AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Israel1 site
  • The Edith Wolfson MC

    Holon

Other trials in Israel

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 groups in NCT01073527
Study groupRoleWhat they receive
Hypertonic saline-salbutamol combinationActive comparatorNaCl 5% - 4cc (with standard treatment - salbutamol 0.5cc)
Receives: Drug: hypertonic saline-salbutamol combination
normal saline-salbutamol combinationPlacebo comparatorStandard 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.

  1. shortening length of stay (LOS)

    Measured: From admision to ready to discharge.

Secondary outcomes (2)
  1. Hospitalization rate

    Measured: From presenting to ED until admission to hospital

  2. 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.

  1. First posted23 Feb 2010 (estimated)
  2. Study startJan 2009
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in