Phase 4
N=179
Budesonide Inhalation Suspension for Acute Asthma in Children
Asthma · Acute Asthma · Reactive Airway Exacerbation
Bottom Line
View on ClinicalTrials.gov: NCT00393367 ↗Enrolled (actual)
179
Serious AEs
2.8%
Results posted
Jul 2011
Primary outcome: Primary: Median Change in Asthma Score 2 Hours After Intervention — -3; -3 Units on a scale — p=0.44
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg (Drug); Prednisolone, prednisone, or methylprednisolone (Drug); Albuterol, ipratropium bromide (Drug); Ipratropium bromide (Drug)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Change in Asthma Score 2 Hours After Intervention |
-3; -3 | 0.44 |
| PRIMARY Mean Change in Asthma Score at 2 Hours |
-2.9; -3.0 | 0.78 |
| SECONDARY Number of Patients Hospitalized |
56; 55 | 0.97 |
| SECONDARY Change in Mean Heart Rate |
12; 13 | — |
| SECONDARY Mean Change in Respiratory Rate. |
-6; -6 | — |
| SECONDARY Oxygen Saturation. |
1.0; 1.0 | — |
| SECONDARY Number of Subjects Remaining in the Severe Asthma Category |
4; 4 | 0.69 |
| SECONDARY Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category |
22; 11 | 0.08 |
| SECONDARY Number of Subjects Moving From the Severe Asthma to Mild Asthma Category |
8; 10 | 0.22 |
| SECONDARY Relapse / Readmission Numbers. |
2; 2 | — |
| SECONDARY Number of Participants With Adverse Events (Non-serious). |
6; 11; 5; 9; 3; 7 | — |
| SECONDARY Serious Adverse Events |
2; 2; 1; 0 | — |
Summary
The purpose of this study is to determine whether the addition of budesonide inhalation suspension (BIS) to the standard therapy of albuterol, ipratropium bromide, and systemic corticosteroids (SCS) for moderate to severe asthma flares in children reduces asthma severity more rapidly than standard therapy alone.
Eligibility Criteria
Inclusion Criteria
- Chief complaint of "respiratory distress", "asthma", "trouble breathing", or "reactive airway disease"
- Males or females age 2 to 18 years
- Weight greater than or equal to 10 kilograms
- Two or more prior Emergency Department or primary care visits for asthma or reactive airway disease
- Identified in triage as either "acute" or "critical"
- Asthma score of 8 or greater
- Systemic corticosteroid prescribed in the Emergency Department
- English-speaking parent/guardian present
- Parental/guardian permission (informed consent) and if appropriate, child assent
Exclusion Criteria
- Systemic corticosteroid use in the last 30 days
- Chronic lung diseases including cystic fibrosis
- Sickle cell anemia
- Immunodeficiency
- Cardiac disease requiring surgery or medications
- Adverse drug reaction or allergy to budesonide, albuterol, ipratropium bromide, prednisone, prednisolone, or methylprednisolone
- Known renal or hepatic dysfunction
- Exposure to varicella in the last 21 days
- Impending respiratory failure requiring positive pressure ventilation
- Altered level of consciousness
- Suspected foreign body aspiration or croup
- Prior enrollment in the study
Data sourced from ClinicalTrials.gov (NCT00393367). 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.