NCT03420651

Brief Summary

Patients presenting to the emergency department with acute asthma exacerbation will be assigned to peak-expiratory flow rate (PEFR) guided management and non-PEFR guided management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
188

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Jan 2018

Longer than P75 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

Study Start

First participant enrolled

January 19, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

4.9 years

First QC Date

January 28, 2018

Last Update Submit

September 20, 2023

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Adequate control of asthma symptoms within 150 minutes

    Proportion of patients reporting no or mild asthma symptoms at 150 minutes after enrollment

    150 minutes

Secondary Outcomes (4)

  • Hospitalization during index encounter

    12 hours

  • ED Length of Stay

    12 hours

  • Number of nebulized treatments with short-acting beta antagonists (SABA)

    12 hours

  • Relapse following discharge within 72 hours

    72 hours

Study Arms (2)

PEFR Guided Management

EXPERIMENTAL

Peak Expiratory Flow Rate (PEFR) Patients in this group will perform PEFR testing every 30 minutes and this data along with the National Asthma Prevention and Education Program guidelines will be considered by primary ED medical providers in the management of this group.

Other: Peak Expiratory Flow Rate (PEFR)

Non-PEFR Guided Management

EXPERIMENTAL

Standard Clinical Judgement Patients in this group will receive management based on primary medical provider's clinical judgement.

Other: Standard Clinical Judgement

Interventions

Peak Expiratory Flow Rate (PEFR)OTHER

PEFR values and the National Asthma Prevention and Education Program guidelines will be used by providers in the management of these patients.

PEFR Guided Management
Standard Clinical JudgementOTHER

Providers will use physical exam and standard clinical judgement to guide management.

Non-PEFR Guided Management

Eligibility Criteria

Age16 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Presumed diagnosis of asthma, requiring at least 2 nebulized albuterol treatments
  • Presenting with acute asthma exacerbation defined as acute or subacute episodes of progressively worsening shortness of breath, cough, wheezing, and chest tightness, or some combination of these symptoms
  • Start of enrollment process must occur within 15 minutes of being roomed in the ED
  • Working phone number and willingness to be contacted at least 72 hours following encounter

You may not qualify if:

  • Prisoner or in custody
  • Pregnant
  • Known diagnosis of COPD
  • Co-morbid medical conditions that patient is seeking treatment for concurrently
  • Non-English speaking
  • Unable to provide informed consent
  • In the resuscitation bay or on non-invasive positive pressure ventilation (NPPV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Peak Expiratory Flow Rate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Forced Expiratory Flow RatesPulmonary VentilationRespiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
When patients are randomized to the non-peak flow guided therapy, physicians are blinded to the peak flow values
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Clinical Research

Study Record Dates

First Submitted

January 28, 2018

First Posted

February 5, 2018

Study Start

January 19, 2018

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)