A Study to Determine the Efficacy and Safety of Two Mometasone Dry Powder Inhalers in the Treatment of Asthma (Study P02524)

Inclusion Criteria

• •Must be \>=18 years of age, of either gender \& of any race.
• •Must have had a diagnosis of asthma for at least 6 months, characterized by recurrent episode of wheezing, breathlessness, chest tightness \& coughing.
• •Baseline FEV1 must be \>=55% and \<=85% of predicted at the Screening Visit, when all restricted medications have been withheld for the specified intervals.
• •Must demonstrate evidence of an increase in absolute FEV1 of \>=12%, with an absolute volume increase of at least 200 mL, after reversibility testing at the Screening Visit or documented in the patients chart reversibility up to 1 year previous to inclusion.
• •Must be free of any clinically significant disease (other than asthma), that would interfere with study evaluations.
• •Must be willing to give written informed consent and be able to adhere to dose \& visit schedules.
• •Must agree to inform their own usual treating physician about their participation in the study.
• •Non-pregnant women of childbearing potential must be using a medically acceptable, adequate form of birth control. This includes: 1) hormonal contraceptive as prescribed by a physician (eg, oral combined, hormonal implant, depot injectable); 2) medically prescribed IUD; 3) condom in combination with a spermicide; 4) Monogamous relationship with a male partner who has had a vasectomy or is using a condom plus spermicide during the study. They must have started this birth control method at least 3 months prior to Screening (with the exception of condom in combination with a spermicide), \& must agree to continue its use for the duration of the study. Women of childbearing potential who are not currently sexually active must agree and consent to using a double-barrier method should they become sexually active during the course of this study. Women who are surgically sterilized or are at least 1 year postmenopausal are considered not to be of childbearing potential. However, all female subjects must have a urine pregnancy test obtained at screening, prior to initiation of treatment, \& at the end of the trial, which must be negative.
• •Subjects who did not use the following medication prior to inclusion:
• •* Beta 2 agonist short-acting (inhaled, oral)(12 Hours)
• •* Beta 2 agonist long-acting (inhaled)(48 Hours)
• •* Ipratropium bromide (12 hours)
• •* Cromolyn sodium, nedocromil (7 days)
• •* Astemizole (3 months)
• •* Cetotifeno (3 months)
• •* Another investigational drug (1 month)
• •* Theophyline (2 weeks)
• •* Antihistamines (7 days)
• •* Anticholinergics (7 days)
• •* Leukotriene modifiers (2 weeks)
• •* Oral decongestant long-acting (72 hours)
• •* Oral decongestant short-acting (24 hours)
• •* Oral corticosteroids (1 month)
• •* Injected corticosteroids (3 months)
• •* Inhaled corticosteroids (24 hours)
• •Baseline portable Peak Expiratory Flow at the Screening Visit must be \>50% of predicted. The best value out of 3 must be considered.