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Hypertonic Saline Treatment and Airway Inflammatory Phenotypes in Preschool Children With Acute Asthmatic Attack

2014-08-27 03:15:43 | BioPortfolio

Summary

To investigate the efficacy of adding Inhaled Hypertonic Saline treatment (HS) for 1-6 year old children with asthmatic attack presenting to Emergency Room (ER) and the relation to airways inflammatory phenotype and to post attack bronchial hyperreactivity.

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.

The inflammatory response to these wheezy attacks and whether the different kind of inflammatory responses correlate to clinical outcomes are not known.

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 (Assouline 1977), 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 room (ER) in preschool children in a prospective, randomized, double-blind, controlled fashion. 2. Investigate the characterization of induced sputum cytology in preschool children with acute asthmatic attack and whether there is a correlation between specific sputum cytology and response to therapy. 3. Investigate airways hyper-responsiveness to adenosine 5'-monophospate and to methacholine in preschool children 2-6 years old at 2 weeks and at 3 months following acute asthmatic exacerbation and look for correlation with the response to treatment and sputum cytology.

Description

A randomized double blind, controlled, (DBCR) trial. To investigate the efficacy of adding inhaled Hypertonic Saline (HS) treatment for 1-6 year old children with asthmatic attack presenting to Emergency Room and the relation to airways inflammatory phenotype and to post attack bronchial hyperreactivity to adenosine 5'-monophosphate and to methacholine.

Background:

Children under the age of 5 years have the highest hospitalization rate of asthma. The most common causes of acute exacerbations of asthma requiring urgent medical care are viral respiratory infections. Most of these children < 6 years old are not atopic.

The inflammatory response to these mostly viral-induced asthmatic attacks is not well characterized in the literature. Moreover, it is not known whether the different kind of inflammatory responses exist in this population and how this correlate to clinical outcomes.

These investigators have previously demonstrated in wheezy infants with acute viral bronchiolitis that nebulized hypertonic saline produces a clinical significant reduction in length of hospital stay and improves the clinical score and is considered an effective and safe treatment for infants with acute viral bronchiolitis (Cochrane 2008).

Hypertonic saline solution acts in the airways in several mechanisms:

It Stimulates cilial beat via the release of prostaglandin E2 (Assouline 1977) and increases mucociliary clearance.

It Breaks the ionic bonds within the mucus gel, thereby reducing the degree of cross linking and entanglements and lowering the viscosity and elasticity of the mucus secretion.

HS induces an osmotic flow of water into the mucus layer, re-hydrating secretions and improving mucus rheology.

HS reduces edema of the airway wall by absorbing water from the mucosa and submucosa.

HS can cause sputum induction and cough, which can help to clear the sputum outside of the bronchi and thus improve airway obstruction.

It is estimated that many of the above hypertonic saline responding elements may play a role in this viral induce wheezing such as: mucosal and submucosal edema, peribronchial infiltrate of inflammatory cells, necrosis and desquamation of ciliated epithelial cells, and excess mucus secretion. The combination of an airway wall swelling, sloughing of necrotic debris, increased mucus production and impaired secretion clearance, eventually contribute in addition to bronchospasm to airway obstruction, gas trapping, atelectasis and impaired gas exchange. Moreover, as postulated in "status asthmaticus", the relative contribution of these "non-spasmodic" pathological and pathophysiological consequences of viral and asthmatic inflammation to airway obstruction, gas trapping, atelectasis and impaired gas exchange become even more important in these children already treated with maximum dilatation dose of bronchodilating drugs in the emergency department.

The above mentioned theoretical benefits provide the rationale for the possible treatment of viral induced acute wheezing ("asthma") attack with nebulized hypertonic saline solution 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 investigate the addition of frequently nebulized 5% HS/albuterol combination to standard therapy of acute asthmatic episodes presenting to the emergency room (ER) in preschool children in a prospective, randomized, double-blind, controlled fashion.

Investigate the characterization of induced sputum cytology in preschool children with acute asthmatic attack and whether there is a correlation between specific sputum cytology and response to therapy.

Investigate airways hyper-responsiveness to adenosine 5'-monophospate and to methacholine in preschool children 2-6 years old at 2 weeks and at 3 months following acute asthmatic exacerbation and look for correlation with the response to treatment and sputum cytology.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Conditions

Asthma

Intervention

hypertonic saline-salbutamol combination, Normal saline-salbutamol combibation

Location

The Edith Wolfson MC
Holon
Israel

Status

Recruiting

Source

Wolfson Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:43-0400

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Medical and Biotech [MESH] Definitions

Hypertonic sodium chloride solution. A solution having an osmotic pressure greater than that of physiologic salt solution (0.9 g NaCl in 100 ml purified water).

A genus of HALOBACTERIACEAE distinguished from other genera in the family by the presence of specific derivatives of TGD-2 polar lipids. Haloarcula are found in neutral saline environments such as salt lakes, marine salterns, and saline soils.

A family of gram-negative, moderately halophilic bacteria in the order Oceanospirillales. Members of the family have been isolated from temperate and Antarctic saline lakes, solar salt facilities, saline soils, and marine environments.

A species of PERCIFORMES commonly used in saline aquaculture.

Water from natural sources which contain significant concentrations of dissolved salts such as sodium chloride.

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