Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study - Full Text View

Sponsor:	Rambam Health Care Campus
Information provided by:	Rambam Health Care Campus
ClinicalTrials.gov Identifier:	NCT00361452

Purpose

Bronchiolitis is a common disease of infancy and a main reason for infants' hospital admissions in the first 2 years of life. The main cause of bronchiolitis is RSV (respiratory syncytial virus). Though, Treatment is mainly supportive, the treatment benefit of nebulized epinephrine or albuterol has been largely debated for the past years. Most of the clinical studies used clinical parameters to detect and compare the effectiveness of such medical interventions. In this study we will use non invasive computerized method of wheeze and crackles quantification to compare the effectiveness of nebulized epinephrine vs albuterol in RSV Bronchiolitis.

Condition	Intervention	Phase
Rsv Bronchiolitis	Drug: nebulized epinephrine and nebulized albuterol	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study

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 Rambam Health Care Campus:

Primary Outcome Measures:

respiratory clinical score
computerized quantification of wheezing and crackles

Estimated Enrollment:	30
Study Start Date:	December 2000
Estimated Study Completion Date:	May 2001

Detailed Description:

Inpatient Infants younger than 2 years of age with first episode of RSV bronchiolitis will be randomly assigned to treatment with nebulized epinephrine (1 mg diluted with 3 ml of 0.9% saline) or nebulized albuterol (2.5 mg diluted with 3.5 ml of 0.9% saline). Both solutions will be provided in identical containers.

Clinical assessment and clinical score will be done before treatment, 10 and 30 minutes after treatment. The following parameters were recorded at each time point, wheezing, respiratory distress, O2 saturation, respiratory rate and heart rate. Computerized lung sounds as well, will be recorded before treatment, 10 and 30 minutes after treatment via 4 contact sensors attached to the chest.

Eligibility

Ages Eligible for Study:	up to 1 Year
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Under one year of age
first episode of wheezing and dyspnea
RSV antigen detected by ELISA
parents signed informed consent.

Exclusion Criteria:

infants with chronic lung disease
cardiac disease
other chronic conditions.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361452

Locations

Israel
Pediatric Ward, Rambam Medical Centre
Haifa, Israel, 31096

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

Principal Investigator:

LEA BENTUR, MD

Rambam medical centre, pediatric pulmonary unit, HAIFA

More Information

No publications provided by Rambam Health Care Campus

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

Beck R, Elias N, Shoval S, Tov N, Talmon G, Godfrey S, Bentur L. Computerized acoustic assessment of treatment efficacy of nebulized epinephrine and albuterol in RSV bronchiolitis. BMC Pediatr. 2007 Jun 2;7:22.

ClinicalTrials.gov Identifier:	NCT00361452 History of Changes
Other Study ID Numbers:	epinephrine_albuterol_rsv.ctil
Study First Received:	August 6, 2006
Last Updated:	August 6, 2006
Health Authority:	Israel: Ethics Commission

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