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[Comparison of tiotropium inhalation capsules and ipratropium metered dose inhaler in a randomized, double-blind, double-dummy, efficacy and safety study in patients with chronic obstructive pulmonary disease].
Zhonghua Jie He He Hu Xi Za Zhi. 2006 Jun; 29(6):363-7.ZJ

Abstract

OBJECTIVE

To compare the efficacy and safety between tiotropium capsule and ipratropium MDI in a 4 week treatment in patients with chronic obstructive pulmonary disease (COPD).

METHODS

A multi-center, randomized, double blind, double dummy and parallel comparison clinical trial was conducted in 221 stable moderate to severe patients with COPD. They were randomized into tiotropium 18 microg once per day arm or ipratropium 2 puffs qid. arm for four weeks. The spirometry was conducted at 5 minutes pre-medication; and 30, 60, 120, and 180 minutes post-medication before; 2 weeks and 4 weeks after treatment.

RESULTS

The forced expiratory volume in one second (FEV(1)) trough response, the primary endpoint, was significantly higher in the tiotropium arm than that of the ipratropium with (0.063 +/- 0.024) L (95% CI 0.016 - 0.111 L, t = 2.63, P = 0.009) after 4 weeks of treatment. Meanwhile the clinical evidences indicated the continuous improvement of bronchodilation in the tiotropium arm. Forced vital capacity (FVC) trough response was also significantly higher in the tiotropium arm 4 weeks after treatment with (0.133 +/- 0.047) L (t = 2.83, P = 0.005). By comparison with baseline, no significant differences were found between these two arms in the average change of FEV(1) as well as FVC 0 - 3 hours after inhalation (all P > 0.05). There was no significant difference in rescue medication consumptions (t = 0.60, P = 0.548). Adverse events occurred in 12 (10.9%) patients in the tiotropium arm and 18 (16.2%) in the ipratropium arm, without statistical difference (chi(2) = 1.326, P = 0.249). The major adverse event in the tiotropium group was dry mouth (5, 4.5%). No cardiac disorder or abnormal electrocardiogram was reported.

CONCLUSION

The results indicated that tiotropium 18 microg once per day is more potent than ipratropium qid. in bronchodilation to COPD patients with the similar tolerance of ipratropium.

Authors+Show Affiliations

Guangzhou Institute of Respiratory Disease, First Hospital Affiliated, Guangzhou Medical College, Guangzhou 510120, China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
English Abstract
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

chi

PubMed ID

17045014

Citation

Zheng, Jin-ping, et al. "[Comparison of Tiotropium Inhalation Capsules and Ipratropium Metered Dose Inhaler in a Randomized, Double-blind, Double-dummy, Efficacy and Safety Study in Patients With Chronic Obstructive Pulmonary Disease]." Zhonghua Jie He He Hu Xi Za Zhi = Zhonghua Jiehe He Huxi Zazhi = Chinese Journal of Tuberculosis and Respiratory Diseases, vol. 29, no. 6, 2006, pp. 363-7.
Zheng JP, Kang J, Cai BQ, et al. [Comparison of tiotropium inhalation capsules and ipratropium metered dose inhaler in a randomized, double-blind, double-dummy, efficacy and safety study in patients with chronic obstructive pulmonary disease]. Zhonghua Jie He He Hu Xi Za Zhi. 2006;29(6):363-7.
Zheng, J. P., Kang, J., Cai, B. Q., Zhou, X., Cao, Z. L., Bai, C. X., & Zhong, N. S. (2006). [Comparison of tiotropium inhalation capsules and ipratropium metered dose inhaler in a randomized, double-blind, double-dummy, efficacy and safety study in patients with chronic obstructive pulmonary disease]. Zhonghua Jie He He Hu Xi Za Zhi = Zhonghua Jiehe He Huxi Zazhi = Chinese Journal of Tuberculosis and Respiratory Diseases, 29(6), 363-7.
Zheng JP, et al. [Comparison of Tiotropium Inhalation Capsules and Ipratropium Metered Dose Inhaler in a Randomized, Double-blind, Double-dummy, Efficacy and Safety Study in Patients With Chronic Obstructive Pulmonary Disease]. Zhonghua Jie He He Hu Xi Za Zhi. 2006;29(6):363-7. PubMed PMID: 17045014.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [Comparison of tiotropium inhalation capsules and ipratropium metered dose inhaler in a randomized, double-blind, double-dummy, efficacy and safety study in patients with chronic obstructive pulmonary disease]. AU - Zheng,Jin-ping, AU - Kang,Jian, AU - Cai,Bai-qiang, AU - Zhou,Xin, AU - Cao,Zhao-long, AU - Bai,Chun-xue, AU - Zhong,Nan-shan, PY - 2006/10/19/pubmed PY - 2010/9/8/medline PY - 2006/10/19/entrez SP - 363 EP - 7 JF - Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases JO - Zhonghua Jie He He Hu Xi Za Zhi VL - 29 IS - 6 N2 - OBJECTIVE: To compare the efficacy and safety between tiotropium capsule and ipratropium MDI in a 4 week treatment in patients with chronic obstructive pulmonary disease (COPD). METHODS: A multi-center, randomized, double blind, double dummy and parallel comparison clinical trial was conducted in 221 stable moderate to severe patients with COPD. They were randomized into tiotropium 18 microg once per day arm or ipratropium 2 puffs qid. arm for four weeks. The spirometry was conducted at 5 minutes pre-medication; and 30, 60, 120, and 180 minutes post-medication before; 2 weeks and 4 weeks after treatment. RESULTS: The forced expiratory volume in one second (FEV(1)) trough response, the primary endpoint, was significantly higher in the tiotropium arm than that of the ipratropium with (0.063 +/- 0.024) L (95% CI 0.016 - 0.111 L, t = 2.63, P = 0.009) after 4 weeks of treatment. Meanwhile the clinical evidences indicated the continuous improvement of bronchodilation in the tiotropium arm. Forced vital capacity (FVC) trough response was also significantly higher in the tiotropium arm 4 weeks after treatment with (0.133 +/- 0.047) L (t = 2.83, P = 0.005). By comparison with baseline, no significant differences were found between these two arms in the average change of FEV(1) as well as FVC 0 - 3 hours after inhalation (all P > 0.05). There was no significant difference in rescue medication consumptions (t = 0.60, P = 0.548). Adverse events occurred in 12 (10.9%) patients in the tiotropium arm and 18 (16.2%) in the ipratropium arm, without statistical difference (chi(2) = 1.326, P = 0.249). The major adverse event in the tiotropium group was dry mouth (5, 4.5%). No cardiac disorder or abnormal electrocardiogram was reported. CONCLUSION: The results indicated that tiotropium 18 microg once per day is more potent than ipratropium qid. in bronchodilation to COPD patients with the similar tolerance of ipratropium. SN - 1001-0939 UR - https://www.unboundmedicine.com/medline/citation/17045014/[Comparison_of_tiotropium_inhalation_capsules_and_ipratropium_metered_dose_inhaler_in_a_randomized_double_blind_double_dummy_efficacy_and_safety_study_in_patients_with_chronic_obstructive_pulmonary_disease]_ L2 - http://journal.yiigle.com/LinkIn.do?linkin_type=pubmed&issn=1001-0939&year=2006&vol=29&issue=6&fpage=363 DB - PRIME DP - Unbound Medicine ER -