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

NCT ID: NCT00588406

Last Updated: 2016-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-12-31

Brief Summary

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.

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).

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

B

Budesonide, 2mg, 4 doses, plus standard care

Group Type: EXPERIMENTAL

Budesonide

Intervention Type: DRUG

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

albuterol

Intervention Type: DRUG

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

Ipratropium bromide

Intervention Type: DRUG

2.5 mg, one dose

Prednisone

Intervention Type: DRUG

60mg PO

P

Placebo plus standard care

Group Type: PLACEBO_COMPARATOR

albuterol

Intervention Type: DRUG

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

Ipratropium bromide

Intervention Type: DRUG

2.5 mg, one dose

Prednisone

Intervention Type: DRUG

60mg PO

Interventions

Budesonide

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

Intervention Type: DRUG

albuterol

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

Intervention Type: DRUG

Ipratropium bromide

2.5 mg, one dose

Intervention Type: DRUG

Prednisone

60mg PO

Intervention Type: DRUG

Other Intervention Names

Pulmicort Respules; proventil; proair; ventolin; salbutamol; Atrovent; deltasone

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Jacobi Medical Center

OTHER

Sponsor Role: collaborator

Nassau University Medical Center

OTHER

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Robert A Silverman

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Silverman, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Nassau University Medical Center

East Meadow, New York, United States

Long Island Jewish Medical Center

Queens, New York, United States

Jacobi Medical Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

07.02.019

Identifier Type: -

Identifier Source: org_study_id