만성 폐쇄성 폐질환 환자에서 Tiotropium 1일 1회, 1회 18㎍ 요법과 Ipratropium 1일 4회, 1회 40㎍ 요법의 치료효과 및 안전성 비교

Abstract

Background : This study compared the bronchodilator efficacy and safety of tiotropium inhalation capsules (18㎍once daily) with a ipratropium metered dose inhaler (2 puffs of 20㎍ q.i.d.) in patients with chronic obstructive pulmonary disease (COPD).

Method : After the initial screening assessment and a two-week run-in period, patients received either tiotropium 18㎍once daily or ipratropium 40㎍four times daily over a period of 4 weeks in a double blind, double dummy, parallel group study. The outcome measures were the lung function, the daily records of the peak expiratory flow rate (PEFR), the patients´ questionnaire, and the use of concomitant salbutamol. The forced expiratory volume in one second (FEV1) and the forced vital capacity (FVC) were measured 5 minutes before inhalation, and 0.5, 1, 2 and 3 hours after inhaling the study drug on days 0, 14 and 28.

Result : In 16 centers, 134 patients with a mean (SD) age of 66 (7) years and a predicted FEV1 of 42 (12)% were analyzed. The trough FEV1 response was significantly higher in the tiotropium group than in the ipratropium group after a four-week treatment period. The weekly mean morning PEFR of the tiotropium group was consistently higher than that of the ipratropium group during the 4-week treatment period with differences ranging from 12.52 to 13.88l/min, which were statistically significant. Tiotropium was well tolerated by the COPD patients during the 4-week treatment period and had a similar safety profile to ipratropium.

Conclusion : This study shows that tiotropium administrated once daily has a superior bronchodilator effect with a similar safety profile in treating COPD patients compared with ipratropium, inhaled four times daily.