ABSTRACT
INTRODUCTION: Sustained vigilance is required by pilots and crew during flight; therefore, the use of antihistamines with sedating properties is widely prohibited. The purpose of this study was to determine the effects of desloratadine, a long-acting, nonsedating antihistamine, on healthy volunteers placed under conditions of simulated cabin pressure. METHODS: In a double-blind crossover study, 21 subjects randomly received single doses of desloratadine 5 mg, diphenhydramine 50 mg (active control), and placebo on different days separated by washout periods of 7 d. On test days, predose levels of alertness and fatigue were determined, as were post-dose levels at 1, 2, 3, 5, and 6 h. Measurements included vigilance and tracking, a multi-attribute task battery, the Stanford Sleepiness Scale, and pulse oximetry. RESULTS: Desloratadine had no detrimental effects on sleepiness or performance of tasks associated with flying ability. Conversely, diphenhydramine (active control) caused significantly more sleepiness than did the placebo [F (2,40) = 6.52, p < 0.01], as well as impaired performance (tracking performance p < 0.05 at 3 h post dose), and an increased percentage of omissions (p < 0.05 at 2 h post dose). CONCLUSION: A single dose of desloratadine 5 mg did not cause sleepiness and did not impair the performance of tasks associated with flying ability.
Subject(s)
Aerospace Medicine , Anti-Allergic Agents/pharmacology , Diphenhydramine/pharmacology , Histamine H1 Antagonists, Non-Sedating/pharmacology , Loratadine/analogs & derivatives , Loratadine/pharmacology , Psychomotor Performance/drug effects , Administration, Oral , Adolescent , Adult , Affect/drug effects , Analysis of Variance , Anti-Allergic Agents/administration & dosage , Anti-Allergic Agents/adverse effects , Cross-Over Studies , Diphenhydramine/administration & dosage , Diphenhydramine/adverse effects , Double-Blind Method , Histamine H1 Antagonists, Non-Sedating/administration & dosage , Histamine H1 Antagonists, Non-Sedating/adverse effects , Humans , Loratadine/administration & dosage , Loratadine/adverse effects , Male , Oximetry , Sleep/drug effects , Statistics, NonparametricABSTRACT
BACKGROUND: Mometasone furoate nasal spray (MFNS) 400 microg, twice daily, as adjunctive treatment with oral antibiotic significantly improved symptoms of recurrent rhinosinusitis. OBJECTIVE: To evaluate the effectiveness and safety of MFNS 200 microg, twice daily, and 400 microg, twice daily, compared with placebo as adjunctive treatment with oral antibiotic for acute rhinosinusitis. METHODS: In this multicenter, double-blind, placebo-controlled study, 967 outpatients with computed tomographic scan-confirmed moderate to severe rhinosinusitis received amoxicillin/clavulanate potassium (Augmentin, GlaxoSmithKline, Research Triangle Park, NC) 875 mg, twice daily, for 21 days with adjunctive twice daily MFNS 200 microg, MFNS 400 microg, or placebo nasal spray. Patients recorded scores of six rhinosinusitis symptoms and any adverse events twice daily. Pre- and postcosyntropin-stimulation plasma cortisol levels were measured in a subset of patients at selected study sites. RESULTS: Treatment with MFNS 200 microg or 400 microg, twice daily, produced significantly greater improvements in total symptoms score (primary efficacy variable) day 1 to day 15 average (50% and 51%, respectively) than placebo (44%, P < or = 0.017). Both doses of MFNS produced significant total symptoms score improvement over placebo by day 4, and maintained efficacy over the entire 21-day study. Relief of individual symptoms showed a similar pattern. Both doses of MFNS were well tolerated, and adverse events were similar to that of placebo. Cosyntropin stimulation showed no evidence of hypothalamic-pituitary-adrenal axis suppression. CONCLUSIONS: As adjunctive therapy to oral antibiotic treatment, MFNS at doses of 200 microg or 400 microg, twice daily, was well tolerated and significantly more effective in reducing the symptoms of rhinosinusitis than antibiotic therapy alone.
