Dose-ranging study of the clinical efficacy of twice-daily triamcinolone acetonide inhalation aerosol in moderately severe asthma.

Abstract:

OBJECTIVES:This multicenter, double-blind, placebo-controlled study evaluated the dose response to 6 weeks of triamcinolone acetonide inhalation aerosol (TAA, 100 microg per puff) in patients with moderately severe asthma. STUDY DESIGN:A total of 285 patients were randomly assigned to treatment with 1, 2, 4, or 8 puffs TAA (total daily doses of 200, 400, 800, and 1,600 microg, respectively), administered twice daily, or matching placebos. Efficacy was assessed by changes in FEV1, asthma symptom scores, albuterol use, and peak flow rates. RESULTS:Linear trend analyses showed a dose response for all efficacy variables across the dose range of 200 to 1,600 microg daily. Therapeutic activity was evident at a dose of 200 microg daily for all variables, with significant clinical efficacy (p<0.05) demonstrated for all doses except for reduction in inhaled albuterol use which achieved statistical significance at 400 microg/d. Daily doses of 400 microg and higher showed response plateaus at 3 weeks of treatment that were maintained for the remainder of the trial. The incidence of adverse events was similar in all treatment groups, although more patients treated with TAA reported pharyngitis in a dose-related manner. CONCLUSIONS:Our findings suggest that most patients with chronic, moderately severe asthma can be treated adequately with doses of TAA between 200 microg (1 puff bid) and 800 microg (4 puffs bid) daily. At this dose range, clinically significant improvements are evident in symptoms, pulmonary function, and rescue medication use.

journal_name

Chest

journal_title

Chest

authors

Welch MJ,Levy S,Smith JA,Feiss G,Farrar JR

doi

10.1378/chest.112.3.597

subject

Has Abstract

pub_date

1997-09-01 00:00:00

pages

597-606

issue

3

eissn

0012-3692

issn

1931-3543

pii

S0012-3692(16)31725-1

journal_volume

112

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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