Study HZA106829: 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); Fluticasone Propionate Inhalation 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 administered once daily each evening with fluticasone furoate inhalation powder administered alone once daily each evening in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.

Official title: HZA106829: A Randomised, Double-blind, Parallel Group, Multicentre Study of Fluticasone Furoate/GW642444 Inhalation Powder, Fluticasone Furoate Inhalation Powder Alone, and Fluticasone Propionate 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:

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

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

Secondary outcome:

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

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

Change in total AQLQ (+12) score

Clinic visit, 12-hour FEV1 will be assessed in a subset of subjects that are performing serial FEV1 assessments

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

Mean change from baseline in daily AM PEF averaged

Mean change from baseline in daily PM PEF averaged

Number of withdrawals due to lack of efficacy

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

Unscheduled Health Care Resource Utilization for Asthma: Number of healthcare contacts related to asthma or the treatment of asthma

Asthma Control Test (ACT): Assesses how well patient's asthma is controlled (kept from home/work activities, shortness of breath, asthma symptoms, use of rescue medicine, rate control)

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

Criteria:

Inclusion Criteria:

- Outpatient at least 12 years of age

- Both genders; females of childbearing potential must be willing to use birth control

method

- Pre-bronchodilator FEV1 of 40-90% predicted

- Reversibility FEV1 of at least 12% and 200mls

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

prior to first visit

Exclusion Criteria:

- History of life-threatening asthma

- Respiratory infection or oral candidiasis

- Asthma exacerbation within 12 weeks

- Concurrent respiratory disease or other disease that would confound study

participation or affect subject safety

- Allergies to study drugs, study drugs' excipients, medications related to study drugs

- Taking another investigational medication or medication prohibited for use during

this study

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

GSK Investigational Site, Hyogo 672-8048, Japan; Recruiting
Akira Tanaka, Principal Investigator

GSK Investigational Site, Kagawa 762-0031, Japan; Not yet recruiting
Hiroyuki Nakamura, Principal Investigator

GSK Investigational Site, Shizuoka 438-8550, Japan; Not yet recruiting
Kazumasa Yasuda, Principal Investigator

GSK Investigational Site, Bell Gardens, California 90201, United States; Not yet recruiting
Galal N Salem, Principal Investigator

GSK Investigational Site, Huntington Beach, California 92647, United States; Recruiting
Paul Y Qaqundah, Principal Investigator

GSK Investigational Site, Long Beach, California 90808, United States; Recruiting
Steven M Meltzer, Principal Investigator

GSK Investigational Site, Roseville, California 95661, United States; Not yet recruiting
Mark A King, Principal Investigator

GSK Investigational Site, San Diego, California 92128, United States; Not yet recruiting
Louis Maletz, Principal Investigator

GSK Investigational Site, Oklahoma City, Oklahoma 73103, United States; Recruiting
Jeremy Cole, Principal Investigator

GSK Investigational Site, Lake Oswego, Oregon 97035, United States; Not yet recruiting
James W Baker, Principal Investigator

GSK Investigational Site, Medford, Oregon 97504, United States; Recruiting
Edward M Kerwin, Principal Investigator

GSK Investigational Site, Orangeburg, South Carolina 29118, United States; Recruiting
Richard E Sterling, Principal Investigator

Starting date: June 2010
Last updated: July 15, 2010