Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
210
Countries
1
Sites
2
Rhinovirus-induced Wheezing
The main objective of the study is to determine whether children aged 6 months to 2 years, who suffer from acute wheezing that has been shown to be rhinovirus- or other picornavirus-induced (using point-of-care test at the emergency department) benefit from oral prednisolone.
Key facts
- Sponsor
- University Of Oulu
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 11 Feb 2022 → ongoing
- Decision date (initial)
- 2024-04-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512561-13-00
- EudraCT number
- 2021-006050-31
- ClinicalTrials.gov
- NCT05444699
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
The main objective of the study is to determine whether children aged 6 months to 2 years, who suffer from acute wheezing that has been shown to be rhinovirus- or other picornavirus-induced (using point-of-care test at the emergency department) benefit from oral prednisolone.
Conditions and MedDRA coding
Rhinovirus-induced Wheezing
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Age 6 months to 2 years
- Acute wheezing diagnosed by an emergency department physician
- Positive rhinovirus- or other picornavirus in nasal swap
- Arrival at the hospital within the past 6 hours
- Salbutamol treatment at the emergency department
Exclusion criteria 14
- Need for immediate resuscitation
- Need for immediate transfer to an intensive care unit
- Suspected pneumonia in auscultation
- Suspected serious bacterial infection
- Positive RS-virus in nasal swab
- Positive SARS-CoV-2 in nasal swab
- Positive Mycoplasma pneumoniae in nasal swab
- Positive Bordetella pertussis in nasal swab
- Chickenpox exposure within the previous 14 days
- Active chickenpox infection
- Suspected foreign body in respiratory tract
- Immunosuppressive treatment
- Systemic glucocorticoid treatment within the previous 14 days
- Allergy to glucocorticoids
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The difference (in minutes) between the study entry and the time that the patient is deemed to be fit for discharge (sign off for discharge)
Secondary endpoints 17
- The total length of hospital stay (the difference between the study entry and the actual time of discharge from the hospital) (in minutes)
- Intensive care unit (ICU) admission
- The total duration of the need for supplemental oxygen (in minutes)
- The maximum decrease in PEWS score within 12 hours after study entry. PEWS scores range from 0 to 32, depending on the child's respiratory rate, work of breathing, saturation of peripheral oxygen, need for supplemental oxygen, blood pressure, heart rate, capillary refill and level of consciousness. 0 refers to low and > 7 to high risk of deterioration.
- The recurrence of wheezing after the initial episode within the 56 days following study enrollment
- Hospital readmission or emergency department visit occurring within 56 days after discharge from the hospital following study enrollment
- Cough at 14 days of study entry
- The duration of cough (without relapse within 3 days) during the 14 days following study enrollment (in days)
- The duration of cough (without relapse within 3 days) during the 28 days following study enrollment (in days)
- The total number of days of salbutamol use during the 14 days following study enrollment
- The duration of respiratory distress (without relapse within 3 days) during the 14 days following study enrollment (in days)
- Death of any cause
- The recurrence of wheezing diagnosed by a physician after the initial episode within two months following study enrollment
- The recurrence of wheezing diagnosed by a physician after the initial episode within 12 months following study enrollment
- Time to recurrence of wheezing diagnosed by a physician withing one year following study enrollment (in days)
- Time to prescription of daily administrated asthma medication within two years following study enrollment (in days)
- Purchases of antibiotics and asthma medications during two years following study enrollment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB04018MIG · Substance
- Active substance
- Prednisolone Sodium Phosphate
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 90 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB12600MIG · Substance
- Active substance
- Sucrose
- Pharmaceutical form
- SYRUP
- Route of administration
- ORAL
- Max daily dose
- 6 ml millilitre(s)
- Max total dose
- 18 ml millilitre(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Of Oulu
- Sponsor organisation
- University Of Oulu
- Address
- P. O. Box 5000
- City
- Oulu
- Postcode
- 90014
- Country
- Finland
Scientific contact point
- Organisation
- University Of Oulu
- Contact name
- The university help desk
Public contact point
- Organisation
- University Of Oulu
- Contact name
- The university help desk
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 210 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Finland | 2022-02-11 | 2022-10-11 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-27 | Finland | Acceptable 2024-04-10
|
2024-04-10 |