A comparison of tiotropium 18μg, once daily and ipratropium 40μg, 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 YooHong 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

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background: This study compared the bronchodilator efficacy and safety of tiotropium inhalation capsules (18μg once daily) with a ipratropium metered dose inhaler (2 puffs of 20μg 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 18μg once daily or ipratropium 40μg 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 (FEV 1) 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 FEV 1 of 42 (12)% were analyzed. The trough FEV 1 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.

Original languageEnglish
Pages (from-to)498-506
Number of pages9
JournalTuberculosis and Respiratory Diseases
Volume58
Issue number5
Publication statusPublished - 2005 May 1

Fingerprint

Ipratropium
Chronic Obstructive Pulmonary Disease
Safety
Inhalation
Peak Expiratory Flow Rate
Bronchodilator Agents
Metered Dose Inhalers
Albuterol
Vital Capacity
Forced Expiratory Volume
Capsules
Tiotropium Bromide
Therapeutics
Outcome Assessment (Health Care)
Lung
Pharmaceutical Preparations

Keywords

  • COPD
  • Efficacy
  • Ipratropium
  • Safety
  • Tiotropium

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Infectious Diseases

Cite this

A comparison of tiotropium 18μg, once daily and ipratropium 40μg, 4 times daily in a double-blind, double-dummy, efficacy and safety study in adults with chronic obstructive pulmonary disease. / Kim, Seung Joon; Kim, Myung Sook; Lee, Sang Haak; Kim, Young Kyoon; Moon, Hwa Sik; Park, Sung Hak; Lee, Sang Yeub; In, Kwang Ho; Lee, Chang Youl; Kim, Young Sam; Kim, Hyung Jung; Ahn, Chul Min; Kim, Sung Kyu; Kim, Kyung Rok; Cha, Seung Ick; Jung, Tae Hoon; Kim, Mi Ok; Park, Sung Soo; Choi, Cheon Woong; Yoo, Jee Hong; Kang, Hong Mo; Koh, Won Jung; Ham, Hyoung Suk; Kang, Eun Hae; Kwon, O. Jung; Lee, Yang Deok; Lee, Heung Bum; Lee, Yong Chul; Rhee, Yang Keun; Shin, Won Hyuk; Kwon, Sung Yeon; Kim, Woo Jin; Yoo, Chul Gyu; Kim, Young Whan; Shim, Young Soo; Han, Sung Koo; Park, Hye Kyung; Kim, Yun Seong; Lee, Min Ki; Park, Soon Kew; Kim, Mi Hye; Lee, Won Yeon; Yong, Suk Joong; Shin, Kye Chul; Choi, Byoung Whui; Oh, Yeon Mok; Lim, Chae Man; Lee, Sang Do; Kim, Woo Sung; Kim, Dong Soon; Jung, Sung Soo; Kim, Ju Ock; Ko, Young Chun; Kim, Young Chul; Yoo, Nam Soo.

In: Tuberculosis and Respiratory Diseases, Vol. 58, No. 5, 01.05.2005, p. 498-506.

