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NCT06291740 Clinical Trial

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

Emergency Department Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06291740
Other study ID # MTU-EC-EM-2-008/67
Secondary ID Faculty of Medic
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date May 2025

Study information
Verified date February 2024
Source Thammasat University
Contact Kumpol Kornthatchapong, Assoc.Prof.
Phone +66954951555
Email kump29@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date May 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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
• 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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Thammasat University

Outcome
Type Measure Description Time frame Safety issue
Other Hospital admission through study completion, an average of 1 year
Other ED revisit within 48 hours revisit with acute asthma exacerbation through study completion, an average of 1 year
Primary Length of ED stay duration of ED management through study completion, an average of 1 year
Secondary pulmonary function test Forced Expiratory Volume in one second(FEV1), Peak Expiratory Flow(PEF) through study completion, an average of 1 year
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