Clinical trial • Phase IV • Respiratory

Budesonide for Episodic expiratory wheezing

Phase IV trial of Budesonide for Episodic expiratory wheezing.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Episodic expiratory wheezing
Trial Stage
Phase IV
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
29-07-2025
First CTIS Authorization Date
09-10-2025

Trial design

Randomised, comparison of daily inhaled corticosteroids (ics) for at least 6 weeks with bronchodilators if needed, versus ics and bronchodilators during symptoms and only bronchodilators during symptoms (no drug doses or schedules specified).-controlled Phase IV trial across 3 sites in Netherlands.

Randomised
Yes
Comparator
Comparison of daily inhaled corticosteroids (ICS) for at least 6 weeks with bronchodilators if needed, versus ICS and bronchodilators during symptoms and only bronchodilators during symptoms (no drug doses or schedules specified).
Target Sample Size
285
Trial Duration For Participant
365

Eligibility

Recruits 285 paediatric patients.

Vulnerable Population
Vulnerable population: children aged 1-6 years are included (isVulnerablePopulationSelected = true). Informed consent materials and ICFs for parents are provided (documents: L1_SIS and ICF_parents_* for ErasmusMC, LUMC, RadboudUMC) and a subject information leaflet for children is present (L2_Other subject information material_information leaflet children). No explicit assent process for children is described in the provided metadata.

Inclusion criteria

  • {"criterion_text":"- Children aged 1-6 years (age between ≥1 and <6)\n- Visited the general practitioner or out-of-hour services, because of episodic expiratory wheezing, from a second episode onwards"}

Exclusion criteria

  • {"criterion_text":"- Already known with cystic fibrosis, bronchopulmonary dysplasia or other chronic lung disease\n- Premature birth <32 weeks\n- Daily inhaled corticosteroids use or oral corticosteroids use within four weeks prior to inclusion\n- Current antibiotic use for respiratory complaints"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Symptom control","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
285
Recruitment Window Months
42
Consent Approach
Informed consent is to be obtained from parents (parental/guardian consent). Subject information leaflet for children and separate parent ICF/SIS documents are provided per site (documents: L2_Other subject information material_information leaflet children; L1_SIS and ICF_parents_ErasmusMC, L1_SIS and ICF_parents_LUMC, L1_SIS and ICF_parents_RadboudUMC). No explicit description of child assent or available languages is provided in the supplied metadata.

Methods

  • Invitation from general practices in the Netherlands to parents of eligible children (invitation from general practices) as per recruitment materials (K2_Recruitment material_invitation from general practices).
  • Waiting room screening in GP practices (waiting room screen) to identify potentially eligible children in the Netherlands (K2_Recruitment material_waiting room screen).
  • Recruitment arranged via general practice and out-of-hours services, targeting parents of children aged 1-6 who have visited for episodic expiratory wheezing (Netherlands).

Geography

Total Number Of Sites
3
Total Number Of Participants
285

Netherlands

Earliest CTIS Part Ii Submission Date
29-09-2025
Latest Decision Or Authorization Date
09-10-2025
Processing Time Days
10
Number Of Sites
3
Number Of Participants
285

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
General practice
Contact Person Name
Evelien van Meel
Contact Person Email
e.vanmeel@erasmusmc.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Public Health and Primary Care
Contact Person Name
Rosalie Mensink-Bout
Contact Person Email
s.m.mensink-bout@lumc.nl
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Primary and Community Care
Contact Person Name
Lisette van den Bemt

Sponsor

Primary sponsor

Full Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
BUDESONIDE
Active Substance
Budesonide
Modality
Small molecule
Routes Of Administration
Inhalation
Route
Inhalation
Authorisation Status
Authorised
Maximum Dose
400 µg per day
Investigational Product Name
BECLOMETASONE
Active Substance
Beclometasone dipropionate
Modality
Small molecule
Routes Of Administration
Inhalation
Route
Inhalation
Authorisation Status
Authorised
Maximum Dose
400 µg per day
Investigational Product Name
SALBUTAMOL
Active Substance
Salbutamol sulfate
Modality
Small molecule
Routes Of Administration
Inhalation
Route
Inhalation
Authorisation Status
Authorised
Maximum Dose
1600 µg per day
Investigational Product Name
FLUTICASONE
Active Substance
Fluticasone propionate
Modality
Small molecule
Routes Of Administration
Inhalation
Route
Inhalation
Authorisation Status
Authorised
Maximum Dose
250 µg per day
Combination Treatment
Yes

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