Asthma Study Comparing Anti-Inflammatory Effects of 3 Doses of Mometasone Furoate/Formoterol Fumarate and Medium Dose Mometasone Furoate (Study P05122 AM1)(COMPLETED)
Condition: Asthma; Airway Inflammation
MeSH terms: Asthma; Inflammation
Intervention: mometasone furoate/formoterol 100/10 mcg; mometasone furoate/formoterol 200/10 mcg; mometasone furoate/formoterol 400/10 mcg; MF DPI 200 mcg; MF MDI 200 mcg; Placebo
Intervention description: mometasone furoate/formoterol 100/10 mcg twice daily (BID) (two inhalations of MF/F 50/5 from a metered-dose inhaler) for 14 days; mometasone furoate/formoterol 200/10 mcg twice daily (BID) (two inhalations of MF/F 100/5 from a metered-dose inhaler) for 14 days; mometasone furoate/formoterol 400/10 mcg twice daily (BID) (two inhalations of MF/F 200/5 mcg from a metered-dose inhaler) for 14 days; MF DPI 200 mcg twice daily (BID) (one inhalation of MF DPI 200 mcg) for 14 days; MF MDI 200 mcg twice daily (BID) (two inhalations of MF MDI 100 mcg) for 14 days; MF/F MDI placebo twice daily (BID) (2 inhalations)
Intervention MeSH terms: Mometasone Furoate; Formoterol Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 93.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: mometasone; formoterol

Summary:

      This is a 2-week double-blind, placebo-controlled, parallel group study comparing the
      anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol
      fumarate (MF/F) metered dose inhaler (MDI) formulation and medium dose mometasone furoate
      (MF) dry powder inhaler (DPI) and MDI formulations in adults and adolescents with persistent
      allergic asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  To document asthma diagnosis, historical reversibility defined as an increase in
             absolute forced expiratory volume (in liters) in 1 second (FEV1) of >= 12% and >= 200
             mL must have been performed within 12 months of Screening. For subjects without
             historical reversibility, one of the following methods can be used at the Screening
             Visit or at any time before the Baseline Visit:

               -  Demonstration of an increase in absolute FEV1 of at least 12% and a volume
                  increase of at least 200 mL within 15-20 minutes after administration of 4
                  inhalations of albuterol/salbutamol (total dose 360 to 400 mcg) or of nebulized
                  short-acting beta agonist (SABA) (2.5 mg), if confirmed as standard office
                  practice, OR

               -  Demonstration of a peak expiratory flow (PEF) variability of more than 20%
                  expressed as a percentage of the mean highest and lowest morning
                  prebronchodilator PEF over at least 1 week, OR

               -  Demonstration of a diurnal variation PEF of more than 20% based on the difference
                  between the prebronchodilator (before taking albuterol/salbutamol) morning value
                  and the postbronchodilator 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. {The calculation formula: Diurnal PEF
                  Variation = Absolute [(highest of 3 readings, PM Post-bronchodilator (BD) PEF
                  from prior evening) - (highest of 3 readings, AM Pre-BD from morning
                  value)]/[(highest PM Post-BD + highest AM Pre-BD)/2] * 100}

          -  At Screening and Baseline Visits, a subject must have persistent allergic asthma with
             an FEV1 >65% predicted.

          -  A subject must be allergic to at least one common allergen (grasses, trees, weeds,
             house dust mites, molds, dog and cat) as demonstrated by clinical symptoms when
             exposed to the allergen(s), and by skin prick testing or a radioallergosorbent (RAST)
             class >1 (excluding modified RAST procedure [mRAST]) within 2 years of inclusion in
             the study.

          -  If, based upon the medical judgment of the investigator, there is no inherent harm in
             changing the subject's current asthma therapy, the subject and/or parent/guardian)
             must agree to discontinue prescribed inhaled corticosteroid (ICS), anticholinergics,
             leukotriene receptor inhibitors, and long-acting beta-2 agonists at the Screening
             Visit as per required washouts, and be transferred to treatment with SABA for relief
             for 2 weeks before the Baseline/Randomization Visit.

          -  Clinical laboratory tests (complete blood count, blood chemistries, and urinalysis)
             conducted at the Screening Visit must be within normal limits or clinically acceptable
             to the investigator.

          -  An electrocardiogram (ECG) performed at the Screening Visit or within 30 days prior to
             Screening Visit must be clinically acceptable to the investigator and have a QTc
             interval <440 milliseconds for males and <450 msec for females.

          -  At Screening or any time prior to Baseline, a subject must have an eNO level of >30
             parts per billion (ppb) at a flow rate of 50 mL/second.

          -  At Screening or any time before Baseline, a subject must have a sputum eosinophil
             count >3% of total cell count.

          -  Willingness to give written informed consent and ability to adhere to dose and visit
             schedules. A subject 12 to 17 years of age must also provide written assent.

          -  A nonpregnant female subject of childbearing potential (with a negative serum
             pregnancy test at Screening) must use a medically acceptable, adequate form of birth
             control. If not currently sexually active she must agree to use a double-barrier
             method if she becomes sexually active during the study.

        Exclusion Criteria:

          -  Use of systemic glucocorticosteroids within 3 months before Screening.

          -  Upper or lower respiratory tract infection within 4 weeks before Screening.

          -  Decrease in absolute FEV1 >20% between Screening and Baseline Visits.

          -  Requirement for > 8 inhalations per day of SABA MDI, or 2 or more nebulized treatments
             of 2.5 mg SABA, on any 2 consecutive days between the Screening and Baseline Visits.

          -  A decrease in AM or PM PEF below the Run-in Period stability limit on any 2
             consecutive days before Baseline. At Visit 1, the Run-in Period stability limit for
             PEF will be established based on the subject's personal best. If the subject does not
             have a historical personal best, the historical PEF measurement will be the PEF
             predicted based on the subject's sex, age, and height. PEF value to be multiplied by
             0.70 to determine stability limit.

          -  A clinical asthma exacerbation defined as a clinical deterioration of asthma that
             results in emergency treatment, hospitalization for asthma, or treatment with
             additional, excluded asthma medication (including oral or other systemic
             corticosteroids but allowing SABA), as per investigator, between Screening and
             Baseline Visits.

          -  Inability to induce sputum after 1 or 2 trys.