Safety Study of the Effects of Inhaled Fluticasone Furoate/GW642444 on the Hypothalamic-Pituitary-Adrenal (HPA) Axis

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effect of six weeks' treatment with two once-daily strengths of Fluticasone Furoate/GW642444 Inhalation Powder on the HPA axis system

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Xhance

Criteria

Inclusion Criteria:

• Outpatient with ability to comply with study requirements and complete two 24-hour clinic visits

• Clinical diagnosis of asthma for greater than/equal to 12 weeks

• Reversibility FEV1 of at least twelve percent and two hundred milliliters

• FEV1 greater than or equal to fifty percent of predicted

Exclusion Criteria:

• History of life threatening asthma

• Respiratory infection or oral candidiasis

• Asthma exacerbation

• Uncontrolled disease or clinical abnormality

• Allergies to study drugs, study drugs' excipients, medications related to study drugs

• Taking another investigational medication or prohibited medication