WARNING: INCREASED RISK OF ASTHMA-RELATED DEATH
Long-acting beta2-adrenergic agonists may 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 may apply to formoterol (a long-acting beta2-adrenergic agonist), the active ingredient in PERFOROMIST Inhalation Solution. [see 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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COPD is independent risk factor for cardiovascular death, but not risk of stroke
Source: Cardiovascular / Cardiology News From Medical News Today [2015.05.21]
Chronic obstructive pulmonary disease, or COPD, is associated with increased risk of dying from a cardiovascular disease such as heart failure or a heart attack, as well as diseases not associated...
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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)
A Study in Asthmatic Children (6 to <12 Yrs) Comparing Single Doses of Formoterol and ForadilŪ Evaluating Efficacy [Recruiting]
This purpose of the study is to investigate the bronchodilating effects of 3 different
dosages of formoterol given in combination with budesonide as Symbicort pMDI.
Pharmacokinetic Pilot Study on Budesonide/Formoterol [Recruiting]
Prn Budesonide/Formoterol Versus Regular Budesonide/Formoterol Plus Prn Terbutaline in Mild-Moderate Asthma [Recruiting]
Study No. 001 about Budesonide/Formoterol use in ASthMA sponsored by Agenzia Italiana del
FArmaco (Italian Drug Agency) (AIFA-ASMA-BF-001) The aim of the study is to verify whether
asthma not controlled by low doses inhaled corticosteroids, thus in need for step up
therapy, can be equally controlled by guidelines recommended regular bid treatment with long
acting beta agonist/inhaled corticosteroid (ICS/LABA) combination or the symptom driven use
of an ICS/LABA combination in the absence of maintenance therapy. The study is designed to
be able to evaluate the non inferiority of regular placebo plus prn inhaled
budesonide/formoterol (experimental treatment) versus regular, twice daily 160/4. 5 mcg
inhaled budesonide/formoterol combination plus prn inhaled terbutaline (guidelines
Lung Deposition of CHF 1535 (Fixed Combination of Beclometasone + Formoterol) Administered Via the NEXT DPI in Healthy Subjects, Asthmatic and Chronic Obstructive Pulmonary Disease (COPD) Patients [Not yet recruiting]
The purpose of this study is to investigate the lung deposition and distribution pattern of
Beclometasone and Formoterol using a gamma-scintigraphic technique after inhalation of a
single dose of 99mTc-radiolabelled BDP/formoterol fixed combination administered Via the
NEXT DPI in healthy volunteers, asthmatic and COPD patients. Additionally, the systemic
exposures to formoterol, BDP and its monopropionate metabolite (B17MP) will be investigated.
Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease [Recruiting]
The purpose of this study is to assess the long-term safety and tolerability of inhaled
aclidinium bromide/formoterol in patients with moderate to severe, stable chronic
obstructive pulmonary disease (COPD).
Reports of Suspected Perforomist (Formoterol Inhalation) Side Effects
DRY Mouth (2),
Heart Rate Irregular (2),
Cough (2), more >>
Page last updated: 2015-05-21