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CLINICAL TRIALS PROFILE FOR ALBUTEROL SULFATE

Clinical Trials for Albuterol Sulfate

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00000579	Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	The purposes of this study are to assess rapidly innovative treatment methods in patients with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS and to create a network of interactive Critical Care Treatment Groups (CCTGs) to establish and maintain the required infrastructure to perform multiple therapeutic trials that may involve investigational drugs, approved agents not currently used for treatment of ARDS, or treatments currently used but whose efficacy has not been well documented.
NCT00144846	Inhaled Albuterol Sulfate For Acute Wheezing Due To Obstructive Airways Disease In Children	Completed	GlaxoSmithKline	Phase 3	This study evaluates the effect of cumulative dose administration of albuterol sulfate inhalation aerosol delivered with valved holding chamber and facemask. This is a four week study in birth to 23 month old subjects who are experiencing acute wheezing due to obstructive airways disease.
NCT00462540	A Crossover Study in the Treatment of Patients With COPD	Completed	Dey	Phase 3	The purpose of this study is to compare the efficacy of Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol [2 inhalations from metered dose inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID], and to Compare the preference/compliance of BID nebulization to QID use of MDI
NCT00522444	Nebulized Magnesium Sulfate in Pediatric Asthma	Terminated	Children's Hospital Medical Center, Cincinnati	Phase 3	Nebulized Magnesium Sulfate has been shown to be of benefit in adults with acute asthma exacerbations, though limited work has been done in the pediatric population. Current therapeutic questions include the effect of more than one dose of nebulized magnesium, the possibility of a sustained effect (greater than 20 minutes) after a treatment, the potential benefit in children younger than 5 years of age, and the use of an asthma score to re-assess patients after treatment with this medication. The purpose of this double-blind randomized placebo-controlled clinical trial is the evaluate the effect of multiple doses of nebulized magnesium sulfate versus saline in addition to standard asthma therapy on clinical asthma score and FEV1 in children 7 to 18 years of age with a moderate to severe acute asthma exacerbation. Our hypothesis is that nebulized magnesium sulfate, when added to traditional bronchodilator therapy, will improve acute asthma exacerbations more rapidly than standard therapy alone. The primary outcomes are asthma score and FEV1 values obtained after two nebulized magnesium sulfate compared to placebo treatments. This therapy will be supplemental to standard therapy of albuterol and ipratropium nebulized treatments and systemic corticosteroids. The secondary outcome is patient disposition (discharge home or hospitalization). Patients with known asthma will be approached for enrollment and informed consent obtained if the asthma score after the first albuterol treatment is "2" or greater. One hundred-seventy patients will be enrolled and randomized to either the treatment group or the placebo group. The change from baseline in asthma scores and FEV1 values will be compared among the control and treatment groups to assess for any benefit of the addition of nebulized magnesium sulfate to the treatment regimen.
NCT00565591	Study Mild Intermittent Asthma to Assess the Topical Safety and Tolerability of Albuterol Sulfate Acu-30™ DPI	Completed	Respirics Inc.	Phase 1	This open label single blind study will determine the safety of albuterol sulfate dry powder in a novel inhaler by observing for the potential occurrence of reflex bronchial constriction after inhalation of increasing doses of the compound.
NCT00577655	Albuterol HFA MDI in Pediatric Participants With Asthma	Completed	Teva Branded Pharmaceutical Products, R&D Inc.	Phase 3	The primary objective of this study is to evaluate the chronic-dose and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.
Trial ID	Title	Status	Sponsor	Phase	Summary