Phase 4
N=61
Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00189436 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Wheezing/Asthma/Bronchospasm Relapse Rate — 8.7; 4.0 percentage of cases of asthma relapse
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nebulized Budesonide (Drug); Usual care (albuterol with or without oral steroid) (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Deborah Gentile
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wheezing/Asthma/Bronchospasm Relapse Rate |
8.7; 4.0 | — |
| SECONDARY Urinary Cortisol Levels |
95.4; 141.6 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) |
86.2; 85.7 | — |
Summary
Subjects aged 1-8 years who have been discharged from the emergency department/outpatient care facility with a diagnosis of asthma/bronchospasm/wheezing after usual standard care will be enrolled into this open-label, randomized, parallel-group study to compare the efficacy of nebulized budesonide and oral corticosteroids in preventing asthma exacerbation relapse rates during the 21-day follow-up period.
Eligibility Criteria
Inclusion Criteria
- Children ages 1-8 years old
- Discharge from emergency department/outpatient clinic with a diagnosis of asthma exacerbation after usual standard care
- Subjects must be able to show efficient use with a jet nebulizer
Exclusion Criteria
- Subjects requiring hospitalization
- Subjects receiving oral steroids 1 week prior to presentation to emergency department.
- Subjects with FEV1 < 50% of predicted
- Subjects with co-morbid medical conditions (renal or cardiovascular disease)
- Subjects with reported history of HIV
- Subjects unable to follow up for study visits
- Subjects who are frequently enuretic
Data sourced from ClinicalTrials.gov (NCT00189436). 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.