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

NCT06291740 | Not Yet Recruiting DMC

• 2 other identifiers: MTU-EC-EM-2-008/67Faculty of Medicine
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Asthma Exacerbation; Emergency Department; Nebulization

Keywords

asthma exacerbation; continuous nebulization; intermittent nebulization

Outcome Measures

Primary Outcomes (1)

• Length of ED stay

  duration of ED management

  through study completion, an average of 1 year

Secondary Outcomes (1)

• pulmonary function test

  through study completion, an average of 1 year

Other Outcomes (2)

• Hospital admission

  through study completion, an average of 1 year

• ED revisit within 48 hours

  through study completion, an average of 1 year

Study Arms (2)

Continuous nebulization

EXPERIMENTAL

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

intermittent nebulization

ACTIVE COMPARATOR

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

Interventions

continuous nebulization DEVICE

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

Continuous nebulization

Intermittent nebulization DEVICE

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

intermittent nebulization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• asthma exacerbation

You may not qualify if:

• 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

Sponsors & Collaborators

• Thammasat University: lead

Related Links

• Comparison of intermittent and continuously nebulized albuterol for treatment of asthma in an urban emergency department
• Continuous versus intermittent albuterol nebulization in the treatment of acute asthma
• A randomized, clinical trial comparing the efficacy of continuous nebulized albuterol (15 mg) versus continuous nebulized albuterol (15 mg) plus ipratropium bromide (2 mg) for the treatment of acute asthma

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kumpol Kornthatchapong

  Faculty of Medicine, Thammasat university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kumpol Kornthatchapong, Assoc.Prof.

CONTACT

+66954951555; kump29@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Model Details: randomized controlled trial (RCT)

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 4, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 4, 2024

Record last verified: 2024-02