Asthma Exacerbation Study
Asthma Exacerbation Study
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.
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