BE Study of Fluticasone Propionate/Salmeterol Inhalation Powder in Asthma Patients

This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the
reference product in terms of FEV1 measured at different time-points in adult patients with
asthma.

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)4 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).

Exclusion Criteria:

- Life-threatening asthma, defined as a history of asthma episode(s) requiring
intubation, and/or associated with hypercapnoea; respiratory arrest or hypoxic
seizures, asthma related syncopal episode(s), or hospitalizations within the past year
or during the run-in period.

- Evidence or history of clinically significant disease or abnormality including
congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery
disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or
current evidence of significant hematologic, hepatic neurologic, psychiatric, renal,
or other diseases that in the opinion of the investigator, would put the patient at
risk through study participation, or would affect the study analyses if the disease
exacerbated during the study.

- Hypersensitivity to any sympathomimetic drug (e.g., salmeterol or albuterol) or any
inhaled, intranasal, or systemic corticosteroid therapy

- Viral or bacterial, upper or lower respiratory tract infection or sinus or middle ear
infection within 4 weeks prior to the screening visit or during the run-in period.

- Factors (e.g., infirmity, disability or geographic location) that the investigator
felt would likely limit the patient's compliance with the study protocol or scheduled
clinic visits.

- Use of Medication(s) with the potential to affect the course of asthma or to interact
with sympathomimetic amines.