FEV1 improvement within minutes1
Mean change from baseline in FEV1 at Week 12 in a 12-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled trial to assess the efficacy and tolerability of BROVANA 15 mcg vs placebo in patients with COPD.1
FEV1=forced expiratory volume in 1 second; ITT=intent to treat.
All patients (including those in placebo group) received rescue albuterol and supplemental ipratropium for use as needed throughout the trial, except within 6 hours of pulmonary function test visit.2
- Increases in mean trough FEV1 of 100 mL or greater are considered clinically important and are associated with patients’ perceptions of improvement and decreases in frequency of exacerbations3
- In an additional study, an ad hoc analysis of 212 COPD patients showed that the majority (56%, n=118) of COPD patients had ≥100 mL improvement in trough FEV1 at Week 124*
*Pooled data from 2 identical 12-week, double-blind, double-dummy, placebo-controlled, randomized, multicenter trials (Trials A and B) assessing the efficacy and tolerability of BROVANA 15 mcg twice daily (n=288) vs placebo (n=293) in patients with COPD.
Overall efficacy of BROVANA was maintained throughout the 12-week trial duration. Some tolerance to the bronchodilator effect of BROVANA was observed after 6 weeks of dosing (at the end of the dosing interval), although the FEV1 improvement remained statistically significant. This was not accompanied by other clinical manifestations of tolerance.
Mean change from baseline in FEV1 at Week 0 in a 12-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled trial to assess the efficacy and tolerability of BROVANA 15 mcg vs placebo in patients with COPD. Salmeterol was an active comparator, and there was no statistically significant difference between the BROVANA and salmeterol treatment groups for the primary efficacy end point.
FEV1=forced expiratory volume in 1 second; ITT=intent-to-treat.
- Following the first dose, the median time to onset of bronchodilation (defined as a 15% improvement in FEV1) was 6.7 minutes
- Peak bronchodilator effect was generally seen within 1-3 hours of dosing
FEV1 improvement in minutes1,4,5
Mean change in FEV1 over time for Clinical Trial A at Week 0 (Day 1)1,4,5
Some tolerance to the bronchodilator effect of BROVANA was observed after 6 weeks of dosing (at the end of the dosing interval), although the FEV1 improvement remained statistically significant. This was not accompanied by other clinical manifestations of tolerance.
BROVANA should not be initiated in patients with acutely deteriorating COPD or potentially life-threatening episodes of COPD, or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.
BROVANA Safety Profile
Proven safety profile vs placebo across 3 trials (one 52-week and two 12-week)1
Five most common adverse events (AEs) with BROVANA and occurring more frequently than with placebo in two 12-week pivotal trials1
Low incidence of cardiovascular adverse events (AEs) was comparable to placebo in two 12-week pivotal trials6
*Patients were allowed to use rescue albuterol and supplemental ipratropium as needed. More patients in the placebo group used rescue albuterol than in the BROVANA group.
†Serious adverse events included any fatal or life-threatening, or permanently disabling, experience; or events that required or prolonged hospitalization, were a congenital anomaly, or necessitated intervention to prevent permanent damage.
‡Includes coded adverse event terms: angina pectoris, bundle branch block, coronary artery disorder, myocardial infarct, myocardial ischemia, ST depressed, ST elevated, or T wave inverted.
§Includes coded adverse event terms: arrhythmia, atrial or ventricular fibrillation, atrial flutter, AV block, AV block first or second degree, extrasystoles, ventricular or supraventricular extrasystoles, heart block, heart arrest, syncope, tachycardia, ventricular or supraventricular tachycardia, or ventricular arrhythmia.
||Includes deaths: 1 patient (arformoterol 15 mcg twice daily) from abdominal aortic aneurysm.
As with other inhaled beta2-agonists, BROVANA can produce paradoxical bronchospasm that may be life-threatening in COPD patients. If paradoxical bronchospasm occurs, BROVANA treatments should be discontinued immediately and alternative COPD therapy instituted.
BROVANA, as with other beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval, because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents.
BROVANA should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Beta2-adrenergic agonists may produce significant hypokalemia in some patients.
Adults with COPD long-term (52-week) safety trial1
In this 52-week double-blind, randomized, placebo-controlled safety trial of patients with moderate to severe COPD, the primary endpoint was time to either respiratory death or first COPD exacerbation-related hospitalization, whichever occurred first1
- The event had to be a death or hospitalization for which the patient’s respiratory status was predominant and/or inciting contributor, as determined by the clinical investigator
- The objective of the trial was to demonstrate that the risk of respiratory death or COPD exacerbation-related hospitalization for patients treated with BROVANA was not greater than 40% more than the risk for patients treated with placebo
A total of 841 patients with COPD were randomized: 420 to BROVANA and 421 to placebo1
- Of the randomized patients, 255 (61%) in the BROVANA group and 211 (50%) in the placebo group completed one year of treatment
The trial objective was met demonstrating that COPD patients treated with BROVANA are not at an increased risk of respiratory death or COPD exacerbation-related hospitalization compared to placebo.1
BROVANA is not indicated for the treatment of acute episodes of bronchospasm, ie, rescue therapy, and does not replace fast-acting rescue inhalers.
BROVANA should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition.
BROVANA should not be used in conjunction with other inhaled, long-acting beta2-agonists.
- BROVANA [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc.; 2014.
- Baumgartner RA, Hanania NA, Calhoun WJ, Sahn SA, Sciarappa K, Hanrahan JP. Nebulized arformoterol in patients with COPD: a 12-week, multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled trial. Clin Ther. 2007;29(2):261-278.
- Donohue JF. Minimal clinically important differences in COPD lung function. COPD. 2005;2:111-124.
- Data on file, from a pooled analysis of trials 091-050 and 091-051. Sunovion Pharmaceuticals Inc.
- Hanrahan JP, Hanania NA, Calhoun WJ, Sahn SA, Sciarappa K, Baumgartner RA. Effect of nebulized arformoterol on airway function in COPD: results from two randomized trials. COPD. 2008;5(1):25-34.
- Hanrahan JP, Grogan DR, Baumgartner RA, et al. Arrhythmias in patients with chronic obstructive pulmonary disease (COPD): occurrence frequency and the effect of treatment with the inhaled long-acting beta2-agonists arformoterol and salmeterol. Medicine. 2008;87(6):319-328.