NCT02774941

Brief Summary

The purpose of this study is to compare clinical outcomes related to the current practice of using a jet nebulizer (JN) with aerosol mask (AM) or mouthpiece (MP) versus a vibrating mesh nebulizer (VMN) with a valved-mask (VM) or MP in the treatment of acute moderate to severe asthma in Children's Medical Center Dallas Emergency Department (CMCED).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2019

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 31, 2020

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

2.6 years

First QC Date

May 13, 2016

Results QC Date

January 13, 2020

Last Update Submit

January 21, 2020

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects Hospitalized

    The primary outcome measure is rate of hospitalization between the two treatment groups overall

    Within emergency department visit time frame (no more than 12 hours)

Secondary Outcomes (1)

  • Number of Treatments Required to Achieve Mild Asthma Score - Discharge Criteria

    Within emergency department visit time frame (no more than 12 hours)

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard single patient-use small volume JN (AirLife™ Sidestream® High-Efficiency Nebulizer, CareFusion, Yorba Linda, CA)

Device: Jet Nebulizer

Study

EXPERIMENTAL

Vibrating Mesh Nebulizer (Aerogen® Solo with Ultra adapter, Aerogen Ltd, Galway, Ireland)

Device: Vibrating Mesh Nebulizer

Interventions

Jet NebulizerDEVICE

Standard single patient-use small volume JN (AirLife™ Sidestream® High-Efficiency Nebulizer, CareFusion, Yorba Linda, CA)

Control
Vibrating Mesh NebulizerDEVICE

Vibrating Mesh Nebulizer (Aerogen® Solo with Ultra adapter, Aerogen Ltd, Galway, Ireland)

Study

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • to 18 year old (up to 19th birthday) otherwise healthy children with primary diagnosis of acute moderate to severe exacerbation of asthma presenting to Children's Medical Center Emergency Department, Dallas

You may not qualify if:

  • Children \< 2 years old
  • Children with comorbid/complex medical conditions such as: congenital or acquired cardiovascular disease, cystic fibrosis, chronic lung disease (other than asthma), bronchopulmonary dysplasia, airway anomalies (e.g., tracheomalacia) or immunodeficiency syndromes.
  • Patients with coexisting medical condition such as pneumonia
  • Patients in impending respiratory failure as determined by treating physician
  • Patients that have had oral corticosteroids within 24hrs of CMCED admission
  • Patients that have had bronchodilator treatment within one hour of CMCED admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Medical Center

Dallas, Texas, 75235, United States

Location

Related Publications (1)

  • Moody GB, Luckett PM, Shockley CM, Huang R, Ari A. Clinical Efficacy of Vibrating Mesh and Jet Nebulizers With Different Interfaces in Pediatric Subjects With Asthma. Respir Care. 2020 Oct;65(10):1451-1463. doi: 10.4187/respcare.07538. Epub 2020 Mar 24.

    PMID: 32209712DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Clinical Research Coordinator - Respiratory Care Dept
Organization
Children's Health - Children's Medical Center, Dallas
gerald.moody@childrens.com
214-456-1367

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2016

First Posted

May 17, 2016

Study Start

August 1, 2016

Primary Completion

March 8, 2019

Study Completion

March 8, 2019

Last Updated

January 31, 2020

Results First Posted

January 31, 2020

Record last verified: 2020-01

Locations

US(1)