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Accuneb (Albuterol Sulfate Inhalation Solution) - Summary

 
 



ACCUNEB SUMMARY

AccuNeb® (albuterol sulfate) inhalation solution is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate is a relatively selective beta2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY).

AccuNeb is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).


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NEWS HIGHLIGHTS

Published Studies Related to Accuneb (Albuterol Inhalation)

Comparative efficacy of inhaled albuterol between two hand-held delivery devices in horses with recurrent airway obstruction. [2011.07]
REASONS FOR PERFORMING STUDY: Studies investigating the clinical efficacy of albuterol administered with the same propellant and commercially available delivery devices in horses with recurrent airway obstruction (RAO) are not currently available. OBJECTIVES: To determine the efficacy of aerosolised albuterol administered to horses with RAO by means of 2 commercially available, hand-held delivery devices... CONCLUSIONS: Aerosolised albuterol is an effective bronchodilator in horses with recurrent airway obstruction. There is no statistically significant difference between the 2 commercially available aerosol delivery devices in terms of efficacy. POTENTIAL RELEVANCE: Aerosolised albuterol is effectively delivered using currently available devices leading to maximal bronchodilation in horses with RAO at an average dose of 540 microg. (c) 2011 EVJ Ltd.

Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler versus MDI. [2010.08]
We compared the efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler, a novel propellant-free inhaler, versus chlorofluorocarbon (CFC)-metered dose inhaler (MDI) and ipratropium Respimat inhaler in patients with COPD. This was a multinational, randomized, double-blind, double-dummy, 12-week, parallel-group, active-controlled study...

Repeat dosing of albuterol via metered-dose inhaler in infants with acute obstructive airway disease: a randomized controlled safety trial. [2010.03]
BACKGROUND: Airway obstruction and bronchial hyperactivity often times lead to emergency department visits in infants. Inhaled short-acting beta2-agonist bronchodilators have traditionally been dispensed to young children via nebulizers in the emergency department. Delivery of bronchodilators via metered-dose inhalers (MDIs) in conjunction with holding chambers (spacers) has been shown to be effective. STUDY OBJECTIVE:: Safety and efficacy evaluations of albuterol sulfate hydrofluoroalkane (HFA) inhalation aerosol in children younger than 2 years with acute wheezing caused by obstructive airway disease... CONCLUSIONS: Cumulative dosing with albuterol HFA 180 microg or 360 microg via MDI-spacer and face mask in children younger than 2 years did not result in any significant safety issues and improved MTASS by at least 48%.

Beneficial effects of warmed humidified oxygen combined with nebulized albuterol and ipratropium in pediatric patients with acute exacerbation of asthma in winter months. [2009.11]
BACKGROUND: The objective of this study was to determine whether a combination of nebulized albuterol and ipratropium with warmed humidified oxygen would be more beneficial when compared to the same combination with humidified oxygen at room temperature. Albuterol alone was tested in the same settings... CONCLUSION: Our study shows that warmed humidified oxygen given along with the combination of nebulized albuterol and ipratropium is more beneficial for pediatric patients having an acute exacerbation of bronchial asthma in the winter months when compared to nebulized albuterol alone with warmed humidified oxygen, nebulized albuterol alone with room temperature humidified oxygen, or a combination of nebulized albuterol and ipratropium with room temperature humidified oxygen.

Bronchodilator effects of exercise hyperpnea and albuterol in mild-to-moderate asthma. [2009.08]
In asthmatic patients, either bronchodilatation or bronchoconstriction may develop during exercise. In 18 patients with mild-to-moderate asthma, we conducted two studies with the aims to 1) quantify the bronchodilator effect of hyperpnea induced by incremental-load maximum exercise compared with effects of inhaled albuterol (study 1, n=10) and 2) determine the time course of changes in airway caliber during prolonged constant-load exercise (study 2, n=8)...

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Clinical Trials Related to Accuneb (Albuterol Inhalation)

Safety and Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Pediatrics Subjects With Asthma [Completed]
The purpose of this study is to compare the safety and tolerability of levalbuterol HFA metered dose inhaler (MDI) versus racemic albuterol HFA MDI in pediatric subjects 4-11 years of age with asthma

Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects With Reactive Airways Disease (RAD) [Completed]
The purpose of this study is to compare the efficacy of two dose levels of levalbuterol compared with one dose level of racemic albuterol in pediatric subjects aged birth to 48 months old.

Controlled, 12-Week Study of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Asthmatic Patients [Active, not recruiting]
This 12-week clinical study evaluates the safety and efficacy of Albuterol Sulfate HFA Inhalation Aerosol (Albuterol-HFA, or: A004), Armstrong's proposed HFA formulation of metered dose inhaler (MDI) of Albuterol (Treatment T), in comparison with:

1. Placebo control: (HFA propellant only, Treatment P); and

2. Active control: 3M/Key's Proventil-HFA (Treatment R).

The treatments will be given as self-administered oral inhalations in adult and adolescent patients with mild-to-moderate asthma, for 12-weeks. Dosing regimen throughout the 12-week study is two actuations four times daily (QID).

Safety and Tolerability Study of Levalbuterol HFA Compared to Racemic Albuterol HFA in Subjects With Asthma [Completed]

Costs & Outcomes of Hospitalization/Treatment With Levalbuterol & Albuterol in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Subjects [Completed]
An analysis of the costs and outcomes associated with hospitalization and treatment of Levalbuterol versus Racemic Albuterol in subjects with Asthma and COPD.

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Page last updated: 2011-12-09

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