Asthma Exacerbation Study
Status: | Completed |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 1/26/2018 |
Start Date: | February 22, 2010 |
End Date: | September 15, 2011 |
A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects With Asthma
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.
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
We found this trial at
62
sites
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