Hypertonic Saline as Add on Therapy in Preschool Children With Acute Wheezing Attack.
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| ClinicalTrials.gov Identifier: NCT01073527 |
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Recruitment Status :
Completed
First Posted : February 23, 2010
Last Update Posted : August 9, 2011
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Asthma | Drug: hypertonic saline-salbutamol combination Drug: Normal saline-salbutamol combination | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 41 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 |
| Study Start Date : | January 2009 |
| Actual Primary Completion Date : | July 2011 |
| Actual Study Completion Date : | July 2011 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Hypertonic saline-salbutamol combination
NaCl 5% - 4cc (with standard treatment - salbutamol 0.5cc)
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Drug: hypertonic saline-salbutamol combination
hypertonic saline 5% with 0.5cc salbutamol
Other Name: Preschool asthma,Induced sputum, Metacholine,Adenosine |
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Placebo Comparator: normal saline-salbutamol combination
Standard treatment normal saline 4cc with salbutamol 0.5cc
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Drug: Normal saline-salbutamol combination
normal saline - 4cc with salbutamol 0.5cc
Other Name: Preschool asthma |
- shortening length of stay (LOS) [ Time Frame: From admision to ready to discharge. ]
- Hospitalization rate [ Time Frame: From presenting to ED until admission to hospital ]
- Improvement in clinical score (CS) [ Time Frame: Post inhalations on presentation to the ED and daily during hospitalization ]
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| Ages Eligible for Study: | 1 Year to 6 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073527
| Israel | |
| The Edith Wolfson MC | |
| Holon, Israel | |
| Principal Investigator: | Avigdor Mandelberg, MD | The Sackler School of Medicine, Tel Aviv University, Israel |
| 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 |
| Other Study ID Numbers: |
1038 |
| First Posted: | February 23, 2010 Key Record Dates |
| Last Update Posted: | August 9, 2011 |
| Last Verified: | August 2011 |
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Child, preschool Pediatric emergency department |
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Adenosine Albuterol Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Tocolytic Agents Reproductive Control Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists |
Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Anti-Arrhythmia Agents Vasodilator Agents Purinergic P1 Receptor Agonists Purinergic Agonists Purinergic Agents |