NCT03042065

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable asthma

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

January 25, 2017

Last Update Submit

February 1, 2017

Conditions

Asthma

Keywords

pediatricsasthmanebulizationvibrating meshsalbutamolEfficiency

Outcome Measures

Primary Outcomes (4)

  • 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

    2 minutes

  • 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

    2 minutes

  • 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

    2 minutes

  • 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

    2 minutes

Study Arms (2)

vibrating Mesh nebulizer

EXPERIMENTAL

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

Device: vibrating Mesh nebulizer

jet nebulizer

ACTIVE COMPARATOR

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 a jet nebulizer

Device: jet nebulizer

Interventions

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

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

jet nebulizer

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Jean BERGOUNIOUX, MD

    APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JEAN BERGOUNIOUX, MD

CONTACT

0033147101131jean.bergounioux@aphp.fr

sandra POTTIER, CRA

CONTACT

0033147104469sandra.pottier@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2017

First Posted

February 3, 2017

Study Start

March 1, 2017

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

February 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share