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Sponsors and Collaborators: |
University of Turku Academy of Finland |
Information provided by: | University of Turku |
ClinicalTrials.gov Identifier: | NCT00494624 |
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.
Condition | Intervention | Phase |
Wheezing |
Drug: prednisolone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 300 |
Study Start Date: | September 2000 |
Estimated Study Completion Date: | May 2008 |
Show Detailed Description |
Ages Eligible for Study: | 3 Months to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tuomas Jartti, MD | +358 2 313 0000 | tuomas.jartti@utu.fi |
Contact: Olli Ruuskanen, MD | +358 2 313 0000 | olli.ruuskanen@tyks.fi |
Finland | |||||
Turku University Hospital | Recruiting | ||||
Turku, Finland, 20520 | |||||
Contact: Tuomas Jartti, MD +358 2 313 0000 tuomas.jartti@utu.fi | |||||
Contact: Olli Ruuskanen, MD +358 2 313 0000 olli.ruuskanen@tyks.fi | |||||
Sub-Investigator: Pasi Lehtinen, MD |
University of Turku |
Academy of Finland |
Principal Investigator: | Tuomas Jartti, MD | Turku University Hospital |
Principal Investigator: | Olli Ruuskanen, MD | Turku University Hospital |
Study ID Numbers: | VINKU |
First Received: | June 29, 2007 |
Last Updated: | June 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00494624 |
Health Authority: | Finland: National Agency for Medicines |
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