ABSTRACT
OBJECTIVE: To evaluate the efficacy and safety of fluticasone propionate administered as a once-daily or twice-daily regimen over a period of 1 year to patients with moderate asthma. DESIGN: Double-blind, randomized, parallel group, and placebo-controlled phase (12 weeks) and an open-label phase (54 weeks). SETTING: Multicenter study in an outpatient setting. PARTICIPANTS: Patients (n = 253; age, > or = 12 years) with a mean FEV(1) of 67% predicted normal were stratified according to baseline therapy of maintenance inhaled corticosteroids vs beta(2)-agonists alone. MEASUREMENTS AND INTERVENTIONS: Fluticasone propionate (250 microg bid or 500 microg qd) or placebo (bid) was administered via the Diskus multidose powder inhaler (Glaxo Wellcome; Research Triangle Park, NC) for 12 weeks. During open-label treatment, patients were re-randomized to once-daily or twice-daily fluticasone propionate. RESULTS: Compared to placebo, fluticasone propionate administered qd or bid significantly improved FEV(1) (p < 0.001), morning (p < 0.001) and evening peak expiratory flow (PEF; p < 0.001), asthma symptom scores (p < or = 0.001), and albuterol use (p
Subject(s)
Androstadienes/administration & dosage , Anti-Asthmatic Agents/administration & dosage , Asthma/drug therapy , Administration, Inhalation , Adolescent , Adrenergic beta-Agonists/administration & dosage , Adult , Aged , Albuterol/administration & dosage , Asthma/physiopathology , Child , Circadian Rhythm , Double-Blind Method , Drug Administration Schedule , Female , Fluticasone , Follow-Up Studies , Forced Expiratory Volume/drug effects , Humans , Male , Middle Aged , Nebulizers and Vaporizers , Powders , Safety , Severity of Illness IndexABSTRACT
Placement of a urethral catheter has been recommended to ensure adequate methotrexate elimination in patients with a neobladder; however, the need for this and its impact on methotrexate elimination have not been determined. A 53-year-old man with a cecal continent urinary diversion received intravenous methotrexate 30 mg/m2 on two occasions, with and without urethral catheter drainage of the neobladder. Serum methotrexate concentrations declined at a rate that resulted in 24- and 48-hour values falling below the accepted toxic concentration threshold of 5-50 mumol/L, and 0.05 mumol/L, respectively. In this man, who received low-dose methotrexate, catheterization of the neobladder did not alter methotrexate elimination sufficiently to justify its cost, risk, and inconvenience.
