A Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™) With Fluticasone or Flovent to Treat Moderate to Severe Asthma in Adolescents and Adults
A Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™) With Fluticasone or Flovent to Treat Moderate to Severe Asthma in Adolescents and Adults
The medications being used in this study are individually approved by the Food and Drug
 Administration (FDA). The medication under investigation is a combination of two medications
 in one inhaler. The purpose of this study is to determine how well your asthma is controlled
 when taking one of the three treatment.
This Phase 3 randomized, double-blind, active-controlled, parallel group, stratified,
 multi-center study will evaluate the safety and efficacy of FlutiForm (250/10ug) after twice
 daily dosing over 12 weeks delivered by SKP HFA pMDI compared with Fluticasone propionate
 (250ug of twice daily) delivered by SKP HFA pMDI and Flovent® Fluticasone 250ug HFA pMDI in
 adolescent and adult patients with moderate to severe asthma. Only steroid-requiring patients
 (inhaled steroid regimen stable for at least 4 weeks prior to the Screening Visit at a dose
 not greater than 500ug/day Fluticasone propionate or equivalent) will be eligible. All
 patients will undergo a Run-In Period of 14 ± 3 days during which they will receive asthma
 maintenance therapy using Fluticasone HFA pMDI (Flovent® HFA 50 ug/actuation: 100µg/day (one
 inhalation twice daily) if they were using less than or equal to 250mg/day Fluticasone
 propionate or equivalent inhaled steroid, or 200ug/day (two inhalations twice daily) if they
 were using greater than 250ug/day Fluticasone propionate or equivalent inhaled steroid prior
 to the Screening Visit.). The use of rescue Salbutamol (Albuterol) pMDI will be permitted for
 all patients as needed for the control of worsening asthma symptoms during the Run-In Period.
 At the Baseline Visit (Week 0) following the Run-In period, eligible patients will be
 randomized to the treatment groups. Treatment assignment will be stratified according to
 their Baseline FEV1 % predicted (40-60% or >60-80%).Study drug will be administered twice
 daily over a 12-week period. Patient visits will occur at Weeks 2, 4, 8, and 12 during which
 assessments (including serial PFTs up to 4 hours) will be made. In a subset of at least 66
 patients (22 patients per treatment group) from selected centers, post-dose 12-hour serial
 PFTs will be performed at Baseline, Weeks 2 and 12. During the Treatment Period, patients may
 only take their blinded study medication; all other asthma medications will be withheld for
 the duration of the Treatment Period. However, the use of rescue Salbutamol (Albuterol) pMDI
 will be permitted in all patients as needed during the Treatment Period for the control of
 worsening asthma symptoms.
Main Inclusion Criteria:

 -  ≥ Age 12 years at the Screening Visit.

 -  History of asthma for 12 months prior to the Screening Visit.

 -  Documented use of an inhaled corticosteroid for at least 4 weeks prior to the
 Screening Visit.

 -  Steroid-requiring patient

 -  patients must demonstrate (1) an FEV1 of 40% to 80% (inclusive) of predicted normal
 values at both the Screening and Baseline Visits and (2) documented reversibility
 within 12 months of the Screening Visit, defined as a ≥ 15%

 Main Exclusion Criteria:

 -  Life-threatening asthma within the past year or during the Run-In Period.

 -  History of systemic (oral or injectable) corticosteroid medication within 3 months
 before the Screening Visit.

 -  An upper or lower respiratory infection within 4 weeks prior to the Screening Visit or
 during the Run-In Period.

 -  Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary
 disease [COPD], cystic fibrosis, bronchiectasis).

 -  A smoking history equivalent to "10 pack years" (i.e., at least 1 pack of 20
 cigarettes /day for 10 years or 10 packs/day for 1 year, etc.).

 -  Current smoking history within 12 months prior to the Screening Visit.

 -  Previous exposure to FlutiForm