HZA113091 Efficacy and Safety of Fluticasone Furoate/Vilanterol (GW642444) in Adults and Adolescents - 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 with fluticasone propionate/salmeterol administered twice daily 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 propionate/salmeterol Inhalation Powder Drug: Placebo (1) Drug: Placebo (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:	A Randomised, Double-blind, Double-dummy, Parallel-group Multicentre Study to Assess Efficacy and Safety of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Propionate/Salmeterol Inhalation Powder 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 Salmeterol Fluticasone Salmeterol xinafoate Fluticasone furoate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Weighted mean for 24 hour serial FEV1 [ Time Frame: At the end of the 24-week treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Individual serial FEV1 assessments including the 12 hour and 24 hour post dose trough values [ Time Frame: At the end of the 24-week treatment period ] [ Designated as safety issue: No ]
Time to onset of bronchodilator effect [ Time Frame: 5, 15, 30 and 60minutes and 2, 3 and 4 hours post first dose ] [ Designated as safety issue: No ]
Weighted Mean serial FEV1 over 0 to 4 hours post first dose [ Time Frame: 5, 15, 30 and 60minutes and 2, 3 and 4 hours post first dose ] [ Designated as safety issue: No ]
Weighted Mean serial FEV1 over 0 to 4 hours post dose [ Time Frame: At the end of the 24-week treatment period ] [ Designated as safety issue: No ]
Percent of subjects obtaining at least 12% and at least 200mLs increase from baseline in FEV1 at 12 hours [ Time Frame: At the end of the 24-week treatment period ] [ Designated as safety issue: No ]
Percent of subjects obtaining at least 12% and at least 200mLs increase from baseline in FEV1 at 24 hours [ Time Frame: At the end of the 24-week treatment period ] [ Designated as safety issue: No ]
Change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 [ Time Frame: At the end of the 24-week treatment period ] [ Designated as safety issue: No ]
Asthma Control Test: 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 the 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 ]
Asthma Quality of Life Questionnaire: Measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma [ Time Frame: At the end of the 24-week treatment period ] [ Designated as safety issue: No ]
EQ-5D: A standardized instrument for measuring health outcome (mobility, self-care, activities, pain, anxiety/depression, health state, demography) [ Time Frame: At the end of the 24-week treatment period ] [ Designated as safety issue: No ]

Enrollment:	810
Study Start Date:	June 2010
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fluticasone furoate/Vilanterol (GW642444) 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 Drug: Placebo (2) Inhalation powder inhaled orally twice daily for 24 weeks
Active Comparator: Fluticasone propionate/salmeterol Fluticasone propionate/salmeterol inhalation powder twice daily + placebo inhalation powder once daily for 24 weeks	Drug: Fluticasone propionate/salmeterol Inhalation Powder Fluticasone propionate/salmeterol Inhalation Powder inhaled orally twice daily for 24 weeks Drug: Placebo (1) Inhalation powder inhaled orally once daily for 24 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Clinical diagnosis of asthma
Reversibility of at least 12% and at least 200mLs within 10-40 minutes following 2-4 inhalations of albuterol
FEV1 of 40-85% predicted normal
Currently using inhaled corticosteroid therapy

Exclusion Criteria:

History of life-threatening asthma within previous 5 years (requiring intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxic seizures)
Respiratory infection or oral candidiasis
Asthma exacerbation requiring oral corticosteroids or that resulted in overnight hospitalisation requiring additional asthma treatment
Uncontrolled disease or clinical abnormality
Allergies
Taking another investigational medication or prohibited medication
Night shift workers
Current smokers or subjects with smoking history of at least 10 pack years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01147848

Locations

Argentina
GSK Investigational Site
Buenos Aires, Argentina, C1425BEN
GSK Investigational Site
Mendoza, Argentina, M5500CCG
Chile
GSK Investigational Site
Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500691
GSK Investigational Site
Valparaiso, Valparaíso, Chile, 2341131
GSK Investigational Site
Viña del Mar, Valparaíso, Chile
Korea, Republic of
GSK Investigational Site
Incheon, Korea, Republic of, 400-711
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
GSK Investigational Site
Seoul, Korea, Republic of, 135-710

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01147848 History of Changes
Other Study ID Numbers:	113091
Study First Received:	May 27, 2010
Last Updated:	May 2, 2013
Health Authority:	Argentina: Ministry of Health - A.N.M.A.T Chile: Instituto de Salud Publica de Chile Netherlands: Ministry of Health, Welfare and Sports Philippines: Bureau of Food and Drugs South Korea: Food and Drug Administration United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Salmeterol
fluticasone furoate
Vilanterol
fluticasone propionate
GW642444

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013