INNOVATIVE STEROID TREATMENT TO REDUCE ASTHMA DEVELOPMENT IN CHILDREN AFTER FIRST-TIME RHINOVIRUS INDUCED WHEEZING – THE INSTAR STUDY - INSTAR

St. Olavs Hospital0 个研究点目标入组 280 人开始时间: 2019年12月6日最近更新: 2020年2月1日

适应症

试验速览

暂无简介。

•1.age 3-24 months,
•2.first acute severe wheezing episode, defined as first-time acute breathing difficulty with wheezing ever, appearing less than 7 days from onset of symptoms, in a child admitted to hospital, and with one or more of
•-hypoxia (SAT O2 = 92%)
•-retractions (inter-, subcostal),
•-prolonged expiration (on auscultation),
•-expiratory rhonchi (on auscultation)
•3.rhinovirus positive PCR test in nasopharyngeal secrete,
•4.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.
•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

•1.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
•2.gestational age <37 weeks
•3.chronic illness other than atopy (eczema),
•4.previous systemic or inhaled corticosteroid treatment,
•5.participation to another trial,
•6.varicella infection or contact during the last 2-3 weeks,
•7.need for intensive care unit treatment during the present infection, except for respiratory support with high flow nasal cannula ventilation,
•8.any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures).

发起方

St. Olavs Hospital