Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139)
Condition: Asthma
MeSH terms: Asthma
Intervention: mometasone furoate combination MDI 200/10 mcg BID; mometasone furoate combination MDI 400/10 mcg BID; Fluticasone/Salmeterol 250/50 mcg BID; Fluticasone/Salmeterol 500/50 mcg BID
Intervention description: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year; MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year; F/SC 250/50 twice daily for 1 year; F/SC 500/50 twice daily for 1 year
Intervention MeSH terms: Fluticasone; Xhance; Mometasone Furoate; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 404.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.