Tuberc Respir Dis > Volume 58(5); 2005 > Article
Tuberculosis and Respiratory Diseases 2005;58(5):498-506.
DOI:    Published online May 1, 2005.
A Comparison of Tiotropium 18microgram, Once Daily and Ipratropium 40microgram, 4 Times Daily in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults with Chronic Obstructive Pulmonary Disease.
Seung Joon Kim, Myung Sook Kim, Sang Haak Lee, Young Kyoon Kim, Hwa Sik Moon, Sung Hak Park, Sang Yeub Lee, Kwang Ho In, Chang Youl Lee, Young Sam Kim, Hyung Jung Kim, Chul Min Ahn, Sung Kyu Kim, Kyung Rok Kim, Seung Ick Cha, Tae Hoon Jung, Mi Ok Kim, Sung Soo Park, Cheon Woong Choi, Jee Hong Yoo, Hong Mo Kang, Won Jung Koh, Hyoung Suk Ham, Eun Hae Kang, O Jung Kwon, Yang Deok Lee, Heung Bum Lee, Yong Chul Lee, Yang Keun Rhee, Won Hyuk Shin, Sung Yeon Kwon, Woo Jin Kim, Chul Gyu Yoo, Young Whan Kim, Young Soo Shim, Sung Koo Han, Hye Kyung Park, Yun Seong Kim, Min Ki Lee, Soon Kew Park, Mi Hye Kim, Won Yeon Lee, Suk Joong Yong, Kye Chul Shin, Byoung Whui Choi, Yeon Mok Oh, Chae Man Lim, Sang Do Lee, Woo Sung Kim, Dong Soon Kim, Sung Soo Jung, Ju Ock Kim, Young Chun Ko, Young Chul Kim, Nam Soo Yoo
1Department of Internal Medicine, Catholic University, Korea.
2Department of Internal Medicine, Korea University, Korea.
3Department of Internal Medicine, Yonsei University, Korea.
4Department of Internal Medicine, Kyungpook University, Korea.
5Department of Internal Medicine, Hanyang University, Korea.
6Department of Internal Medicine, Kyung Hee University, Korea.
7Department of Internal Medicine, Sungkyunkwan University, Korea.
8Department of Internal Medicine, Chonbuk University, Korea.
9Department of Internal Medicine, Seoul University, Korea.
10Department of Internal Medicine, Pusan University, Korea.
11Department of Internal Medicine, Yonsei Wonju University, Korea.
12Department of Internal Medicine, ChungAng University, Korea.
13Department of Internal Medicine, Ulsan University, Korea.
14Department of Internal Medicine, Chungnam University, Korea.
15Department of Internal Medicine, Chonnam University, Korea.
16Department of Internal Medicine, National Medical Center, Korea.
This study compared the bronchodilator efficacy and safety of tiotropium inhalation capsules (18microgram once daily) with a ipratropium metered dose inhaler (2 puffs of 20microgram 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 18microgram once daily or ipratropium 40microgram 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 13.88 l/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.
Key Words: Tiotropium, Ipratropium, COPD, Efficacy, Safety
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