HELIOX-DRIVEN BETA2-AGONISTS NEBULIZATION FOR CHILDREN WITH MODERATE TO SEVERE ACUTE ASTHMA: A RANDOMIZED CONTROLLED TRIAL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004959-50-ES

Enrollment

Registered

2015-12-03

Start date

2016-05-29

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe exacerbations of asthma MedDRA version: 19.0 Level: PT Classification code 10064823 Term: Asthmatic crisis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: Heliox (Helium 22% Oxygen 78%) Pharmaceutical Form: Medicinal gas, compressed INN or Proposed INN: OXYGEN CAS Number: 7782-44-7 Concentration unit: % percent Concentration type: equal Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All inclusion criteria are: (1)All participants or their parents or guardians will give their informed written consent to participate. (2) Age 6-16 years. (3) Diagnosis of asthma according to the guidelines. (4) Patients attending to an ED for an acute exacerbation. (5) Pulmonary score of = 4 Are the trial subjects under 18? yes Number of subjects for this age range: 58 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: (1) Altered consciousness. (2) Pulse oximetry reading of less than 90% (3) Systolic blood pressure greater than 180 mm Hg, (4) Patients requiring non-invasive ventilation, or intubation and/or mechanical ventilation. (5) Other concomitant diseases than asthma. (6) Be treated with corticosteroids until 6 hours before

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this study is to evaluate the efficacy of the use of heliox (He/O2 = 78%/22%) as a discontinuous nebulizer of rapid-acting beta2-agonists (salbutamol) compared to Air Synthetic Medicinal (O2 22%/N2 78%), in children and adolescents with acute severe asthma, attending to an Emergency Department. The authors hypothesized that nebulization using heliox (because it reduces the turbulent flow and increases the deposition of aerosolized particles)could show greater clinical improvement than Air Synthetic nebulization, in children and adolescents with acute severe asthma, treated with salbutamol. The secondary objective of the study is to evaluate the safety of the treatment, especially in the hypoxia events (SaO2 < 90%) suffered by the patients. Patients with very severe crisis can present a desaturation, requiring higher O2 levels than air or heliox mix used. ;Secondary Objective: Percentage of patients that suffered early termination of the study due to SaO2 < 90%. Percentage of patients that suffered early termination of the study due to PS = 0. Percentage of patients in which hospitalization is required at the end of the treatment. Percentage of patients that require ITU hospitalization, orotracheal intubation or exitus during the study. Pulmonary function [Change of PEF with respect to basal value, measured by flow meter in patients who can perform forced expiratory manoeuvre (the best of three measures)]. *Number of hypoxia episodes [SaO2 < 90%] occurred during the treatment and that could require an increase in O2 administration or patient withdrawal. ;Primary end point(s): The main objective of this study is to evaluate the efficacy of the use of heliox (He/O2 = 78%/22%) as a discontinuous nebulizer of rapid-acting beta2-agonists (salbutamol) compared to Air Synthetic Medicinal (O2 22%/N2 78%), in children and adolescents with acute severe asthma, attending to an Emergency Department. The authors hypothesized that nebuli	—

Measure

Time frame

Main Objective: The main objective of this study is to evaluate the efficacy of the use of heliox (He/O2 = 78%/22%) as a discontinuous nebulizer of rapid-acting beta2-agonists (salbutamol) compared to Air Synthetic Medicinal (O2 22%/N2 78%), in children and adolescents with acute severe asthma, attending to an Emergency Department. The authors hypothesized that nebulization using heliox (because it reduces the turbulent flow and increases the deposition of aerosolized particles)could show greater clinical improvement than Air Synthetic nebulization, in children and adolescents with acute severe asthma, treated with salbutamol. The secondary objective of the study is to evaluate the safety of the treatment, especially in the hypoxia events (SaO2 < 90%) suffered by the patients. Patients with very severe crisis can present a desaturation, requiring higher O2 levels than air or heliox mix used. ;Secondary Objective: *Percentage of patients that suffered early termination of the study due to SaO2 < 90%. *Percentage of patients that suffered early termination of the study due to PS = 0. *Percentage of patients in which hospitalization is required at the end of the treatment. *Percentage of patients that require ITU hospitalization, orotracheal intubation or exitus during the study. *Pulmonary function [Change of PEF with respect to basal value, measured by flow meter in patients who can perform forced expiratory manoeuvre (the best of three measures)].* *Number of hypoxia episodes [SaO2 < 90%] occurred during the treatment and that could require an increase in O2 administration or patient withdrawal. ;Primary end point(s): The main objective of this study is to evaluate the efficacy of the use of heliox (He/O2 = 78%/22%) as a discontinuous nebulizer of rapid-acting beta2-agonists (salbutamol) compared to Air Synthetic Medicinal (O2 22%/N2 78%), in children and adolescents with acute severe asthma, attending to an Emergency Department. The authors hypothesized that nebuli

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Secondary

Measure	Time frame
Secondary end point(s): Percentage of patients that suffered early termination of the study due to SaO2 < 90%. Percentage of patients that suffered early termination of the study due to PS = 0. Percentage of patients in which hospitalization is required at the end of the treatment. Percentage of patients that require ITU hospitalization, orotracheal intubation or exitus during the study. Pulmonary function [Change of PEF with respect to basal value, measured by flow meter in patients who can perform forced expiratory manoeuvre (the best of three measures)]. *Number of hypoxia episodes [SaO2 < 90%] occurred during the treatment and that could require an increase in O2 administration or patient withdrawal. ;Timepoint(s) of evaluation of this end point: 30, 60, and 90 min.	—

Measure

Time frame

Secondary end point(s): *Percentage of patients that suffered early termination of the study due to SaO2 < 90%. *Percentage of patients that suffered early termination of the study due to PS = 0. *Percentage of patients in which hospitalization is required at the end of the treatment. *Percentage of patients that require ITU hospitalization, orotracheal intubation or exitus during the study. *Pulmonary function [Change of PEF with respect to basal value, measured by flow meter in patients who can perform forced expiratory manoeuvre (the best of three measures)].* *Number of hypoxia episodes [SaO2 < 90%] occurred during the treatment and that could require an increase in O2 administration or patient withdrawal. ;Timepoint(s) of evaluation of this end point: 30, 60, and 90 min.

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Countries

Spain

Contacts

Public ContactEuropean Regulatory Affairs Manager

S.E. Carburos Metálicos S.A. grupo Air Products

hoischv@airproducts.com0034916579472NA

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026