Efficacy and Safety of Mometasone Furoate for Persistent Asthma Previously Treated With Low-Dose Inhaled Glucocorticosteroids (ICS) (Study P06115)
Efficacy and Safety of Mometasone Furoate for Persistent Asthma Previously Treated With Low-Dose Inhaled Glucocorticosteroids (ICS) (Study P06115)
Mometasone furoate (MF) is a synthetic glucocorticosteroid that, when administered to asthma
 patients with a dry powder inhaler (Asmanex® Twisthaler®) at dosages of 100 to 400 mcg twice
 daily, has been shown to improve lung function, reduce symptoms of asthma, and reduce
 frequency and severity of exacerbations by reducing airway inflammation, with a relatively
 low potential to cause systemic side effects such as hypothalamic-pituitary-adrenal (HPA)
 axis suppression.

 An experimental formulation of MF 100 mcg delivered twice daily via a pressurized
 metered-dose inhaler (MDI) also has been shown to be effective in improving lung function of
 asthma patients as measured by forced expiratory volume in 1 second (FEV1). This trial is
 designed to verify the effectiveness of twice daily MF MDI 100 mcg in treating asthma in
 adults and adolescents previously treated with low dosages of inhaled corticosteroids (ICS),
 as measured by improvement in morning FEV1 and time to first asthma exacerbation over 12
 weeks of treatment.
Inclusion Criteria:

 -  An adult or adolescent subject with a diagnosis of persistent asthma of >=6 months
 duration may be selected for this study.

 -  Both subject (and/or parent/guardian, if appropriate) and investigator must agree that
 changing therapy is acceptable and poses no inherent risk.

 -  Subject must have been using a low daily maintenance dose of inhaled corticosteroids
 (ICS), with or without added long-acting β2-agonist (LABA), for >=12 weeks prior to
 Screening, and must have been on a stable regimen (daily dose unchanged) for at least
 the last 2 weeks of that period.

 -  At Screening, the subject must have a prebronchodilator FEV1 between 60% and 90% of
 the predicted value when restricted medications have been withheld.

 -  To be randomized, the subjects must be symptomatic with FEV1 at Baseline must be
 between 50% and 85% of predicted.

 Exclusion Criteria:

 -  A subject must not have been admitted to the hospital for management of airway
 obstruction within the last 3 months prior to Screening, and must not have experienced
 an occurrence of any clinical deterioration of asthma that resulted in emergency
 treatment, hospitalization due to asthma, or treatment with additional, excluded
 asthma medication, as judged by the clinical investigator at any time from Screening
 to Baseline/Randomization.

 -  In addition, a subject must not have demonstrated a decrease in absolute FEV1 of >20%
 at any time from Screening to Baseline, or a decrease in AM peak expiratory flow (PEF)
 below the PEF stability limit on any 2 consecutive days prior to
 Baseline/Randomization.