Tolerance

Not an actual COPD patient.

BROVANA® (arformoterol tartrate):
No tolerance over 6 months as measured by mean change in FEV1 AUC0-61,2

Mean change in FEV1 AUC0-6 from baseline1,2

Double-blind, double-dummy, multicenter, randomized, active-controlled, parallel-group safety study that evaluated the long-term safety of nebulized BROVANA® (arformoterol tartrate) Inhalation Solution 15 mcg twice daily in 149 patients with COPD over 6 months. Formoterol was an active comparator.1,2

  • The primary endpoint of this study was to evaluate the overall occurrence of adverse events including COPD exacerbations2
  • While primarily designed to assess safety, secondary endpoints included FEV1 change and percent change in FEV1 from study baseline and visit predose1,2

BROVANA® (arformoterol tartrate) Inhalation Solution is not indicated for the treatment of acute episodes of bronchospasm, ie, rescue therapy, and does not replace fast-acting rescue inhalers.

BROVANA® (arformoterol tartrate) Inhalation Solution should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition.

BROVANA® (arformoterol tartrate) Inhalation Solution should not be used in conjunction with other inhaled, long-acting beta2-agonists.


References:

1. Data on file, CSR 091-061. Sunovion Pharmaceuticals Inc. 2. Hanania NA, Donohue JF, Nelson H, et al. The safety and efficacy of arformoterol and formoterol in COPD. COPD. 2010;7(1):17-31.