Asthma Clinical Trial
Official 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
Verified date | December 2015 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 95 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Jacobi Medical Center | Bronx | New York |
United States | Nassau University Medical Center | East Meadow | New York |
United States | Long Island Jewish Medical Center | Queens | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health | AstraZeneca, Jacobi Medical Center, Nassau University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FEV1 Percent Predicted | 4 hours post-randomization | Yes | |
Secondary | Hospitalization | 6 hours | Yes |
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