Clinical trial • Phase III • Respiratory

Ipratropium bromide monohydrate for Acute asthma|Acute asthma exacerbation

Phase III trial of Ipratropium bromide monohydrate for Acute asthma|Acute asthma exacerbation.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Acute asthma|Acute asthma exacerbation
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
15-07-2024
First CTIS Authorization Date
21-10-2024

Trial design

Randomised, salbutamol monotherapy versus combination of salbutamol plus ipratropium bromide (atroaldo 20 micrograms/puff inhalation). placebo of atroaldo is used as comparator control for blinding. specific dose schedule for ipratropium in the protocol is not specified in the ctis metadata. Phase III trial across 5 sites in Spain.

Randomised
Yes
Comparator
Salbutamol monotherapy versus combination of salbutamol plus ipratropium bromide (ATROALDO 20 micrograms/puff inhalation). Placebo of ATROALDO is used as comparator control for blinding. Specific dose schedule for ipratropium in the protocol is not specified in the CTIS metadata.
Target Sample Size
476

Eligibility

Recruits 476 paediatric patients.

Pregnancy Exclusion
- Pregnant or breastfeeding women.
Vulnerable Population
Participants are children aged ≥1 and <18 years. Written informed consent must be obtained from parents or legal guardians. Assent is required for patients 12 years of age or older. Subject information and informed consent forms for parents and for 12-17 year olds are included in the study documents.

Inclusion criteria

  • {"criterion_text":"- Male or female patient ≥1 years old and <18 years old with the characteristics of moderate asthma exacerbation according to Pulmonary Score."}
  • {"criterion_text":"- 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)."}
  • {"criterion_text":"- Written informed consent obtained from parents or legal guardians and assent in patients 12 years of age or older"}

Exclusion criteria

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

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Admission percentage defined as: number of children with moderate asthma attacks admitted divided by number of children with moderate asthma attacks treated in the emergency department."}

Recruitment

Planned Sample Size
476
Recruitment Window Months
19
Consent Approach
Written informed consent must be obtained from parents or legal guardians. Assent is required for participants aged 12 years or older. Subject information and informed consent form documents are provided for parents and for 12-17 year olds (documents available in the submission, titles indicate Spanish language versions).

Geography

Total Number Of Sites
5
Total Number Of Participants
476

Spain

Earliest CTIS Part Ii Submission Date
24-09-2024
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
595
Number Of Sites
5
Number Of Participants
476

Sites

Site Name
Hospital Universitario De Cruces
Department Name
Paediatric Emergency Department
Principal Investigator Name
Natalia Paniagua
Principal Investigator Email
natalia_paniagua@hotmail.com
Contact Person Name
Natalia Paniagua
Contact Person Email
natalia_paniagua@hotmail.com
Site Name
Hospital General De Granollers
Department Name
Pediatric Emergency Department
Principal Investigator Name
Sandra Bustamante Hernández
Principal Investigator Email
sbustamante@fphag.org
Contact Person Name
Sandra Bustamante Hernández
Contact Person Email
sbustamante@fphag.org
Site Name
Hospital Infantil Universitario Nino Jesus
Department Name
Paediatric Emergency Department
Principal Investigator Name
Francesco Giuseppe Ecclesia
Contact Person Name
Francesco Giuseppe Ecclesia
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Paediatric Emergency Department
Principal Investigator Name
Carmen García Malagón
Principal Investigator Email
raul.martin.acosta@juntadeandalucia.es
Contact Person Name
Carmen García Malagón
Site Name
Hospital Infantil Universitario Nino Jesus
Department Name
Paediatric Emergency Department
Principal Investigator Name
Esther Pérez Suárez
Principal Investigator Email
epsuarez@salud.madrid.org
Contact Person Name
Esther Pérez Suárez
Contact Person Email
epsuarez@salud.madrid.org

Sponsor

Primary sponsor

Full Name
Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
ATROALDO 20 microgramos/pulsación, solución para inhalación en envase a presión
Active Substance
Ipratropium bromide monohydrate
Modality
Small molecule
Routes Of Administration
INHALATION
Route
INHALATION
Authorisation Status
Authorised (marketing authorisation number 72581 in ES)
Maximum Dose
800 µg (max daily dose amount reported: 800 µg)
Investigational Product Name
Placebo de ATROALDO 20 mcg/pulsación solución para inhalación en envase a presión
Modality
Other
Combination Treatment
Yes

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