A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Moderate-Dose ICS Therapy.

INCLUSION CRITERIA

Subjects eligible for enrolment in the study must meet all of the following criteria:

• Type of Subject: Outpatient
• Age: 12 years of age or older at Visit 1. For sites in the following countries, subjects recruited will be ≥18 years of age: Bulgaria, Czech Republic, Germany, Greece, Lithuania, New Zealand, Russian Federation, Turkey and any other countries where local regulations or the regulatory status of study medication permit enrolment of adults only.
• 3. Gender: Male or Eligible Female
• To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control, as defined by the following:
• Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject
• Implants of levonorgestrel
• Injectable progestogen
• Oral contraceptive (either combined estrogen/progestin or progestin only)
• Any intrauterine device (IUD) with a documented failure rate of less than 1% per year.
• Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse throughout the clinical trial and for a period after the trial to account for elimination of the drug (minimum of six days).
• Double barrier method - spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a spermicide and female diaphragm).
• NB: For German sites, female subjects must use a method of birth control other than the double barrier method.
• The contraceptive transdermal patch, Ortho Evra (if the subject is less than 198 pounds)
• Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation. A serum pregnancy test is required of all females. This test will be performed at the initial screening visit (Visit 1) and Visit 8. In addition, a urine pregnancy test will be performed on the evening of the double-blind treatment visit, prior to randomization (Visit 3) and at Visits 4 through 7.
• Asthma Diagnosis: Asthma as defined by the National Institutes of Health [National Institutes of Health, 2007].
• Severity of Disease: A best FEV1 of 40%-85% of the predicted normal value during the morning Visit 1 screening period or a best FEV1 of 40%-90% of the predicted normal value during the evening Visit 1 screening period.
• Reversibility of Disease: Demonstrated a ≥ 12% and ≥200mL reversibility of FEV1 within approximately 30-minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol (if required, spacers are permitted for reversibility testing only) or one nebulized albuterol/salbutamol solution during the screening period.

Re-screening of subjects during the Visit 1 screening period: If a subject does not meet the inclusion criteria based upon FEV1 percent predicted and/or reversibility, the subject may return to the site once within 4 days and repeat the lung function tests.

• Current Anti-Asthma Therapy: Subjects must have been using a inhaled corticosteroid for at least 8 weeks prior to Visit 1 and maintained on a stable dose of inhaled corticosteroids for four weeks prior to Visit 1 at one of the following doses: [fluticasone propionate MDI CFC/HFA >176 ≤ 440mcg exactuator or > 200 ≤500mcg ex valve]; [fluticasone propionate DPI > 200≤500mcg]; [beclomethasone dipropionate DPI > 420 ≤ 840mcg exactuator or > 500 ≤ 1000mcg ex-valve]; [beclomethasone dipropionate HFA Qvar > 160 ≤ 480mcg exactuator or > 200 ≤ 500mcg ex-valve]; [budesonide DPI MDI >400 ≤1200mcg]; [flunisolide > 1000 ≤ 2000mcg]; [triamcinolone acetonide >1000 ≤1600mcg]; [mometasone furoate DPI >200 ≤ 440mcg]; [ciclesonide MDI HFA >160 mcg ≤ 320mcg ex-actuator dose / >200mcg ≤ 400mcg ex-valve dose}
• Short- Acting Beta2-Agonists: All subjects must be able to replace their current short-acting beta2-agonists with albuterol/salbutamol inhalation aerosol at Visit 1 for use as needed for t