WARNING: ASTHMA RELATED DEATH
-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 beta
-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 Inhalation Solution [see
WARNINGS AND PRECAUTIONS (5.1)
]. The safety and efficacy of BROVANA Inhalation Solution in patients with asthma have not been established. All LABA, including BROVANA Inhalation Solution, are contraindicated in patients with asthma without use of a long-term asthma control medication [see
WARNINGS AND PRECAUTIONS (5.1)
BROVANA (arformoterol tartrate) Inhalation Solution is a sterile, clear, colorless, aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol. Arformoterol is a selective beta2-adrenergic bronchodilator.
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.
Published Studies Related to Brovana (Arformoterol Inhalation)
The safety and efficacy of arformoterol and formoterol in COPD. [2010.02]
This study evaluated the safety and efficacy of arformoterol and formoterol over 6-months in subjects with COPD. In a multi-center, 6-month randomized, double-blind, double-dummy trial, subjects with COPD (mean FEV(1) 1.21 L, approximately 41.0% predicted) were randomized to receive either nebulized arformoterol (15 microg BID [n = 149][ARF 15], 25 microg BID [n = 147][ARF 25]), or racemic formoterol (12 microg BID [n = 147][FORM]) delivered by DPI...
Comparison of the efficacy and safety of arformoterol 15 microg twice daily and arformoterol 30 microg once daily in COPD: a single-dose, multicenter, randomized, modified-blind, two-way crossover study. [2009.08]
OBJECTIVE: The aim of this study was to compare the efficacy and safety of nebulized arformoterol 15 microg/2 mL twice daily (ARF15 BID) and 30 microg/4 mL once daily (ARF30 QD) in subjects with moderate to severe chronic obstructive pulmonary disease (COPD)... CONCLUSIONS: In these subjects with moderate to severe COPD, single-day administrations of ARF15 BID or ARF30 QD were associated with FEV(1) responses over a period of 24 hours that were considered equivalent per the protocol definition employed in the present study. FEV1 improvement over 12 hours was greater for ARF30 QD after the morning dose and for ARF15 BID after the evening dose. ClinicalTrials.gov Identifier: NCT00571428.
Effects of arformoterol twice daily, tiotropium once daily, and their combination in patients with COPD. [2009.04]
PURPOSE: Current guidelines support using in combination more than one class of long-acting bronchodilator for COPD patients whose symptoms are not controlled by mono-therapy. This 2-week, multi-center (34 sites), randomized, modified-blind, parallel group study evaluated the efficacy and safety of concomitant treatment with nebulized arformoterol (the formoterol(R,R)-isomer) BID and tiotropium DPI QD... CONCLUSION: In this study, the combination of nebulized arformoterol 15microg BID plus tiotropium 18microg DPI QD was the most effective in improving pulmonary function and disease symptoms. Mono-therapy improvement with arformoterol or tiotropium was similar. All three treatments were well tolerated.
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. [2008.11]
Beta-adrenergic stimulation may increase heart rate and the potential for cardiac arrhythmias. The effect of inhaled long-acting beta2-agonists (LABAs) on these outcomes was evaluated in patients with chronic obstructive pulmonary disease (COPD) in 2 double-blind randomized clinical trials...
Nebulized arformoterol in patients with COPD: A 12-week, multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled trial. [2007.02]
OBJECTIVE:: The aim of this study was to assess the efficacy and tolerability of nebulized arformoterol tartrate (a selective, long-acting beta(2)-adretlergic agonist that is the [R,R] isomer of formoterol) and salmeterol xinafoate versus placebo in patients with chronic obstructive pulmonary disease (COPD)... CONCLUSIONS:: In this trial, patients with moderate tosevere COPD administered nebulized arformoterol over 12 weeks were observed to have significant and sustained improvements in airway function and dyspnea compared with placebo. The results also suggest that all doses of arforrnoterol, including the lowest dose (15 mug BID), were effective. Overall, nebulized arformoterol was well tolerated.
Clinical Trials Related to Brovana (Arformoterol Inhalation)
A Dose Ranging Study of Arformoterol Given Once Daily Compared to Arformoterol Given Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD) [Completed]
A dose ranging study to evaluate the safety, tolerability and efficacy of arformoterol
(given once or twice a day) in subjects with COPD.
Study of Arformoterol Tartrate Inhalation Solution and Racemic Formoterol in Subjects With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) [Completed]
The purpose of this study is to compare the blood levels of arformoterol tartrate inhalation
solution to racemic formoterol in male and female subjects with mild to moderate Chronic
Obstructive Pulmonary Disease (COPD).
Sunovion Brovana Versus Serevent Inspiratory Capacity High Resolution Computed Tomography [Recruiting]
This is a PI-initiated study taking place only at UCLA, sponsored by Sunovion. The
investigators plan to enroll about 20 subjects who are at least 40 years old and have
Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study is to compare the
effectiveness of Brovana and Serevent in helping relieve COPD symptoms. Specifically, the
investigators are looking at how much and for how long the two drugs can open up the small
airways in the lungs. This will be done with breathing tests on all subjects, and with high
resolution CT scans on subjects who agree to this optional part of the study. Half of
subjects will take Brovana (arformoterol tartrate inhalation solution) for 2 weeks and then
Serevent (salmeterol xinafoate inhalation powder) for 2 weeks; the other half will take
Serevent the first two weeks and Brovana the second two weeks. All subjects will also take
Spiriva (tiotropium) and will be provided with albuterol for immediate relief of symptoms.
After a Screening Visit to determine eligibility, subjects will be randomly assigned to
receive Brovana or Serevent for the first 2 weeks, complete Test Visit 1, then receive the
other study drug for 2 weeks, and finally complete Test Visit 2. Visits will include
questionnaires, review of health and medications, and breathing tests before and after
taking the study drug. Subjects who agree to be in the sub-study will also undergo CT scans
before and after taking the study drug at both test visits.
A Pivotal Study of the Safety and Effectiveness of Arformoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD) [Completed]
A 12 week study to investigate the safety and effectiveness of arformoterol given twice
daily compared to placebo in subjects with COPD.
Perforomist Versus Foradil Evaluated by Inspiratory Capacity and High Resolution Computed Tomography (HRCT) [Withdrawn]
The purpose of this study is to compare the effects of nebulized formoterol fumarate
(Perforomist) to dry-powder inhaler formoterol fumarate (Foradil). Perforomist is a
solution that is made into very fine spray (using a nebulizer) that is then breathed in over
10-15 minutes. Foradil is taken in a single quick, deep inhalation.
Reports of Suspected Brovana (Arformoterol Inhalation) Side Effects
Chest Pain (3),
Oedema Peripheral (3),
Blood Pressure Increased (3),
Heart Rate Increased (3),
Drug Ineffective (2),
Petechiae (2), more >>
Page last updated: 2010-10-05