Hypertonic Saline as Add on Therapy in Preschool Children With Acute Wheezing Attack.
Condition: Asthma
Study type: Interventional

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.
    

Detailed 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 ED

      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.

      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 ciliar beat via the release of prostaglandin E2 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 asthmatic", 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 ED in preschool children in a prospective, randomized, double-blind,
      controlled fashion.
    

Intervention name(s): hypertonic saline-salbutamol combination; Normal saline-salbutamol combination
Intervention type(s): Drug; Drug
Intervention description(s): hypertonic saline 5% with 0.5cc salbutamol; normal saline - 4cc with salbutamol 0.5cc
Other intervention name(s): Preschool asthma,Induced sputum, Metacholine,Adenosine; Preschool asthma
Intervention MeSH terms: Adenosine; Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Child, preschool; Pediatric emergency department