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

December 15, 2015 updated by: Robert A Silverman, Northwell Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Jacobi Medical Center
      • East Meadow, New York, United States, 11554
        • Nassau University Medical Center
      • Queens, New York, United States, 11042
        • Long Island Jewish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B
Budesonide, 2mg, 4 doses, plus standard care
Drug: Budesonide
2mg/dose by nebulizer, four doses over 3 hours
Other Names:
  • Pulmicort Respules
Drug: albuterol
2.5mg/dose by nebulizer, 7 doses over 6 hours
Other Names:
  • proventil
  • proair
  • ventolin
  • salbutamol
Drug: Ipratropium bromide
2.5 mg, one dose
Other Names:
  • Atrovent
Drug: Prednisone
60mg PO
Other Names:
  • deltasone
Placebo Comparator: P
Placebo plus standard care
Drug: albuterol
2.5mg/dose by nebulizer, 7 doses over 6 hours
Other Names:
  • proventil
  • proair
  • ventolin
  • salbutamol
Drug: Ipratropium bromide
2.5 mg, one dose
Other Names:
  • Atrovent
Drug: Prednisone
60mg PO
Other Names:
  • deltasone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospitalization
Time Frame: 6 hours
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Collaborators

AstraZeneca
Jacobi Medical Center
Nassau University Medical Center

Investigators

  • Principal Investigator: Robert Silverman, MD, Northwell Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

January 8, 2008

Study Record Updates

Last Update Posted (Estimate)

January 21, 2016

Last Update Submitted That Met QC Criteria

December 15, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07.02.019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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