Background Indacaterol is a long-acting inhaled β2-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 μg (n=437) or 600 μg (n=428), twice-daily formoterol 12 μg (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 (FEV1) 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 FEV1 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 β2-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.
- Pulmonary disease, chronic obstructive
- bronchodilator agents, indacaterol, formoterol, clinical trial, COPD pharmacology
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Funding The study was funded by Novartis Pharma AG. Novartis was responsible for the conception and design of the study and analysis and interpretation of data. All authors had access to the study data, reviewed and revised the initial draft and subsequent versions of the manuscript, had final responsibility for the decision to submit for publication and approved the version submitted.
Competing interests DJ, PB, RO, MH and BK are employees of Novartis. RD has participated in advisory boards for Novartis, AstraZeneca, Boehringer-Ingelheim, Pfizer, ALK-Abello, UCB, Nycomed, Dainippon and ONO. KFC has received honoraria and research support from Novartis and has served on Novartis Advisory Boards. He also has similar relationships with GSK, Gilead, Merck and Boehringer-Ingelheim. RB has received reimbursement for attending scientific conferences and/or fees for speaking and/or consulting from Novartis. He also has similar relationships with AstraZeneca, Boehringer Ingelheim, GSK, Nycomed and Pfizer. The Pulmonary Department at Mainz University Hospital received financial compensation for services performed during participation in clinical trials organised by Novartis. HM has received fees for membership of advisory boards of various pharmaceutical companies (Altana, Boehringer Ingelheim, AstraZeneca) and for speaking (Boehringer Ingelheim, AstraZeneca, Chiesi, Altana). VN has no conflict of interest.
Ethics approval The study protocol was approved by the institutional review boards or independent ethics committees of participating centres. All patients provided their written informed consent.
Provenance and peer review Not commissioned; externally peer reviewed.
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