Wheezing | Efficacy of Systemic Glucocorticoid in the Treatment of Wheezing in Children
Wheezing research study
What is the primary objective of this study?
We can not predict which wheezing child younger than 3 years of age benefits from systemic glucocorticoid and which one does not. It is not known whether the differences in the efficacy are related to the differences in viral etiology, atopy, immunogical maturity or age of the patient. The study aims to answer the following questions: 1. What is the viral etiology of acute childhood expiratory wheezing? 2. What is the efficacy of prednisolone in relation to age, atopy and viral etiology in acute childhood wheezing? 3. Does prednisolone treatment increase risk for secundary bacterial infection in acute childhood expiratory wheezing? 4. What is the significance of inflammatory markers in predicting the efficacy of systemic steroid or patient outcome in acute childhood expiratory wheezing? Study will follow randomized, double blind, placebo-controlled parallel design. Study will start in Septemper 2000 and will be performed at the Department of Pediatrics, Turku University Hospital, Turku Finland. The study population will be 300 hospitalized wheezing children aged 3 months – 15 years. Investigational drug will be prednisolone, first dose 2 mg/kg, then 2 mg/kg/d/3 (max. 60 mg/vrk) p.o. for 3 d and comparative drug will be placebo tablet similar to investigational drug with the equal dosage. The primary outcome will be the time until ready for discharge. The study will provide new and important information for the diagnostics, treatment, disease outcome and prevention of acute childhood expiratory wheezing.
Who is eligible to participate?
Inclusion Criteria: - age 3 months to 16 years - hospitalization for expiratory wheezing - written informed consent from the parents Exclusion Criteria: - Any chronic disease (other than allergy or asthma), e.g. heart disease, immune deficiency, or diabetes - varicella and exposure to varicella if not previously have had it - Systemic glucocorticoid 4 weeks prios to the study - Severe disease that needs treatment in the intensive care unit or oxygen saturation below 92% despite of additional oxygen and frequent salbutamol inhalations
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: September 2000
Completed Date: May 2008
Phase: Phase 4
Primary Outcome: The time until ready for discharge
Secondary Outcome: Oxygen saturation during hospital stay
Study sponsors, principal investigator, and references
Principal Investigator: Tuomas Jartti, MD
Lead Sponsor: University of Turku
Collaborator: Academy of Finland