NCT00588406

Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.

Emergency Department (ED) Use of Nebulized Budesonide as an Adjunct to Standardized Therapy in Acutely Ill Adults With Refractory Asthma: a Randomized, Double-blinded, Placebo-controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Budesonide	2mg/dose by nebulizer, four doses over 3 hours
DRUG	albuterol	2.5mg/dose by nebulizer, 7 doses over 6 hours
DRUG	Ipratropium bromide	2.5 mg, one dose
DRUG	Prednisone	60mg PO

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-01-08
• Last updated: 2016-01-21
• Results posted: 2016-01-21

Locations

3 sites across 1 country: United States