Asthma Exacerbation Study

• Status: Completed
• Trial end date: 2011-09-15
• Target enrollment: 0
• Participant gender: All

Summary

This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone; Xhance

Criteria

Inclusion Criteria:

• Clinical diagnosis of asthma

• Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol

• FEV1 of fifty to ninety percent of predicted

• Currently using inhaled corticosteroid therapy

• History of one or more asthma exacerbations requiring treatment with oral/systemic corticosteroids or emergency department visit or in-patient hospitalization in previous year

Exclusion Criteria:

• History of life threatening asthma in previous 5 years (requiring intubation, and/or associated with hypercapnia, hypoxic seizure or respiratory arrest

• Respiratory infection or oral candidiasis

• - Uncontrolled disease or clinical abnormality

• Allergies

• Taking another investigational medication or prohibited medication