Initial results from three pivotal Phase III trials show the Novartis investigational bronchodilator QAB149 (indacaterol) delivered clinically-relevant lung function improvements within five minutes of the first dose, lasting for 24 hours in patients with chronic obstructive pulmonary disease.
The Swiss drug major presented data at the American Thoracic Society Conference, in San Diego, California, which showed that QAB149, a long-acting beta2-agonist, significantly improved lung function from the first day of therapy to up to one year of treatment. The data also reveal that all evaluated doses of QAB149 were well-tolerated and the product had a good overall safety profile, according to the company.
All doses of once-daily QAB149 met the primary efficacy endpoint of significant improvement in forced expiratory volume in one second versus placebo at twelve weeks. This improvement was seen as early as five minutes post-dose and at every subsequent time point measured in each study. QAB149 also showed significant improvements over formoterol in trough FEV1 difference vs placebo at three months.
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