study of mometasone furoate/formoterol combination and fluticasone/salmeterol in persistent asthmatics previously treated with inhaled glucocorticosteroids (p04139)

Conditions: Asthma

Summary: the purpose of this study is to evaluate the long-term safety of mometasone furoate/formoterol (mf/f) metered dose inhaler (mdi) 200/10 mcg twice-a-day (bid) and mf/f mdi 400/10 mcg bid and two doses of fluticasone/salmeterol combination (f/sc) (250/50 mcg bid and 500/50 mcg bid) in subjects with persistent asthma who require maintenance treatment on inhaled glucocorticosteroids (ics); evaluator-blind. in addition, the extrapulmonary effects on 24-hour plasma cortisol area under curve (auc), of mf/f mdi 200/10 mcg bid, mf/f mdi 400/10 mcg bid, f/sc mdi 250/50 mcg bid, and f/sc mdi 500/50 mcg bid will be evaluated.


Eligibility criteria:
inclusion criteria: * subjects of either sex and any race, at least 12 years of age, with a diagnosis of asthma of at least 12 months. * use of medium or high daily dose of ics (alone or in combination with long-acting beta-agonist \[laba\]) for at least 12 weeks prior to screening and have been on a stable regimen for at least 2 weeks prior to screening. * medium daily doses of ics: * \> 500 to 1000 mcg beclomethasone chlorofluorocarbon (cfc) * \> 250 to 500 mcg beclomethasone hydrofluoroalkane (hfa) * \> 600 to 1000 mcg budesonide dry powder inhaler (dpi) * \> 1000 to 2000 mcg flunisolide * \> 250 to 500 mcg fluticasone * 400 mcg mf * \> 1000 to 2000 mcg triamcinolone acetonide * high daily doses of ics: * \> 1000 mcg beclomethasone cfc * \> 500 mcg beclomethasone hfa * \> 1000 mcg budesonide dpi * \> 2000 mcg flunisolide * \> 500 mcg fluticasone * \> 400 mcg mf * \> 2000 mcg triamcinolone acetonide * if there is no inherent harm in changing the subject's current asthma therapy, the subject must discontinue prescribed ics or ics/laba combination at baseline. * must show evidence of reversibility within the last 12 months or during the screening period. historical reversibility defined as an increase in absolute forced expiratory volume in 1 second (fev1) of \>= 12% and \>= 200 ml will qualify if performed within 12 months of screening. if no historical reversibility, subject must demonstrate an absolute fev1 of \>= 12% and \>= 200 ml within 10 to 15 minutes after four puffs of salbutamol at visit 1 or anytime prior to baseline. * at screening and baseline, fev1 must be \>= 50% predicted, when restricted medications are withheld for the appropriate intervals. * complete blood count, blood chemistries, urinalysis, and electrocardiogram (ecg) conducted at screening must be within normal limits or clinically acceptable to the investigator/sponsor. a chest x-ray performed at screening or within 12 months prior must be clinically acceptable. * a female of childbearing potential must be using a medically acceptable, adequate form of birth control: * prescribed hormonal contraceptives; * medically prescribed intrauterine device (iud); * medically prescribed transdermal contraceptive; * condom in combination with spermicide; * monogamous relationship with a male partner who has had a vasectomy. birth control must have started at least 3 months prior to screening. subject must agree to continue its use for the duration of the study. a subject of childbearing potential who is not currently sexually active must agree to use a medically acceptable method should she become sexually active during the study. women who have been surgically sterilized or are at least 1 year postmenopausal are not considered to be of childbearing potential. a subject of childbearing potential must have a negative serum pregnancy test at screening. key exclusion criteria: * a change (increase or decrease) in absolute fev1 of \> 20% at any time from the screening visit up to, and including, the baseline visit. * a subject who requires the use of \> 12 inhalations per day of short-acting beta-agonist (saba) mdi or \> 2 nebulized treatments per day of 2.5 mg salbutamol, on any 2 consecutive days from the screening visit up to, and including, the baseline visit. * a subject who experiences a clinical asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication \[other than saba\]) at any time from the screening visit up to, and including, the baseline visit. * a subject who has ever required ventilator support for respiratory failure secondary to asthma. * a subject who is a smoker or ex-smoker and has smoked within the previous year or has had a cumulative smoking history \> 10 pack-years.