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Paid Asthma Clinical Trial Now Enrolling at Achieve Clinical Research Near Birmingham, Alabama; Accepting M/F Patients with Asthma Age 12 - 75
Date:11/19/2013

children. The results from this review demonstrated that treatment with this combination therapy resulted in greater benefit in lung function compared with either on it’s own plus other treatment. Similar results were seen for symptom-free days, rescue-free days and quality of life in adults and children. Concurrent use of these asthma drugs was also shown to significantly reduce exacerbations requiring treatment with systemic corticosteroids.

PRIMARY OBJECTIVES

The primary objective of the study is to evaluate whether the combination therapy is non-inferior to the inhalation therapy alone in terms of the risk of serious asthma related events (asthma-related hospitalization, endotracheal intubation, and death). To declare non-inferiority the relative risk of serious events associated with this combination treatment compared with the inhalation medication alone must be less than 2.0 (a 2-fold increase), based on the upper bound of the 95% confidence interval on the estimate of relative risk.

As similar brand specific studies will be performed by the other manufacturers of these medications, that have an indication for asthma, a further objective is to study asthma-related mortality across the brand specific studies and to evaluate whether the concomitant use of this combination therapy increases asthma mortality compared with inhalation alone.

Each sponsor specific study is statistically powered on the same primary objective.

INCLUSION CRITERIA

1. Informed Consent:
a. The subject and/or the subject’s legal guardian (if applicable) must provide written informed assent/consent to take part in the study.
b. Subjects and/or their legal guardians (if applicable) understand that they must comply with study treatment and study assessments including recording of daily information regarding their asthma status and attend scheduled study visits, and be accessible by telephone.

2. Subject: 12 years of ag
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