Onbrez® Breezhaler® from Novartis provides greater clinical benefits than tiotropium in new study of COPD patients
Novartis today announced new results from a blinded Phase III head-to-head study showing that once-daily Onbrez® Breezhaler® (indacaterol) was as effective as tiotropium in improving lung function in patients with chronic obstructive pulmonary disease (COPD), while providing greater clinical benefits in terms of reduced breathlessness, lower use of rescue medication and improved health status[1].
- (1888PressRelease) November 03, 2010 - The results were presented at the annual CHEST meeting of the American College of Chest Physicians (ACCP) in Vancouver, Canada.
* Study shows Onbrez Breezhaler superior to tiotropium in reducing breathlessness and use of rescue medication and in improving overall health status[1]
* INTENSITY is first blinded head-to-head study with primary goal of comparing once-daily Onbrez Breezhaler with tiotropium, an established COPD therapy
* Study shows once-daily Onbrez Breezhaler was as effective as tiotropium in improving patients' lung function[1]
* Phase III study adds to comprehensive data supporting Onbrez Breezhaler as effective and well-tolerated treatment for chronic obstructive pulmonary disease
INTENSITY is the first blinded head-to-head study whose primary objective was to compare Onbrez Breezhaler, a novel long-acting beta-2 agonist (LABA), with tiotropium (Spiriva® HandiHaler®*), a long-acting anti-muscarinic (LAMA) and an established treatment for COPD. The two medicines have different modes of action but are both inhaled once-daily to provide bronchodilation, i.e. increased airflow into the patient's lungs.
"These results add to the growing body of evidence supporting the use of indacaterol in COPD, delivering sustained improvements in lung function that can translate into real patient benefits,'' said Leonard Dunn, MD, FCCP, Medical Director for Pulmonology at Clinical Research of West Florida, Clearwater, Florida, and lead investigator in the INTENSITY study. "The study confirms that indacaterol is an effective and well-tolerated treatment that should be considered, where available, as a maintenance therapy option for COPD patients."
A total of 1,598 patients with moderate-to-severe COPD were enrolled in the blinded, double-dummy study in which they received once-daily treatment with either Onbrez Breezhaler 150 mcg or tiotropium 18 mcg[1]. The study met its primary endpoint by demonstrating non-inferiority of Onbrez Breezhaler to tiotropium after 12 weeks in terms of lung function, measured by forced expiratory volume of breath in one second (FEV1)[1]. Results showed that baseline-adjusted trough FEV1 at 12 weeks was 1.44 L with Onbrez Breezhaler and 1.43 L with tiotropium (mean of 23 hrs 10 mins and 23 hrs 45 mins post-dose, p
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