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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Budesonide
* Drug: albuterol
* Drug: Ipratropium bromide
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B<br>Budesonide, 2mg, 4 doses, plus standard care | Drug: Budesonide<br>* 2mg/dose by nebulizer, four doses over 3 hours<br>* Other names: Pulmicort Respules;Drug: albuterol<br>* 2.5mg/dose by nebulizer, 7 doses over 6 hours<br>* Other names: salbutamol;Drug: Ipratropium bromide<br>* 2.5 mg, one dose<br>* Other names: Atrovent;Drug: Prednisone<br>* 60mg PO<br>* Other names: deltasone;|
| Placebo Comparator: P<br>Placebo plus standard care | Drug: albuterol<br>* 2.5mg/dose by nebulizer, 7 doses over 6 hours<br>* Other names: salbutamol;Drug: Ipratropium bromide<br>* 2.5 mg, one dose<br>* Other names: Atrovent;Drug: Prednisone<br>* 60mg PO<br>* Other names: deltasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 Percent Predicted |  | 4 hours post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization |  | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute, emergency department