Phase 3
N=95
Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00588406 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: FEV1 Percent Predicted — 51.7; 52.6 percent predicted of FEV1
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Budesonide (Drug); albuterol (Drug); Ipratropium bromide (Drug); Prednisone (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwell Health
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY FEV1 Percent Predicted |
51.7; 52.6 | — |
| SECONDARY Hospitalization |
39; 39 | — |
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.
Eligibility Criteria
Inclusion Criteria
- FEV1 15 pack years smoking
Data sourced from ClinicalTrials.gov (NCT00588406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.