A multicenter, placebo-controlled study of twice daily triamcinolone acetonide (800 μg per day) for the treatment of patients with mild-to-moderate asthma

被引:8
作者
Bernstein, DI
Cohen, R
Ginchansky, E
Pedinoff, AJ
Tinkelman, DG
Winder, JA
机构
[1] Bernstein Clin Res Ctr, Cincinnati, OH USA
[2] Ctr Asthma & Allergy, Lawrenceville, NJ USA
[3] Ctr Asthma & Allergy, Dallas, TX USA
[4] Princeton Allergy & Asthma Associates, Princeton, NJ USA
[5] Atlanta Asthma & Allergy Res, Atlanta, GA USA
[6] Allergy & Asthma Res Ctr Toledo, Sylvania, OH USA
关键词
triamcinolone; asthma; inhaled corticosteroid;
D O I
10.1016/S0091-6749(98)70349-5
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
Background: National and international guidelines recommend the use of inhaled antiinflammatory medications in patients with all but the mildest forms of asthma. Twice daily dosing may increase compliance with therapy. Objective: We sought to evaluate the safety and efficacy of 400 mu g twice daily triamcinolone acetonide (TAA) compared with placebo in adult patients with mild-to-moderate asthma who were poorly controlled by beta(2)-agonist therapy. Methods: We performed a multicenter, randomized, double-blind, placebo-controlled study, including a screening visit, a 7- to 21-day pretreatment baseline phase, and a 6-week double-blind treatment phase. Efficacy was measured by weekly spirometry and daily diary recordings of peak flow rates, asthma symptom scores, and albuterol use. Eligible patients used albuterol four or more times per day, had total asthma symptom scores of 15 or greater (possible total, 60) over 5 of 7 baseline days, and had FEV1 measurements of 60% of predicted value or greater. Results: One hundred twenty-one patients were randomized to treatment. TAA was superior to placebo for all efficacy measures, with significant improvements in asthma symptoms, albuterol use, morning and evening peak flow rates, and forced vital capacity evident at Treatment Week 1. Significant improvements in other pulmonary function measurements were observed after 2 or more weeks. All efficacy variables improved progressively throughout the study. Conclusions: Twice daily TAA (400 mu g) decreased asthma symptoms and improved lung function in patients with mild-to-moderate asthma compared with placebo. Therapeutic benefit was evident within 1 week and increased throughout treatment.
引用
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页码:433 / 438
页数:6
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