Study HZA106829: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics - Full Text View

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Fluticasone Furoate/Vilanterol Inhalation Powder Drug: Fluticasone Furoate Inhalation Powder Drug: Fluticasone Propionate Inhalation Powder Other: Placebo Inhalation Powder 1 Other: Placebo Inhalation Powder 2	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Fluticasone Fluticasone furoate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 in all subjects [ Time Frame: At the end of the 24-week treatment period ] [ Designated as safety issue: No ]
Weighted mean serial FEV1 over 0-24 hours post-dose calculated in a subset of subjects performing serial FEV1 [ Time Frame: At the end of the 24-week treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

POWERED: Change in the percentage of rescue-free 24-hour periods [ Time Frame: At the end of the 24-week treatment period ] [ Designated as safety issue: No ]
Change from baseline in the percentage of symptom-free 24-hour periods [ Time Frame: At the end of the 24-week treatment period ] [ Designated as safety issue: No ]
Change in total AQLQ (+12) score [ Time Frame: At the end of 12 weeks and the full 24-week treatment period ] [ Designated as safety issue: No ]
Clinic visit, 12-hour FEV1 will be assessed in a subset of subjects that are performing serial FEV1 assessments [ Time Frame: At the end of the 24-week treatment period ] [ Designated as safety issue: No ]
Weighted mean serial FEV1 over 0-4 hours post-dose calculated in the subset of subjects performing serial FEV1 [ Time Frame: At the end of the 24-week treatment period ] [ Designated as safety issue: No ]
Mean change from baseline in daily AM PEF averaged [ Time Frame: At the end of 12 weeks and the full 24-week treatment period ] [ Designated as safety issue: No ]
Mean change from baseline in daily PM PEF averaged [ Time Frame: At the end of 12 weeks and the full 24 week treatment period ] [ Designated as safety issue: No ]
Number of withdrawals due to lack of efficacy [ Time Frame: At the end of the 24-week treatment period ] [ Designated as safety issue: No ]
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) [ Time Frame: At the end of 12 weeks and the full 24-week treatment period ] [ Designated as safety issue: No ]
Global assessment of change: Asseses asthma symptom change (improve, same, worse) and rescue use (more, same less) [ Time Frame: At the end of 4 weeks, 12 weeks, and the full 24-week treatment period ] [ Designated as safety issue: No ]
Unscheduled Health Care Resource Utilization for Asthma: Number of healthcare contacts related to asthma or the treatment of asthma [ Time Frame: At the end of the 24-week treatment period ] [ Designated as safety issue: No ]

Enrollment:	587
Study Start Date:	June 2010
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fluticasone Furoate/Vilanterol Fluticasone furoate/vilanterol inhalation powder once daily + Placebo inhalation powder twice daily for 24 weeks	Drug: Fluticasone Furoate/Vilanterol Inhalation Powder Fluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 24 weeks Other: Placebo Inhalation Powder 2 Placebo in Diskus inhaler twice daily
Active Comparator: Fluticasone Furoate Fluticasone furoate inhalation powder once daily + Placebo inhalation powder twice daily for 24 weeks	Drug: Fluticasone Furoate Inhalation Powder Fluticasone furoate inhalation powder inhaled orally once daily for 24 weeks Other: Placebo Inhalation Powder 2 Placebo in Diskus inhaler twice daily
Active Comparator: Fluticasone Propionate Fluticasone propionate inhalation powder twice daily + Placebo inhalation powder once daily for 24 weeks	Drug: Fluticasone Propionate Inhalation Powder Fluticasone propionate inhalation powder inhaled orally twice daily for 24 weeks Other: Placebo Inhalation Powder 1 Placebo in novel dry powder inhaler once daily

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134042

Show 68 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01134042 History of Changes
Other Study ID Numbers:	106829
Study First Received:	May 27, 2010
Last Updated:	September 27, 2012
Health Authority:	Poland: Centralna Ewidencja Badań Klinicznych Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych Japan: Pharmaceutical and Medical Device Agency Russia: Federal Service of Surveillance in Healthcare and Social development of Russian federation Romania: National Medicines Agency Germany: Federal Institute for Drugs and Medical Devices United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Fluticasone propionate
asthma
vilanterol
GW642444
Fluticasone furoate

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Bronchodilator Agents

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013