Hypertonic Saline for Outpatient Bronchiolitis (Hypertonic)

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.

ClinicalTrials.gov Identifier: NCT00696540

Recruitment Status : Unknown

Verified June 2008 by University Diego Portales.
Recruitment status was: Recruiting

First Posted : June 12, 2008

Last Update Posted : June 12, 2008

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Clínica Vespucio, Santiago, Chile

Information provided by:

University Diego Portales

Study Description

Brief Summary:

We will study if small children who become ill with respiratory distress during the RSV epidemic are better relieved with salbutamol nebulizations diluted in hypertonic (3%), instead of normal (0.9%) saline.

Condition or disease	Intervention/treatment	Phase
Bronchiolitis Respiratory Distress	Drug: Inhalation of salbutamol diluted in hypertonic saline Drug: Inhalation of salbutamol diluted in normal saline	Phase 2

Detailed Description:

In Santiago, Chile, a near collapse of health services is a notorious feature of every winter when vast numbers of small children line for attention because of respiratory distress caused by a probable RSV infection.

Our study will examine if nebulized salbutamol diluted in hypertonic (3%), instead of normal (0.9%) saline, provides better relief in outpatients.

If hypertonic saline proves safe and effective, the patients could be better managed and the pressure for attention diminished at a low cost, by a simple change in the saline ampule.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	74 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Safety and Efficacy of Hypertonic Vrs. Normal Saline as Diluent of Salbutamol to Reduce Respiratory Distress in Outpatients With the Clinical Diagnosis of Bronchiolitis During the RSV Epidemic.
Study Start Date :	June 2008
Estimated Primary Completion Date :	September 2008
Estimated Study Completion Date :	October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Sodium chloride Albuterol Levalbuterol Levalbuterol hydrochloride Albuterol sulfate Levalbuterol tartrate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1 Salbutamol is diluted in hypertonic (3%) saline.	Drug: Inhalation of salbutamol diluted in hypertonic saline The first of 3 nebulizations of 0.5 mg of Salbutamol is diluted in 3.5 ml of hypertonic (3%) saline. The second and the third are diluted in normal (0.9%) saline. Other Name: Albuterol diluted in hypertonic saline
Active Comparator: 2 Salbutamol is diluted in normal (0.9%) saline.	Drug: Inhalation of salbutamol diluted in normal saline The 3 nebulizations of 0.5 mg of Salbutamol are diluted in 3.5 ml of normal (0.9%) saline. Other Name: Albuterol diluted in normal saline

Outcome Measures

Primary Outcome Measures :

Change in the respiratory distress score (Tal) between the basal score and the final score after 3 salbutamol nebulizations [ Time Frame: 1 hour ]

Secondary Outcome Measures :

Change in the respiratory distress score (Tal) between the basal score and the first nebulization [ Time Frame: 15 to 20 minutes ]
Change in the respiratory distress score (Tal) between the basal score and the second nebulization [ Time Frame: 15 to 20 minutes after the first nebulization ]
Change in pulse oxymetry reading between the basal score and after each of the three nebulizations [ Time Frame: 1 hour ]
Change in cardiac frequency, irritability, general condition or anything else between the basal score and the first, second and third nebulization [ Time Frame: 1 hour ]

Eligibility Criteria

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.

Layout table for eligibility information

Ages Eligible for Study:	1 Month to 24 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 1 to 24 months
Mild to moderate respiratory distress (Tal score below 9)
Up to 5 days of respiratory symptoms, including today
Expiratory wheezing heard on chest auscultation
Indication of salbutamol nebulization treatment by attending physician

Exclusion Criteria:

Two prior episodes of wheezing
Premature birth (below 38 weeks), if below 6 months of age
Lobar pneumonia
Body temperature above 38 degree Celsius
Use of salbutamol during the previous 6 hours
Pulse oxymetry reading below 90%
Congenital heart disease
Chronic pulmonary disease: Asthma, cystic fibrosis, bronchopulmonary dysplasia
Other chronic or genetic condition or disease

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): NCT00696540

Contacts

Layout table for location contacts

Contact: Irmeli Roine, MD, PhD	+56-2-6762916	irmeli.roine@prof.udp.cl
Contact: Ricardo Mercado, MD	+56-9-3320792	rmercado@ssmso.cl

Locations

Layout table for location information

Chile
Clínica Vespucio	Recruiting
Santiago, Chile, 00300
Contact: Ricardo Mercado, MD +56-2-8206500 rmercado@ssmso.cl
Contact: Patricio Olivares, MD +56-2-8206500 patovares@gmail.com

Sponsors and Collaborators

University Diego Portales

Clínica Vespucio, Santiago, Chile

Investigators

Layout table for investigator information

Principal Investigator:	Irmeli Roine, MD, PhD	University Diego Portales
Study Director:	Ricardo Mercado, MD	Clinica Vespucio, Santiago, Chile

More Information

Publications:

Sarrell EM, Tal G, Witzling M, Someck E, Houri S, Cohen HA, Mandelberg A. Nebulized 3% hypertonic saline solution treatment in ambulatory children with viral bronchiolitis decreases symptoms. Chest. 2002 Dec;122(6):2015-20. doi: 10.1378/chest.122.6.2015.

Mandelberg A, Tal G, Witzling M, Someck E, Houri S, Balin A, Priel IE. Nebulized 3% hypertonic saline solution treatment in hospitalized infants with viral bronchiolitis. Chest. 2003 Feb;123(2):481-7. doi: 10.1378/chest.123.2.481.

Layout table for additonal information

Responsible Party:	Irmeli Roine, Facultad de Ciencias de la Salud, Universidad Diego Portales, Santiago. Chile
ClinicalTrials.gov Identifier:	NCT00696540
Other Study ID Numbers:	UDP-CT1-08
First Posted:	June 12, 2008 Key Record Dates
Last Update Posted:	June 12, 2008
Last Verified:	June 2008

Keywords provided by University Diego Portales:


Bronchiolitis, respiratory distress, hypertonic saline

Additional relevant MeSH terms:

Layout table for MeSH terms

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

To Top