Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT00588406
- Lead Sponsor
- Northwell Health
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
- FEV1<50% predicted after bronchodilator therapy, age 18-60, presenting to an emergency department with acute asthma
- other chronic lung disease, >15 pack years smoking
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Budesonide Budesonide, 2mg, 4 doses, plus standard care B albuterol Budesonide, 2mg, 4 doses, plus standard care B Ipratropium bromide Budesonide, 2mg, 4 doses, plus standard care P Ipratropium bromide Placebo plus standard care P Prednisone Placebo plus standard care P albuterol Placebo plus standard care B Prednisone Budesonide, 2mg, 4 doses, plus standard care
- Primary Outcome Measures
Name Time Method FEV1 Percent Predicted 4 hours post-randomization
- Secondary Outcome Measures
Name Time Method Hospitalization 6 hours
Trial Locations
- Locations (3)
Nassau University Medical Center
🇺🇸East Meadow, New York, United States
Long Island Jewish Medical Center
🇺🇸Queens, New York, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States