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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Fluticasone Propionate Inhalation Powder; Drug: Fluticasone Furoate/Vilanterol Inhalation Powder; Drug: Fluticasone Furoate Inhalation Powder; Other: Placebo Inhalation Powder 1; Other: Placebo Inhalation Powder 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01134042

106829

Details and patient eligibility

About

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.

Enrollment: 587 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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587 participants in 3 patient groups

Fluticasone Furoate/Vilanterol

Experimental group

Description:

Fluticasone furoate/vilanterol inhalation powder once daily + Placebo inhalation powder twice daily for 24 weeks

Treatment:

Drug: Fluticasone Furoate/Vilanterol Inhalation Powder

Other: Placebo Inhalation Powder 2

Fluticasone Furoate

Active Comparator group

Description:

Fluticasone furoate inhalation powder once daily + Placebo inhalation powder twice daily for 24 weeks

Treatment:

Other: Placebo Inhalation Powder 2

Drug: Fluticasone Furoate Inhalation Powder

Fluticasone Propionate

Active Comparator group

Description:

Fluticasone propionate inhalation powder twice daily + Placebo inhalation powder once daily for 24 weeks

Treatment:

Drug: Fluticasone Propionate Inhalation Powder

Other: Placebo Inhalation Powder 1