First wheezing episode (=acute expiratory breathing difficulty) associated with rhinovirus infection in 3 to 23 -month-old children. MedDRA version: 9.1 Level: LLT Classification code 10047925 Term: Wheezing expiratory
Conditions
Interventions
Trade Name: Prednisolon
Product Name: Prednisolone
Product Code: not applicable
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Turku University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General Inclusion Criteria Age 3-24 months, be delivered at >37 weeks, first wheezing episode OR upper respiratory tract infection without wheezing, written informed consent from guardian. Inclusion Criteria for the Intervention Rhinovirus PCR positive wheezing episode and still signs of lower respiratory symptoms (cough, noisy breathing or wheezing) at the time the initiation of study drug. Inclusion Criteria for the Follow-up First wheezing episode induced by rhinovirus or RSV OR rhinovirus induced upper respiratory tract infection without wheezing, written informed consent from guardian. Are the trial subjects under 18? yes Number of subjects for this age range: 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
Exclusion criteria: Chronic illness other than atopy, previous systemic or inhaled corticosteroid treatment, participation to another study (excluding long-term follow-up studies in childhood), varicella contact if previously intact, or poor understanding of Finnish.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main Hypothesis and Anticipated Results Therapeutic intervention with systemic corticosteroid: Systemic corticosteroid in children susceptible for rhinovirus-induced early wheezing 6. decreases the severity and relapses of the first wheezing episode, 7. decreases persistence of rhinovirus infection and prevents recurrent wheezing, and asthma, 8. prevents Th2-polarization, favours Th1- and Treg-responses during the treatment period. ;Secondary Objective: Main Hypothesis and Anticipated Results Virology: 1. Rhinovirus is a common causative agent of bronchiolitis. 2. Persistence of rhinovirus infections worsens long-term outcome. 3. The dose of virus inoculation at the time of acute wheezing (assessed semi-quantitatively for rhinovirus and respiratory syncytial virus) is related to outcome. Immunology: 4. Children susceptible to rhinovirus induced early wheezing have altered immunology (T cell regulation and interferon responses) when compared to RSV induced wheezers and children with rhinovirus induced upper respiratory infection without wheezing. 5. These immunological events are related to recurrent wheezing and asthma inception. ;Primary end point(s): The occurrence of and time to a new physician-confirmed wheezing episode within 2 months after discharge; number of physician-confirmed wheezing episodes during the first 12 months after discharge; diagnoses of asthma during the full study period. Asthma is defined as >4 episodes of wheezing (at least 2 weeks apart) in the past year that lasted more than one day and affected sleep and who have risk factors for the development of asthma (parental history of asthma or physician-diagnosed atopic dermatitis or two of the following: physician diagnosed allergic rhinitis, wheezing apart from colds or peripheral blood eosinophilia >0.3 x 109/l). | — |
Countries
Finland
Outcome results
None listed