A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease

doi:10.1183/09031936.02.00269802

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A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease

R. Casaburi¹, D.A. Mahler², P.W. Jones³, A. Wanner⁴, G. San Pedro⁵, R.L. ZuWallack⁶, S.S. Menjoge⁷, C.W. Serby⁷ and T. Witek, Jr⁷

¹ Harbor-UCLA Research and Education Institute, Torrance, CA, ² Dartmouth Hitchcock Medical Center, Lebanon, NH, ⁴ University of Miami School of Medicine, Miami, FL, ⁵ Louisiana State University Medical Center, Shreveport, LA, ⁶ St Francis Hospital and Medical Center, Hartford, CT, and ⁷ Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA. ³ St George's Hospital, London, UK

CORRESPONDENCE: R. Casaburi, Harbor-UCLA Research and Education Institute, Building RB-2, 1124 W. Carson Street, Torrance, CA, 90502, USA. Fax: 1 310 3289849. E-mail: casaburi@ucla.edu

Keywords: chronic obstructive pulmonary disease, dyspnoea, exacerbations, quality of life, tiotropium

Received: August 9, 2001
Accepted November 2, 2001

This study was supported by Boehringer Ingelheim Pharmaceuticals, Inc.

Currently available inhaled bronchodilators used as therapyfor chronic obstructive pulmonary disease (COPD) necessitatemultiple daily dosing. The present study evaluates the long-termsafety and efficacy of tiotropium, a new once-daily anticholinergicin COPD.

Patients with stable COPD (age 65.2±8.7 yrs (mean±sd),n=921) were enrolled in two identical randomized double-blindplacebo-controlled 1-yr studies. Patients inhaled tiotropium18 µg or placebo (mean screening forced expiratoryvolume in one second (FEV₁) 1.01 versus 0.99 L, 39.1 and38.1% of the predicted value) once daily as a dry powder. Theprimary spirometric outcome was trough FEV₁ (i.e. FEV₁ priorto dosing). Changes in dyspnoea were measured using the TransitionDyspnea Index, and health status with the disease-specific St.George's Respiratory Questionnaire and the generic Short Form36. Medication use and adverse events were recorded.

Tiotropium provided significantly superior bronchodilation relativeto placebo for trough FEV₁ response ( $~$ 12% over baseline) (p<0.01)and mean response during the 3 h following dosing ( $~$ 22%over baseline) (p<0.001) over the 12-month period. Tiotropiumrecipients showed less dyspnoea (p<0.001), superior healthstatus scores, and fewer COPD exacerbations and hospitalizations(p<0.05). Adverse events were comparable with placebo, exceptfor dry mouth incidence (tiotropium 16.0% versus placebo 2.7%,p<0.05).

Tiotropium is an effective, once-daily bronchodilator that reducesdyspnoea and chronic obstructive pulmonary disease exacerbationfrequency and improves health status. This suggests that tiotropiumwill make an important contribution to chronic obstructive pulmonarydisease therapy.

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J.B. Oostenbrink, M.P.M.H. Rutten-van Molken, M.J. Al, J.A. Van Noord, and W. Vincken
One-year cost-effectiveness of tiotropium versus ipratropium to treat chronic obstructive pulmonary disease
Eur. Respir. J., February 1, 2004; 23(2): 241 - 249.
[Abstract] [Full Text] [PDF]

D. Turck, W. Weber, R. Sigmund, K. Budde, H.-H. Neumayer, L. Fritsche, K.-L. Rominger, U. Feifel, and T. Slowinski
Pharmacokinetics of Intravenous, Single-Dose Tiotropium in Subjects with Different Degrees of Renal Impairment
J. Clin. Pharmacol., February 1, 2004; 44(2): 163 - 172.
[Abstract] [Full Text] [PDF]

M. Cazzola and M. G. Matera
Long-Acting Bronchodilators Are the First-Choice Option for the Treatment of Stable COPD
Chest, January 1, 2004; 125(1): 9 - 11.
[Full Text] [PDF]

D. P. Tashkin and C. B. Cooper
The Role of Long-Acting Bronchodilators in the Management of Stable COPD
Chest, January 1, 2004; 125(1): 249 - 259.
[Abstract] [Full Text] [PDF]

N. K. Leidy, S. I. Rennard, J. Schmier, M. K. C. Jones, and M. Goldman
The Breathlessness, Cough, and Sputum Scale: The Development of Empirically Based Guidelines for Interpretation
Chest, December 1, 2003; 124(6): 2182 - 2191.
[Abstract] [Full Text] [PDF]

B. R. Celli
A 62-Year-Old Woman With Chronic Obstructive Pulmonary Disease
JAMA, November 26, 2003; 290(20): 2721 - 2729.
[Full Text] [PDF]

D. D. Sin, F. A. McAlister, S. F. P. Man, and N. R. Anthonisen
Contemporary Management of Chronic Obstructive Pulmonary Disease: Scientific Review
JAMA, November 5, 2003; 290(17): 2301 - 2312.
[Abstract] [Full Text] [PDF]

B. Celli, R. ZuWallack, S. Wang, and S. Kesten
Improvement in Resting Inspiratory Capacity and Hyperinflation With Tiotropium in COPD Patients With Increased Static Lung Volumes
Chest, November 1, 2003; 124(5): 1743 - 1748.
[Abstract] [Full Text] [PDF]