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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
EU CTIS ID: 2024-514065-19-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- - 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.