IMPACT OF THE ADMINISTRATION OF SYSTEMIC GLUCOCORTICOIDS ON INFLAMMATORY RESPONSE AND CLINICAL EVOLUTION OF PATIENTS DIAGNOSED WITH MODERATE-SEVERE BRONCHIOLITIS

• Conditions: Viral bronchiolitis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]; MedDRA version: 14.0Level: PTClassification code 10038718Term: Respiratory syncytial virus bronchiolitisSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2011-000337-36-ES
• Lead Sponsor: FUNDACIÓ SANT JOAN DE DÉ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-04
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

The study will recruit paediatric patients under one year old who require hospitalization for moderate-severe bronchiolitis according to the HSJD BRONCHIOLITIS SCORE of Sant Joan de Deu Hospital (Annex 1).
Are the trial subjects under 18? yes
Number of subjects for this age range: 78
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

a) Patients of either gender under one year old with mild bronchiolitis.
b) Patients with bronchiolitis in which the principal symptom is apnoea.
c) Patients who have received corticotherapy before admission to hospital.
d) No consent from parents or tutors.
e) Patients with previous acquired or innate immunodepression.
f) Patients enrolled in other clinical trials.

Study & Design

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