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Late-Stage Trial Shows Inhaled Indacaterol Noninferior to Salmeterol/Fluticasone for COPD

Phase IV study meets primary objective

Positive results have been reported from the phase IV INSTEAD trial in patients with chronic obstructive pulmonary disease (COPD), which met its primary objective.

Once-daily inhaled indacaterol (Onbrez Breezhaler, Novartis) 150 mcg demonstrated noninferiority in lung function at week 12 to twice-daily salmeterol/fluticasone propionate (SFC) (Seretide, GlaxoSmithKline) 50/500 mcg in patients with moderate COPD and no exacerbations during the previous year.

The INSTEAD study also showed similar symptomatic benefits in terms of shortness of breath and health status after 12 and 26 weeks in patients treated with inhaled indacaterol and those treated with SFC.

COPD is a progressive life-threatening disease that has a destructive effect on patients’ quality of life. It is often considered to be a disease of later years, but estimates suggest that 50% of those with COPD are less than 65 years old, resulting in increases in absenteeism, premature retirement, and reductions in workforce participation. COPD affects an estimated 210 million people worldwide and is projected to be the third leading cause of death by 2020.

The INSTEAD trial was a global, randomized, double-blind, parallel-group, 26-week study. The trial randomly assigned 581 patients with moderate COPD who had been taking SFC for at least 3 months to either continue treatment with SFC or switch to inhaled indacaterol. The study’s primary objective was to demonstrate the noninferiority of indacaterol compared with SFC in lung function (trough forced expiratory volume in 1 second [FEV1]) after 12 weeks of treatment in patients with moderate COPD who had experienced no exacerbations during the previous year.

Inhaled indacaterol is a once-daily long-acting beta2-adrenergic agonist (LABA) that offers clinically relevant 24-hour bronchodilation combined with a rapid onset of action within 5 minutes at first dose, as demonstrated in the INERGIZE phase III trial program. Inhaled indacaterol 150 mcg provided greater clinical benefits in terms of reduced shortness of breath, a reduced use of rescue medication, and an improved health status, compared with tiotropium 18 mcg.

Indacaterol inhalation powder is currently available in the U.S. as Arcapta Neohaler (Novartis) 75 mcg once-daily.

Source: Novartis; April 25, 2014.

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