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New treatment option for Asthma
Official title Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing
ClinicalTrials.gov ID: NCT03889743
What this study is testing
What is Dexamethasone treatment during 3 days?
Dexamethasone treatment during 3 days is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for asthma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 23
You may be able to join if
- 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...
- one or more of the following:(a) fever, (b) hypoxia (SAT O2 \<= 92%), (c) retractions (inter-, subcostal), (d) prolonged expiration (on...
- evidence of rhinovirus infection by PCR-test in nasopharyngeal secretions
- signed informed consent and expected cooperation of the patients for the treatment and follow-up must be obtained and documented according to ICH...
You likely can't join if
- previous episodes with wheezing, defined as a history of acute breathing difficulty with wheezing in need of treatment at a general practitioner or...
- gestational age \<37 weeks
- chronic illness other than atopy (eczema),
- previous systemic or inhaled corticosteroid treatment,
- participation to another trial,
- varicella infection or contact during the last 2-3 weeks,
See the full eligibility criteria
- 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
- signed informed consent and expected cooperation of the patients for the treatment and follow-up must be obtained and documented according to ICH GCP, and national/local regulations.
- 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...
- gestational age \<37 weeks
- chronic illness other than atopy (eczema),
- previous systemic or inhaled corticosteroid treatment,
- participation to another trial,
- varicella infection or contact during the last 2-3 weeks,
- need for intensive care unit treatment during the present infection, except for respiratory support with non-invasive methods (high flow nasal cannula ventilation, CPAP or BiPAP),
- any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures).
- COVID-19 related disease.
The study team makes the final eligibility decision.
Where it's taking place
- Turku, Finland
- Bergen, Norway
- Oslo, Norway
- Stavanger, Norway
- Tromsø, Norway
- Trondheim, Norway
- Stockholm, Sweden
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 months to 23 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turku, Finland; Bergen, Norway; Oslo, Norway; Stavanger, Norway; Tromsø, Norway; Trondheim, Norway and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.