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Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD.
Thorax. 2010 Jun; 65(6):473-9.T

Abstract

BACKGROUND

Indacaterol is a long-acting inhaled beta(2)-agonist (LABA) for the treatment of chronic obstructive pulmonary disease (COPD). In previous studies, indacaterol provided 24 h bronchodilation on once-daily dosing with a fast onset of action. This study compared the efficacy and safety of indacaterol with the twice-daily LABA formoterol and placebo over 1 year.

METHODS

Patients with moderate to severe COPD were randomised to receive once-daily indacaterol 300 microg (n=437) or 600 microg (n=428), twice-daily formoterol 12 microg (n=435) or placebo (n=432) for 52 weeks in a double-blind double-dummy parallel group study. The primary efficacy variable was forced expiratory volume in 1 s (FEV(1)) measured 24 h postdose after 12 weeks (indacaterol vs placebo). Other outcomes included dyspnoea (transition dyspnoea index, TDI), use of as-needed salbutamol, symptom-based measures recorded on diary cards, exacerbations, health status (St George's Respiratory Questionnaire), BODE index (body mass index, obstruction, dyspnoea, exercise), safety and tolerability.

RESULTS

Indacaterol increased 24 h postdose FEV(1) after 12 weeks by 170 ml (both doses) versus placebo and by 100 ml versus formoterol (all p<0.001). These significant differences were maintained at 52 weeks. Symptomatic outcomes were improved compared with placebo with all active treatments, and indacaterol was more effective than formoterol in improving TDI score and reducing the need for as-needed salbutamol. Indacaterol was well tolerated and had a good overall safety profile, including minimal impact on QTc interval and systemic beta(2)-mediated events.

CONCLUSIONS

Once-daily indacaterol is an effective 24 h bronchodilator that improves symptoms and health status and confers clinical improvements over a twice-daily 12 h LABA as a treatment for patients with moderate to severe COPD.

TRIAL REGISTRATION NUMBER

NCT 00393458.

Authors+Show Affiliations

Department of Respiratory Diseases, Aarhus University Hospital, Aarhus, Denmark. ronadahl@rm.dkNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20522841

Citation

Dahl, Ronald, et al. "Efficacy of a New Once-daily Long-acting Inhaled Beta2-agonist Indacaterol Versus Twice-daily Formoterol in COPD." Thorax, vol. 65, no. 6, 2010, pp. 473-9.
Dahl R, Chung KF, Buhl R, et al. Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax. 2010;65(6):473-9.
Dahl, R., Chung, K. F., Buhl, R., Magnussen, H., Nonikov, V., Jack, D., Bleasdale, P., Owen, R., Higgins, M., & Kramer, B. (2010). Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax, 65(6), 473-9. https://doi.org/10.1136/thx.2009.125435
Dahl R, et al. Efficacy of a New Once-daily Long-acting Inhaled Beta2-agonist Indacaterol Versus Twice-daily Formoterol in COPD. Thorax. 2010;65(6):473-9. PubMed PMID: 20522841.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. AU - Dahl,Ronald, AU - Chung,Kian Fan, AU - Buhl,Roland, AU - Magnussen,Helgo, AU - Nonikov,Vladimir, AU - Jack,Damon, AU - Bleasdale,Patricia, AU - Owen,Roger, AU - Higgins,Mark, AU - Kramer,Benjamin, AU - ,, PY - 2010/6/5/entrez PY - 2010/6/5/pubmed PY - 2010/11/5/medline SP - 473 EP - 9 JF - Thorax JO - Thorax VL - 65 IS - 6 N2 - BACKGROUND: Indacaterol is a long-acting inhaled beta(2)-agonist (LABA) for the treatment of chronic obstructive pulmonary disease (COPD). In previous studies, indacaterol provided 24 h bronchodilation on once-daily dosing with a fast onset of action. This study compared the efficacy and safety of indacaterol with the twice-daily LABA formoterol and placebo over 1 year. METHODS: Patients with moderate to severe COPD were randomised to receive once-daily indacaterol 300 microg (n=437) or 600 microg (n=428), twice-daily formoterol 12 microg (n=435) or placebo (n=432) for 52 weeks in a double-blind double-dummy parallel group study. The primary efficacy variable was forced expiratory volume in 1 s (FEV(1)) measured 24 h postdose after 12 weeks (indacaterol vs placebo). Other outcomes included dyspnoea (transition dyspnoea index, TDI), use of as-needed salbutamol, symptom-based measures recorded on diary cards, exacerbations, health status (St George's Respiratory Questionnaire), BODE index (body mass index, obstruction, dyspnoea, exercise), safety and tolerability. RESULTS: Indacaterol increased 24 h postdose FEV(1) after 12 weeks by 170 ml (both doses) versus placebo and by 100 ml versus formoterol (all p<0.001). These significant differences were maintained at 52 weeks. Symptomatic outcomes were improved compared with placebo with all active treatments, and indacaterol was more effective than formoterol in improving TDI score and reducing the need for as-needed salbutamol. Indacaterol was well tolerated and had a good overall safety profile, including minimal impact on QTc interval and systemic beta(2)-mediated events. CONCLUSIONS: Once-daily indacaterol is an effective 24 h bronchodilator that improves symptoms and health status and confers clinical improvements over a twice-daily 12 h LABA as a treatment for patients with moderate to severe COPD. TRIAL REGISTRATION NUMBER: NCT 00393458. SN - 1468-3296 UR - https://www.unboundmedicine.com/medline/citation/20522841/Efficacy_of_a_new_once_daily_long_acting_inhaled_beta2_agonist_indacaterol_versus_twice_daily_formoterol_in_COPD_ DB - PRIME DP - Unbound Medicine ER -