Therapeutic Equivalence of Two Formulations of Fluticasone Propionate and Salmeterol Inhalation Powder in Subjects With Asthma

Inclusion Criteria

• Male or non-pregnant, non-lactating female, ≥ 12 years and ≤ 75 years of age.
• Signed informed consent form that meets all criteria of current Food and Drug Administration (FDA) regulations. For subjects who are considered minors in the state the study is being conducted ( 18 years old. For subjects 12 to 18 years old, BMI between 15 kg/m2 and 35 kg/m2, inclusive.
• Female subjects who are of non-childbearing potential must meet one of the following criteria:
• surgically sterile (e.g., bilateral oophorectomy, tubal ligation, hysterectomy or permanent sterilization procedures), with the procedure performed at least 3 months before initial dosing
• naturally postmenopausal (no menses) for at least 1 year before initial dosing and/or has a documented FSH level ≥ 40 mIU/mL at screening
• pre-menarchal
• Females of childbearing potential must not be pregnant or lactating at Screening or Randomization as confirmed by a negative serum pregnancy test with a sensitivity of 25 mIU/mL of human chorionic gonadotropin at Screening, and a negative urine pregnancy test with a sensitivity of less than 50 mIU/mL at all other visits. The subject may enter the placebo run-in period prior to receipt of test results at Screening, if not yet received from the clinical laboratory, but should be evaluated by the Investigator for continued participation once test results are received.

Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, intrauterine device, a double-barrier method, oral, transdermal, injected or implanted non- or hormonal contraceptive), throughout the study. A sterile sexual partner is not considered an adequate form of birth control. Subjects on hormonal contraceptives must have been on the same hormonal contraceptive for at least one month before the Screening and continue throughout the duration of the study.

• Diagnosis of asthma (based on National Asthma Education and Prevention Program [NAEPP] guidelines) at least 12 weeks before Screening.
• Pre-bronchodilator FEV1 ≥ 40% and ≤ 85% of predicted at Screening and Randomization.
• Airway reversibility ≥ 15% of FEV1 within 30 minutes after receiving 4 puffs of albuterol inhalation (360 mcg, pressurized metered-dose inhaler) at Screening.
• Able to discontinue use of their asthma medications during the run-in period and for the remainder of the study.
• Able to replace current short-acting beta-agonists [SABAs] with the study supplied salbutamol/albuterol rescue inhaler for use as needed for the duration of the study. Subjects must be able to withhold all SABAs for at least 6 hours before lung function assessments on study visits.
• Able to continue on stable regimen of theophylline for the duration of the study and able to withhold theophylline as judged by the Investigator for the required time intervals before study visits. See Section 10.2.4 for required washouts.
• Able to discontinue oral corticosteroids, parenteral corticosteroids and oral SABAs for the time intervals before study visits as specified in Section 10.2.4.
• Able to perform valid and reproducible pulmonary function tests as per ATS American Thoracic Society including no evidence of spirometry effort-induced bronchoconstriction.
• Currently non-smoking (including vapor cigarettes), no use of any tobacco products within 1 year prior to Screening and has ≤ 10 pack-years smoking of historical use (i.e., one pack per day for 10 years).
• Ability to use the inhalation products correctly.

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 asthma-related hospitalizations within one year before Screening or during the run-in period.
• Allergy or significant history of hypersensitivity, idiosyncratic reactions, or intolerance to any symp