First acute wheezing episode
Conditions
Interventions
Trade Name: Dexametason Abcur 1.0 mg tablet
Product Name: Dexametason Abcur 1.0 mg tablet
Pharmaceutical Form: Tablet
INN or Proposed INN: DEXAMETHASONE
Other descriptive name: Deksametason
Concentrat
Sponsors
St Olavs Hospital HF
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1) Previous episodes of expiratory breathing difficulties 2) gestational age < 37 weeks 3) Chronic illness other than atopy (eczema) 4) previous systemic or inhaled corticosteroid treatment 5) COVID-19 related disease 6) participation to another trial 7) varicella infection or contact during the last 2-3 weeks 8) need for intensive care unit treatment during the present infection except for respiratory support with non-invasive ventilation methods (high frequency nasal cannula ventilation, CPAP or BiPAP). 8) need for intensive care unit treatment, except for respiratory support with high frequency nasal cannula ventilation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: The secondary objectives are to determine duration and severity in each acute episode with acute expiratory breathing difficulty, the number and duration of episodes with acute expiratory breathing difficulty, quality of life, degree of pulmonary hyperreactivity and safety measures including se-cortisol, height and weight, within 24 months after study entry.;Primary end point(s): Primary endpoints are the time to a new physician-confirmed wheezy episode, and time to need for a regular controller medication for asthma within 24 months after study entry. Primary interaction analyses: Age, gender, atopic predisposition as indicated by presence of atopic eczema, elevated blood-eosinophile count and allergic sensitization, risk genotype [the 17q locus or CDHR3], rhinovirus genome load and co-dectection of respiratory syncytial virus and other airway viruses.;Timepoint(s) of evaluation of this end point: Continuously (symptom diary, scheduled calls and visits) for two years; using questionnaire, patient charts and final visit until 6 year follow-up, and national registry data of drug purchases until 14 years of age. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Determined at the first episode of acute breathing difficulty within 24 months of study entry: - duration and severity of symptoms Determined at each scheduled follow-up visit within 24 months of study entry: -number, duration and severity of episodes with acute breathing difficulty since start of study medication -degree of pulmonary hyperreactivity -quality of life -height and weight ;Timepoint(s) of evaluation of this end point: Continuously (symptom diary, scheduled calls and visits) for two years. | — |
Countries
Finland, Norway, Sweden
Contacts
Public ContactThe Department of Pediatrics
St Olavs Hospital HF
Outcome results
None listed