Phase 3
N=2,183
Asthma Exacerbation Study
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01086384 ↗Enrolled (actual)
2,183
Serious AEs
3.5%
Results posted
Sep 2013
Primary outcome: Primary: Number of Participants With 1 or More Severe Asthma Exacerbations — 186; 154 participants — p=0.036
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fluticasone Furoate/GW642444 (Drug); Fluticasone furoate (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With 1 or More Severe Asthma Exacerbations |
186; 154 | 0.036 sig |
| SECONDARY Number of Severe Asthma Exacerbations |
271; 200 | — |
| SECONDARY Change From Baseline in Evening Pre-dose Trough FEV1 at Week 36 |
0.265; 0.348 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01086384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.