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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

e and older.

3. Gender: Male or female.

4. Asthma Diagnosis: Persistent asthma, defined by national and international asthma guidelines for at least 1 year prior to study enrolment. If the subject is naïve to the study site, the diagnosis of asthma must be confirmed by subject history.

5. PEF: A clinic PEF=50% of predicted normal value. Percent predicted PEF values must be calculated using NHANES III with relevant equations that adjust for race and national origin.

6. Current Asthma Therapy: Subjects must be appropriately using one of the following for the treatment of asthma and meet the criteria outlined below:
a. The inhaled drug on it’s own or combined with one or more adjunctive therapies for at least 4 weeks prior to randomization. Any subject maintained on a stable high dose of this inhaled medication or stable high dose of the combination must have an ACQ-6 < 1.5 (i.e., controlled) at Visit 1.
b. A monotherapy at a stable dose for at least 4 weeks prior to randomization. Subjects on monotherapy are eligible only if they record an ACQ-6 score of = 1.5 (i.e. not well controlled) and in the Investigator’s clinical judgement, the subject’s asthma severity could justify treatment with the inhalation treatment or combination treatment.
c. Daily rescue medication in the 4 weeks prior to randomization. Subjects on this medication are eligible only if they record an ACQ-6 score of = 1.5 and in the investigator’s clinical judgement, the subject’s asthma severity could justify treatment with the inhalation treatment or combination treatment.

7. Exacerbation History: Subject must have a history of one of the following:
a. at least one asthma exacerbation requiring treatment with a systemic corticosteroid (tablets, suspension, or injection) between 30 days and 12 months prior to randomization OR
b. an asthma-related hospitalization (defined as an inpatient stay or a 24-hour stay in an obse
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