Journal of the Formosan Medical Association
Volume 105, Issue 9 , Pages 708-714, 2006

Double-blind Randomized Parallel Group Study Comparing the Efficacy and Safety of Tiotropium and Ipratropium in the Treatment of COPD Patients in Taiwan

  • Jeng-Yuan Hsu

      Affiliations

    • Division of Chest Medicine, Taichung Veterans General Hospital, Taiwan
    • Institute of Medicine, Chung-Shan Medical University, Taichung, Taiwan
    • Corresponding Author InformationCorrespondence to: Dr Jeng-Yuan Hsu, Division of Chest Medicine, Taichung Veterans General Hospital, 160 Chung-Kang Road, Section 3, Taichung 407, Taiwan
    • ,
  • Reury-Pemg Perng

      Affiliations

    • Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan
    • ,
  • Jau-Yeong Lu

      Affiliations

    • Division of Chest Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan
    • ,
  • Chin-Pyng Wu

      Affiliations

    • Division of Chest Medicine, Tri-Service General Hospital, Taipei, Taiwan
    • ,
  • Ming-Shyan Huang

      Affiliations

    • Division of Chest Medicine, Chung-Ho Memorial Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
    • ,
  • Kwen-Tay Luh

      Affiliations

    • Division of Chest Medicine, National Taiwan University Hospital, Taipei, Taiwan
    • ,
  • Pan-Chyr Yang

      Affiliations

    • Division of Chest Medicine, National Taiwan University Hospital, Taipei, Taiwan

Received 4 November 2005; received in revised form 12 December 2005; accepted 7 February 2006.

Article Outline

Background/Purpose

To compare the efficacy and safety of tiotropium and ipratropium in patients with chronic obstructive pulmonary disease (COPD) in Taiwan.

Methods

This double-blind, randomized, placebo-controlled, parallel group study was conducted at six hospitals in Taiwan. COPD patients aged ≥ 40 years, with a forced expiratory volume in 1 second (FEV1) ≤65% of predicted and FEV1/forced vital capacity (FVC) ≤ 70% were enrolled. After a 2-week screening/baseline period, 132 patients were randomized to receive 4 weeks of treatment with either tiotropium 18 μg once daily from a dry powder inhaler (HandiHaler(r)) or two puffs of ipratropium 20 μg four times daily from a metered dose inhaler. The primary outcome was the change in trough FEV1 from baseline to week 4. The secondary outcome measures were trough FVC response, FEV1 and FVC responses at 2 hours postinhalation.

Results

After 4 weeks, trough FEV1 had increased by 61.7 + 25.3 mL for tiotropium but decreased by 16.4 + 27.9 mL for ipratropium. The difference between groups was significant (p<0.05; 95% CI, 10-146.1). The trough FVC also increased by 137.2 + 49.3 mL for tiotropium but was decreased by 84.5 + 54.5 mL for ipratropium (p< 0.001; 95% CI, 89.0-354.3). No major drug-related adverse events associated with tiotropium and ipratropium were observed.

Conclusion

Tiotropium 18 μg once daily using HandiHaler(r) was significantly more effective than ipratropium 40 p, g four times daily in improving trough FEV1 and FVC over a 4-week period. The safety profiles of both drugs are comparable.

Key Words:  chronic obstructive pulmonary disease , HandiHaler , ipratropium , metered dose inhaler , tiotropium

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PII: S0929-6646(09)60198-4

doi:10.1016/S0929-6646(09)60198-4

Journal of the Formosan Medical Association
Volume 105, Issue 9 , Pages 708-714, 2006

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