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Abstract: Poster Presentations |

ADDITION OF FORMOTEROL TO TIOTROPIUM PRODUCES BETTER FEV1 AND FVC RESPONSES WHEN MEASURED OVER 24 HOURS FOLLOWING SINGLE-DOSE ADMINISTRATION IN SUBJECTS WITH MODERATE-TO-SEVERE COPD FREE TO VIEW

Bill Brashier, MBBS; Ashwini Jantikar, MBBS; Manisha Maganji, MBBS; Anchala Raghupathy, MBBS; Sapna Valsa, MS; Partha Gokhale, MD; Purnima Mahadik, MS; Jaideep Gogtay, MD; Sundeep S. Salvi, MD*
Author and Funding Information

Chest Research Foundation, Pune, India


Chest


Chest. 2005;128(4_MeetingAbstracts):258S. doi:10.1378/chest.128.4_MeetingAbstracts.258S
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Abstract

PURPOSE:  Tiotropium, a new long-acting anticholinergic drug is recommended as first-line bronchodilator in the management of COPD. The aim of this study was to investigate whether addition of Formoterol, a long-acting b2-agonist produces a superior bronchodilator response when compared to Tiotropium alone in subjects with moderate-to-severe stable COPD.

METHODS:  23 male subjects (mean age: 59.6 ± 7.6 yrs) diagnosed with COPD and no histories of exacerbation over the previous 4 weeks, were recruited into this study. Single doses of Tiotropium (18mcg) and a combination of Tiotropium plus Formoterol [18 and 12 mcg respectively) administered through a single ihaler, were given with a pMDI plus non-static spacer on two separate study days, 4-7 days apart, in a randomized, double-blind, cross-over manner. FEV1 and FVC were measured at baseline and 5min, 15min, 30min, 60min, 2hr, 3hr, 4hr, 6hr, 8hr, 12hr and 24hr following the study drug administration with a Vitalograph Gold Standard dry bellows Spirometer.

RESULTS:  The mean baseline FEV1 value in this study population was 40.6 ± 14.1% predicted. Tiotropium plus Formoterol produced a significantly better mean difference in area under the curve change from baseline to 24 hrs for both FEV1 (p = 0.001) and FVC (p = 0.02). Also, the mean difference in trough (24 hr) values from baseline were significantly better with the combination than Tiotropium alone [(FEV1 –289.6mL vs 185.7mL; p = 0.001)(FVC –503.5mL vs 297mL; p = 0.007). The combination showed a faster onset of action for FVC, defined as an increase of at least 150mL from baseline (5.0 mins vs 12.1 mins; p = 0.02) and tended to show a longer duration of action when compared to Tiotropium alone (FEV1: p = 0.06; FVC: p = 0.05).

CONCLUSION:  In patients with moderate-to-severe COPD, addition of Formoterol to Tiotropium (in a single inhaler) produces better FEV1 and FVC responses than Tiotropium alone when measured over 24 hrs.

CLINICAL IMPLICATIONS:  Combination of Tiotropium and Formoterol may produce better clinical response in patients with moderate-to-severe COPD.

DISCLOSURE:  Sundeep Salvi, Grant monies (from industry related sources) Cipla Ltd.

Wednesday, November 2, 2005

12:30 PM - 2:00 PM


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