Phase 3 Completed N=2,183 Randomized Triple-blind Treatment

Asthma Exacerbation Study

Asthma

Source: ClinicalTrials.gov NCT01086384 ↗

Enrolled (actual)

2,183

Serious AEs

3.5%

Results posted

Sep 2013

Primary outcomePrimary: Number of Participants With 1 or More Severe Asthma Exacerbations — 186; 154 participants — p=0.036

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.