Study HZA106827: 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: Placebo Inhaltion Powder; Drug: Fluticasone Furoate Inhalation Powder; Drug: Fluticasone furoate/Vilanterol Inhalation Powder

Study type: Interventional

Funder types: Industry

Identifiers

NCT01165138

106827

Details and patient eligibility

About

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.

Enrollment: 612 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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612 participants in 3 patient groups, including a placebo group

Fluticasone furoate/Vilanterol (GW642444)

Experimental group

Description:

Fluticasone furoate/Vilanterol inhalation powder once daily for 12 weeks

Treatment:

Drug: Fluticasone furoate/Vilanterol Inhalation Powder

Fluticasone Furoate

Experimental group

Description:

Fluticasone furoate inhalation powder once daily for 12 weeks

Treatment:

Drug: Fluticasone Furoate Inhalation Powder

Placebo

Placebo Comparator group

Description:

Placebo inhalation powder once daily for 12 weeks

Treatment:

Drug: Placebo Inhaltion Powder