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Completed

NCT Number: NCT00588406

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

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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Key information

Conditions

Asthma Bronchial Diseases Disease Attributes Emergencies Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nassau University Medical Center, East Meadow, New York, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide

Drug

2mg/dose by nebulizer, four doses over 3 hours

Other names: Pulmicort Respules

albuterol

Drug

2.5mg/dose by nebulizer, 7 doses over 6 hours

Other names: proventil, proair, ventolin, salbutamol

ipratropium bromide

Drug

2.5 mg, one dose

Other names: Atrovent

Prednisone

Drug

60mg PO

Other names: deltasone

Primary outcomes

  1. FEV1 Percent Predicted

    Time frame: 4 hours post-randomization

Secondary outcomes

  1. Hospitalization

    Time frame: 6 hours

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • AstraZeneca
  • Jacobi Medical Center
  • Nassau University Medical Center

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 8, 2008
Registry last updated
Jan 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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