WARNING :
Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. Therefore, when treating patients with asthma, FORADIL AEROLIZER should only be used as additional therapy for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies, including FORADIL AEROLIZER. 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 may apply to formoterol (a long-acting beta2-adrenergic agonist), the active ingredient in FORADIL AEROLIZER (see WARNINGS).
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FORADIL SUMMARY
Foradil Aerolizer
FORADIL® AEROLIZER® consists of a capsule dosage form containing a dry powder formulation of FORADIL (formoterol fumarate) intended for oral inhalation only with the AEROLIZER® Inhaler.
FORADIL AEROLIZER is indicated for long-term, twice-daily (morning and evening) administration in the maintenance treatment of asthma and in the prevention of bronchospasm in adults and children 5 years of age and older with reversible obstructive airways disease, including patients with symptoms of nocturnal asthma, who require regular treatment with inhaled, short-acting, beta2-agonists. It is not indicated for patients whose asthma can be managed by occasional use of inhaled, shortacting, beta2-agonists.
FORADIL AEROLIZER is also indicated for the acute prevention of exercise-induced bronchospasm (EIB) in adults and children 5 years of age and older, when administered on an occasional, as-needed basis.
FORADIL AEROLIZER can be used to treat asthma concomitantly with short-acting beta2-agonists, inhaled or systemic corticosteroids, and theophylline therapy (see PRECAUTIONS, Drug Interactions). A satisfactory clinical response to FORADIL AEROLIZER does not eliminate the need for continued treatment with an anti-inflammatory agent.
FORADIL AEROLIZER is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with Chronic Obstructive Pulmonary Disease including chronic bronchitis and emphysema.
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NEWS HIGHLIGHTS
Published Studies Related to Foradil (Formoterol Inhalation)
An economic evaluation of budesonide/formoterol for maintenance and reliever treatment in asthma in general practice. [2009.09.19]
INTRODUCTION: In budesonide/formoterol (Symbicort(R) Turbuhaler(R), AstraZeneca, Lund, Sweden) maintenance and reliever therapy (SMART), patients with asthma take a daily maintenance dose of budesonide/formoterol, with the option of taking additional doses for symptom relief instead of a short-acting beta(2)-agonist (SABA). This study assesses the cost-effectiveness of SMART compared with usual care in patients with mild-to-moderate persistent asthma treated by general practitioners in the Netherlands from a societal perspective... CONCLUSIONS: Treating primary care patients with mild-to-moderate persistent asthma with SMART instead of ICS plus bronchodilators does not affect health outcomes and does not increase costs; therefore, is likely to be an alternative for guideline-directed treatment, from a health and economic perspective.
Efficacy and tolerability of once-daily budesonide/formoterol pressurized metered-dose inhaler in adults and adolescents with asthma previously stable with twice-daily budesonide/ formoterol dosing. [2009.07]
BACKGROUND: The goal of asthma therapy is to control symptoms using minimal pharmacologic intervention. OBJECTIVE: To evaluate the efficacy and tolerability of once-daily budesonide/formoterol vs once-daily budesonide in patients stable with twice-daily budesonide/formoterol... CONCLUSIONS: Pulmonary function and asthma control were more effectively maintained with all budesonide/formoterol regimens vs once-daily budesonide and with twice-daily budesonide/formoterol at twice the daily formoterol dose vs both once-daily budesonide/formoterol doses.
Airway inflammation in patients with asthma with high-fixed or low-fixed plus as-needed budesonide/formoterol. [2009.05]
BACKGROUND: Budesonide/formoterol maintenance and reliever therapy maintains asthma control and reduces exacerbation frequency compared with higher fixed-dose combination regimens. Its effects on eosinophilic airway inflammation and structure are unknown. OBJECTIVE: We sought to compare the effects of budesonide/formoterol 200/6 microg twice daily plus as-needed with budesonide/formoterol 800/12 microg twice daily on airway eosinophils and remodeling... CONCLUSION: Compared with fixed-dose combination treatment containing a 4-fold higher maintenance dose of budesonide, budesonide/formoterol maintenance and reliever therapy is associated with higher eosinophil counts, but these remain within the range associated with stable clinical control.
Effect of formoterol with or without budesonide in repeated low-dose allergen challenge. [2009.04]
The use of combination therapy in mild asthma is debated. The current authors evaluated the effects of formoterol alone and a formoterol/budesonide combination inhaler on asthma deterioration induced by repeated low-dose allergen exposure... Signs of deteriorating asthma, provoked by low-dose allergen, are prevented by short-term use of budesonide/formoterol but not by temporary use of formoterol alone.
Budesonide/formoterol as effective as prednisolone plus formoterol in acute exacerbations of COPD. A double-blind, randomised, non-inferiority, parallel-group, multicentre study. [2009.02.19]
BACKGROUND: Oral corticosteroids and inhaled bronchodilators with or without antibiotics represent standard treatment of COPD exacerbations of moderate severity. Frequent courses of oral steroids may be a safety issue. We wanted to evaluate in an out-patient setting whether a 2-week course of inhaled budesonide/formoterol would be equally effective for treatment of acute COPD exacerbations as standard therapy in patients judged by the investigator not to require hospitalisation... CONCLUSION: High dose budesonide/formoterol was as effective as prednisolone plus formoterol for the ambulatory treatment of acute exacerbations in non-hospitalized COPD patients. An early increase in budesonide/formoterol dose may therefore be tried before oral corticosteroids are used. CLINICAL TRIAL REGISTRATION: NCT00259779.
Clinical Trials Related to Foradil (Formoterol Inhalation)
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).
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.
Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort Pressurized Metered-Dose Inhaler (pMDI) or Oxis Turbuhaler [Completed]
The purpose of this study is to compare the therapeutic effects of formoterol in Symbicort
with formoterol in Oxis Turbuhaler for the treatment of adults with stable asthma.
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.
Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects With COPD [Completed]
The purpose of this study is to assess the bronchodilator effect and safety of multiple daily
doses of arformoterol administered for 12 weeks as maintenance treatment in patients with
COPD
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Page last updated: 2009-10-20
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