NCT03889743

Brief Summary

The overall objective of the study is to determine the efficacy of corticosteroids in preventing recurrent wheezing and asthma in high-risk, first-time severe wheezing children with rhinovirus infection, stratified by rhinovirus genome load. The secondary objectives are to determine duration and severity of each acute episode with acute expiratory breathing difficulty, the number of episodes with acute expiratory breathing difficulty, degree of pulmonary hyperreactivity and quality of life within 24 months after study entry.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for phase_4 asthma

Timeline
24mo left

Started May 2019

Longer than P75 for phase_4 asthma

Geographic Reach
3 countries

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
May 2019May 2028

First Submitted

Initial submission to the registry

March 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 8, 2019

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

9 years

First QC Date

March 23, 2019

Last Update Submit

June 10, 2025

Conditions

AsthmaInflammation

Keywords

Respiratory SoundsSteroidsRhinovirus

Outcome Measures

Primary Outcomes (2)

  • time to a new physician-confirmed wheezy episode within 24 months after study entry

    24 months

  • time to need for a regular controller medication for asthma within 24 months after study entry

    24 months

Secondary Outcomes (8)

  • duration of respiratory symptoms

    24 months

  • severity of respiratory symptoms

    24 months

  • the number of episodes with acute breathing difficulty since start of study medication

    24 months

  • the duration of episodes with acute breathing difficulty since start of study medication

    24 months

  • the degree of pulmonary hyperreactivity

    24 months

  • +3 more secondary outcomes

Study Arms (2)

Dexamethasone

EXPERIMENTAL
Drug: Dexamethasone treatment during 3 days

controls

PLACEBO COMPARATOR
Drug: placebo treatment during 3 days

Interventions

Dexamethasone treatment during 3 daysDRUG

Dexamethasone 1,0 mg oral tablets. The exact daily dose of dexamethasone will be 0.3 mg/kg (maximum 6.0 mg). The recommended administration of all tablets is to crush the tablets to a smooth powder and then mix with jelly or yogurt. The dissolved dexamethasone is given by mouth and it is recommended to give it in relation to a meal/breastfeeding. If a child vomits within 30 min, the same dose will be given one more time after a break.

Dexamethasone
placebo treatment during 3 daysDRUG

1,0 mg oral tablets. The exact daily dose of lactose (instead of dexamethasone) will be 0.3 mg/kg (maximum 6.0 mg). The recommended administration of all tablets is to crush the tablets to a smooth powder and then mix with jelly or yogurt. The dissolved dexamethasone is given by mouth and it is recommended to give it in relation to a meal/breastfeeding. If a child vomits within 30 min, the same dose will be given one more time after a break.

Also known as: lactose
controls

Eligibility Criteria

Age3 Months - 23 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • admitted to pediatric acute wards in the participating hospitals in Norway, Finland, Sweden.
  • referred for first severe wheezing episode, defined as first-time acute breathing difficulty with wheezing ever, appearing less than 7 days from onset of symptoms
  • one or more of the following:(a) fever, (b) hypoxia (SAT O2 \<= 92%), (c) retractions (inter-, subcostal), (d) prolonged expiration (on auscultation), (e) expiratory rhonchi (on auscultation)
  • evidence of rhinovirus infection by PCR-test in nasopharyngeal secretions
  • 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.

You may not qualify if:

  • 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
  • gestational age \<37 weeks
  • chronic illness other than atopy (eczema),
  • previous systemic or inhaled corticosteroid treatment,
  • participation to another trial,
  • varicella infection or contact during the last 2-3 weeks,
  • need for intensive care unit treatment during the present infection, except for respiratory support with non-invasive methods (high flow nasal cannula ventilation, CPAP or BiPAP),
  • any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures).
  • COVID-19 related disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Turku University Hospital

Turku, Finland

RECRUITING

Haukeland University Hospital

Bergen, Norway

RECRUITING

Akershus University Hospital

Oslo, Norway

RECRUITING

Ullevål University Hospital

Oslo, Norway

RECRUITING

Stavanger University Hospital

Stavanger, Norway

RECRUITING

University Hospital of North Norway

Tromsø, Norway

RECRUITING

St Olavs Hospital

Trondheim, Norway

RECRUITING

Karolinska Universitetssjukhuset

Stockholm, Sweden

RECRUITING

Related Publications (1)

  • Elvebakk T, Dollner H, Partty A, Jartti H, Vuorinen T, Oymar K, Nerheim S, Moe N, Nordbo SA, Follestad T, Koski J, Vollsaeter M, Hofstad A, Klingenberg C, Leknessund CB, Skjerven HO, Risnes K, Soderhall C, Sissener E, Inchley CS, Konradsen JR, Jartti T. INnovative Steroid Treatment to reduce Asthma development in children after first-time Rhinovirus-induced wheezing (INSTAR): protocol for a randomised placebo-controlled trial. BMJ Open. 2025 Jul 30;15(7):e103530. doi: 10.1136/bmjopen-2025-103530.

    PMID: 40738645DERIVED

MeSH Terms

Conditions

AsthmaInflammationRespiratory Sounds

Interventions

Lactose

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Geir Bråthen

    St. Olavs Hospital

    STUDY DIRECTOR

Central Study Contacts

Henrik Døllner, md phd

CONTACT

0047 73559531henrik.dollner@ntnu.no

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: In Sweden and Finland children who are rhinovirus negative but otherwise fulfill the inclusion criteria, will be included for comparison. They will not be randomized and participate in the intervention but receive follow-up as rhinovirus positive participants.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2019

First Posted

March 26, 2019

Study Start

May 8, 2019

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

June 13, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

NO(6)SE(1)FI(1)