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

This study has been completed.
Sponsor:
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01073527
First received: August 18, 2009
Last updated: August 7, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Asthma
Drug: hypertonic saline-salbutamol combination
Drug: Normal saline-salbutamol combination

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interventional Study: Hypertonic Saline as Add on Treatment to the Usual Therapy for Preschool Children With Acute "Asthmatic" Attack Presenting to the ER: A Double Blind Control Study

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • shortening length of stay (LOS) [ Time Frame: From admision to ready to discharge. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospitalization rate [ Time Frame: From presenting to ED until admission to hospital ] [ Designated as safety issue: No ]
  • Improvement in clinical score (CS) [ Time Frame: Post inhalations on presentation to the ED and daily during hospitalization ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: January 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hypertonic saline-salbutamol combination
NaCl 5% - 4cc (with standard treatment - salbutamol 0.5cc)
Drug: hypertonic saline-salbutamol combination
hypertonic saline 5% with 0.5cc salbutamol
Other Name: Preschool asthma,Induced sputum, Metacholine,Adenosine
Placebo Comparator: normal saline-salbutamol combination
Standard treatment normal saline 4cc with salbutamol 0.5cc
Drug: Normal saline-salbutamol combination
normal saline - 4cc with salbutamol 0.5cc
Other Name: Preschool asthma

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.

  Eligibility

Ages Eligible for Study:   1 Year to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children, age: 1-6 years old
  • Presenting to the ED with acute wheezing episode

Exclusion Criteria:

  • Any chronic (lung, cardiac, immunologic, neurologic) disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073527

Locations
Israel
The Edith Wolfson MC
Holon, Israel
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: Avigdor Mandelberg, MD The Sackler School of Medicine, Tel Aviv University, Israel
  More Information

No publications provided by Wolfson Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Avigdor Mandelberg MD, Director, Pediatric Pulmonary Unit, Wolfson Medical Center, Holon, Israel, The Sackler School of Medicine, Tel Aviv University
ClinicalTrials.gov Identifier: NCT01073527     History of Changes
Other Study ID Numbers: 1038
Study First Received: August 18, 2009
Last Updated: August 7, 2011
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Wolfson Medical Center:
Child, preschool
Pediatric emergency department

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 17, 2014