A Study of the Equivalent Effectiveness of 400 mcg Mometasone Furoate Using Two Different Dry Powder Inhalers in Moderate Asthmatics (Study P04828)
Condition: Asthma
MeSH terms: Asthma
Intervention: Mometasone furoate dry powder inhaler; Placebo
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 672.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is a placebo-controlled study with 8-weeks of double-blind treatment of mometasone
      furoate dry powder inhaler (MF DPI) 200 mcg twice daily (BID) using two different inhalers,
      preceded by the Screening Period and by 2 weeks of open-label treatment with one inhalation
      of MF DPI 200 mcg twice daily in corticosteroid-dependent asthmatic subjects. The objective
      of this study is to evaluate the therapeutic equivalency of the 100 mcg and 200 mcg MF DPIs
      when providing the same total daily dose (400 mcg/day).
    

Eligibility criteria:

        Inclusion Criteria:

        18 years of age, either sex, any race, with a diagnosis of asthma of at least 12 months'
        duration.

          -  Must be on a stable regimen of a medium daily dose of ICS for at least 4 weeks
             immediately prior to Screening. Medium daily doses of ICS are:

               -  >500 to 1000 mcg beclomethasone CFC

               -  >250 to 500 mcg beclomethasone HFA

               -  >600 to 1000 mcg budesonide DPI

               -  >1000 to 2000 mcg flunisolide

               -  >250 to 500 mcg fluticasone

               -  400 mcg MF

               -  >1000 to 2000 mcg triamcinolone acetonide.

          -  Must have a documented reversibility test obtained within 12 months prior to signing
             the informed consent form. Otherwise, to document a diagnosis of asthma and ensure the
             subject's responsiveness to bronchodilators, one of the following methods can be used
             at the Screening Visit, or thereafter, but prior to the Baseline Visit:

               -  An increase in absolute FEV1 of >=12% and >=200 mL within 30 minutes of
                  administration of 4 puffs of albuterol.

               -  A PEF variability of >20%, expressed as a percent of the best and lowest morning
                  pre-bronchodilator PEF over at least 1 week.

               -  A diurnal variation in PEF of >20% based on the difference between the
                  pre-bronchodilator AM value and the post-bronchodilator value from the evening
                  before, expressed as a percentage of the mean daily PEF value any day during the
                  Run-in Period.

          -  At Screening and Baseline, the subject's FEV1 must be >=60% predicted, when all
             restricted medications have been withheld for the appropriate intervals. If, based on
             the clinical judgment of the investigator, there is no harm in changing the subject's
             asthma therapy, subjects on LABAs must be willing to discontinue the LABA and be
             transferred to open-label treatment with MF MDI 200 mcg BID for 2 weeks prior to
             randomization.

          -  Clinical laboratory tests conducted at the Screening Visit must be within normal
             limits or clinically acceptable to the investigator/sponsor before the subject is
             instructed to start using open-label MF DPI run-in medication. A chest x-ray performed
             at the Screening Visit or any type of chest imaging within 12 months prior to the
             Screening Visit must be clinically acceptable to the investigator.

          -  A female of childbearing potential must be using a medically acceptable, adequate form
             of birth control. This includes: 1) hormonal contraceptives as prescribed by a
             physician (oral combined, hormonal implant); 2) medically prescribed IUD; 3) condom in
             combination with a spermicide (double-barrier method); 4) monogamous relationship with
             a male partner who has had a vasectomy. The subject must have started this birth
             control method at least 3 months prior to Screening (with the exception of condom in
             combination with spermicide), and 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 and consent to using a medically acceptable method should she become
             sexually active during the course of this 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.

        Exclusion Criteria:

          -  A change in absolute FEV1 of >20% at any time from the Screening Visit up to and
             including the Baseline Visit.

          -  A clinical asthma exacerbation (defined as a deterioration of asthma that results in
             emergency treatment, hospitalization, or treatment with additional, excluded asthma
             medication at any time from the Screening Visit up to and including the Baseline
             Visit).

          -  Treatment in the emergency department or admission to the hospital for an asthma
             exacerbation 12 months prior to Screening.

          -  An upper or lower respiratory tract infection within the 4 weeks of to Screening.
             Visits can be rescheduled to meet this requirement.

          -  Evidence of clinically significant oropharyngeal candidiasis at Baseline with or
             without treatment. If there is evidence of oropharyngeal candidiasis at Screening
             and/or during the MF DPI Run-in Period, the subject may be treated as appropriate and
             the Baseline Visit can be scheduled upon resolution. If there is evidence of
             oropharyngeal candidiasis at the Baseline Visit, the subject may be treated as
             appropriate and the visit can be rescheduled upon resolution.

          -  A smoker or ex-smoker and has smoked within the previous year or has had a cumulative
             smoking history >10 pack-years.

          -  Requires more than twelve inhalations of albuterol or more than 2 treatments with
             nebulized beta-agonists on any 2 consecutive days during the Run-in Period.

          -  Ever required mechanical ventilation secondary to an asthma exacerbation.