A Study to Compare Fluticasone Propionate 100mcg/Salmeterol 50 mcg Inhalation Powder to Advair Discus 100/50

Inclusion Criteria

• •Male or female subjects (≥ 12 years of age) of non-child bearing potential or of child bearing potential committing to consistent and correct use of an acceptable method of birth control.
• •Diagnosed with asthma as defined by the National Asthma Education and Prevention Program (NAEPP) at least 12 weeks prior to screening.
• •Pre-bronchodilator FEV1 of ≥40% and ≤85% of the predicted value during the screening visit and on the first day of treatment.
• •Currently non-smoking; had not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and had ≤ 10 pack-years of historical use.
• •≥15% reversibility of FEV1 within 30 minutes following 360 mcg of albuterol inhalation (pMDI).
• •Able to discontinue their asthma medications (inhaled corticosteroids and long-acting β agonists) during the run-in period and for remainder of the study.
• •Able to replace current short-acting β agonists (SABAs) with salbutamol/albuterol inhaler for use as needed for the duration of the study (subjects should be able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits).
• •Able to continue the following medications without a significant adjustment of dosage, formulation, dosing interval for the duration of the study, and judged able by the investigator to withhold them for the specified minimum time intervals prior to each clinic visit:
• •* short-acting forms of theophylline 12 hours
• •* twice-a-day controlled-release forms of theophylline 24 hours
• •* once-a-day controlled-release forms of theophylline 36 hours
• •* Able to discontinue the following medications for the specified minimum time intervals prior to the run-in period and for the remainder of the study:
• •* oral corticosteroids 1 month
• •* parenteral corticosteroids 1 month
• •* oral short-acting β-agonists 12 hours
• •Willingness to give their (and in the case of a minor their parent/guardian was able to give) written informed consent to participate in the study.