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
Key facts
- Where
- Barakaldo, Granollers, Madrid és Sevilla, SpanyolországSee the 4 sites
- Phase
- 3. fázis
Where in Spanyolország
- Hospital Universitario de CrucesBarakaldo, SpanyolországTaking people
- Hospital General de GranollersGranollers, SpanyolországTaking people
- Hospital Infantil Universitario Nino JesusMadrid, SpanyolországTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus
- Trial code
- EU 2024-514065-19-00
- Record updated
- 2026. október 5.
- Original description
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 admissionsRead full original descriptionShow less
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
Inclusion: 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.
Exclusion: 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.