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

This study has been terminated.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00361452

First Posted: August 8, 2006

Last Update Posted: August 8, 2006

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Rambam Health Care Campus

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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double 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 Epinephrine hydrochloride Racepinephrine hydrochloride Racepinephrine Albuterol Levalbuterol 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	up to 1 Year (Child)
Sexes Eligible for Study:	All
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

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): 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

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
First Submitted:	August 6, 2006
First Posted:	August 8, 2006
Last Update Posted:	August 8, 2006
Last Verified:	November 2000

Additional relevant MeSH terms:


Bronchiolitis Bronchitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Epinephrine Racepinephrine Albuterol 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 Mydriatics Sympathomimetics Vasoconstrictor Agents Tocolytic Agents Reproductive Control Agents Adrenergic beta-2 Receptor Agonists

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