subjects performing serial FEV1 assessments

Mean change in daily AM PEF

Mean change in daily PM PEF

Change in Asthma control Test (ACT)

Global assessment of change (assess asthma symptom change (improve, same, worse) and rescue use (more, same, less)

Unscheduled Healthcasre Resource Utilisation for Asthma

Inhaler use assessment

Ease of use assessment on the inhaler

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Outpatients at least 12 years of age

- Male and female; female subjects of childbearing potential must be willing to use

birth control

- Pre-bronchodilator FEV1 of 40-90% predicted normal

- Reversibility FEV1 of at least 12% and 200mL

- Current asthma therapy includes inhaled corticosteroid use for at least 12 weeks

prior to first visit

Exclusion Criteria:

- History of life-threatening asthma during last 10 years

- Respiratory infection or oral candidiasis

- Asthma exacerbation requiring oral corticosteroids or that required overnight

hospitalisation requiring additional asthma treatment

- Uncontrolled disease or clinical abnormality

- Allergies to study drugs or the excipients

- Taking another investigational medication or prohibited medication

- Night shift workers

- Current smokers or subjects with a smoking history of at least 10 pack years

US GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Investigational Site, Fukuoka 811-1394, Japan; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
EU GSK Clinical Trials Call Center, Phone: 0800 007 5189, Email: info@clinicaltrialsforgsk.com

GSK Investigational Site, Hiroshima 732-0052, Japan; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
EU GSK Clinical Trials Call Center, Phone: 0800 007 5189, Email: info@clinicaltrialsforgsk.com

GSK Investigational Site, Hyogo 672-8048, Japan; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
EU GSK Clinical Trials Call Center, Phone: 0800 007 5189, Email: info@clinicaltrialsforgsk.com

GSK Investigational Site, Kagawa 762-0031, Japan; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
EU GSK Clinical Trials Call Center, Phone: 0800 007 5189, Email: info@clinicaltrialsforgsk.com

GSK Investigational Site, Okinawa 901-2132, Japan; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
EU GSK Clinical Trials Call Center, Phone: 0800 007 5189, Email: info@clinicaltrialsforgsk.com

GSK Investigational Site, Tokyo 194-0023, Japan; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
EU GSK Clinical Trials Call Center, Phone: 0800 007 5189, Email: info@clinicaltrialsforgsk.com

GSK Investigational Site, Bell Gardens, California 90201, United States; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
EU GSK Clinical Trials Call Center, Phone: 0800 007 5189, Email: info@clinicaltrialsforgsk.com

GSK Investigational Site, Huntington Beach, California 92647, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
EU GSK Clinical Trials Call Center, Phone: 0800 007 5189, Email: info@clinicaltrialsforgsk.com

GSK Investigational Site, Long Beach, California 90808, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
EU GSK Clinical Trials Call Center, Phone: 0800 007 5189, Email: info@clinicaltrialsforgsk.com

GSK Investigational Site, Los Angeles, California 90048, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
EU GSK Clinical Trials Call Center, Phone: 0800 007 5189, Email: info@clinicaltrialsforgsk.com

GSK Investigational Site, Riverside, California 92506, United States; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
EU GSK Clinical Trials Call Center, Phone: 0800 007 5189, Email: info@clinicaltrialsforgsk.com

GSK Investigational Site, Roseville, California 95661, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
EU GSK Clinical Trials Call Center, Phone: 0800 007 5189, Email: info@clinicaltrialsforgsk.com

GSK Investigational Site, San Diego, California 92120, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
EU GSK Clinical Trials Call Center, Phone: 0800 007 5189, Email: info@clinicaltrialsforgsk.com

GSK Investigational Site, Miami, Florida 33173, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
EU GSK Clinical Trials Call Center, Phone: 0800 007 5189, Email: info@clinicaltrialsforgsk.com

GSK Investigational Site, Rolla, Missouri 65401, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
EU GSK Clinical Trials Call Center, Phone: 0800 007 5189, Email: info@clinicaltrialsforgsk.com

GSK Investigational Site, Oklahoma City, Oklahoma 73103, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
EU GSK Clinical Trials Call Center, Phone: 0800 007 5189, Email: info@clinicaltrialsforgsk.com

GSK Investigational Site, Lake Oswego, Oregon 97035, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
EU GSK Clinical Trials Call Center, Phone: 0800 007 5189, Email: info@clinicaltrialsforgsk.com

GSK Investigational Site, Medford, Oregon 97504, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
EU GSK Clinical Trials Call Center, Phone: 0800 007 5189, Email: info@clinicaltrialsforgsk.com

GSK Investigational Site, Portland, Oregon 97213, United States; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
EU GSK Clinical Trials Call Center, Phone: 0800 007 5189, Email: info@clinicaltrialsforgsk.com

GSK Investigational Site, Orangeburg, South Carolina 29118, United States; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
EU GSK Clinical Trials Call Center, Phone: 0800 007 5189, Email: info@clinicaltrialsforgsk.com

Starting date: August 2010
Last updated: October 1, 2010