BronchiolitisNCT00114478
Trial of Epinephrine and Albuterol in Bronchiolitis
A study testing Epinephrine and albuterol (salbutamol) in people with Bronchiolitis, run by Kern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to see which of the two most common drugs used to treat bronchiolitis works better. A child's participation in this study is expected to last less than 4 hours. Approximately 600 patients will be recruited to participate in this study at Kern Medical Center (KMC). Read more about this study
- Who is it for?
- Ages Up to 18 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Epinephrine and albuterol (salbutamol)
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to May 2006
- 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 Up to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A clinical diagnosis of bronchiolitis
Who cannot join
- Age greater than 18 months
- Disease too mild to warrant any treatment
- Emergent intubation on arrival at the ED
- Participation within another study within 30 days
- Refusal of informed parental consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Epinephrine and Albuterol in Bronchiolitis
The purpose of this study is to see which of the two most common drugs used to treat bronchiolitis works better. A child's participation in this study is expected to last less than 4 hours. Approximately 600 patients will be recruited to participate in this study at Kern Medical Center (KMC).
Bronchiolitis is a very common lung infection in babies. There are many drugs used to treat this disease but nobody knows which one, if any, works the best. Two of the most commonly used drugs are albuterol and epinephrine. These are both drugs given during breathing treatments with oxygen and a mask. We are doing this study to see which of these drugs works better or if they are both equally good. The study works as follows: after the consent process the baby gets three treatments.
Read more
- Nebulizer 1 (Treatment)
- Treatment + 30 minutes (approximately) Nebulizer 2
- Treatment + 60 minutes (approximately) Nebulizer 3
- Treatment + 120 minutes (approximately)
The baby will be reevaluated and either discharged home or revert to standard therapy. If the baby is discharged directly from the emergency department (E.D.), we will call you in three days time to see how he/she is doing.
Read the detailed description
Double blind RCT. Primary outcome measure is admission defined as actual admission or discharge with unscheduled return leading to admission within 72 hours. Secondary endpoints include change in severity of illness and response of respiratory parameters to treatment.
- Conditions
- Bronchiolitis
- Being tested
- Epinephrine, albuterol (salbutamol)
- Keywords
- Bronchiolitis, disposition, pediatric, epinephrine, albuterol
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinephrineDrug
albuterol (salbutamol)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful hospital discharge at three days
Secondary outcomes (2)
Improvement in severity of disease score
Improvement in respiratory status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2005 (estimated)
- Study startNov 2003
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies 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
- Masking
- Double blind
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Kern Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Paul Walsh, Paul Walsh, MD MSc(peds), Principal investigator, Kern Medical Center, David Geffen School of Medicine, UCLAPaul Walsh, Principal investigator, Research Director, Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114478
- Sponsor's protocol ID
- KMC03034
- Status last verified
- Jan 2008
- First submitted
- 15 Jun 2005
- Last updated
- 25 Jan 2008
- Results posted
- No
Publications
Walsh P, Rothenberg SJ, O'Doherty S, Hoey H, Healy R. A validated clinical model to predict the need for admission and length of stay in children with acute bronchiolitis. Eur J Emerg Med. 2004 Oct;11(5):265-72. doi: 10.1097/00063110-200410000-00005.
PubMed 15359199Walsh P, Caldwell J, McQuillan KK, Friese S, Robbins D, Rothenberg SJ. Comparison of nebulized epinephrine to albuterol in bronchiolitis. Acad Emerg Med. 2008 Apr;15(4):305-13. doi: 10.1111/j.1553-2712.2008.00064.x.
PubMed 18370982
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Epinephrine and Albuterol in Bronchiolitis
- ClinicalTrials.gov ID
- NCT00114478
- Acronym / sponsor ID
- KMC03034
- Conditions
- Bronchiolitis
- Keywords
- Bronchiolitis, disposition, pediatric, epinephrine, albuterol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants
- Lead sponsor
- Kern Medical CenterUniversity, hospital or other
- Study start
- Nov 2003
- Study completion
- May 2006
- First posted
- 16 Jun 2005 (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.
The purpose of this study is to see which of the two most common drugs used to treat bronchiolitis works better. A child's participation in this study is expected to last less than 4 hours. Approximately 600 patients will be recruited to participate in this study at Kern Medical Center (KMC).
Bronchiolitis is a very common lung infection in babies. There are many drugs used to treat this disease but nobody knows which one, if any, works the best. Two of the most commonly used drugs are albuterol and epinephrine. These are both drugs given during breathing treatments with oxygen and a mask. We are doing this study to see which of these drugs works better or if they are both equally good. The study works as follows: after the consent process the baby gets three treatments.
- Nebulizer 1 (Treatment)
- Treatment + 30 minutes (approximately) Nebulizer 2
- Treatment + 60 minutes (approximately) Nebulizer 3
- Treatment + 120 minutes (approximately)
The baby will be reevaluated and either discharged home or revert to standard therapy. If the baby is discharged directly from the emergency department (E.D.), we will call you in three days time to see how he/she is doing.
Detailed description
Double blind RCT. Primary outcome measure is admission defined as actual admission or discharge with unscheduled return leading to admission within 72 hours. Secondary endpoints include change in severity of illness and response of respiratory parameters to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- Up to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- A clinical diagnosis of bronchiolitis
Key exclusion criteria (5 listed)
- Age greater than 18 months
- Disease too mild to warrant any treatment
- Emergent intubation on arrival at the ED
- Participation within another study within 30 days
- Refusal of informed parental consent
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 |
|---|---|---|
| Epinephrine | Drug | – |
| albuterol (salbutamol) | Drug | – |
Primary outcome
Successful hospital discharge at three days
2 secondary outcomes
Improvement in severity of disease score
Improvement in respiratory status
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2008.
- Background: PubMed 15359199Walsh P, Rothenberg SJ, O'Doherty S, Hoey H, Healy R. A validated clinical model to predict the need for admission and length of stay in children with acute bronchiolitis. Eur J Emerg Med. 2004 Oct;11(5):265-72. doi: 10.1097/00063110-200410000-00005.
- Derived from this study: PubMed 18370982Walsh P, Caldwell J, McQuillan KK, Friese S, Robbins D, Rothenberg SJ. Comparison of nebulized epinephrine to albuterol in bronchiolitis. Acad Emerg Med. 2008 Apr;15(4):305-13. doi: 10.1111/j.1553-2712.2008.00064.x.
- Research assistant site for this study. Restricted access.Link 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.
Paul Walsh, Paul Walsh, MD MSc(peds) principal investigator
Kern Medical Center, David Geffen School of Medicine, UCLA
Paul Walsh principal investigator
Research Director, Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epinephrine and albuterol (salbutamol) in people with Bronchiolitis, run by Kern Medical Center at 1 site in United States.
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 25 Jan 2008. 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 United States. 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. 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?
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?
Successful hospital discharge at three days. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00114478, which also lists 2 linked publications.
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 25 Jan 2008.