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Trial of Epinephrine and Albuterol in Bronchiolitis

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ClinicalTrials.gov Identifier: NCT00114478
Recruitment Status : Unknown
Verified January 2008 by Kern Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : June 16, 2005
Last Update Posted : January 25, 2008
Information provided by:
Kern Medical Center

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
Bronchiolitis Drug: Epinephrine Drug: albuterol (salbutamol)

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 Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Completion Date : May 2006

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114478

United States, California
Kern Medical Center
Bakersfield, California, United States, 93312
Sponsors and Collaborators
Kern Medical Center
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00114478     History of Changes
Other Study ID Numbers: KMC03034
First Posted: June 16, 2005    Key Record Dates
Last Update Posted: January 25, 2008
Last Verified: January 2008

Keywords provided by Kern Medical Center:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Epinephryl borate
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
Vasoconstrictor Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists