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

NCT00588406 — Phase 3, Completed, 95 participants, Northwell Health

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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

Registry	NCT00588406
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	95 (Actual)
Sponsor	Northwell Health (Other); collaborators: AstraZeneca, Jacobi Medical Center, Nassau University Medical Center
Conditions	Asthma
Interventions	Budesonide, albuterol, Ipratropium bromide, Prednisone (Drug)
Dates	start 2007-09-01, primary completion 2009-12-01, completion 2009-12-01, first posted 2008-01-08, last updated 2016-01-21
Locations	3 sites in United States

-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.

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+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 and interventions

Arm	Type	Interventions	Description
B	Experimental	Drug: Budesonide; Drug: albuterol; Drug: Ipratropium bromide; Drug: Prednisone	Budesonide, 2mg, 4 doses, plus standard care
P	Placebo comparator	Drug: albuterol; Drug: Ipratropium bromide; Drug: Prednisone	Placebo plus standard care

Budesonide (Drug), also known as Pulmicort Respules: 2mg/dose by nebulizer, four doses over 3 hours
albuterol (Drug), also known as proventil, proair, ventolin, salbutamol: 2.5mg/dose by nebulizer, 7 doses over 6 hours
Ipratropium bromide (Drug), also known as Atrovent: 2.5 mg, one dose
Prednisone (Drug), also known as deltasone: 60mg PO

+Outcome measures

Primary outcomes

FEV1 Percent Predicted [4 hours post-randomization]

Secondary outcomes

Hospitalization [6 hours]

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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

+Posted results

Participant flow

Milestone	Budesonide	Placob
Started	46	49
Completed	46	49
Not completed	0	0

Outcome results

FEV1 Percent Predicted (Primary), Mean, percent predicted of FEV1: Budesonide 51.7 +/- 16.8; Placebo 52.6 +/- 15.8
Hospitalization (Secondary), Number, percentage of participants: Budesonide 39; Placebo 39

Adverse events

Arm	Deaths	Serious adverse events	Other adverse events
Budesonide	0	0/46 (0.0%)	0/46 (0.0%)
Placebo	0	0/49 (0.0%)	0/49 (0.0%)

+Locations (3)

Facility	City	Country
Nassau University Medical Center	East Meadow, New York	United States
Long Island Jewish Medical Center	Queens, New York	United States
Jacobi Medical Center	The Bronx, New York	United States

+Investigators

Robert Silverman, MD, Principal investigator, Northwell Health