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PHASE III, DOUBLE-BLIND, RANDOMIZED, CONTROLLED, NON-INFERIORITY, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY OF SALBUTAMOL MONOTHERAPY COMPARED TO SALBUTAMOL PLUS IPRATROPIUM BROMIDE IN THE MANAGEMENT OF MODERATE ACUTE ASTHMATIC EXARCEBATIONS IN CHILDREN IN THE EMERGENCY DEPARTMENT

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514065-19-00
Enrollment
476
Registered
2024-10-21
Start date
2025-03-27
Completion date
Unknown
Last updated
2025-09-16

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

Conditions

Acute asthma. Patients with moderate asthma attacks will be included. Asthmatic crisis/exacerbation (AE) is defined as moderate according to Pulmonary Score and SO2

Brief summary

The main goal of the study is to determine whether monotherapy with salbutamol in the inhaled bronchodilator treatment of moderate asthma exacerbations in children in the PED is not inferior to the combination of ipratropium bromide (IB) and salbutamol in reducing the rate of admissions. Admission percentage (main variable) is defined as number of children with moderate asthma attacks admitted / number of children with moderate asthma attacks treated in the emergency department.

Interventions

DRUGPlacebo de ATROALDO 20 mcg/pulsación solución para inhalación en envase a presión
DRUGATROALDO 20 microgramos/pulsación
DRUGsolución para inhalación en envase a presión

Sponsors

Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
The main goal of the study is to determine whether monotherapy with salbutamol in the inhaled bronchodilator treatment of moderate asthma exacerbations in children in the PED is not inferior to the combination of ipratropium bromide (IB) and salbutamol in reducing the rate of admissions. Admission percentage (main variable) is defined as number of children with moderate asthma attacks admitted / number of children with moderate asthma attacks treated in the emergency department.—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026