Conditions: Asthma
Keywords: acute, emergency department
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 95
Healthy volunteers: no

Brief summary:
To determine whether adding nebulized inhaled steroids to the standard care of acutely ill ED patients with refractory acute asthma helps improve forced expiratory volume at one second (FEV1) and decrease the need for hospitalization.

Detailed 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).

Arms:
arm 1: Budesonide, 2mg, 4 doses, plus standard care arm 2: Placebo plus standard care

Interventions: intervention 1: Budesonide intervention 2: albuterol intervention 3: Ipratropium bromide intervention 4: Prednisone
Intervention descriptions: intervention 1: 2mg/dose by nebulizer, four doses over 3 hours intervention 2: 2.5mg/dose by nebulizer, 7 doses over 6 hours intervention 3: 2.5 mg, one dose intervention 4: 60mg PO

Protocol document: