Once-Daily Bronchodilators for Chronic Obstructive Pulmonary Disease

Donohue, James F.; Fogarty, Charles; Lötvall, Jan; Mahler, Donald A.; Worth, H.; Yorgancıoğlu, Arzu; Iqbal, Amir; Swales, James; Owen, Roger; Higgins, Mark; Krämer, Benjamin

doi:10.1164/rccm.200910-1500oc

Cited by 334 publications

(388 citation statements)

References 30 publications

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“…Analogously, indacaterol may represent a further therapeutic advance over tiotropium. The present results also support and expand on those of a previous 6-month study of indacaterol versus tiotropium in which tiotropium was administered unblinded [2].…”

Section: Discussionsupporting

confidence: 87%

“…Tiotropium treatment was not blinded in that study [2]. A short-term blinded comparison of indacaterol with tiotropium supported the findings of DONOHUE et al [2] of similar bronchodilator efficacy [3]. Both studies were placebo controlled.…”

supporting

confidence: 55%

“…Previous study results provided an assumed treatment difference (indacaterol-tiotropium) of 40 mL for trough FEV1 at week 12 [2], with a standard deviation of 225 mL [2,11,12]. A sample size of 666 evaluable patients per treatment group was needed to detect this difference as statistically significant at the 5% level (two-sided) with 90% power.…”

Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

“…In a 26-week study, DONOHUE et al [2] demonstrated that indacaterol was at least as effective a bronchodilator as tiotropium and was similarly or more effective for a number of symptomatic and health status end-points. Tiotropium treatment was not blinded in that study [2]. A short-term blinded comparison of indacaterol with tiotropium supported the findings of DONOHUE et al [2] of similar bronchodilator efficacy [3].…”

mentioning

confidence: 99%

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

Buhl¹,

Dunn²,

Disdier³

et al. 2011

Eur Respir J

130

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on behalf of the INTENSITY study investigators ABSTRACT: Two, once daily (q.d.) inhaled bronchodilators are available for the treatment of chronic obstructive pulmonary disease (COPD): the b 2 -agonist indacaterol and the anticholinergic tiotropium. This blinded study compared the efficacy of these two agents and assessed their safety and tolerability.Patients with moderate-to-severe COPD were randomised to treatment with indacaterol 150 mg q.d. (n5797) or tiotropium 18 mg q.d. (n5801) for 12 weeks.After 12 weeks, the two treatments had similar overall effects on ''trough'' (24 h post-dose) forced expiratory volume in 1 s. Indacaterol-treated patients had greater improvements in transition dyspnoea index (TDI) total score (least squares means 2.01 versus 1.43; p,0.001) and St George's Respiratory Questionnaire (SGRQ) total score (least squares means 37.1 versus 39.2; p,0.001; raw mean change from baseline -5.1 versus -3.0), and were significantly more likely to achieve clinically relevant improvements in these end-points (indacaterol versus tiotropium odds ratios of 1.49 for TDI and 1.43 for SGRQ, both p,0.001). Adverse events were recorded for 39.7% and 37.2% of patients in the indacaterol and tiotropium treatment groups, respectively. The most frequent adverse events were COPD worsening, cough and nasopharyngitis.Both bronchodilators demonstrated spirometric efficacy. The two treatments were well tolerated with similar adverse event profiles. Compared with tiotropium, indacaterol provided significantly greater improvements in clinical outcomes.

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Section: Discussionsupporting

confidence: 87%

supporting

confidence: 55%