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news.Novartis has released new results from a blinded Phase III head-to-head Intensity 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 clinical benefits in terms of reduced breathlessness, lower use of rescue medication and improved health status.
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Onbrez Breezhaler is indicated for the maintenance bronchodilator treatment of airflow obstruction in adult patients with COPD in EU.
Intensity is the first blinded head-to-head study whose primary objective was to compare Onbrez Breezhaler, a new beta-2 agonist (LABA), with Tiotropium (Spiriva HandiHaler), an anti-muscarinic (LAMA) and an established treatment for COPD.
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).
Onbrez Breezhaler showed superiority to tiotropium on other secondary endpoints relating to key patient outcomes.
Additionally, breathlessness improved more with Onbrez Breezhaler than tiotropium.
Clinical Research of West Florida, Clearwater, Florida, Pulmonology medical director Leonard Dunn said that the study confirms that Indacaterol is an effective and well-tolerated treatment that should be considered as a maintenance therapy option for COPD patients.
Novartis Pharma Development global head Trevor Mundel said that the study provides further evidence of the additional benefits that Onbrez Breezhaler can bring to COPD patients compared to medicines that are used in current clinical practice.