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Last Updated: January 22, 2020

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CLINICAL TRIALS PROFILE FOR ALBUTEROL

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505(b)(2) Clinical Trials for Albuterol

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Dosage NCT01323010 Efficacy and Safety of Increasing Doses of Inhaled Albuterol in Children With Acute Wheezing Episodes Completed Fundação de Amparo à Pesquisa do Estado de São Paulo N/A 2011-09-01 Metered dose inhalers with spacers are devices capable of providing higher rates of lung deposition of drugs such as beta agonists when compared to conventional nebulizers, but there is no consensus about the optimal dose when this is the device of choice and there is evidence that younger children need proportionally higher doses of albuterol (in μg/kg) when compared to older children. Other factors that may interfere with response to albuterol treatment include the genetics of the beta adrenergic receptor (ADRβ2) and infectious etiology of the wheezing attack. This study will assess the effectiveness of a dose regimen that prioritizes higher doses of albuterol, with doses in μg/kg higher for younger children. Security of this new dosing regimen will be assessed by monitoring clinical side effects and serum levels of albuterol, but the investigators will also examine the presence of 12 different respiratory viruses in these patients and evaluate the influence of ADRβ2 receptor genetics in the response to albuterol. The primary outcome measure will be the need for hospitalization. Secondary outcomes will include a change in clinical score, respiratory rate and forced expiratory volume in the first second, the need for additional treatments and length of stay in the emergency room for those not hospitalized.
New Dosage NCT01323010 Efficacy and Safety of Increasing Doses of Inhaled Albuterol in Children With Acute Wheezing Episodes Completed University of Sao Paulo N/A 2011-09-01 Metered dose inhalers with spacers are devices capable of providing higher rates of lung deposition of drugs such as beta agonists when compared to conventional nebulizers, but there is no consensus about the optimal dose when this is the device of choice and there is evidence that younger children need proportionally higher doses of albuterol (in μg/kg) when compared to older children. Other factors that may interfere with response to albuterol treatment include the genetics of the beta adrenergic receptor (ADRβ2) and infectious etiology of the wheezing attack. This study will assess the effectiveness of a dose regimen that prioritizes higher doses of albuterol, with doses in μg/kg higher for younger children. Security of this new dosing regimen will be assessed by monitoring clinical side effects and serum levels of albuterol, but the investigators will also examine the presence of 12 different respiratory viruses in these patients and evaluate the influence of ADRβ2 receptor genetics in the response to albuterol. The primary outcome measure will be the need for hospitalization. Secondary outcomes will include a change in clinical score, respiratory rate and forced expiratory volume in the first second, the need for additional treatments and length of stay in the emergency room for those not hospitalized.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Albuterol

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000575 Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3) Completed CAMP Steering Committee Phase 3 1991-09-01 The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
NCT00000575 Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1991-09-01 The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
NCT00000575 Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3) Completed Johns Hopkins Bloomberg School of Public Health Phase 3 1991-09-01 The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
NCT00000577 Asthma Clinical Research Network (ACRN) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1993-09-01 This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.
NCT00000578 NHLBI/NICHD Collaborative Studies of Asthma in Pregnancy Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 3 1994-04-01 To conduct a collaborative program of research on asthma and pregnancy consisting of two studies: the Asthma in Pregnancy Study (APS) was an observational study to evaluate relationships between asthma severity and treatment programs and perinatal outcome, and the Asthma Therapy in Pregnancy Trial (ATPT) was a randomized clinical trial of inhaled beclomethasone versus theophylline in the treatment of moderate asthma during pregnancy. Both studies were conducted in the Maternal-Fetal Medicine Unit (MFMU) Network, an ongoing group of participating obstetric centers supported by the National Institute of Child Health and Human Development. Studies were co-funded by the NHLBI.
NCT00000578 NHLBI/NICHD Collaborative Studies of Asthma in Pregnancy Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1994-04-01 To conduct a collaborative program of research on asthma and pregnancy consisting of two studies: the Asthma in Pregnancy Study (APS) was an observational study to evaluate relationships between asthma severity and treatment programs and perinatal outcome, and the Asthma Therapy in Pregnancy Trial (ATPT) was a randomized clinical trial of inhaled beclomethasone versus theophylline in the treatment of moderate asthma during pregnancy. Both studies were conducted in the Maternal-Fetal Medicine Unit (MFMU) Network, an ongoing group of participating obstetric centers supported by the National Institute of Child Health and Human Development. Studies were co-funded by the NHLBI.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Albuterol

Condition Name

Condition Name for Albuterol
Intervention Trials
Asthma 120
Pulmonary Disease, Chronic Obstructive 28
COPD 12
Chronic Obstructive Pulmonary Disease 8
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Condition MeSH

Condition MeSH for Albuterol
Intervention Trials
Asthma 108
Lung Diseases 50
Pulmonary Disease, Chronic Obstructive 45
Lung Diseases, Obstructive 29
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Clinical Trial Locations for Albuterol

Trials by Country

Trials by Country for Albuterol
Location Trials
Germany 106
China 49
Mexico 37
Canada 33
Argentina 28
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Trials by US State

Trials by US State for Albuterol
Location Trials
California 84
Texas 58
Florida 57
North Carolina 53
Missouri 52
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Clinical Trial Progress for Albuterol

Clinical Trial Phase

Clinical Trial Phase for Albuterol
Clinical Trial Phase Trials
Phase 4 50
Phase 3 70
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Albuterol
Clinical Trial Phase Trials
Completed 150
Recruiting 29
Terminated 18
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Clinical Trial Sponsors for Albuterol

Sponsor Name

Sponsor Name for Albuterol
Sponsor Trials
GlaxoSmithKline 42
Sunovion 20
Teva Branded Pharmaceutical Products, R&D Inc. 19
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Sponsor Type

Sponsor Type for Albuterol
Sponsor Trials
Other 164
Industry 138
NIH 25
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