N/A
Completed N=980
A Randomized Trial Comparing Metered Dose Inhalers and Breath Actuated Nebulizers
Source: ClinicalTrials.gov NCT02777125 ↗Enrolled (actual)
980
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: Number of Participant's Admitted to the Hospital for Further Treatment — 53; 57 Participants admitted to the Hospital
Summary
This study is determines if metered dose inhalers are as effective as breath actuated nebulizers for the treatment of mild to moderate asthma exacerbations in pediatric patients presenting to the emergency department. Half of the participating patients received albuterol via the metered dose inhaler whereas the other half received albuterol via the breath actuated nebulizer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participant's Admitted to the Hospital for Further Treatment |
53; 57 | — |
| SECONDARY Emergency Department Length of Stay |
192; 197; 232; 245 | — |
| SECONDARY Number of Patients With Tachycardia After Treatment |
101; 141 | — |
| SECONDARY Number of Patients Requiring Ondansetron Dosing |
14; 18 | — |
| SECONDARY Number of Participants Requiring Repeat Visits |
5; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Patients presenting either with a first time wheeze or with an asthma exacerbation of a mild to moderate severity, both defined by a pediatric asthma score (PAS)11 of 5 to 11.
Exclusion Criteria
- Subjects were excluded if they had initiated therapy at an outlying medical facility or had a history of any chronic lung disease
- Congenital heart disease, tracheostomy, or were receiving diuretic therapy.
- Patients diagnosed by the treating physician with bronchiolitis or pneumonia were excluded along with children who were wards of the state or whose parents did not speak English.
Data sourced from ClinicalTrials.gov (NCT02777125). 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. Informational only — not medical advice.