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 formoterol, the active ingredient in PERFOROMIST Inhalation Solution. The safety and efficacy of PERFOROMIST in patients with asthma have not been established. All LABA, including PERFOROMIST, are contraindicated in patients with asthma without use of a long-term asthma control medication [see CONTRAINDICATION (4), WARNINGS AND PRECAUTIONS].
PERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of PERFOROMIST Inhalation Solution is formoterol fumarate dihydrate, a racemate. Formoterol fumarate dihydrate is a beta2-adrenergic bronchodilator.
PERFOROMIST (formoterol fumarate) Inhalation Solution is indicated for the following:
Maintenance Treatment of COPD
PERFOROMIST (formoterol fumarate) Inhalation Solution 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 (COPD), including chronic bronchitis and emphysema.
Important Limitations of Use
PERFOROMIST Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see WARNINGS AND PRECAUTIONS].
PERFOROMIST Inhalation Solution is not indicated to treat asthma. The safety and effectiveness of PERFOROMIST Inhalation Solution in asthma have not been established.
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New research method questions traditional efficacy trial model
Source: Clinical Trials / Drug Trials News From Medical News Today [2016.09.06]
Traditional efficacy trials have limited relevance to everyday clinical practice and should be changed, according the authors of a new study into chronic obstructive pulmonary disease (COPD)...
Published Studies Related to Perforomist (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...
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.
Bronchodilator responsiveness and onset of effect with budesonide/formoterol pMDI in COPD. [2011.08]
BACKGROUND: Chronic obstructive pulmonary disease (COPD) patients are thought to have limited bronchodilator response, determined by changes in forced expiratory volume in 1s (FEV(1)). In this study, we assessed bronchodilator response in patients with COPD using not only FEV(1) but also changes in lung volume expressed as forced vital capacity (FVC) and inspiratory capacity (IC). We also evaluated the speed of onset of bronchodilation... CONCLUSIONS: Most patients with moderate to very severe COPD exhibit ATS-defined bronchodilator reversibility based on flow and lung volume measures after budesonide/formoterol pMDI or formoterol treatment. Budesonide/formoterol pMDI also has a rapid (within 5min) onset of bronchodilation that is maintained over time compared with formoterol alone. Copyright (c) 2011. Published by Elsevier Ltd.
Budesonide/formoterol maintenance and reliever therapy versus conventional best standard treatment in asthma in an attempted 'real life' setting. [2011.07]
AIMS: The purpose of this study was to compare the efficacy of budesonide/formoterol maintenance and reliever therapy (Symbicort(R) SMART(R), AstraZeneca AB, Sodertalje, Sweden) with conventional best standard treatment (CBST) in patients with persistent asthma in an attempted 'real life' setting... CONCLUSION: Budesonide/formoterol maintenance and reliever therapy resulted in a better overall asthma control with a significant lower daily IGCS dose compared with CBST. (c) 2010 Blackwell Publishing Ltd.
Effects of formoterol and tiotropium bromide on mucus clearance in patients with COPD. [2011.06]
BACKGROUND: Lung mucociliary clearance is impaired in patients with chronic obstructive pulmonary disease (COPD). Treatment guidelines recommend that patients with COPD receive maintenance therapy with long-acting beta-agonists and anticholinergic agents... CONCLUSION: Formoterol (12 mug) enhances mucus clearance in patients with mild to moderate COPD when given as a single dose, and may do so when given for 14 days. Studies of longer duration would be needed in order to assess the effects of the study drugs on mucus clearance when they are used for long-term maintenance therapy. Copyright (c) 2011. Published by Elsevier Ltd.
Clinical Trials Related to Perforomist (Formoterol Inhalation)
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.
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).
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.
Bronchoprotective Effect of Arformoterol in Children With Exercise-Induced Bronchospasm (EIB) [Terminated]
It is our primary hypothesis that pretreatment with arformoterol will provide superior
protection against EIB in children with mild-moderate asthma compared to placebo added to
the current asthma regimen.
Our secondary hypothesis is that nebulized arformoterol has comparable protection against
EIB compared to inhaled formoterol by dry powder inhaler.
Reports of Suspected Perforomist (Formoterol Inhalation) Side Effects
DRY Mouth (2),
Heart Rate Irregular (2),
Cough (2), more >>