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).
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.
Published Studies Related to Foradil (Formoterol Inhalation)
Safety and Tolerability of High-Dose Budesonide/Formoterol via Turbuhaler(R) in Japanese Patients with Asthma: A Randomized, Double-Blind, Crossover, Active Comparator-Controlled, Phase III Study. [2012.01.01]
Background: The use of budesonide/formoterol as both maintenance and reliever therapy in asthma is recommended in many countries; however, there are limited data available for the Asian patient population. Objective: This study aimed to evaluate the short-term safety and tolerability of a fixed high-dose combination of the inhaled corticosteroid budesonide and the long-acting beta(2)-adrenoceptor agonist formoterol with that of the beta(2)-agonist terbutaline for acute symptom relief in Japanese adults with persistent asthma who were already receiving a combination of budesonide/formoterol maintenance therapy...
AZD9668, a neutrophil elastase inhibitor, plus ongoing budesonide/formoterol in
patients with COPD. 
well tolerated at doses of 60 mg bid during Phase I/IIa development... CONCLUSIONS: Three months' treatment with AZD9668 did not improve lung function,
Budesonide/Formoterol Pressurized Metered-Dose Inhaler versus Budesonide: A Randomized Controlled Trial in Black Patients with Asthma. [2011.12.01]
Objective.In this population of black asthma patients, BUD/FM pMDI resulted in greater improvements in pulmonary function and asthma control versus BUD DPI, with similar safety profiles.
A comparison of budesonide/formoterol maintenance and reliever therapy versus conventional best practice in asthma management in Spain. [2011.10]
OBJECTIVE: To study the effectiveness and safety in a real-life setting of budesonide/formoterol (Symbicort) Maintenance And Reliever Therapy(R) (Symbicort SMART(R)), a simplified management approach with one inhaler, compared with conventional best practice (CBP) with multiple inhalers in patients with persistent asthma... CONCLUSIONS: A simplified regimen using budesonide/formoterol maintenance and reliever therapy (Symbicort SMART) was at least as effective at improving clinical control compared with CBP with a significantly lower ICS dose and lower drug costs.
Efficacy of budesonide/formoterol pressurized metered-dose inhaler versus budesonide pressurized metered-dose inhaler alone in Hispanic adults and adolescents with asthma: a randomized, controlled trial. [2011.09]
BACKGROUND: Few clinical trials in asthma have focused on Hispanic populations. OBJECTIVE: To compare the efficacy and safety of budesonide/formoterol (BUD/FM) with BUD in an ethnically diverse group of Hispanic participants with asthma previously treated with inhaled corticosteroids (ICS)... CONCLUSIONS: Improvement in clinically relevant control end points occurred in both BUD/FM and BUD groups; both treatments were well tolerated in this Hispanic asthma population but were not significantly differentiated. Copyright (c) 2011 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
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
Reports of Suspected Foradil (Formoterol Inhalation) Side Effects
Blood Pressure Increased (7),
Urticaria (6), more >>
Page last updated: 2013-02-10