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-SE
• Lead Sponsor: St. Olavs Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-06
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 280

Inclusion Criteria

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 admitted to hospital, and with one or more of
-fever,
-hypoxia (SAT O2 = 92%)
-retractions (inter-, subcostal),
-prolonged expiration (on auscultation),
-expiratory rhonchi (on auscultation)
3.rhinovirus positive 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.

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 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.participation to another trial,
6.varicella infection or contact during the last 2-3 weeks,
7.need for intensive care unit treatment during the present infection, except for respiratory support with high flow nasal cannula ventilation,
8.any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures).

Study & Design

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