ASTHMA MedDRA version: 14.1 Level: PT Classification code 10049585 Term: Infantile asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Se utilizará el nombre comercial de este principio activo que este disponible en el Hospital
Product Name: DEXAMETHASONE
Product Code: DEXAMETHASONE
Pharmaceutical Form: Oral suspension
IN
Sponsors
FRANCISCO JAVIER BENITO FERNANDEZ
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children admitted SUP aged 1 to 16 years. With acute asthma: any child with respiratory symptoms (cough, shortness of breath, tachypnea) attributed to bronchospasm (wheezing, prolonged expiration, hypoventilation, etc ...), regardless of the possible trigger (infection, mites, pollen, etc ...) or the presence or absence of previous episodes. Children after initial treatment with salbutamol (1 dose) did not exhibit clinical improvement and require treatment with systemic corticosteroids. He has informed the patient and their parents / guardians have been given sufficient time and opportunity to consider their participation and have given consent. Subject is willing and able to meet all the requirements of the study. Are the trial subjects under 18? yes Number of subjects for this age range: 1000 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: Patients with other airway pathology not define as asthma. Patients with concomitant diseases that make it advisable hospital treatment. Patients requiring advanced stabilization of the airway. Any problem of cultural, social, disease or problem of any kind that do presuppose the absence of collaboration possible for the patient and / or their legal representatives. Patients and / or guardians / parents who do not sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine whether administration of 2 doses of oral dexamethasone is as effective or more effective than the administration of prednisolone 5 days / oral prednisone in the improvement of symptoms of asthma;Secondary Objective: Determine whether the administration of 2 doses of oral dexamethasone is more effective or as effective as 5-day administration of prednisolone / oral prednisone in the prevention of relapse and re-visits to the emergency room. To assess the safety and tolerability of the treatment given in this context.;Primary end point(s): Percentage of children with persistent symptoms at 7 days after hospital discharge with oral steroid therapy (dexamethasone versus prednisone / prednisolone) following an acute asthma attack.;Timepoint(s) of evaluation of this end point: During the participation of the child in the trial (7 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: During the participation of the child in the trial (15 days);Secondary end point(s): Percentage of children requiring hospitalization after their stay in the observation unit Percentage of patients requiring a stay in the observation unit before discharge to home Percentage of children who require hospitalization after a revisit Adherence to treatment with oral corticosteroids Percentage of children who have episodes of vomiting during oral corticosteroid treatment Satisfaction of parents with corticosteroid treatment assigned to their children Revisit to the emergency room or your primary care pediatrician at 7 and 15 days after discharge to home Truancy days from the onset of the acute episode until the incorporation of the child to school Absenteeism days of the mother, father and / or guardian from the beginning of the acute episode to recovery of child | — |
Countries
Spain
Contacts
Public ContactFRANCISCO JAVIER BENITO FERNANDEZ
HOSPITAL UNIVERSITARIO CRUCES (OSAKIDETZA)
Outcome results
None listed