DAR No 1. Indacaterol (Onbrez breezhaler®) Maintenance bronchodilator therapy in patients with COPD

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Uncertainty regarding safety

Indacaterol is a long-acting beta 2 agonist that is administered once daily and authorized for patients with chronic obstructive pulmonary disease (COPD).
It has not been clinically proven that this agent is more effective than tiotropium or the other long-acting beta 2 agonists, salmeterol or formeterol.
Clinical trials available are short lasting, less than a year, with few patients and important exclusion criteria. Thus, the safety profile of the agent is not conclusive.
The rapid onset of its action could result in inadequate use of the drug as rescue therapy.

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