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AsthmaSIBILANTNCT03042065

Salbutamol in the Pediatric Emergencies: Nebulization Estimated Via AerogeN or Jet

A study testing vibrating Mesh nebulizer and jet nebulizer in people with Asthma, run by Centre d'Investigation Clinique et Technologique 805.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Controlled trial of nebulized salbutamol using jet nebulizer or vibrating mesh technology in children presenting with acute moderate to severe asthma. Read more about this study

Who is it for?
Ages 8 to 16 years
Conditions the study is for
Asthma
What is being tested?
vibrating Mesh nebulizer and jet nebulizer
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Mar 2017to Sep 2017
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 8 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children aged 8-16 years.
  • Patient with severe asthma (maximum expiratory flow <50%).
  • Patient admitted to pediatric emergency.
  • Patient who has agreed to participate, as well as the parents or legal guardian.

Who cannot join

  • Chronic respiratory failure, infectious disease, heart disease.
  • Refusal to participate in the study.
  • No affiliation to a social security scheme (beneficiary or beneficiary).
  • Immediate intubation criteria

Trial locations and contacts

No sites are listed yet.

JEAN BERGOUNIOUX, MD contact

0033147101131

jean.bergounioux@aphp.fr

sandra POTTIER, CRA contact

0033147104469

sandra.pottier@aphp.fr

About this study

Controlled trial of nebulized salbutamol using jet nebulizer or vibrating mesh technology in children presenting with acute moderate to severe asthma.

Read the detailed description

Asthma is a chronic (long-term) lung disease that inflames and narrows the airways. Asthma causes recurring periods of wheezing (a whistling sound when you breathe), chest tightness, shortness of breath, and coughing. The coughing often occurs at night or early in the morning. Sometimes asthma symptoms are mild and go away on their own or after minimal treatment with asthma medicine. Other times, symptoms continue to get worse. When symptoms get more intense and/or more symptoms occur, it is called an asthma attack. Asthma attacks also are called flare-ups or exacerbation.

International Study of Asthma and Allergies in Childhood (ISAAC) found that about 14% of the world's children were likely to have had asthmatic symptoms in the last year and, crucially, the prevalence of childhood asthma varies widely between countries, and between centers within countries studied. These conclusions resulted from ISAAC's groundbreaking survey of a representative sample of 798,685 children aged 13-14 years in 233 centers in 97 countries. (ISAAC also studied a younger age group of children (6-7 years) and the findings were generally similar to the older children). These adolescents were asked whether they had experienced wheeze in the preceding 12 months. Prevalence of recent wheeze varied widely. The highest prevalence (>20%) was generally observed in Latin America and in English-speaking countries of Australasia, Europe and North America as well as South Africa. The lowest prevalence (<5%) was observed in the Indian subcontinent, Asia-Pacific, Eastern Mediterranean, and Northern and Eastern Europe. In Africa, 10-20% prevalence was mostly observed .

The majority of children with asthma have stable disease, and only a minority experience exacerbations needing hospitalization or emergency room visits. In older children, recent advances in treatment seem to have reduced chronic morbidity as well as the number of acute exacerbations. In infants and younger children, this goal may be more difficult to achieve, given the heterogeneity of obstructive lung disease in this age group. Viral wheeze is a very common clinical scenario in young children, and identification and proper treatment of subjects with potential for development of asthma and future exacerbations is still an unresolved challenge. Even if severe asthma exacerbations are relatively common, mortality from asthma in children is rare and declining. In the United Kingdom the mortality rate for children 0-14 years is less than one per 100.000 children per year. In contrast, there has been a vast increase in the economic costs associated with asthma. However, the main economic burden of childhood asthma is linked to indirect costs, long-term follow up and medication, and not to hospitalization .

Acute severe asthma represents one of the most common medical emergency situations and the most serious clinical presentation of asthma. Asthma is typically characterized by the presence of severe respiratory distress due to an asthma episode that requires the use of bronchodilators, oxygen and corticosteroids. Asthma attack can be severe and even life threatening. Features of acute severe attack include; Peak expiratory flow (PEF) 33-50% of best (use % predicted if recent best unknown), tachycardia and tachypnea. Life threatening attack includes pulse oxymetry <92%, Silent chest, cyanosis, or feeble respiratory effort, Arrhythmia or hypotension Exhaustion, altered consciousness. A severe asthma exacerbation can usually be presented clinically with dyspnea at rest; interferes with conversation and peak expiratory flow rate (PEFR) < 40%, usually requires hospitalization .

