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 FEV1 and decrease the need for hospitalization.

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).

• Drug: Budesonide
  2mg/dose by nebulizer, four doses over 3 hours
  Other Name: 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 Name: Atrovent
• Drug: Prednisone
  60mg PO
  Other Name: deltasone

• Experimental: B
  Budesonide, 2mg, 4 doses, plus standard care
  Interventions:

  • Drug: Budesonide
  • Drug: albuterol
  • Drug: Ipratropium bromide
  • Drug: Prednisone
• Placebo Comparator: P
  Placebo plus standard care
  Interventions:

  • Drug: albuterol
  • Drug: Ipratropium bromide
  • Drug: Prednisone

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

• AstraZeneca
• Jacobi Medical Center
• Nassau University Medical Center