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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)

Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate [Completed]

Efficacy and Safety Comparison of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients [Completed]
This is a multicenter, randomized, double-blind, double-dummy, placebo-controlled, single-dose, 5-treatment, 5-period, 5-way crossover study in pediatric patients with persistent asthma. The primary purpose of this study is to compare the efficacy and safety of Albuterol Spiromax with that of ProAir HFA in pediatric asthma patients at 2 delivered dose levels equivalent to 90 mcg and 180 mcg of albuterol base.

Preterm Infant Inhaled Albuterol Dosing [Recruiting]
The purpose of this study is to help determine the best dose of albuterol in premature babies at risk of developing bronchopulmonary dysplasia (BPD). BPD is the chronic lung disease of prematurity and is associated with increased morbidity and mortality, longer hospital stays, and increased healthcare utilization. Albuterol is an inhaled medication frequently used in premature infants with chronic lung disease and in people with asthma. It is believed to be safe, but the optimal dose for infants is not clear. The investigators hypothesize that albuterol may help a subset of premature infants with lung disease, but they need to determine the best dose prior to doing research about how effective it is for chronic lung disease/BPD. Response to each of three doses of albuterol will be measure using pulmonary function tests.

Continuous Levalbuterol for Treatment of Status Asthmaticus in Children [Completed]
This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when delivered continuously in a high-dose regimen for children with severe exacerbations of asthma. Primary hypothesis

- Children with severe asthma receiving continuous levalbuterol will have a shorter

duration of continuous therapy as compared to racemic albuterol. Secondary hypotheses

- Children receiving continuous levalbuterol will have improved lung function measured by

forced expiratory volume at 1 second (FEV1) as compared to racemic albuterol.

- Children receiving continuous levalbuterol will have improved clinical asthma score as

compared to racemic albuterol.

Adding Nebulized Salbutamol to Intravenous Atropine and Oxygen in OP Poisoning [Recruiting]
We hypothesize that salbutamol will speed removal of alveolar fluid compared to atropine alone in OP poisoned patients. We propose to compare the effect of two stat doses of nebulized salbutamol (2. 5 mg; 5. 0 mg), with nebulized saline placebo, in symptomatic patients receiving standard resuscitation with atropine, oxygen, and fluids after poisoning with OP pesticides. 25 patients will be randomised to each arm (total 75 patients). Primary outcome will be oxygen saturation's over the following 60 min during resuscitation. Secondary outcomes will include atropine dose administered, speed to stabilization, aspiration or pneumonia, intubation, tachydysrhythmias, and mortality. A positive outcome will result in design of a large definitive phase III study.

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Page last updated: 2011-12-09

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