Overview
Sponsor-declared trial summary
Episodic expiratory wheezing
To assess the effectiveness of daily ICS for at least 6 weeks and bronchodilators if needed, compared with ICS and bronchodilators during symptoms and only bronchodilators during symptoms on symptom control, exacerbation frequency and quality of life in children aged 1-6 years with EEW treated in general practice, afte…
Key facts
- Sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Decision date (initial)
- 2025-10-09
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess the effectiveness of daily ICS for at least 6 weeks and bronchodilators if needed, compared with ICS and bronchodilators during symptoms and only bronchodilators during symptoms on symptom control, exacerbation frequency and quality of life in children aged 1-6 years with EEW treated in general practice, after 1 and 12 months of follow-up.
Conditions and MedDRA coding
Episodic expiratory wheezing
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Children aged 1-6 years (age between ≥1 and <6)
- Visited the general practitioner or out-of-hour services, because of episodic expiratory wheezing, from a second episode onwards
Exclusion criteria 4
- Already known with cystic fibrosis, bronchopulmonary dysplasia or other chronic lung disease
- Premature birth <32 weeks
- Daily inhaled corticosteroids use or oral corticosteroids use within four weeks prior to inclusion
- Current antibiotic use for respiratory complaints
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Symptom control
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
SCP117250074 · ATC
- Active substance
- Budesonide
- Route of administration
- INHALATION
- Max daily dose
- 400 µg microgram(s)
- Max total dose
- 400 µg microgram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03BA02 — BUDESONIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP102635494 · ATC
- Active substance
- Beclometasone Dipropionate
- Substance synonyms
- BECLOMETHASONE DIPROPIONATE, BECLOMETHASONE 17,21-DIPROPRIONATE
- Route of administration
- INHALATION
- Max daily dose
- 400 µg microgram(s)
- Max total dose
- 400 µg microgram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03BA01 — BECLOMETASONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP111080421 · ATC
- Active substance
- Salbutamol Sulfate
- Substance synonyms
- Salbutamol hemisulfate, ALBUTEROL SULFATE, ALBUTEROL SULPHATE, SALBUTAMOL SULPHATE
- Route of administration
- INHALATION
- Max daily dose
- 1600 µg microgram(s)
- Max total dose
- 1600 µg microgram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03AC02 — SALBUTAMOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP101886959 · ATC
- Active substance
- Fluticasone Propionate
- Substance synonyms
- PF-00241939, EP104IAR-201
- Route of administration
- INHALATION
- Max daily dose
- 250 µg microgram(s)
- Max total dose
- 250 µg microgram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03BA05 — FLUTICASONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Sponsor organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Address
- Dr. Molewaterplein 40
- City
- Rotterdam
- Postcode
- 3015 GD
- Country
- Netherlands
Scientific contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Evelien van Meel
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Evelien van Meel
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 285 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 14 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-522694-11-00 | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_invitation from general practices | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_waiting room screen | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_parents_ErasmusMC | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_parents_LUMC | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_parents_RadboudUMC | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_information leaflet children | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Beclometasone_ATC R03BA01 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Budesonide_ATC R03BA02 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fluticasone_ATC R03BA05 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Salbutamol_ATC R03AC02 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN_2025-522694-11-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL_2025-522694-11-00 | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-29 | Netherlands | Acceptable 2025-10-09
|
2025-10-09 |