Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing - The INSTAR study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

St. Olavs Hospital HF

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

12 Apr 2019 → ongoing

Decision date (initial)

2025-01-24

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-515350-25-01

EudraCT number

2015-001077-40

ClinicalTrials.gov

NCT03889743

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

The primary objective is to determine the efficacy of systemic corticosteroids in preventing recurrent wheezing and asthma in first-time severely wheezing children with rhinovirus infection, stratified by rhinovirus genome load.

Secondary objectives 1

1. The secondary objectives are to determine number of wheezy episodes, severity and duration of each acute wheezy episode, degree of bronchial hyperreactivity and quality of life (QoL) within 24 months follow-up.

Conditions and MedDRA coding

Acute wheezing/bronchiolitis

Regulatory references

Plan to share IPD

Yes

IPD plan description

The participants are children <2 years old who not able to consent themselves. Consent to participate and to store data is given by their caregivers. The data are sensitive health data. We may consider sharing selected anonymous data after a reasonable request, and if sharing have been approved after a new request to participants turning older than 12 years old.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. All of the following conditions must apply to the prospective patient prior to receiving study agent: 1) age 3-24 months, 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), 3) evidence of rhinovirus infection by PCR test in nasopharyngeal secrete, 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 1

1. 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, 2) gestational age <37 weeks, 3) chronic illness other than atopy (eczema), 4) previous systemic or inhaled corticosteroid treatment, 5) COVID-19 related disease, 6) participation to another trial, 7) varicella infection or contact during the last 2-3 weeks, 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, 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 and secondary outcome measures (English text)

Primary endpoints 1

1. Primary endpoints are 1) the time to a new physician-confirmed wheezy episode, and 2) time to fullfill astma criteria defined as need for a regular controller medication for asthma within 24 months after study entry.

Secondary endpoints 1

1. 1) Determined at the first episode of acute breathing difficulty within 24 months of study entry: a) duration and severity of symptoms. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

St. Olavs Hospital HF

Sponsor organisation

St. Olavs Hospital HF

Address

Prinsesse Kristinas G. 3

City

Trondheim

Postcode

7030

Country

Norway

Scientific contact point

Organisation

St. Olavs Hospital HF

Contact name

Henrik Døllner

Public contact point

Organisation

St. Olavs Hospital HF

Contact name

Henrik Døllner

Locations

3 EU/EEA countries · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications