Randomized, Placebo-controlled Study Comparing Efficacy of Fluticasone/Salmeterol Combination to Advair in Asthmatics
Randomized, Placebo-controlled Study Comparing Efficacy of Fluticasone/Salmeterol Combination to Advair in Asthmatics
This is a pivotal trial that will examine therapeutic equivalence (BE) of a new generic
 fixed-dose combination product containing fluticasone propionate 100 mcg / salmeterol 50 mcg
 (as xinafoate salt) and reference listed drug (RLD) Advair® Diskus 100/50 in adult patients
 with chronic but stable asthma as defined in the National Asthma Education and Prevention
 Program Expert Panel Report 3 (NAEPP 3) guidelines
This pivotal trial will examine therapeutic equivalence of a new generic fixed-dose
 combination product containing fluticasone propionate 100 mcg / salmeterol 50 mcg (as
 xinafoate salt) and reference listed drug (RLD) Advair® Diskus 100/50 in adult patients with
 chronic but stable asthma as defined in National Asthma Education and Prevention Program
 Expert Panel Report 3 (NAEPP 3) guidelines [2]. To ensure adequate study sensitivity the test
 and reference products should both be statistically superior to placebo (p<0.05) with regard
 to the BE study primary endpoints.

 A secondary study objective is the safety and tolerability of the test compound.
Inclusion Criteria:

 -  Adult male or female subjects of non-childbearing or of childbearing potential
 committed 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),5 at least 6 months prior to screening

 -  Moderate-to-severe asthma with a pre-bronchodilator FEV1 of >45% and <85% of predicted
 normal, measured at least 6 hours after short-acting β agonist (SABA)and at least 24
 hours after the last dose of long-acting β agonist (LABA), at the screening visit and
 on the day of treatment

 -  >15% and >0.20 L reversibility of FEV1 within 30 minutes following 360 mcg of
 albuterol inhalation (pMDI)

 -  Patients should be stable on their chronic asthma treatment regimen for at least 4
 weeks prior to enrollment

 -  Currently non-smoking; having not used tobacco products (i.e., cigarettes, cigars,
 pipe tobacco) within the past year, and having < 10 pack-years of historical use

 -  Able to replace current regularly scheduled short-acting β agonists (SABAs) with
 salbutamol/albuterol inhaler for use only on an as-needed basis 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)

 -  Willing to discontinue their asthma medications (inhaled corticosteroids and
 long-acting β agonists) during the run-in period and for the remainder of the study

 -  Willingness to give their written informed consent to participate in the study

 Exclusion Criteria:

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

 -  Significant respiratory disease other than asthma (chronic obstructive pulmonary
 disease (COPD), interstitial lung disease, etc.)

 -  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

 -  Patients who required systemic corticosteroids (for any reason) within the past 4
 weeks

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

 -  Patients currently receiving β-blockers