Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-23
SponsorSt. Olavs Hospital
About this trial
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, stratified by rhinovirus genome load.
The secondary objectives are to determine duration and severity of each acute episode with acute expiratory breathing difficulty, the number of episodes with acute expiratory breathing difficulty, degree of pulmonary hyperreactivity and quality of life within 24 months after study entry.
Eligibility criteria
Qualifiers
admitted to pediatric acute wards in the participating hospitals in Norway, Finland, Sweden.
referred for first severe wheezing episode, defined as first-time acute breathing difficulty with wheezing ever, appearing less than 7 days from onset of symptoms
one or more of the following:(a) fever, (b) hypoxia (SAT O2 <= 92%), (c) retractions (inter-, subcostal), (d) prolonged expiration (on auscultation), (e) expiratory rhonchi (on auscultation)
evidence of rhinovirus infection by PCR-test in nasopharyngeal secretions
Disqualifiers
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
gestational age <37 weeks
chronic illness other than atopy (eczema),
previous systemic or inhaled corticosteroid treatment,
Trial design
Treatments tested in this trial
- Dexamethasone treatment during 3 days
- placebo treatment during 3 days
Treatment groups
280 Participants
are divided into 2 treatment groupsSponsors and collaborators
St. Olavs Hospital
Lead sponsor
Turku University Hospital
Collaborator
Karolinska University Hospital
Collaborator
Haukeland University Hospital
Collaborator
University Hospital, Akershus
Collaborator
Helse Stavanger HF
Collaborator
University Hospital of North Norway
Collaborator
Ullevaal University Hospital
Collaborator
Source ClinicalTrials.gov