Comparison of Breath-Enhanced and T-Piece Nebulizers in Children With Acute Asthma

NCT02566902 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2021-05-06

Study results available
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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.

Conditions

Interventions

DEVICE

T-Piece Nebulizer

Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ)

DEVICE

Breath-Enhanced Nebulizer

Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA)

DRUG

Albuterol

One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.

PROCEDURE

Pre-Treatment Spirometry Measurement

Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer.

PROCEDURE

Post-Treatment Spirometry Measurement

Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer.

Sponsors & Collaborators

  • University of Texas

    collaborator OTHER
  • Seton Healthcare Family

    lead OTHER

Principal Investigators

  • Matthew Wilkinson, MD · Seton Healthcare Family

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02566902 on ClinicalTrials.gov