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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Salmeterol Xinafoate; Xhance

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