Overview

This trial is active, not recruiting.

Condition asthma
Treatments budesonide, albuterol, ipratropium bromide, prednisone
Phase phase 3
Sponsor North Shore Long Island Jewish Health System
Collaborator AstraZeneca
Start date September 2007
End date March 2012
Trial size 96 participants
Trial identifier NCT00588406, 07.02.019

Summary

To determine whether adding nebulized inhaled steroids to the standard care of acutely ill ED patients with refractory acute asthma helps improve FEV1 and decrease the need for hospitalization.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Budesonide, 2mg, 4 doses, plus standard care
budesonide Pulmicort Respules
2mg/dose by nebulizer, four doses over 3 hours
albuterol proventil
2.5mg/dose by nebulizer, 7 doses over 6 hours
ipratropium bromide Atrovent
2.5 mg, one dose
prednisone deltasone
60mg PO
(Placebo Comparator)
Placebo plus standard care
albuterol proventil
2.5mg/dose by nebulizer, 7 doses over 6 hours
ipratropium bromide Atrovent
2.5 mg, one dose
prednisone deltasone
60mg PO

Primary Outcomes

Measure
FEV1
time frame: 6 hours

Secondary Outcomes

Measure
Hospitalization
time frame: 6 hours

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Emergency Department Use of Nebulized Budesonide as an Adjunct to Standardized Therapy in Acutely Ill Adults With Refractory Asthma: a Randomized, Double-blinded, Placebo-controlled Trial
Principal investigator Robert Silverman, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by North Shore Long Island Jewish Health System.