Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1)
Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1)
This study is being conducted to demonstrate the non-inferiority between two inhaled
 glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone
 furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone
 propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the
 onset of action, the overall safety, and how the drugs control asthma will also be assessed.
 The study is approximately 1 year in duration.
Inclusion Criteria:

 -  Participants must have a diagnosis of asthma for at least 12 months' duration.

 -  A participant must have been using a medium daily dose of inhaled glucocorticosteroids
 (alone or in combination with long-acting beta 2-agonist [LABA]) for at least 12 weeks
 and must have been on a stable regimen for at least 2 weeks prior to Screening.

 -  If there is no inherent harm in changing the participant's current asthma therapy, the
 participant must be willing to discontinue his/her prescribed inhaled
 glucocorticosteroid (ICS) or ICS/LABA prior to initiating MF MDI run-in medication.

 -  The diagnosis of asthma must be documented by either demonstrating an increase in
 absolute forced expiratory volume in 1 second (FEV1) of at least 12% and a volume
 increase of at least 200 mL within approximately 15 to 20 minutes after administration
 of 4 inhalations of albuterol/salbutamol or of nebulized short-acting beta 2-agonist
 (SABA) OR peak expiratory flow (PEF) variability of more than 20% OR a diurnal
 variation PEF of more than 20% based on the difference between pre-bronchodilator
 (before taking albuterol/salbutamol) morning value and the post-bronchodilator value
 (after taking albuterol/salbutamol) from the evening before, expressed as a percentage
 of the mean daily PEF value on any day during the open-label Run-in Period.

 -  A participant must have a history of >= 2 asthma-related unscheduled visits to a
 physician or to an emergency room within the past year AND >= 3 asthma-related
 unscheduled visits within the past 2 years.

 -  Prior to randomization participants must have used a total of 12 or more inhalations
 of SABA rescue medication during the last 10 days of run-in.

 -  Clinical laboratory tests (complete blood counts [CBC], blood chemistries, including
 serum pregnancy for females of child-bearing potential, and urinalysis) conducted at
 the Screening Visit must be within normal limits or clinically acceptable to the
 investigator/sponsor before the participant is instructed to start using open-label MF
 MDI run-in medication.

 -  An electrocardiogram (ECG) performed at the Screening Visit, using a centralized
 trans-telephonic technology, must be clinically acceptable to the investigator.

 -  A chest x-ray performed at the Screening Visit, or within 12 months prior to the
 Screening Visit, must be clinically acceptable to the investigator.

 -  A non-pregnant female participant of childbearing potential must be using a medically
 acceptable, adequate form of birth control. A female participant of childbearing
 potential must have a negative serum pregnancy test at Screening in order to be
 considered eligible for enrollment.

 Exclusion Criteria:

 -  A participant who demonstrates a change in absolute FEV1 of > 20% at any time between
 the Screening and Baseline Visits on any 2 consecutive days between the Screening and
 Baseline visits.

 -  A participant who requires the use of greater than 8 inhalations per day of SABA MDI
 or 2 or more nebulized treatments per day of 2.5 mg SABA on any 2 consecutive days
 between the Screening and Baseline Visits.

 -  A participant who experiences a decrease in AM or PM PEF below the Run-in Period
 stability limit on any 2 consecutive days prior to randomization. The average AM and
 average PM PEF respective values from the preceding 7 days are added, divided by the
 number of non-missing values, and multiplied by 0.70 to determine the stability limit.

 -  A participant who experiences a clinical asthma exacerbation: defined as a clinical
 deterioration of asthma as judged by the clinical investigator between the Screening
 and Baseline Visits, that results in emergency treatment, hospitalization due to
 asthma, or treatment with additional, excluded asthma medication (including oral or
 other systemic corticosteroids, but allowing SABA).