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.
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: FP >= 100 - <= 500 mcg/day; BUD >= 200 - <=
1000mcg/day; BDP >= 200 - <= 1000 mcg/day; TA >= 400 - <= 2000 mcg/day
- During the 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
