Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139)
Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139)
The purpose of this study is to evaluate the long-term safety of mometasone
 furoate/formoterol (MF/F) metered dose inhaler (MDI) 200/10 mcg twice-a-day (BID) and MF/F
 MDI 400/10 mcg BID and two doses of fluticasone/salmeterol combination (F/SC) (250/50 mcg BID
 and 500/50 mcg BID) in subjects with persistent asthma who require maintenance treatment on
 inhaled glucocorticosteroids (ICS); evaluator-blind.

 In addition, the extrapulmonary effects on 24-hour plasma cortisol area under curve (AUC), of
 MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, F/SC MDI 250/50 mcg BID, and F/SC MDI
 500/50 mcg BID will be evaluated.
Inclusion Criteria:

 -  Subjects of either sex and any race, at least 12 years of age, with a diagnosis of
 asthma of at least 12 months.

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

 -  Medium daily doses of ICS:

 -  > 500 to 1000 mcg beclomethasone chlorofluorocarbon (CFC)

 -  > 250 to 500 mcg beclomethasone hydrofluoroalkane (HFA)

 -  > 600 to 1000 mcg budesonide dry powder inhaler (DPI)

 -  > 1000 to 2000 mcg flunisolide

 -  > 250 to 500 mcg fluticasone

 -  400 mcg MF

 -  > 1000 to 2000 mcg triamcinolone acetonide

 -  High daily doses of ICS:

 -  > 1000 mcg beclomethasone CFC

 -  > 500 mcg beclomethasone HFA

 -  > 1000 mcg budesonide DPI

 -  > 2000 mcg flunisolide

 -  > 500 mcg fluticasone

 -  > 400 mcg MF

 -  > 2000 mcg triamcinolone acetonide

 -  If there is no inherent harm in changing the subject's current asthma therapy, the
 subject must discontinue prescribed ICS or ICS/LABA combination at Baseline.

 -  Must show evidence of reversibility within the last 12 months or during the Screening
 Period. Historical reversibility defined as an increase in absolute forced expiratory
 volume in 1 second (FEV1) of >= 12% and >= 200 mL will qualify if performed within 12
 months of Screening. If no historical reversibility, subject must demonstrate an
 absolute FEV1 of >= 12% and >= 200 mL within 10 to 15 minutes after four puffs of
 salbutamol at Visit 1 or anytime prior to Baseline.

 -  At Screening and Baseline, FEV1 must be >= 50% predicted, when restricted medications
 are withheld for the appropriate intervals.

 -  Complete blood count, blood chemistries, urinalysis, and electrocardiogram (ECG)
 conducted at Screening must be within normal limits or clinically acceptable to the
 investigator/sponsor. A chest x-ray performed at Screening or within 12 months prior
 must be clinically acceptable.

 -  A female of childbearing potential must be using a medically acceptable, adequate form
 of birth control:

 -  prescribed hormonal contraceptives;

 -  medically prescribed intrauterine device (IUD);

 -  medically prescribed transdermal contraceptive;

 -  condom in combination with spermicide;

 -  monogamous relationship with a male partner who has had a vasectomy.

 Birth control must have started at least 3 months prior to Screening. Subject must agree to
 continue its use for the duration of the study. A subject of childbearing potential who is
 not currently sexually active must agree to use a medically acceptable method should she
 become sexually active during the study. Women who have been surgically sterilized or are
 at least 1 year postmenopausal are not considered to be of childbearing potential. A
 subject of childbearing potential must have a negative serum pregnancy test at Screening.

 Key Exclusion Criteria:

 -  A change (increase or decrease) in absolute FEV1 of > 20% at any time from the
 Screening Visit up to, and including, the Baseline Visit.

 -  A subject who requires the use of > 12 inhalations per day of short-acting
 beta-agonist (SABA) MDI or > 2 nebulized treatments per day of 2.5 mg salbutamol, on
 any 2 consecutive days from the Screening Visit up to, and including, the Baseline
 Visit.

 -  A subject who experiences a clinical asthma exacerbation (defined as a deterioration
 of asthma that results in emergency treatment, hospitalization due to asthma, or
 treatment with additional, excluded asthma medication [other than SABA]) at any time
 from the Screening Visit up to, and including, the Baseline Visit.

 -  A subject who has ever required ventilator support for respiratory failure secondary
 to asthma.

 -  A subject who is a smoker or ex-smoker and has smoked within the previous year or has
 had a cumulative smoking history > 10 pack-years.