Actively Recruiting

Phase 4
Age: 3Months - 23Months
All Genders
NCT03889743

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

Led by St. Olavs Hospital · Updated on 2025-06-13

280

Participants Needed

8

Research Sites

468 weeks

Total Duration

On this page

Sponsors

S

St. Olavs Hospital

Lead Sponsor

T

Turku University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 3Months - 23Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admitted to pediatric acute wards in participating hospitals in Norway, Finland, Sweden
  • Referred for first severe wheezing episode with acute breathing difficulty and wheezing lasting less than 7 days
  • One or more of the following symptoms: fever, oxygen saturation ≤ 92%, chest retractions, prolonged expiration, or expiratory rhonchi
  • Rhinovirus infection confirmed by PCR test in nasopharyngeal secretions
  • Signed informed consent and expected cooperation for treatment and follow-up according to regulations
Not Eligible

You will not qualify if you...

  • Previous wheezing episodes needing treatment or similar breathing difficulties reported by parents
  • Born before 37 weeks of gestation
  • Chronic illness other than eczema
  • Previous systemic or inhaled corticosteroid treatment
  • Participation in another clinical trial
  • Varicella infection or contact in the last 2-3 weeks
  • Need for intensive care unit treatment during current infection, except non-invasive respiratory support
  • Any reason investigator considers the patient unsuitable, such as inability to comply with procedures
  • COVID-19 related disease

AI-Screening

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Trial Site Locations

Total: 8 locations

1

Turku University Hospital

Turku, Finland

Actively Recruiting

2

Haukeland University Hospital

Bergen, Norway

Actively Recruiting

3

Akershus University Hospital

Oslo, Norway

Actively Recruiting

4

Ullevål University Hospital

Oslo, Norway

Actively Recruiting

5

Stavanger University Hospital

Stavanger, Norway

Actively Recruiting

6

University Hospital of North Norway

Tromsø, Norway

Actively Recruiting

7

St Olavs Hospital

Trondheim, Norway

Actively Recruiting

8

Karolinska Universitetssjukhuset

Stockholm, Sweden

Actively Recruiting

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Research Team

H

Henrik Døllner, md phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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