Indacaterol is an ultra-long-acting beta-adrenoceptor agonist developed by by Novartis

Novartis

Novartis International AG is a multinational pharmaceutical company based in Basel, Switzerland, ranking number three in sales among the world-wide industry...

.It was approved by the European Medicines Agency

European Medicines Agency

The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...

 (EMA) under the trade name Onbrez on November 30, 2009, and by the United States Food and Drug Administration (FDA), under the trade name Arcapta Neohaler, on July 1, 2011. It needs to be taken only once a day, unlike the currently available formoterol

Formoterol

Formoterol or eformoterol is a long-acting β2-agonist used in the management of asthma and/or chronic obstructive pulmonary disease...

 and salmeterol

Salmeterol

Salmeterol is a long-acting beta2-adrenergic receptor agonist drug that is currently prescribed for the treatment of asthma and chronic obstructive pulmonary disease. It is currently available as a dry powder inhaler that releases a powdered form of the drug...

. It is licensed only for the treatment of chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease , also known as chronic obstructive lung disease , chronic obstructive airway disease , chronic airflow limitation and chronic obstructive respiratory disease , is the co-occurrence of chronic bronchitis and emphysema, a pair of commonly co-existing diseases...

 (COPD) (long-term data in patients with asthma

Asthma

Asthma is the common chronic inflammatory disease of the airways characterized by variable and recurring symptoms, reversible airflow obstruction, and bronchospasm. Symptoms include wheezing, coughing, chest tightness, and shortness of breath...

 are thus far lacking). It is delivered as an aerosol formulation through a dry powder inhaler

Dry powder inhaler

A Dry powder inhaler is a device that delivers medication to the lungs in the form of a dry powder. DPIs are commonly used to treat respiratory diseases such as asthma, bronchitis, emphysema and COPD although DPIs have also been used in the treatment of diabetes mellitus.DPIs are an alternative...

.

Clinical trials

A Phase III trial published in March 2010 examined the efficacy and safety of indacaterol in COPD patients. This study, conducted in the U.S., New Zealand, and Belgium, compared indacaterol dry-powder inhaler to placebo in 416 COPD patients, mostly moderate to severe (mean FEV₁ of 1.5 L). Indacaterol produced statistically improved FEV₁ (both trough and AUC) and decreased use of rescue medication compared to placebo, but with safety and tolerability similar to those of placebo.

A year-long, placebo-controlled trial published in July 2010 suggests indacaterol may be significantly

Statistical significance

In statistics, a result is called statistically significant if it is unlikely to have occurred by chance. The phrase test of significance was coined by Ronald Fisher....

more effective than twice-daily formoterol in improving FEV₁. There were some reductions in the need for rescue medication, but these were not significantly different; nor was there any difference in the rate of exacerbation between the 2 active treatments.