Acute BronchiolitisPhase 4NCT01660867
Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department
A Phase 4 study testing 0.9% saline + oral dexamethasone in people with Acute Bronchiolitis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This is a prospective, randomized, controlled, double-blinded, clinical trial Subject : 3mo ~ 24mo. aged infants with bronchiolitis The effect of 3 % NaCl nebulizer or dexamethasone on admission rate of these infants in ED. Read more about this study
- Who is it for?
- Ages 3 to 24 months
- Conditions the study is for
- Acute Bronchiolitis
- What is being tested?
- 0.9% saline + oral dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Dec 2014
- Phase
- Phase 4
- 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 3 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 3mo ~ 24mo aged patients with bronchiolitis visit to emergency departments
- RDAI score 4-15
Who cannot join
- < 3mo, > 24mo
- infants who had received oral or inhaled corticosteroids during the preceding 2 weeks
- infants with a previous episode of wheezing or a diagnosis of asthma
- any chronic cardiopulmonary disease
- immunodeficiency
- infants needed intubation
Show all 9Show fewer
- infants with a previous history of apnea or intubation
- infants with side effect of dexamethasone
- infants born at less than 37 weeks of gestation who had a corrected age of less than 6 weeks at presentation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
This is a prospective, randomized, controlled, double-blinded, clinical trial
Subject : 3mo ~ 24mo. aged infants with bronchiolitis
The effect of 3 % NaCl nebulizer or dexamethasone on admission rate of these infants in ED.
Read the detailed description
Randomly assigned to one of three groups
- Group I : nebulized epinephrine + 0.9% saline + placebo
- Group II : nebulized epinephrine + 3% saline + placebo
- Group III : nebulized epinephrine + 0.9% saline + dexamethasone
Group I received two treatments of nebulized epinephrine mixed 0.9% saline and a total of six oral doses of placebo, group II received nebulized epinephrine mixed 3% saline and oral placebo, and group III received nebulized epinephrine mixed 0.9% saline and oral dexamethasone.
The primary outcome is hospital admission within 7 days after the day of enrollment
- Conditions
- Acute Bronchiolitis
- Being tested
- 3% saline + oral placebo, 0.9% saline + oral dexamethasone
- Keywords
- hospital admission within 7 days of 3% NaCl nebulizer vs dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% saline + oral placeboDrug
nebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline
0.9% saline + oral dexamethasoneDrug
nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| 0.9% saline + oral placebo | Placebo comparator | nebulized epinephrine + 0.9% saline + placebo => epinephrine + 0.9% saline Receives: Drug: 0.9% saline + oral dexamethasone |
| 3% saline + oral placebo | Experimental | nebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline Receives: Drug: 3% saline + oral placebo |
| 0.9% saline + oral dexamethasone | Active comparator | nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline Receives: Drug: 0.9% saline + oral dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital admission within 7 days after the day of enrollment
hospital admission within 7 days after the day of enrollment(the initial visit to the emergency department)
Measured: within 7 days
Secondary outcomes (5)
RDAI score
RDAI score
Measured: baseline, between nebulizer, 60min, 120min, 180min, 240min
respiratory rate
respiratory rate
Measured: baseline, between nebulizer, 60min, 120min, 180min, 240min
Heart rate
Heart rate
Measured: baseline, between nebulizer, 60min, 120min, 180min, 240min
Oxygen saturation
Oxygen saturation
Measured: baseline, between nebulizer, 60min, 120min, 180min, 240min
unplanned revisit and admission rate after revisit
unplanned revisit admission rate after revisit
Measured: in 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: there was no eligible patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute BronchiolitisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Hee Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660867
- Sponsor's protocol ID
- Bronchiolitis_1
- Status last verified
- Jan 2018
- First submitted
- 3 Aug 2012
- Last updated
- 9 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department
- ClinicalTrials.gov ID
- NCT01660867
- Acronym / sponsor ID
- Bronchiolitis_1
- Conditions
- Acute Bronchiolitis
- Keywords
- hospital admission within 7 days of 3% NaCl nebulizer vs dexamethasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: there was no eligible patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Aug 2012 (estimated)
- 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.
This is a prospective, randomized, controlled, double-blinded, clinical trial
Subject : 3mo ~ 24mo. aged infants with bronchiolitis
The effect of 3 % NaCl nebulizer or dexamethasone on admission rate of these infants in ED.
Detailed description
Randomly assigned to one of three groups
- Group I : nebulized epinephrine + 0.9% saline + placebo
- Group II : nebulized epinephrine + 3% saline + placebo
- Group III : nebulized epinephrine + 0.9% saline + dexamethasone
Group I received two treatments of nebulized epinephrine mixed 0.9% saline and a total of six oral doses of placebo, group II received nebulized epinephrine mixed 3% saline and oral placebo, and group III received nebulized epinephrine mixed 0.9% saline and oral dexamethasone.
The primary outcome is hospital admission within 7 days after the day of enrollment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.9% saline + oral placebo | Placebo comparator | Drug: 0.9% saline + oral dexamethasonenebulized epinephrine + 0.9% saline + placebo => epinephrine + 0.9% saline |
| 3% saline + oral placebo | Experimental | Drug: 3% saline + oral placebonebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline |
| 0.9% saline + oral dexamethasone | Active comparator | Drug: 0.9% saline + oral dexamethasonenebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline |
Who may qualify
- Ages
- 3 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 3mo ~ 24mo aged patients with bronchiolitis visit to emergency departments
- RDAI score 4-15
Key exclusion criteria (9 listed)
- < 3mo, > 24mo
- infants who had received oral or inhaled corticosteroids during the preceding 2 weeks
- infants with a previous episode of wheezing or a diagnosis of asthma
- any chronic cardiopulmonary disease
- immunodeficiency
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 |
|---|---|---|
| 3% saline + oral placebonebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline | Drug | 3% saline + oral placebo |
| 0.9% saline + oral dexamethasonenebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline | Drug | 0.9% saline + oral dexamethasone, 0.9% saline + oral placebo |
Primary outcome
hospital admission within 7 days after the day of enrollment
Time frame: within 7 days
hospital admission within 7 days after the day of enrollment(the initial visit to the emergency department)
5 secondary outcomes
RDAI score
Time frame: baseline, between nebulizer, 60min, 120min, 180min, 240min
respiratory rate
Time frame: baseline, between nebulizer, 60min, 120min, 180min, 240min
Heart rate
Time frame: baseline, between nebulizer, 60min, 120min, 180min, 240min
Oxygen saturation
Time frame: baseline, between nebulizer, 60min, 120min, 180min, 240min
unplanned revisit and admission rate after revisit
Time frame: in 7days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.9% saline + oral dexamethasone in people with Acute Bronchiolitis, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 9 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: withdrawn, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospital admission within 7 days after the day of enrollment (time frame: within 7 days). 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 9 Jan 2018.