Hypertonic Saline for Outpatient Bronchiolitis (Hypertonic)

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.

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.

Study Overview

• Status: Unknown
• Conditions: Bronchiolitis; Respiratory Distress
• Intervention / Treatment: Drug: Inhalation of salbutamol diluted in hypertonic saline; Drug: Inhalation of salbutamol diluted in normal 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.

• Study Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Irmeli Roine, MD, PhD; Phone Number: +56-2-6762916; Email: irmeli.roine@prof.udp.cl
• Study Contact Backup: Name: Ricardo Mercado, MD; Phone Number: +56-9-3320792; Email: rmercado@ssmso.cl

Study Locations

• Chile
  • Santiago, Chile, 00300
    • Recruiting
    • Clinica Vespucio
    • Contact: Ricardo Mercado, MD; Phone Number: +56-2-8206500; Email: rmercado@ssmso.cl
    • Contact: Patricio Olivares, MD; Phone Number: +56-2-8206500; Email: patovares@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Albuterol diluted in normal saline

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Diego Portales
• Collaborators: Clínica Vespucio, Santiago, Chile
• Investigators: Principal Investigator: Irmeli Roine, MD, PhD, University Diego Portales; Study Director: Ricardo Mercado, MD, Clinica Vespucio, Santiago, Chile

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Anticipated): September 1, 2008
• Study Completion (Anticipated): October 1, 2008

Study Registration Dates

• First Submitted: June 9, 2008
• First Submitted That Met QC Criteria: June 9, 2008
• First Posted (Estimate): June 12, 2008

Study Record Updates

• Last Update Posted (Estimate): June 12, 2008
• Last Update Submitted That Met QC Criteria: June 9, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: Bronchiolitis, respiratory distress, hypertonic saline
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol
• Other Study ID Numbers: UDP-CT1-08