Chapman et al extended their 6-month Phase III trial for once-daily long-acting beta agonist indacaterol for another 6 months. FEV1 improvements of 170 mL, reduced albuterol use of 1 puff / day, and slight absolute decreases in exacerbation rates were all preserved, without evidence of tolerance or increased adverse events. The drug made about 24% of people cough after inhalation. CHEST 2011;140:68-75.
The FDA approved indacaterol around July 1 at the 75 mcg dose, which was 1/2 to 1/4 the doses used in these trials, citing safety concerns at the higher doses. The main safety concern seemed to surround expected off-label use of the drug for asthma. (FDA.gov)