Clinical trial • Phase IV • Respiratory

BETAMETHASONE SODIUM PHOSPHATE for Bronchiolitis | Acute wheezing

Phase IV trial of BETAMETHASONE SODIUM PHOSPHATE for Bronchiolitis | Acute wheezing.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Bronchiolitis | Acute wheezing
Trial Stage
Phase IV
Drug Modality
Small molecule|Other
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
06-12-2024
First CTIS Authorization Date
23-01-2025

Trial design

Randomised, placebo tablets identical to dexamethasone abcur 1.0 mg tablets-controlled Phase IV trial across 8 sites in Finland, Norway, Sweden.

Randomised
Yes
Comparator
Placebo tablets identical to dexamethasone Abcur 1.0 mg tablets
Biomarker Stratified
True, biomarker: rhinovirus genome load
Target Sample Size
280
Trial Duration For Participant
730

Stratification factors

  • Rhinovirus genome load

Eligibility

Recruits 280 paediatric patients.

Vulnerable Population
Participants are children aged 3-24 months (<2 years) who cannot consent themselves; consent to participate and to store data is given by their caregivers/parents. The study notes data are sensitive health data and that sharing selected anonymous data may require approval and a new consent request when participants turn older than 12 years.

Inclusion criteria

  • {"criterion_text":"- All of the following conditions must apply to the prospective patient prior to receiving study agent: 1) age 3-24 months"}
  • {"criterion_text":"- 2) first acute severe wheezing episode, defined as first-time acute breathing difficulty with wheezing ever, appearing less than 7 days from onset of symptoms, in a child referred to hospital, and with one or more of a) fever, b) hypoxia (SAT O2 ≤ 92%), c) retractions (inter-, subcostal), d) prolonged expiration (on auscultation), e) expiratory rhonchi (on auscultation)"}
  • {"criterion_text":"- 3) evidence of rhinovirus infection by PCR test in nasopharyngeal secrete"}
  • {"criterion_text":"- 4) signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations."}

Exclusion criteria

  • {"criterion_text":"- Patients will be excluded from the study if they meet any of the following criteria: 1) previous episodes with wheezing, defined as a history of acute breathing difficulty with wheezing in need of treatment at a general practitioner or at hospital, or parental information about similar breathing difficulties"}
  • {"criterion_text":"- 2) gestational age <37 weeks"}
  • {"criterion_text":"- 3) chronic illness other than atopy (eczema)"}
  • {"criterion_text":"- 4) previous systemic or inhaled corticosteroid treatment"}
  • {"criterion_text":"- 5) COVID-19 related disease"}
  • {"criterion_text":"- 6) participation to another trial"}
  • {"criterion_text":"- 7) varicella infection or contact during the last 2-3 weeks"}
  • {"criterion_text":"- 8) need for intensive care unit treatment during the present infection, except for non-invasive respiratory support with high flow nasal cannula ventilation, CPAP or BIPAP"}
  • {"criterion_text":"- 9) any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Primary endpoints are 1) the time to a new physician-confirmed wheezy episode","definition_or_measurement_approach":"Time-to-event measure: time from study entry to a new physician-confirmed wheezy episode (physician-confirmed diagnosis)."}
  • {"endpoint_text":"- Primary endpoints are 2) time to fullfill astma criteria defined as need for a regular controller medication for asthma within 24 months after study entry.","definition_or_measurement_approach":"Time-to-event measure: time from study entry to meeting asthma criteria, defined as initiation/need for a regular controller medication for asthma within 24 months."}

Secondary endpoints

  • {"endpoint_text":"- 1) Determined at the first episode of acute breathing difficulty within 24 months of study entry: a) duration and severity of symptoms.","definition_or_measurement_approach":"At first acute episode within 24 months: measurement of duration and severity of symptoms (clinical assessment at episode)."}
  • {"endpoint_text":"- 2) Determined at each scheduled follow-up visit within 24 months of study entry: a) number, duration and severity of episodes with acute breathing difficulty since start of study medication, b) degree of pulmonary hyperreactivity, c) quality of life, d) height and weight","definition_or_measurement_approach":"At scheduled follow-ups within 24 months: count and characterize episodes (number, duration, severity), assess pulmonary hyperreactivity, quality of life measures, and record height and weight."}

