Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.
This trial is active, not recruiting.
|Treatments||budesonide, albuterol, ipratropium bromide, prednisone|
|Sponsor||North Shore Long Island Jewish Health System|
|Start date||September 2007|
|End date||March 2012|
|Trial size||96 participants|
|Trial identifier||NCT00588406, 07.02.019|
To determine whether adding nebulized inhaled steroids to the standard care of acutely ill ED patients with refractory acute asthma helps improve FEV1 and decrease the need for hospitalization.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
time frame: 6 hours
time frame: 6 hours
Male or female participants from 18 years up to 60 years old.
Inclusion Criteria: - FEV1<50% predicted after bronchodilator therapy, age 18-60, presenting to an emergency department with acute asthma Exclusion Criteria: - other chronic lung disease, >15 pack years smoking
|Official title||Emergency Department Use of Nebulized Budesonide as an Adjunct to Standardized Therapy in Acutely Ill Adults With Refractory Asthma: a Randomized, Double-blinded, Placebo-controlled Trial|
|Principal investigator||Robert Silverman, MD|
|Description||This is a randomized clinical trial studying the effect of nebulized budesonide (Pulmicort) in acutely ill adults presenting to the Emergency Department with severe asthma. Budesonide is an inhaled steroid FDA approved for the treatment of pediatric chronic asthma. ED entry criteria include hyporesponsiveness to nebulized beta-agonists and an FEV1<50% predicted. The trial will evaluate the efficacy of multiple doses of nebulized budesonide as an adjunct to a highly regimented standardized treatment protocol; standard care consists of bronchodilators (beta-agonists/anticholinergics), systemic steroids, and intravenous magnesium sulfate (if the FEV1<25% predicted). The primary efficacy endpoint will be the FEV1 4 hours after administration of the study intervention. An additional safety and efficacy endpoint will take place at 5 hours after study intervention. The treatments will be coupled with a protocol-defined assessment regimen, with endpoints measured before each treatment and on ED disposition (at 5 hours after study intervention).|
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