Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
476
Countries
1
Sites
5
Acute asthma. Patients with moderate asthma attacks will be included. Asthmatic crisis/exacerbation (AE) is defined as moderate according to Pulmonary Score and SO2
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
Key facts
- Sponsor
- Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 27 Mar 2025 → ongoing
- Decision date (initial)
- 2024-10-21
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Therapy
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
Secondary objectives 1
- - Determine whether inhaled monotherapy with salbutamol compared to the combination of ipratropium bromide and salbutamol in the bronchodilator treatment of moderate AE in children does not lengthen the time of stay in the PED. - Determine whether inhaled monotherapy with salbutamol is not inferior to the combination of ipratropium bromide and salbutamol in the bronchodilator treatment of moderate AE in children in the PED, in improving the clinical evolution at 2, 4 and 8 hours after starting the bronchodilator treatment according to Pulmonary Score (PS) and Oxygen Saturation (SO2) (Annex A). - Determine whether inhaled monotherapy with salbutamol compared to the combination of ipratropium bromide and salbutamol in the bronchodilator treatment of moderate AE in children in the PED does not increase the need for second-line treatments, readmissions in the following 72 hours, readmissions in the following 72 hours with admission and adverse effects.
Conditions and MedDRA coding
Acute asthma. Patients with moderate asthma attacks will be included. Asthmatic crisis/exacerbation (AE) is defined as moderate according to Pulmonary Score and SO2
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Multicenter, randomized, double-blind, controlled, phase III, non-inferiority clinical trial The overall duration of the study is estimated at about 24 months, from study design to publication. The patient recruitment period will last about 12 months.
|
Randomised Controlled | Double | [{"id":177423,"code":1,"name":"Subject"},{"id":177422,"code":5,"name":"Carer"}] |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 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 criteria 1
- - 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
ATROALDO 20 microgramos/pulsación, solución para inhalación en envase a presión
PRD325667 · Product
- Active substance
- Ipratropium Bromide Monohydrate
- Pharmaceutical form
- PRESSURISED INHALATION, SOLUTION
- Route of administration
- INHALATION
- Max daily dose
- 800 µg microgram(s)
- Max total dose
- 800 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- R03BB01 — IPRATROPIUM BROMIDE
- Marketing authorisation
- 72581
- MA holder
- LABORATORIO ALDO-UNIÓN, S.L.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Placebo de ATROALDO 20 mcg/pulsación solución para inhalación en envase a presión
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus
- Sponsor organisation
- Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus
- Address
- Avenida Menendez Pelayo 65
- City
- Madrid
- Postcode
- 28009
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus
- Contact name
- Francesco Giuseppe Ecclesia
Public contact point
- Organisation
- Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus
- Contact name
- Manuel Cabrera Moreno
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 476 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario De Cruces
Paediatric Emergency Department, Cruces Plaza S/n, 48903, Barakaldo
Hospital Infantil Universitario Nino Jesus
Paediatric Emergency Department, Avenida Menendez Pelayo 65, 28009, Madrid
University Hospital Virgen Del Rocio S.L.
Paediatric Emergency Department, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Infantil Universitario Nino Jesus
Paediatric Emergency Department, Avenida Menendez Pelayo 65, 28009, Madrid
Hospital General De Granollers
Pediatric Emergency Department, Calle De Francesc Ribas 1, 08402, Granollers
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2025-03-27 | 2025-04-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 26 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-514065-19-00_v2_20240905 | 1 |
| Protocol (for publication) | D1_Protocol_2024-514065-19-00_v2_20240905_TC | 1 |
| Protocol (for publication) | Protocol summary for publication | 1 |
| Protocol (for publication) | Protocol_2024-514065-19-00_MR 1_Version 3 mayo 2025_clean | 1 |
| Protocol (for publication) | Protocol_2024-514065-19-00_MR 1_Version 3 mayo 2025_TC | 1 |
| Protocol (for publication) | Protocol_2024-514065-19-00_MR 3_Version 19 febrero 2026_clean | 4 |
| Protocol (for publication) | Protocol_2024-514065-19-00_MR 3_Version 19 febrero 2026_TC | 4 |
| Protocol (for publication) | Protocolo para publicar | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements_signedv1 | 1 |
| Subject information and informed consent form (for publication) | HOJA DE INFORMACION Y ASENTIMIENTO MAYORES DE 12 ANOS Version 1 | 1 |
| Subject information and informed consent form (for publication) | HOJA DE INFORMACION Y CONSENTIMIENTO INFORMADO PARA REPRESENTANTE LEGAL Version 1 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-17 yr_V2 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-17 yr_V3_CC | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-17 yr_V3_clean | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-17 yr_V4_clean | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-17 yr_V4_TC | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF parents_V2 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF parents_V3_CC | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF parents_V3_clean | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF parents_V4_clean version | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF parents_V4_TC | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Atroaldo | 1 |
| Synopsis of the protocol (for publication) | Protocol sum for publication | 1 |
| Synopsis of the protocol (for publication) | Resumen protocolo para publicar | 1 |
| Synopsis of the protocol (for publication) | Sinopsis Protocolo V4_Castellano | 4 |
| Synopsis of the protocol (for publication) | Version 1_sinopsis protocolo V3_Castellano | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-15 | Spain | Acceptable 2024-10-21
|
2024-10-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-15 | Spain | Acceptable 2025-09-15
|
2025-09-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-05 | Spain | Acceptable 2026-05-08
|
2026-05-12 |