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

Northwell Health

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Ipratropium bromide; Drug: Prednisone; Drug: Budesonide; Drug: albuterol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00588406

07.02.019

Details and patient eligibility

About

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.

Full 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).

Enrollment: 95 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

95 participants in 2 patient groups, including a placebo group

B

Experimental group

Description:

Budesonide, 2mg, 4 doses, plus standard care

Treatment:

Drug: albuterol

Drug: Budesonide

Drug: Prednisone

Drug: Ipratropium bromide

P

Placebo Comparator group

Description:

Placebo plus standard care

Treatment:

Drug: albuterol

Drug: Prednisone

Drug: Ipratropium bromide