Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.
| Status: | Completed |
|---|---|
| Conditions: | Asthma, Asthma, Hospital |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/21/2016 |
| Start Date: | September 2007 |
| End Date: | December 2009 |
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
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.
ED patients with refractory acute asthma helps improve forced expiratory volume at one
second (FEV1) and decrease the need for hospitalization.
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).
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).
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
We found this trial at
3
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