montelukast and Sleep-Initiation-and-Maintenance-Disorders

During the course of development of montelukast, a cysteinyl leukotriene receptor 1 antagonist, for treatment of seasonal allergic rhinitis, a double-blind, non-inferiority study was carried out to evaluate the efficacy and safety of montelukast 5mg and 10mg compared with pranlukast 450mg, which has a similar mechanism of action.. Montelukast 5mg, 10mg or pranlukast 450mg and the corresponding placebo were orally administered to patients with seasonal allergic rhinitis three times a day for 2 weeks. Non-inferior efficacy of montelukast 5mg and 10mg to pranlukast 450mg was investigated by the change from the baseline in the composite nasal symptoms scores over the 2-week treatment period.. Montelukast 5mg, 10mg once daily and the pranlukast 450mg/day showed significant improvements in the change from the baseline in the composite, daytime and nighttime nasal symptom scores, and the improvement lasted for 2 weeks. Montelukast 5mg and 10mg were non-inferior to pranlukast 450mg in the change from the baseline in the composite nasal symptoms scores. The incidence rates of adverse experiences and drug-related adverse experiences were not significantly different among the three treatment groups.. The results indicate that administration of montelukast 5mg and 10mg once daily are potent alternatives for the treatment of seasonal allergic rhinitis and demonstrated that the efficacy and the safety profiles are comparable with pranlukast 450mg/day.

Topics: Acetates; Adult; Chromones; Cyclopropanes; Double-Blind Method; Female; Humans; Leukotriene Antagonists; Male; Middle Aged; Nasal Obstruction; Quinolines; Rhinitis, Allergic, Seasonal; Severity of Illness Index; Sleep Initiation and Maintenance Disorders; Sneezing; Sulfides; Treatment Outcome

To compare the long-term effects of an inhaled corticosteroid with those of a leukotriene modifier on measures of clinical efficacy, subject preference, and safety in patients with persistent asthma.. Between November 17, 1998, and May 26, 2000, we conducted a multicenter, randomized, double-blind, double-dummy, parallel-group study of patients aged 15 years or older with persistent asthma. The patients were symptomatic while taking short-acting beta2-agonists alone and were treated with fluticasone propionate (88 microg [2 puffs of 44 microg] twice daily) or montelukast (10 mg/d) for 24 weeks. Measures of pulmonary function, asthma symptoms, albuterol use, nighttime awakenings, physician assessments of efficacy, patient satisfaction, asthma-related quality of life, and safety were evaluated.. A total of 522 patients were randomized to receive fluticasone or montelukast, and 395 patients completed the study. At end point, treatment with fluticasone significantly improved pulmonary function, asthma symptom scores, the percentage of symptom-free days, rescue albuterol use, and the number of nighttime awakenings due to asthma when compared with montelukast (P< or = .002, each comparison). Significantly more patients were satisfied with fluticasone therapy (83%) compared with montelukast therapy (66%) (P<.001), and fluticasone therapy was rated as effective by a significantly greater portion of physicians (67%) than was montelukast therapy (54%) (P<.001). Treatment with fluticasone significantly improved asthma-related quality-of-life measures compared with montelukast (P< or =.01). The incidence of asthma exacerbations was similar in the fluticasone (19 patients, 7%) and montelukast (21 patients, 8%) treatment groups, although slightly more patients in the montelukast group were withdrawn from the study because of asthma exacerbations (6% vs 4%, respectively).. Long-term treatment with a low dose of inhaled fluticasone is more effective than oral montelukast as first-line maintenance therapy for the treatment of persistent asthma.

Topics: Acetates; Administration, Inhalation; Administration, Oral; Adolescent; Adult; Aged; Androstadienes; Anti-Allergic Agents; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Chronic Disease; Cyclopropanes; Dose-Response Relationship, Drug; Double-Blind Method; Female; Fluticasone; Headache; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Patient Satisfaction; Quality of Life; Quinolines; Respiratory Tract Infections; Sleep Initiation and Maintenance Disorders; Sulfides; Treatment Outcome

Topics: Acetates; Adolescent; Adult; Anti-Asthmatic Agents; Child; Cyclopropanes; Dreams; Female; Humans; Male; Quinolines; Risk; Sleep Initiation and Maintenance Disorders; Spain; Sulfides