PERFOROMIST SUMMARY
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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NEWS HIGHLIGHTSMedia Articles Related to Perforomist (Formoterol Inhalation)
Chronic Obstructive Pulmonary Disease
Source: MedicineNet Alpha 1 Antitrypsin Deficiency Specialty [2006.10.13]
Title: Chronic Obstructive Pulmonary Disease
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 10/13/2006
Published Studies Related to Perforomist (Formoterol Inhalation)
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.
Lung function and asthma control with beclomethasone and formoterol in a single inhaler. [2009.01]
BACKGROUND: Lung deposition is crucial for asthma treatment. However, there is no study comparing the potential role of lung co-deposition of combination therapy (inhaled corticosteroid and long-acting beta2 agonist) in the same inhaler. In moderate to severe asthmatics, an extra-fine hydrofluoroalkane combination of beclomethasone dipropionate and formoterol given via a single pressurised metered-dose inhaler (pMDI) was compared with beclomethasone dipropionate chlorofluorocarbon (CFC) pMDI and formoterol dry powder inhaler (DPI) given via separate inhalers... INTERPRETATION: In patients with moderate to severe asthma, beclomethasone dipropionate/formoterol in a single inhaler was as effective as beclomethasone dipropionate plus formoterol and superior to beclomethasone dipropionate alone in improving lung function. For the first time with a single inhaler, beclomethasone dipropionate/formoterol was significantly superior to separate components for asthma control.
Efficacy and safety of nebulized formoterol as add-on therapy in COPD patients receiving maintenance tiotropium bromide: Results from a 6-week, randomized, placebo-controlled, clinical trial. [2009]
Current guidelines for the treatment of chronic obstructive pulmonary disease (COPD) recommend the use of long-acting bronchodilators in the maintenance management of COPD. Combining bronchodilators that work through different mechanisms is recommended in patients with continuous symptoms... The addition of nebulized formoterol to tiotropium in maintenance treatment of COPD provided clinically meaningful, statistically significant and sustained improvements in pulmonary function without additional adverse effects.
Clinical Trials Related to Perforomist (Formoterol Inhalation)
Perforomist vs. Foradil Evaluated by Inspiratory Capacity and High Resolution Computed Tomography (HRCT) [Not yet recruiting]
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.
Single Dose Study of the Effect of Formoterol Fumarate in Combination With Mometasone Furoate Inhaled Via a Pressurized Metered Dose Inhaler (pMDI) in Children Aged 5-11 Years Old With Persistent Asthma [Recruiting]
This study is being conducted to compare the pharmacodynamics (bronchodilation, onset and
duration of action), of a single dose of formoterol fumarate in combination with mometasone
furoate to placebo in children of 5-11 years with persistent asthma. The study will also
assess the bronchodilatory effect of a single dose of formoterol fumarate alone and in
combination with mometasone furoate delivered via a pressurized metered dose inhaler (pMDI)
to the bronchodilatory effect of formoterol fumarate delivered via a dry powder inhaler
(DPI). Furthermore, pharmacokinetic assessments of plasma and urine will also be conducted
throughout the study to assess systemic exposure following administration of the study
medication.
Bronchoprotective Effect of Arformoterol in Children With Exercise-Induced Bronchospasm (EIB) [Recruiting]
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.
A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients [Recruiting]
The purpose of this study is to determine the best dose of nebulized arformoterol, a quick
onset but long acting beta agonist, for use in treating acute bronchospasm in asthmatics
presenting to the the Emergency Department. Also this study will evaluate the side effect
and safety profile of arformoterol when used in this situation.
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
recommended treatment).
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