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

Phase 1

• Conditions: Moderate to severe exacerbations of asthma; MedDRA version: 19.0Level: PTClassification code 10064823Term: Asthmatic crisisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-004959-50-ES
• Lead Sponsor: S.E. Carburos Metálicos S.A. grupo Air Products

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-03
• Study Completion: 2021-11-18
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 54

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

(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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified