HZA113091 Efficacy and Safety of Fluticasone Furoate/Vilanterol (GW642444) in Adults and Adolescents

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Placebo (2); Drug: Fluticasone propionate/salmeterol Inhalation Powder; Drug: Placebo (1); Drug: Fluticasone furoate/Vilanterol Inhalation Powder

Study type: Interventional

Funder types: Industry

Identifiers

NCT01147848

113091

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 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.

Enrollment: 810 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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810 participants in 2 patient groups

Fluticasone furoate/Vilanterol (GW642444)

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

Drug: Placebo (2)

Fluticasone propionate/salmeterol

Active Comparator group

Description:

Fluticasone propionate/salmeterol inhalation powder twice daily + placebo inhalation powder once daily for 24 weeks

Treatment:

Drug: Fluticasone propionate/salmeterol Inhalation Powder

Drug: Placebo (1)