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

R. Casaburi, D. A. Mahler, P. W. Jones, Adam Wanner, G. San Pedro, R. L. ZuWallack, S. S. Menjoge, C. W. Serby, Jr Witek

Research output: Contribution to journalArticle

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Abstract

Currently available inhaled bronchodilators used as therapy for chronic obstructive pulmonary disease (COPD) necessitate multiple daily dosing. The present study evaluates the long-term safety and efficacy of tiotropium, a new once-daily anticholinergic in COPD. Patients with stable COPD (age 65.2±8.7 yrs (mean±SD), n=921) were enrolled in two identical randomized double-blind placebo-controlled 1-yr studies. Patients inhaled tiotropium 18 μg or placebo (mean screening forced expiratory volume in one second (FEV1) 1.01 versus 0.99 L, 39.1 and 38.1% of the predicted value) once daily as a dry powder. The primary spirometric outcome was trough FEV1 (i.e. FEV1 prior to dosing). Changes in dyspnoea were measured using the Transition Dyspnea Index, and health status with the disease-specific St. George's Respiratory Questionnaire and the generic Short Form 36. Medication use and adverse events were recorded. Tiotropium provided significantly superior bronchodilation relative to 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. Tiotropium recipients showed less dyspnoea (p<0.001), superior health status scores, and fewer COPD exacerbations and hospitalizations (p<0.05). Adverse events were comparable with placebo, except for dry mouth incidence (tiotropium 16.0% versus placebo 2.7%, p<0.05). Tiotropium is an effective, once-daily bronchodilator that reduces dyspnoea and chronic obstructive pulmonary disease exacerbation frequency and improves health status. This suggests that tiotropium will make an important contribution to chronic obstructive pulmonary disease therapy.

Original languageEnglish
Pages (from-to)217-224
Number of pages8
JournalEuropean Respiratory Journal
Volume19
Issue number2
DOIs
StatePublished - Mar 4 2002
Externally publishedYes

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Chronic Obstructive Pulmonary Disease
Dyspnea
Placebos
Bronchodilator Agents
Health Status
Disease Progression
Health Status Indicators
Forced Expiratory Volume
Cholinergic Antagonists
Tiotropium Bromide
Powders
Mouth
Hospitalization
Safety
Incidence
Therapeutics

Keywords

  • Chronic obstructive pulmonary disease
  • Dyspnoea
  • Exacerbations
  • Quality of life
  • Tiotropium

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. / Casaburi, R.; Mahler, D. A.; Jones, P. W.; Wanner, Adam; San Pedro, G.; ZuWallack, R. L.; Menjoge, S. S.; Serby, C. W.; Witek, Jr.

In: European Respiratory Journal, Vol. 19, No. 2, 04.03.2002, p. 217-224.

Research output: Contribution to journalArticle

Casaburi, R, Mahler, DA, Jones, PW, Wanner, A, San Pedro, G, ZuWallack, RL, Menjoge, SS, Serby, CW & Witek, J 2002, 'A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease', European Respiratory Journal, vol. 19, no. 2, pp. 217-224. https://doi.org/10.1183/09031936.02.00269802
Casaburi, R. ; Mahler, D. A. ; Jones, P. W. ; Wanner, Adam ; San Pedro, G. ; ZuWallack, R. L. ; Menjoge, S. S. ; Serby, C. W. ; Witek, Jr. / A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. In: European Respiratory Journal. 2002 ; Vol. 19, No. 2. pp. 217-224.
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