Recruitment

Planned Sample Size
280
Recruitment Window Months
289
Consent Approach
Consent is provided by caregivers/parents (participants are children 3-24 months and cannot consent themselves). Subject information and informed consent forms for parents/guardians are documented; country-specific parental information materials exist (documents listed for Norway, Sweden, Finland). Data sharing of sensitive health data may be considered only after approval and may require a new consent request when participants turn older than 12 years.

Geography

Total Number Of Sites
8
Total Number Of Participants
280

Finland

Earliest CTIS Part Ii Submission Date
23-12-2024
Latest Decision Or Authorization Date
24-01-2025
Processing Time Days
32
Number Of Sites
1
Number Of Participants
60

Sites

Site Name
Varsinais-Suomen hyvinvointialue
Department Name
Pediatrics
Principal Investigator Name
Tuomas Jartti
Principal Investigator Email
tuomas.jartti@utu.fi
Contact Person Name
Tuomas Jartti
Contact Person Email
tuomas.jartti@utu.fi

Norway

Earliest CTIS Part Ii Submission Date
23-12-2024
Latest Decision Or Authorization Date
23-01-2025
Processing Time Days
31
Number Of Sites
6
Number Of Participants
180

Sites

Site Name
Helse Bergen HF
Department Name
Peadiatric and Adolescent medicine
Principal Investigator Name
Maria Vollsæter
Principal Investigator Email
maria.vollseter@helse-bergen.no
Contact Person Name
Maria Vollsæter
Site Name
Akershus University Hospital
Department Name
Dept. Paediatric and Adolescent Medicine
Principal Investigator Name
Christopher Inchley
Principal Investigator Email
inchley@ahus.no
Contact Person Name
Christopher Inchley
Contact Person Email
inchley@ahus.no
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Paediatric Department
Principal Investigator Name
Claus Klingenberg
Principal Investigator Email
claus.klingenberg@unn.no
Contact Person Name
Claus Klingenberg
Contact Person Email
claus.klingenberg@unn.no
Site Name
St. Olavs Hospital HF
Department Name
Children's Clinic
Principal Investigator Name
Henrik Døllner
Principal Investigator Email
henrik.dollner@ntnu.no
Contact Person Name
Henrik Døllner
Contact Person Email
henrik.dollner@ntnu.no
Site Name
Helse Stavanger HF
Department Name
Pediatric Department
Principal Investigator Name
Knut Øymar
Principal Investigator Email
knut.oymar@sus.no
Contact Person Name
Knut Øymar
Contact Person Email
knut.oymar@sus.no
Site Name
Oslo University Hospital HF
Department Name
Clinic of Pediatrics
Principal Investigator Name
Håvard Ove Skjerven
Principal Investigator Email
uxskjh@ous-hf.no
Contact Person Name
Håvard Ove Skjerven
Contact Person Email
uxskjh@ous-hf.no

Sweden

Earliest CTIS Part Ii Submission Date
23-12-2024
Latest Decision Or Authorization Date
23-01-2025
Processing Time Days
31
Number Of Sites
1
Number Of Participants
40

Sites

Site Name
Karolinska University Hospital
Department Name
Astrid Lindgren children's hospital
Principal Investigator Name
Jon Konradsen
Principal Investigator Email
jon.konradsen@regionstockholm.se
Contact Person Name
Jon Konradsen

Sponsor

Primary sponsor

Full Name
St. Olavs Hospital HF
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Norway

Investigational products

Investigational Product Name
DEXAMETHASONE
Active Substance
BETAMETHASONE SODIUM PHOSPHATE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
6.0 mg per day; 18.0 mg total
Investigational Product Name
Placebo tablets identical to dexamethasone Abcur 1.0 mg tablets
Modality
Other

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