Asthma prevention in high-risk children by using early corticosteroid interventio

Phase 1

• Conditions: First acute wheezing episode; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-001077-40-NO
• Lead Sponsor: St Olavs Hospital HF

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-14
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

1) Age 3-24 months,
2) first acute severe wheezing episode,
3) rhinovirus positive PCR-test in nasopharyngeal aspirate
4) written informed consent.

Are the trial subjects under 18? yes
Number of subjects for this age range: 280
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Previous episodes of expiratory breathing difficulties
2) gestational age <= 36 weeks4
3) Chronic illness other than atopy (eczema)
4) previous systemic or inhaled corticosteroid treatment
5) COVID-19 and/or SARS-CoV-2 positive PCR-test in nasopharyngeal secrete
6) participation to another trial
7) varicella infection or contact during the last 2-3 weeks
8) need for intensive care unit treatment, except for respiratory support with high frequency nasal cannula ventilation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified