Hypertonic Saline for Outpatient Bronchiolitis - Full Text View

Sponsors and Collaborators:	University Diego Portales Clínica Vespucio, Santiago, Chile
Information provided by:	University Diego Portales
ClinicalTrials.gov Identifier:	NCT00696540

Purpose

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	Intervention	Phase
Bronchiolitis Respiratory Distress	Drug: Inhalation of salbutamol diluted in hypertonic saline Drug: Inhalation of salbutamol diluted in normal saline	Phase II

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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.

Further study details as provided by University Diego Portales:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in the respiratory distress score (Tal) between the basal score and the first nebulization [ Time Frame: 15 to 20 minutes ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Change in pulse oxymetry reading between the basal score and after each of the three nebulizations [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	74
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator 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.

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.

Eligibility

Ages Eligible for Study:	1 Month to 24 Months
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696540

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

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

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.

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.

Responsible Party:	Facultad de Ciencias de la Salud, Universidad Diego Portales, Santiago. Chile ( Irmeli Roine )
Study ID Numbers:	UDP-CT1-08
Study First Received:	June 9, 2008
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00696540
Health Authority:	Chile: Instituto de Salud Publica de Chile

Keywords provided by University Diego Portales:

Bronchiolitis, respiratory distress, hypertonic saline

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases

Bronchiolitis
Albuterol
Bronchitis

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Bronchial Diseases
Adrenergic beta-Agonists
Physiological Effects of Drugs
Anti-Asthmatic Agents

Reproductive Control Agents
Pharmacologic Actions
Adrenergic Agonists
Tocolytic Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 15, 2009