Clinical Trial to Assess Efficacy, Safety, Treatment Adherence and Quality of Life Impact of Mometasone Furoate in Asthmatic Patients (Study P04879)(TERMINATED)
Condition: Asthma
Intervention: Mometasone Furoate
Intervention description: Mometasone Furoate 400 mcg once daily, in the evening through 12 weeks.
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 385.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Open label, 12-week clinical trial to assess efficacy, safety, treatment adherence and
      Quality of Life impact of Mometasone Furoate dry powder 400 mcg once-daily in persistent
      mild-moderate asthmatic patients at least 12 years old.

      Protocol deviations may have occurred that resulted in quality issues associated with
      reporting of the data.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willingness to participate and comply with procedures by signing a written informed
             consent

          -  12 years of age or older of either gender and any race

          -  Women of childbearing potential (includes women who are less than 1 year
             postmenopausal and currently are or will become sexually active during the study) must
             be using or agree to use an acceptable method of birth control unless they are
             surgically sterilized

          -  Must understand and be able to adhere to dosing and visit schedules, and agree to
             record symptom severity scores, PEFR values, medication times, and concomitant
             medications accurately and consistently in a daily diary.

          -  Diagnosed history of mild-moderate persistent asthma for at least 12 months.

          -  FEV1 must be >60% of predicted normal or personal best FEV1 during the last 12 months.

          -  Using daily inhaled corticosteroids for at least 30 days prior to Screening. In the
             Screening Visit patients FEV1 should be >= 65% to <= 90% predicted.

          -  Asthma Symptom Total daily (AM+PM) severity score at Screening Visit should be <= 2.

          -  For two weeks prior to Screening, subjects must have been on a stable regimen of one
             of the following twice daily regimen: fluticasone propionate (FP) >= 100 - <= 500
             mcg/day; budesonide (BUD) >= 200 - <= 1000mcg/day; beclomethasone dipropionate (BDP)
             >= 200 - <= 1000 mcg/day; triamcinolone acetonide (TA) >= 400 - <= 2000 mcg/day

          -  During the inhaled corticosteroid (ICS) Dose Reduction period (max. of 4 weeks; min.
             of 1 week) of sequential ICS Dose Reduction (approximately 50% reduction in daily dose
             or discontinue according treatment scheme), subjects must demonstrate a measurable
             loss of asthma control, with both A) Decreased Lung Function (from the Screening value
             in absolute FEV1 of >= 10% or >= 220ml OR a decrease in AM PEFR of 25% from the
             average value for the pre-ICS Dose Reduction period on at least 2 consecutive days out
             of the last 7 days) AND B) Increased Symptoms (Total AM and PM symptom score of >= 10
             out of 24 (using 0-3 scale for each of 4 individual symptoms) on at least 2 days out
             of the last 7 days OR Increased use of rescue medication from the average value for
             the pre-ICS Dose Reduction period (one week) of >= 2 puffs on at least 2 days out of
             the last 7 days)

          -  Once criterion above have been fulfilled, subjects can be initiated if the FEV1 is
             60%-80% predicted

          -  Subjects must agree to inform their usual treating physicians of their participation
             in this study

        Exclusion Criteria:

          -  Females who are pregnant or breast-feeding.

          -  Subjects who have not observed the designated washout periods for any of the
             prohibited medications

          -  Subjects who have used any investigational product within 30 days or any antibodies
             for asthma or allergic rhinitis in the past 90 days prior to enrollment.

          -  Subjects who have any clinically significant deviation from normal in the physical
             examination that may interfere with the study evaluations or affect subject safety.

          -  Subjects who have required systemic steroids within the previous month.

          -  Subjects who are allergic or have an idiosyncratic reaction to corticosteroids.

          -  Subjects who have required inpatient hospitalization for asthma control within the
             previous 3 months, or more than once in the previous 6 months.

          -  Subjects with clinical evidence of chronic obstructive pulmonary disease or lung
             diseases other than asthma.

          -  Subjects who have experienced an upper or lower respiratory tract infection within the
             previous 2 weeks prior to the Screening Visit.

          -  Subjects with evidence of clinically significant oropharyngeal candidiasis

          -  Subjects with any clinically significant immunologic, metabolic, cardiovascular,
             neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disease
             (other than asthma), or any other disorder which may interfere with the study
             evaluations or affect subject safety.

          -  Subjects with a history of drug abuse, antagonistic personality, poor motivation,
             hypochondriasis, or any other emotional or intellectual problems that are likely to
             limit the validity of consent to participate in the study