Asthma ExacerbationNCT06291740
Continuous Versus Intermittent Nebulization Therapy in Acute Asthma Exacerbation at Emergency Department
A study testing continuous nebulization and Intermittent nebulization in people with Asthma Exacerbation and Emergency Department, run by Thammasat University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma Exacerbation, Emergency Department, Nebulization
- What is being tested?
- continuous nebulization and Intermittent nebulization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- asthma exacerbation
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Asthma Exacerbation, Emergency Department, Nebulization
- Being tested
- continuous nebulization, Intermittent nebulization
- Keywords
- asthma exacerbation, continuous nebulization, intermittent nebulization
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous nebulizationDevice
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 nebulizationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Intermittent nebulization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of ED stay
duration of ED management
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
pulmonary function test
Forced Expiratory Volume in one second(FEV1), Peak Expiratory Flow(PEF)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study startApr 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial (RCT)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kumpol Kornthatchapong, Thammasat University
- Investigators
- Kumpol Kornthatchapong, Principal investigator, Faculty of Medicine, Thammasat university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291740
- Sponsor's protocol ID
- MTU-EC-EM-2-008/67
- Other IDs
- Faculty of Medicine
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Intermittent Nebulization Therapy in Acute Asthma Exacerbation at Emergency Department: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06291740
- Acronym / sponsor ID
- MTU-EC-EM-2-008/67
- Conditions
- Asthma Exacerbation, Emergency Department, Nebulization
- Keywords
- asthma exacerbation, continuous nebulization, intermittent nebulization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Continuous nebulization | Experimental | Device: continuous nebulizationcontinuous 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 | Active comparator | Device: Intermittent nebulizationintermittent 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- asthma exacerbation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous nebulizationcontinuous 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 nebulizationintermittent 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 |
Primary outcome
Length of ED stay
Time frame: through study completion, an average of 1 year
duration of ED management
1 secondary outcome
pulmonary function test
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Comparison of intermittent and continuously nebulized albuterol for treatment of asthma in an urban emergency departmentLink provided by the sponsor.
- Continuous versus intermittent albuterol nebulization in the treatment of acute asthmaLink provided by the sponsor.
- 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 asthmaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kumpol Kornthatchapong principal investigator
Faculty of Medicine, Thammasat university
Questions about this trial
What is this clinical trial studying?
A study testing continuous nebulization and Intermittent nebulization in people with Asthma Exacerbation and Emergency Department, run by Thammasat University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kumpol Kornthatchapong, Assoc.Prof. (+66954951555, kump29@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of ED stay (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.