Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate Asthma

Inclusions:

- Patients with mild-to-moderate asthma for at least 6 months prior to Visit 1 (as
defined in the GINA Guidelines) which is unlikely to exacerbate during the study
(e.g., due to seasonal allergen exposure).

- Patients must be on a stable dose of Inhaled Corticosteroids (ICS) for at least 30
days prior to Visit 1. Patients on a combination of ICS/LABA must discontinue the
use of LABA and must be on a stable dose of ICS for 30 days prior to Visit 1.

- Qualifying spirometry at Visit 1 demonstrates highest FEV1 is ≤ 85% and ≥ 60% of
predicted for age, height, and gender using NHANES III (NHANES 2010) when
bronchodilator medications have been withheld the appropriate length of time per the
List of Concomitant Medications (Appendix III)

- Patient demonstrates reversibility with an increase in FEV1 of 12% and 200 mL after
the administration of 360 µg of albuterol.

- Highest pre-dose FEV1 at Visits 2, 4, 6, 8, and 10 must be within 25% of the
qualifying FEV1 at Visit 1

Exclusions:

- Patients with any clinically significant respiratory conditions other than mild to
moderate asthma, such as COPD, active tuberculosis, or history of interstitial lung
disease

- Patients with a severe asthma exacerbation requiring hospitalization in the previous
12 months

- Patient is not able to withhold use of inhaled short-acting beta-agonist (SABA) for
at least 6 hours prior to visit