Acute severe asthma is one of the most common medical emergency situations in childhood, and physicians caring for acutely ill children are regularly faced with this condition. The cornerstones of the management of acute asthma in children are rapid administration of oxygen, inhalations with bronchodilators and systemic corticosteroids. Inhaled bronchodilators may include selective b2-agonists, adrenaline and anticholinergics. Additional treatment in selected cases may involve intravenous administration of theophylline, b2-agonists and magnesium sulphate. Both non-invasive and invasive ventilation may be options when medical treatment fails to prevent respiratory failure. It is important that relevant treatment algorithms exist, applicable to all levels of the treatment chain and reflecting local considerations and circumstances .

Despite recent progress in the treatment of chronic asthma in childhood, acute exacerbations will continue to occur. Physicians working within the field of pediatric emergency medicine will therefore continue to be exposed to this clinical scenario. The cornerstones of acute asthma management in childhood remain rapid onset of oxygen treatment, inhalation of bronchodilators and systemic corticosteroids. Short-acting bronchodilators provide immediate relief of asthma symptoms and effects last four to six hours. The most commonly used short-acting bronchodilator for asthma is albuterol. These medications work quickly, and help to control symptoms of severe asthma attack. The doses as well as the way of delivery are important to reach the best bronchodilator effect. The amount of product that effectively reaches the bronchi is relatively small as 0.1% to 11%, respectively using a lung simulator . Despite this high variation of the amount of product delivery to the patient and the narrow limits of dose between benefice and side effects, the aerosolized route remained the preferred one even in severe cases .

Conditions
Asthma
Being tested
vibrating Mesh nebulizer, jet nebulizer
Keywords
pediatrics, asthma, nebulization, vibrating mesh, salbutamol, Efficiency
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vibrating Mesh nebulizerDevice

    Receive in the same aerosol solution 5 mg of Salbutamol (Ventolin, Glaxo, 5 mg / ml solution for nebulization) mixed with 0.5 mg Ipratropium Bromide (0.25 mg / ml) by nebulization every 20 min For 3 doses during the first hour of treatment, using vibrating Mesh nebulizer

  • jet nebulizerDevice

    Receive in the same aerosol solution 5 mg of Salbutamol (Ventolin, Glaxo, 5 mg / ml solution for nebulization) mixed with 0.5 mg Ipratropium Bromide (0.25 mg / ml) by nebulization every 20 min For 3 doses during the first hour of treatment, using jet nebulizer

Study groups in NCT03042065
Study groupRoleWhat they receive
vibrating Mesh nebulizerExperimentalReceive in the same aerosol solution 5 mg of Salbutamol (Ventolin, Glaxo, 5 mg / ml solution for nebulization) mixed with 0.5 mg Ipratropium Bromide (0.25 mg / ml) by nebulization every 20 min For 3 doses during the first hour of treatment, using vibrating Mesh nebulizer
Receives: Device: vibrating Mesh nebulizer
jet nebulizerActive comparatorReceive, in the same aerosol solution, 5 mg of Salbutamol (Ventolin, Glaxo, 5 mg / ml solution for nebulization) mixed with 0.5 mg Ipratropium Bromide (0.25 mg / ml) by nebulization every 20 min For 3 doses during the first hour of treatment, using a jet nebulizer
Receives: Device: jet nebulizer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The main analysis criteria is the Peak expiratory flow (PEF) value performed before the first aerosol of salbutamol aerosols using Jet or Aerogen spray.

    before the first nebulization

    Measured: 2 minutes

  2. The main analysis criteria is the Peak expiratory flow (PEF) value performed after the first aerosol of salbutamol aerosols using Jet or Aerogen spray.

    after the first nebulization

    Measured: 2 minutes

  3. The main analysis criteria is the Peak expiratory flow (PEF) value performed after the second aerosol of salbutamol aerosols using Jet or Aerogen spray.

    after the second nebulization

    Measured: 2 minutes

  4. The main analysis criteria is the Peak expiratory flow (PEF) value performed after the third aerosol of salbutamol aerosols using Jet or Aerogen spray.

    after the third nebulization

    Measured: 2 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2017 (estimated)
  2. Study startMar 2017 (estimated)
  3. Primary completionSep 2017 (estimated)
  4. Study completionSep 2017 (estimated)

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
Device feasibility
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03042065
Sponsor's protocol ID
2016-A01276-45
Acronym
SIBILANT
Status last verified
Feb 2017
First submitted
25 Jan 2017
Last updated
3 Feb 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing vibrating Mesh nebulizer and jet nebulizer in people with Asthma, run by Centre d'Investigation Clinique et Technologique 805.

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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact JEAN BERGOUNIOUX, MD (0033147101131, jean.bergounioux@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The main analysis criteria is the Peak expiratory flow (PEF) value performed before the first aerosol of salbutamol aerosols using Jet or Aerogen spray. (time frame: 2 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 3 Feb 2017.

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SIBILANT Clinical Trial NCT03042065 | AzTrials