Continuous Versus Intermittent Nebulization Therapy in Acute Asthma Exacerbation at Emergency Department

February 26, 2024 updated by: Kumpol Kornthatchapong, Thammasat University

Continuous Versus Intermittent Nebulization Therapy in Acute Asthma Exacerbation at Emergency Department: A Randomized Controlled Trial

The goal of this clinical is to compare treatment outcomes between continuous nebulization and intermittent therapy in the management of acute exacerbation of asthma in the emergency department(ED). Participants will random assign to either continuous or intermittent nebulization. In the continuous group, patients receive budesonide, fenoterol, ipratropium bromide, and normal saline continuously for an hour. In the intermittent group, the same medications are administer every 20 minutes for an hour. Measurements include symptom severity, respiratory rate, oxygen saturation, and pulmonary function tests. Primary endpoints are ED stay length, hospital admission, and ED revisit within 48 hours post-discharge. Adverse events are documented.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kumpol Kornthatchapong, Assoc.Prof.
  • Phone Number: +66954951555
  • Email: kump29@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • asthma exacerbation

Exclusion Criteria:

  • life-threatening conditions requiring intubation
  • allergy to steroid or its components
  • patient under investigation of Corona Virus Disease, 2019 (COVID-19)
  • pulmonary tuberculosis
  • unable to cooperate for pulmonary function testing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continuous nebulization
continuous nebulization using the MiniHEART-HiFlo® nebulizer containing Budesonide 1000 microgram/2 ml (3 respules) + 1.25 mg of fenoterol and 0.5 mg of ipratropium bromide (Berodual®, 4 ml) and Normal saline 12 ml in the nebulizer chamber. Patients in this group will receive continuous aerosol therapy over a period of 1 hour at an oxygen flow rate of 8 L/min
Device: continuous nebulization
continuous nebulization using the MiniHEART-HiFlo® nebulizer containing Budesonide 1000 microgram/2 ml (3 respules) + 1.25 mg of fenoterol and 0.5 mg of ipratropium bromide (Berodual®, 4 ml) and Normal saline 12 ml in the nebulizer chamber. Patients in this group will receive continuous aerosol therapy over a period of 1 hour at an oxygen flow rate of 8 L/min
Active Comparator: intermittent nebulization
intermittent nebulization using a nebulizer containing Budesonide 1000 microgram/2 ml (1 respules) + 1.25 mg of fenoterol and 0.5 mg of ipratropium bromide (Berodual®, 4 ml) at an oxygen flow rate of 10 L/min every 20 minutes, thrice within 1 hour
Device: Intermittent nebulization
intermittent nebulization using a nebulizer containing Budesonide 1000 microgram/2 ml (1 respules) + 1.25 mg of fenoterol and 0.5 mg of ipratropium bromide (Berodual®, 4 ml) at an oxygen flow rate of 10 L/min every 20 minutes, thrice within 1 hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of ED stay
Time Frame: through study completion, an average of 1 year
duration of ED management
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulmonary function test
Time Frame: through study completion, an average of 1 year
Forced Expiratory Volume in one second(FEV1), Peak Expiratory Flow(PEF)
through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital admission
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
ED revisit within 48 hours
Time Frame: through study completion, an average of 1 year
revisit with acute asthma exacerbation
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Investigators

  • Principal Investigator: Kumpol Kornthatchapong, Faculty of Medicine, Thammasat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Estimated)

March 4, 2024

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTU-EC-EM-2-008/67
  • Faculty of Medicine (Other Identifier: Thammasat University, Thailand)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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