Bronchodilator efficacy of tiotropium-formoterol via single pressurized meter dose inhaler (pMDI) versus tiotropium alone in COPD

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• 作者：Sundeep Salvi ; Bill Brashier ; Dipti Gothi ; Vinaya Karkhanis ; Sapna Madas ; Jaideep Gogtay ; Jyotsna Joshi
• 关键词：Tiotropium ; Formoterol ; COPD
• 刊名：Pulmonary Pharmacology & Therapeutics
• 出版年：February, 2014
• 年：2014
• 卷：27
• 期：1
• 页码：90-95
• 全文大小：747 K

文摘

Background

Bronchodilators form the main stay of treatment for COPD. When symptoms are not adequately controlled with one bronchodilator, addition of another bronchodilator is recommended. We have recently developed a combination of tiotropium and formoterol in a single pressurized metered dose inhaler (pMDI) (Cipla Ltd., India). The aim of this study was to compare the bronchodilator effects of a single dose of 18聽mcg of tiotropium versus a single dose of a combination of 18聽mcg tiotropium plus 12聽mcg formoterol administered via a pMDI in subjects with moderate-to-severe COPD.

Study design

<p>44 COPD subjects were enrolled in this randomized, double-blind, multi-centre, cross-over study. 18聽mcg tiotropium and 18聽mcg tiotropium plus 12聽mcg formoterol were administered via pressurized metered dose inhalers on two separate days. FEV₁, FVC and Inspiratory capacity (IC) were measured before, 15, 30聽min, 1, 2, 3, 4, 6, 8, 12 and 24聽h after the study drugs were administered.

Results

<p>Compared with tiotropium alone, a combination of tiotropium plus formoterol showed a faster onset of bronchodilator response (p聽<聽0.01 for FEV1 and FVC), a greater mean maximum change in FEV1 (p聽=聽0.01) and FVC (p聽=聽0.008) and greater AUC_0-24h values for FEV₁, FVC and IC. Trough FEV₁ and FVC values were also greater in the combination group.

Conclusion

<p>A combination of tiotropium plus formoterol administered via a single inhaler produced a superior bronchodilator response than tiotropium alone over a period of 24聽h.