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

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 mg 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. George9s 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 (y12% over baseline) (pv0.01) and mean response during the 3 h following dosing (y22% over baseline) (pv0.001) over the 12-month period. Tiotropium recipients showed less dyspnoea (pv0.001), superior health status scores, and fewer COPD exacerbations and hospitalizations (pv0.05). Adverse events were comparable with placebo, except for dry mouth incidence (tiotropium 16.0% versus placebo 2.7%, pv0.05).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.

Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD

“…The mean change for indacaterol exceeded the MCID in this study (-5.1 change from baseline). The result for tiotropium (-3.0 from baseline) is similar to previous reports over longer periods (-3.3 at 6 months [17] and -2.3--3.3 units over 4 yrs [18]), although other, smaller studies have reported changes from baseline of 4 units at 6 months [19]. The additional improvement of .2 units following treatment with indacaterol seen in this study is close to the tolerance range limit of 2.4 reported by CAZZOLA et al [14], and is likely to represent a perceptible difference in patients' health status.…”

Effect of Primary-Care Spirometry on the Diagnosis and Management of Copd

“…A few patients were referred for pulmonary rehabilitation. Based on evidence from clinical trials [11][12][13][14][15][16][17], the potential sequelae of this would be improved lung function, better exercise capacity and improved healthrelated quality of life. A reduction in PCP-treated exacerbations in the year following spirometry was also found.…”

Effective management of COPD in primary care — the role of long-acting beta agonist/inhaled corticosteroid combination therapy

“…The long-acting muscarinic receptor antagonist tiotropium has been shown significantly to improve lung function, dyspnoea, exercise tolerance, and health related quality of life in patients with COPD, relative to placebo [16][17][18]. The two currently available LABAs -salmeterol and formoterol -also show significant improvements in lung function, health status, and symptom reduction, compared with both placebo [19][20][21][22] and ipratropium [23,24].…”