N/A
Completed N=118
Comparison of Breath-Enhanced and T-Piece Nebulizers in Children With Acute Asthma
Source: ClinicalTrials.gov NCT02566902 ↗Enrolled (actual)
118
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Change in FEV1 (% Predicted) — 13.8; 9.1 %predicted — p=0.04
Summary
This is a blinded observer randomized controlled trial comparing two nebulizer devices. The objective of this study is to evaluate the efficacy of two different nebulizers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in FEV1 (% Predicted) |
13.8; 9.1 | 0.04 sig |
| SECONDARY Change in PAS Score (Points on a Scale) |
-1; -2 | 0.29 |
| SECONDARY Change in PASS Score (Points on a Scale) |
-1; -1 | 0.97 |
| SECONDARY Percentage of Patients Requiring Inpatient Hospital Admission (% of Subjects) |
11; 11 | 0.96 |
| SECONDARY Emergency Department Length of Stay (Minutes) |
246.3; 246.2 | 0.99 |
| SECONDARY Percentage of Patients Experiencing Medication Side Effects (%) |
5; 5 | 1.00 |
| SECONDARY Total Quantity of Albuterol Given in the Emergency Department (mg) |
18.2; 18.7 | — |
| SECONDARY Change Respiratory Rate (Breaths Per Minute) |
-3.1; -3.2 | — |
| SECONDARY Change in Heart Rate (Beats Per Minute) |
4.34; 15.05 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 6 years and < 18 years
- History of physician diagnosed asthma
- Presenting to ED with breathing difficulty or cough
- Initial FEV1 25%-70% predicted
- Parent or guardian speaks English or Spanish.
Exclusion Criteria
- Pediatric Asthma Score of 0
- Pregnancy or breast-feeding
- Immediate resuscitation required
- Chronic lung disease (other than asthma)
- Congenital heart disease
- Neuromuscular disease
- Suspected intrathoracic foreign body
- Allergy or other contraindication to study medication
Data sourced from ClinicalTrials.gov (NCT02566902). 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.