Asthma
Conditions
Keywords
acute, emergency department
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).
Interventions
DRUGBudesonide
2mg/dose by nebulizer, four doses over 3 hours
DRUGalbuterol
2.5mg/dose by nebulizer, 7 doses over 6 hours
DRUGIpratropium bromide
2.5 mg, one dose
DRUGPrednisone
60mg PO
Sponsors
AstraZeneca
Jacobi Medical Center
Nassau University Medical Center
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV1 Percent Predicted | 4 hours post-randomization |
Secondary
| Measure | Time frame |
|---|---|
| Hospitalization | 6 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Budesonide Budesonide, 2mg, 4 doses, plus standard care
Budesonide: 2mg/dose by nebulizer, four doses over 3 hours
albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours
Ipratropium bromide: 2.5 mg, one dose
Prednisone: 60mg PO | 46 |
| Placebo Placebo plus standard care
albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours
Ipratropium bromide: 2.5 mg, one dose
Prednisone: 60mg PO | 49 |
| Total | 95 |
Baseline characteristics
| Characteristic | Budesonide | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 37.2 years STANDARD_DEVIATION 11.4 | 42.6 years STANDARD_DEVIATION 11.4 | 40 years STANDARD_DEVIATION 11.7 |
| Forced expiratory volume at one second (FEV1) % predicted | 29.5 percent predicted of FEV1 STANDARD_DEVIATION 9.5 | 29 percent predicted of FEV1 STANDARD_DEVIATION 8.1 | 29.2 percent predicted of FEV1 STANDARD_DEVIATION 8.7 |
| Race/Ethnicity, Customized Black | 28 participants | 18 participants | 46 participants |
| Race/Ethnicity, Customized Hispanic | 12 participants | 20 participants | 32 participants |
| Race/Ethnicity, Customized Other | 2 participants | 6 participants | 8 participants |
| Race/Ethnicity, Customized Unknown | 2 participants | 2 participants | 4 participants |
| Race/Ethnicity, Customized White | 2 participants | 3 participants | 5 participants |
| Region of Enrollment United States | 46 participants | 49 participants | 95 participants |
| Sex: Female, Male Female | 29 Participants | 22 Participants | 51 Participants |
| Sex: Female, Male Male | 17 Participants | 27 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 46 | 0 / 49 |
| serious Total, serious adverse events | 0 / 46 | 0 / 49 |
Outcome results
Primary
FEV1 Percent Predicted
Time frame: 4 hours post-randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Budesonide | FEV1 Percent Predicted | 51.7 percent predicted of FEV1 | Standard Deviation 16.8 |
| Placebo | FEV1 Percent Predicted | 52.6 percent predicted of FEV1 | Standard Deviation 15.8 |
Secondary
Hospitalization
Time frame: 6 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Budesonide | Hospitalization | 39 percentage of participants |
| Placebo | Hospitalization | 39 percentage of participants |