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Novel Beta Agonist Indacaterol Safe and Effective in Short-Term Studies of Patients With Persistent Asthma: Presented at ACAAI

By Corinna S. Bowser, MD

PHILADELPHIA, PA -- November 20, 2006 -- The novel, once-daily, long-acting beta agonist indacaterol has demonstrated safety and efficacy for treatment of persistent asthma in 7- and 28-day studies, according to researchers speaking here at the 2006 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI).

"Ultimately, if you can put this with a once-a-day topical steroid, that's as good an you're going to get, and that's what everybody's holy grail would be -- once-a-day therapy with a combination treatment," said investigator Craig F. LaForce, MD, clinical professor of pediatrics, University of North Carolina School of Medicine, Chapel Hill, and medical director, North Carolina Clinical Research, Chapel Hill, North Carolina.

Current combination treatments, such as fluticasone/salmeterol (Advair Diskus) and budesonide/formoterol (Symbicort) are given twice daily, and according to Dr. LaForce, the requirement for twice daily dosing is an issue that may impact patient compliance with treatment.

In their randomized, double-blind, placebo-controlled, dose-ranging study, Dr. LaForce and colleagues evaluated indacaterol in a cohort of 436 patients with persistent asthma that was stable on inhaled corticosteroids.

Patients were randomized to 7 days of treatment with indacaterol at 50, 100, 200, or 400 mg, or placebo, given via a multi-dose dry-powder inhaler.

For all doses of indacaterol, adjusted mean forced expiratory volume in 1 second (FEV₁) was higher than in the placebo group (P < .001) at all time points measured on days 1 and 7. The predose differences between treatment and placebo in adjusted mean FEV₁ on day 7 ranged from 210 to 310 mL (P < .05 vs placebo).

Most adverse events were mild to moderate, with 2 patients discontinuing due to adverse events that may have been related to indacaterol. There were no serious adverse events or deaths.

This study was supported by Novartis Pharma AG.


[Presentation title: Safety and Efficacy of Indacaterol, a Novel Once-Daily B2-Agonist, in Patients With Persistent Asthma. Abstract P162]

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