Early access
Sign in
Taking people in SpainPhase 3

Compares salbutamol alone with salbutamol plus ipratropium for children with asthma attacks

Tests inhaled salbutamol alone against salbutamol with ipratropium in children with moderate asthma attacks.

Key facts

Who runs it
Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus
Where
Barakaldo, Granollers, Madrid, and Sevilla, SpainSee the 4 sites
Registry title
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
Phase
Phase 3
People taking part
476 people, planned
Started
27 Mar 2025
Planned end
31 May 2026
Type of study
Interventional
Record updated
5 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers having a moderate asthma attack in the emergency department. It compares salbutamol alone with salbutamol plus ipratropium bromide.

Age
From 1 year up to under 18 years.
Sex
Boys and girls can join.
Disease stage
A moderate asthma attack (exacerbation), judged by the Pulmonary Score.
Earlier treatment
Cannot have received ipratropium bromide in the previous 24 hours.

Main reasons for not taking part

  • Pneumonia or bronchopneumonia needing antibiotics
  • Nerve and muscle diseases that affect breathing
  • Weakened immune system
  • Chronic lung disease such as cystic fibrosis
  • Allergy to ipratropium bromide

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • Male or female patient ≥1 years old and <18 years old with the characteristics of moderate asthma exacerbation according to Pulmonary Score. Asthma attack/exacerbation will be defined according to the international classification of diseases version 10 (ICD10) and the criteria of the Global Initiative for Asthma (2024 update). - Written informed consent obtained from parents or legal guardians and assent in patients 12 years of age or older

Who cannot take part

  • Having received IB in the previous 24 hours - Pneumonia or bronchopneumonia; suspicion of consolidation by imaging (radiography or ultrasound) and indication of antibiotics for pneumonia or bronchopneumonia. - Neuromuscular diseases that affect respiratory capacity (cerebral palsy, neurodegenerative diseases, complex epileptic syndromes). Immunocompromised patient. Chronic respiratory pathology: cystic fibrosis, hemosiderosis, pulmonary graft versus host disease, obliterans bronchiolitis. Pre-existing obstruction of the urinary outflow tract. Narrow angle glaucoma. - Pregnant or breastfeeding women. - History of hypersensitivity to ipratropium bromide. - Impossibility of tracking. - Parents/legal guardians and/or patient who cannot understand or comply with all study instructions and requirements

Where in Spain

  • Hospital Universitario de CrucesBarakaldo, SpainTaking people
  • Hospital General de GranollersGranollers, SpainTaking people
  • Hospital Infantil Universitario Nino JesusMadrid, SpainTaking people
  • University Hospital Virgen Del Rocio S.L.Sevilla, SpainTaking people

About the trial

What the trial wants to find out

Determine whether monotherapy with salbutamol in the inhaled bronchodilator treatment of moderate asthma exacerbations in children in the pediatric emergency department is not inferior to the combination of ipratropium bromide (IB) and salbutamol in reducing the rate of admissions

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Compares salbutamol alone with salbutamol plus ipratropium for children with asthma attacksGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
5 October 2026