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

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.

Conditions

• Asthma
• Inflammation

Interventions

DRUG

Dexamethasone treatment during 3 days

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.

DRUG

placebo treatment during 3 days

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.

Sponsors & Collaborators

• Turku University Hospital

  collaborator OTHER_GOV

• Karolinska University Hospital

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• University Hospital, Akershus

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• University Hospital of North Norway

  collaborator OTHER

• Ullevaal University Hospital

  collaborator OTHER

• St. Olavs Hospital

  lead OTHER

Principal Investigators

• Geir Bråthen · St. Olavs Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

3 Months

Max Age

23 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-08

Primary Completion

2028-05-31

Completion

2028-05-31

Countries

• Finland
• Norway
• Sweden

Study Locations