Trial of Epinephrine and Albuterol in Bronchiolitis

• ClinicalTrials.gov Identifier: NCT00114478
• Recruitment Status: Unknown
• First Posted: June 16, 2005
• Last Update Posted: January 25, 2008
• Sponsor: Kern Medical Center
• Information provided by: Kern Medical Center

Study Description

Brief 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).

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 or disease	Intervention/treatment	Phase
Bronchiolitis	Drug: Epinephrine; Drug: albuterol (salbutamol)	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of Epinephrine and Albuterol in Bronchiolitis
• Study Start Date: November 2003
• Study Completion Date: May 2006

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Successful hospital discharge at three days

Secondary Outcome Measures :

1. Improvement in severity of disease score
2. Improvement in respiratory status

Eligibility Criteria

• Ages Eligible for Study: up to 18 Months (Child)
• Sexes Eligible for Study: All
• 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

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. 

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.

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. doi: 10.1111/j.1553-2712.2008.00064.x.

• ClinicalTrials.gov Identifier: NCT00114478
• Other Study ID Numbers: KMC03034
• First Posted: June 16, 2005
• Last Update Posted: January 25, 2008
• Last Verified: January 2008

Keywords provided by Kern Medical Center:

Bronchiolitis; disposition; pediatric; epinephrine; albuterol

Additional relevant MeSH terms:

Bronchiolitis; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Epinephrine; Albuterol; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Adrenergic beta-Agonists; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Sympathomimetics; Vasoconstrictor Agents; Tocolytic Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists