[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].
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.


CONCLUSIONS
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.
Zheng
Jin-ping
JP
Guangzhou Institute of Respiratory Disease, First Hospital Affiliated, Guangzhou Medical College, Guangzhou 510120, China.
Kang
Jian
J
Cai
Bai-qiang
BQ
Zhou
Xin
X
Cao
Zhao-long
ZL
Bai
Chun-xue
CX
Zhong
Nan-shan
NS
D000336:Aerosols; D000368:Aged; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D009241:Ipratropium / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011208:Powders; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D012602:Scopolamine Derivatives / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000069447:Tiotropium Bromide
D000336:Aerosols; D001993:Bronchodilator Agents; D011208:Powders; D012602:Scopolamine Derivatives; D009241:Ipratropium; D000069447:Tiotropium Bromide