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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06291740
Enrollment
40
Registered
2024-03-04
Start date
2024-04-30
Completion date
2025-05-31
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma Exacerbation, Emergency Department, Nebulization

Keywords

asthma exacerbation, continuous nebulization, intermittent nebulization

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.

Interventions

DEVICEcontinuous 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

DEVICEIntermittent 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

Sponsors

Thammasat University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

randomized controlled trial (RCT)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Length of ED staythrough study completion, an average of 1 yearduration of ED management

Secondary

MeasureTime frameDescription
pulmonary function testthrough study completion, an average of 1 yearForced Expiratory Volume in one second(FEV1), Peak Expiratory Flow(PEF)

Other

MeasureTime frameDescription
Hospital admissionthrough study completion, an average of 1 year
ED revisit within 48 hoursthrough study completion, an average of 1 yearrevisit with acute asthma exacerbation

Contacts

Primary ContactKumpol Kornthatchapong, Assoc.Prof.
kump29@gmail.com+66954951555

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026