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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Dexamethasone treatment during 3 days
DrugDexamethasone 1,0 mg oral tablets. The exact daily dose of dexamethasone will be 0.3 mg/kg (maximum 6.0 mg). The recommended administration of all tablets is to crush the tablets to a smooth powder and then mix with jelly or yogurt. The dissolved dexamethasone is given by mouth and it is recommended to give it in relation to a meal/breastfeeding. If a child vomits within 30 min, the same dose will be given one more time after a break.
placebo treatment during 3 days
Drug1,0 mg oral tablets. The exact daily dose of lactose (instead of dexamethasone) will be 0.3 mg/kg (maximum 6.0 mg). The recommended administration of all tablets is to crush the tablets to a smooth powder and then mix with jelly or yogurt. The dissolved dexamethasone is given by mouth and it is recommended to give it in relation to a meal/breastfeeding. If a child vomits within 30 min, the same dose will be given one more time after a break.
Treatment groups
280 Participants
are divided into 2 treatment groupsGroup A: DexamethasoneExperimental treatment 1 intervention
Group B: controlsPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
time to a new physician-confirmed wheezy episode within 24 months after study entry
Time frame
24 months2
time to need for a regular controller medication for asthma within 24 months after study entry
Time frame
24 monthsSecondary outcomes
1
duration of respiratory symptoms
as determined at the first episode of acute breathing difficulty within 24 months of study entry
Time frame
24 months2
severity of respiratory symptoms
as determined at the first episode of acute breathing difficulty within 24 months of study entry
Time frame
24 months3
the number of episodes with acute breathing difficulty since start of study medication
as determined at scheduled follow-up visit within 24 months of study entry
Time frame
24 months4
the duration of episodes with acute breathing difficulty since start of study medication
as determined at scheduled follow-up visit within 24 months of study entry
Time frame
24 monthsSponsors and contacts
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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