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Hypertonic Saline as Add on Therapy in Preschool Children With Acute Wheezing Attack.

NCT01073527 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2011-08-09

No results posted yet for this study

Summary

To investigate the efficacy of adding Inhaled Hypertonic Saline treatment (HS) for 1-6 year old children with "asthmatic" attack presenting to Emergency Department (ED).

Background: In 1-6 year old children, the most common causes of acute exacerbations of asthma requiring urgent medical care are viral respiratory infections. Most of these children are not atopic and often do not respond very well to bronchodilators and steroids. Thus novel treatments are needed.

HS is considered an effective and safe treatment for infants with acute viral bronchiolitis (Cochrane 2008). HS acts in the airways in several mechanisms: HS re-hydrates secretions and improving mucus rheology, reduce edema of the airway wall by absorbing water from the mucosa and submucosa, causes sputum induction and cough, which can help to clear the sputum out of the bronchi, stimulates cilial beat via the release of prostaglandin E2, breaks the ionic bonds within the mucus gel, thereby lowering the viscosity and elasticity of the mucus secretion.

It is estimated that all the above HS responding elements may play a role in this viral induce wheezing. The above mentioned theoretical benefits provide the rationale for the possible treatment of viral induced acute wheezing ("asthma") attack with nebulized HS in young pre-school children presenting to the Pediatric Emergency Unit with acute (mostly viral induced) wheezing.

Therefore, the purpose of the present study is to 1. Investigate the addition of frequently nebulized 5% HS/albuterol combination to standard therapy of acute asthmatic episodes presenting to the emergency department (ED) in preschool children in a prospective, randomized, double-blind, controlled fashion.

Conditions

Interventions

DRUG

hypertonic saline-salbutamol combination

hypertonic saline 5% with 0.5cc salbutamol

DRUG

Normal saline-salbutamol combination

normal saline - 4cc with salbutamol 0.5cc

Sponsors & Collaborators

  • Wolfson Medical Center

    lead OTHER_GOV

Principal Investigators

  • Avigdor Mandelberg, MD · The Sackler School of Medicine, Tel Aviv University, Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01073527 on ClinicalTrials.gov