Trial of Epinephrine and Albuterol in Bronchiolitis - Full Text View

Sponsor:	Kern Medical Center
Information provided by:	Kern Medical Center
ClinicalTrials.gov Identifier:	NCT00114478

Purpose

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.

Condition	Intervention
Bronchiolitis	Drug: Epinephrine Drug: albuterol (salbutamol)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Randomized Controlled Trial of Epinephrine and Albuterol in Bronchiolitis

Resource links provided by NLM:

Drug Information available for: Epinephrine bitartrate Epinephrine Albuterol Levalbuterol hydrochloride Albuterol sulfate Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by Kern Medical Center:

Primary Outcome Measures:

Successful hospital discharge at three days

Secondary Outcome Measures:

Improvement in severity of disease score
Improvement in respiratory status

Estimated Enrollment:	600
Study Start Date:	November 2003
Estimated Study Completion Date:	May 2006

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.

Eligibility

Ages Eligible for Study:	up to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A clinical diagnosis of bronchiolitis

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114478

Locations

United States, California
Kern Medical Center
Bakersfield, California, United States, 93312

Sponsors and Collaborators

Kern Medical Center

Investigators

Principal Investigator:	Paul Walsh, Paul Walsh, MD MSc(peds)	Kern Medical Center, David Geffen School of Medicine, UCLA
Principal Investigator:	Paul Walsh	Research Director, Emergency Medicine

More Information

Additional Information:

Research assistant site for this study. Restricted access. This link exits the ClinicalTrials.gov site

Website of the Emergency Department conducting this study This link exits the ClinicalTrials.gov site

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Walsh 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.

ClinicalTrials.gov Identifier:	NCT00114478 History of Changes
Other Study ID Numbers:	KMC03034
Study First Received:	June 15, 2005
Last Updated:	January 23, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Kern Medical Center:

Bronchiolitis
disposition
pediatric
epinephrine
albuterol

Additional relevant MeSH terms:

Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Epinephrine
Albuterol
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists

ClinicalTrials.gov processed this record on February 12, 2012