AsthmaNCT01073527
Hypertonic Saline as Add on Therapy in Preschool Children With Acute Wheezing Attack.
A study testing hypertonic saline-salbutamol combination and Normal saline-salbutamol combination in people with Asthma, run by Wolfson Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Asthma
- What is being tested?
- hypertonic saline-salbutamol combination and Normal saline-salbutamol combination
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children, age: 1-6 years old
- Presenting to the ED with acute wheezing episode
Who cannot join
- Any chronic (lung, cardiac, immunologic, neurologic) disease
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- hypertonic saline-salbutamol combination, Normal saline-salbutamol combination
- Keywords
- Child, preschool, Pediatric emergency department
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypertonic saline-salbutamol combinationDrug
Also called Preschool asthma,Induced sputum, Metacholine,Adenosine
hypertonic saline 5% with 0.5cc salbutamol
Normal saline-salbutamol combinationDrug
Also called Preschool asthma
normal saline - 4cc with salbutamol 0.5cc
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic saline-salbutamol combination | Active comparator | NaCl 5% - 4cc (with standard treatment - salbutamol 0.5cc) Receives: Drug: hypertonic saline-salbutamol combination |
| normal saline-salbutamol combination | Placebo comparator | Standard treatment normal saline 4cc with salbutamol 0.5cc Receives: Drug: Normal saline-salbutamol combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
shortening length of stay (LOS)
Measured: From admision to ready to discharge.
Secondary outcomes (2)
Hospitalization rate
Measured: From presenting to ED until admission to hospital
Improvement in clinical score (CS)
Measured: Post inhalations on presentation to the ED and daily during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startJan 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Investigators
- Avigdor Mandelberg, MD, Principal investigator, The Sackler School of Medicine, Tel Aviv University, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073527
- Sponsor's protocol ID
- 1038
- Status last verified
- Aug 2011
- First submitted
- 18 Aug 2009
- Last updated
- 9 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ater D, Shai H, Bar BE, Fireman N, Tasher D, Dalal I, Ballin A, Mandelberg A. Hypertonic saline and acute wheezing in preschool children. Pediatrics. 2012 Jun;129(6):e1397-403. doi: 10.1542/peds.2011-3376. Epub 2012 May 21.
PubMed 22614767
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01073527
- Acronym / sponsor ID
- 1038
- Conditions
- Asthma
- Keywords
- Child, preschool, Pediatric emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Jan 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertonic saline-salbutamol combination | Active comparator | Drug: hypertonic saline-salbutamol combinationNaCl 5% - 4cc (with standard treatment - salbutamol 0.5cc) |
| normal saline-salbutamol combination | Placebo comparator | Drug: Normal saline-salbutamol combinationStandard treatment normal saline 4cc with salbutamol 0.5cc |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children, age: 1-6 years old
- Presenting to the ED with acute wheezing episode
Key exclusion criteria (1 listed)
- Any chronic (lung, cardiac, immunologic, neurologic) disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypertonic saline-salbutamol combinationAlso: Preschool asthma,Induced sputum, Metacholine,Adenosinehypertonic saline 5% with 0.5cc salbutamol | Drug | Hypertonic saline-salbutamol combination |
| Normal saline-salbutamol combinationAlso: Preschool asthmanormal saline - 4cc with salbutamol 0.5cc | Drug | normal saline-salbutamol combination |
Primary outcome
shortening length of stay (LOS)
Time frame: From admision to ready to discharge.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.
- Derived from this study: PubMed 22614767Ater D, Shai H, Bar BE, Fireman N, Tasher D, Dalal I, Ballin A, Mandelberg A. Hypertonic saline and acute wheezing in preschool children. Pediatrics. 2012 Jun;129(6):e1397-403. doi: 10.1542/peds.2011-3376. Epub 2012 May 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avigdor Mandelberg, MD principal investigator
The Sackler School of Medicine, Tel Aviv University, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypertonic saline-salbutamol combination and Normal saline-salbutamol combination in people with Asthma, run by Wolfson Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shortening length of stay (LOS) (time frame: From admision to ready to discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01073527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2011.