Clinical Study Results

Consistent bronchodilation over 12 hours1,2

See the data  >

FEV1 improvement in minutes1,4,5

See the data  >

Consistent bronchodilation over 12 hours1,2

See the data  >

FEV1 improvement in minutes1,4,5

See the data  >


Consistent bronchodilation over 12 hours1,2

Mean change in FEV1 over time for Clinical Trial A at Week 121,2

Mean change in FEV over time for Clinical Trial A at Week 12

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. Salmeterol was an active comparator, and there was no statistically significant difference between the BROVANA and salmeterol treatment groups for the primary efficacy endpoint.

ITT=intent-to-treat
FEV1=forced expiratory volume in 1 second

Increases in mean trough FEV1 of 100mL or greater are considered clinically important and are associated with patients’ perceptions of improvement and decreases in frequency of exacerbations.

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 

  • Overall efficacy was maintained throughout the 12-week study period. While some tolerance to the bronchodilator effect was observed after 6 weeks of dosing (at the end of the dosing interval), it was not accompanied by other clinical manifestations of tolerance1
  • 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.


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.

 


 

FEV1 improvement in minutes1,4,5

Mean change in FEV1 over time for Clinical Trial A at Week 0 (Day 1)1,4,5

Mean change in FEV over time for Clinical Trial A at Week 0

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 endpoint.

ITT=intent-to-treat
FEV1=forced expiratory volume in 1 second

  • 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

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.


References:
1. BROVANA [prescribing information]. Sunovion Pharmaceuticals Inc.; 2014.
2. 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.
3. Donohue JF. Minimal clinically important differences in COPD lung function. COPD: J Chron Obstruct Pulmon Dis. 2005;2:111-124.
4. Data on file, from a pooled analysis of trials 091-050 and 091-051. Sunovion Pharmaceuticals Inc.
5. 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: J Chron Obstruct Pulmon Dis. 2008;5(1):25-34.

Important Safety Information & Indication

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including arformoterol, the active ingredient in BROVANA (see WARNINGS). The safety and efficacy of BROVANA in patients with asthma have not been established. All LABA, including BROVANA, are contraindicated in patients with asthma without use of a long-term asthma control medication (see CONTRAINDICATIONS).

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 should not be used with other medications containing long-acting beta2-agonists. Patients who have been taking inhaled short-acting beta2-agonists on a regular basis should be instructed to discontinue their regular use and to use them only for symptomatic relief for acute respiratory symptoms.

All LABA, including BROVANA, are contraindicated in patients with asthma without use of a long-term asthma control medication.

As with other inhaled beta2-agonists, BROVANA can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, BROVANA should be discontinued immediately and alternative therapy instituted.

BROVANA, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms.

BROVANA should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines.

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.

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.

The five most common adverse events reported with frequency ≥2% in patients taking BROVANA, and occurring more frequently than in patients taking placebo, were pain (8% vs 5%), chest pain (7% vs 6%), back pain (6% vs 2%), diarrhea (6% vs 4%), and sinusitis (5% vs 4%).

For additional information, please see the full Prescribing Information including Boxed Warning, and Medication Guide for BROVANA (arformoterol tartrate) Inhalation Solution, at www.sunovionprofile.com/brovana.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indication
BROVANA® (arformoterol tartrate) Inhalation Solution is indicated for the long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. BROVANA is for use by nebulization only.