Research output: Contribution to journalArticle

Kim, SJ, Kim, MS, Lee, SH, Kim, YK, Moon, HS, Park, SH, Lee, SY, In, KH, Lee, CY, Kim, YS, Kim, HJ, Ahn, CM, Kim, SK, Kim, KR, Cha, SI, Jung, TH, Kim, MO, Park, SS, Choi, CW, Yoo, JH, Kang, HM, Koh, WJ, Ham, HS, Kang, EH, Kwon, OJ, Lee, YD, Lee, HB, Lee, YC, Rhee, YK, Shin, WH, Kwon, SY, Kim, WJ, Yoo, CG, Kim, YW, Shim, YS, Han, SK, Park, HK, Kim, YS, Lee, MK, Park, SK, Kim, MH, Lee, WY, Yong, SJ, Shin, KC, Choi, BW, Oh, YM, Lim, CM, Lee, SD, Kim, WS, Kim, DS, Jung, SS, Kim, JO, Ko, YC, Kim, YC & Yoo, NS 2005, 'A comparison of tiotropium 18μg, once daily and ipratropium 40μg, 4 times daily in a double-blind, double-dummy, efficacy and safety study in adults with chronic obstructive pulmonary disease', Tuberculosis and Respiratory Diseases, vol. 58, no. 5, pp. 498-506.
Kim, Seung Joon ; Kim, Myung Sook ; Lee, Sang Haak ; Kim, Young Kyoon ; Moon, Hwa Sik ; Park, Sung Hak ; Lee, Sang Yeub ; In, Kwang Ho ; Lee, Chang Youl ; Kim, Young Sam ; Kim, Hyung Jung ; Ahn, Chul Min ; Kim, Sung Kyu ; Kim, Kyung Rok ; Cha, Seung Ick ; Jung, Tae Hoon ; Kim, Mi Ok ; Park, Sung Soo ; Choi, Cheon Woong ; Yoo, Jee Hong ; Kang, Hong Mo ; Koh, Won Jung ; Ham, Hyoung Suk ; Kang, Eun Hae ; Kwon, O. Jung ; Lee, Yang Deok ; Lee, Heung Bum ; Lee, Yong Chul ; Rhee, Yang Keun ; Shin, Won Hyuk ; Kwon, Sung Yeon ; Kim, Woo Jin ; Yoo, Chul Gyu ; Kim, Young Whan ; Shim, Young Soo ; Han, Sung Koo ; Park, Hye Kyung ; Kim, Yun Seong ; Lee, Min Ki ; Park, Soon Kew ; Kim, Mi Hye ; Lee, Won Yeon ; Yong, Suk Joong ; Shin, Kye Chul ; Choi, Byoung Whui ; Oh, Yeon Mok ; Lim, Chae Man ; Lee, Sang Do ; Kim, Woo Sung ; Kim, Dong Soon ; Jung, Sung Soo ; Kim, Ju Ock ; Ko, Young Chun ; Kim, Young Chul ; Yoo, Nam Soo. / A comparison of tiotropium 18μg, once daily and ipratropium 40μg, 4 times daily in a double-blind, double-dummy, efficacy and safety study in adults with chronic obstructive pulmonary disease. In: Tuberculosis and Respiratory Diseases. 2005 ; Vol. 58, No. 5. pp. 498-506.
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abstract = "Background: This study compared the bronchodilator efficacy and safety of tiotropium inhalation capsules (18μg once daily) with a ipratropium metered dose inhaler (2 puffs of 20μg 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 18μg once daily or ipratropium 40μg 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 (FEV 1) 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 FEV 1 of 42 (12){\%} were analyzed. The trough FEV 1 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.",
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author = "Kim, {Seung Joon} and Kim, {Myung Sook} and Lee, {Sang Haak} and Kim, {Young Kyoon} and Moon, {Hwa Sik} and Park, {Sung Hak} and Lee, {Sang Yeub} and In, {Kwang Ho} and Lee, {Chang Youl} and Kim, {Young Sam} and Kim, {Hyung Jung} and Ahn, {Chul Min} and Kim, {Sung Kyu} and Kim, {Kyung Rok} and Cha, {Seung Ick} and Jung, {Tae Hoon} and Kim, {Mi Ok} and Park, {Sung Soo} and Choi, {Cheon Woong} and Yoo, {Jee Hong} and Kang, {Hong Mo} and Koh, {Won Jung} and Ham, {Hyoung Suk} and Kang, {Eun Hae} and Kwon, {O. Jung} and Lee, {Yang Deok} and Lee, {Heung Bum} and Lee, {Yong Chul} and Rhee, {Yang Keun} and Shin, {Won Hyuk} and Kwon, {Sung Yeon} and Kim, {Woo Jin} and Yoo, {Chul Gyu} and Kim, {Young Whan} and Shim, {Young Soo} and Han, {Sung Koo} and Park, {Hye Kyung} and Kim, {Yun Seong} and Lee, {Min Ki} and Park, {Soon Kew} and Kim, {Mi Hye} and Lee, {Won Yeon} and Yong, {Suk Joong} and Shin, {Kye Chul} and Choi, {Byoung Whui} and Oh, {Yeon Mok} and Lim, {Chae Man} and Lee, {Sang Do} and Kim, {Woo Sung} and Kim, {Dong Soon} and Jung, {Sung Soo} and Kim, {Ju Ock} and Ko, {Young Chun} and Kim, {Young Chul} and Yoo, {Nam Soo}",
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T1 - A comparison of tiotropium 18μg, once daily and ipratropium 40μg, 4 times daily in a double-blind, double-dummy, efficacy and safety study in adults with chronic obstructive pulmonary disease

AU - Kim, Seung Joon

AU - Kim, Myung Sook

AU - Lee, Sang Haak

AU - Kim, Young Kyoon

AU - Moon, Hwa Sik

AU - Park, Sung Hak

AU - Lee, Sang Yeub

AU - In, Kwang Ho

AU - Lee, Chang Youl

AU - Kim, Young Sam

AU - Kim, Hyung Jung

AU - Ahn, Chul Min

AU - Kim, Sung Kyu

AU - Kim, Kyung Rok

AU - Cha, Seung Ick

AU - Jung, Tae Hoon

AU - Kim, Mi Ok

AU - Park, Sung Soo

AU - Choi, Cheon Woong

AU - Yoo, Jee Hong

AU - Kang, Hong Mo

AU - Koh, Won Jung

AU - Ham, Hyoung Suk

AU - Kang, Eun Hae

AU - Kwon, O. Jung

AU - Lee, Yang Deok

AU - Lee, Heung Bum

AU - Lee, Yong Chul

AU - Rhee, Yang Keun

AU - Shin, Won Hyuk

AU - Kwon, Sung Yeon

AU - Kim, Woo Jin

AU - Yoo, Chul Gyu

AU - Kim, Young Whan

AU - Shim, Young Soo

AU - Han, Sung Koo

AU - Park, Hye Kyung

AU - Kim, Yun Seong

AU - Lee, Min Ki

AU - Park, Soon Kew

AU - Kim, Mi Hye

AU - Lee, Won Yeon

AU - Yong, Suk Joong

AU - Shin, Kye Chul

AU - Choi, Byoung Whui

AU - Oh, Yeon Mok

AU - Lim, Chae Man

AU - Lee, Sang Do

AU - Kim, Woo Sung

AU - Kim, Dong Soon

AU - Jung, Sung Soo

AU - Kim, Ju Ock

AU - Ko, Young Chun

AU - Kim, Young Chul

AU - Yoo, Nam Soo

PY - 2005/5/1

Y1 - 2005/5/1

N2 - Background: This study compared the bronchodilator efficacy and safety of tiotropium inhalation capsules (18μg once daily) with a ipratropium metered dose inhaler (2 puffs of 20μg 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 18μg once daily or ipratropium 40μg 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 (FEV 1) 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 FEV 1 of 42 (12)% were analyzed. The trough FEV 1 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.

AB - Background: This study compared the bronchodilator efficacy and safety of tiotropium inhalation capsules (18μg once daily) with a ipratropium metered dose inhaler (2 puffs of 20μg 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 18μg once daily or ipratropium 40μg 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 (FEV 1) 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 FEV 1 of 42 (12)% were analyzed. The trough FEV 1 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.

KW - COPD

KW - Efficacy

KW - Ipratropium

KW - Safety

KW - Tiotropium

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