Efficacy of Systemic Glucocorticoid in the Treatment of Wheezing in Children (VINKU)
Recruitment status was Recruiting
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Purpose
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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
- The time until ready for discharge
- Oxygen saturation during hospital stay
- Wheeze and cough during two weeks after discharge from the hospital
- Readmission to the out-patient clinic or hospital for recurrent wheezing during a two-month period after discharge
- Blood eosinophil counts at discharge and two weeks later
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2000 |
| Estimated Study Completion Date: | May 2008 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 3 Months to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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 | |
| Principal Investigator: | Tuomas Jartti, MD | Turku University Hospital |
| Principal Investigator: | Olli Ruuskanen, MD | Turku University Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00494624 History of Changes |
| Other Study ID Numbers: | VINKU |
| Study First Received: | June 29, 2007 |
| Last Updated: | June 29, 2007 |
| Health Authority: | Finland: Finnish Medicines Agency |
Keywords provided by University of Turku:
|
Wheezing virus child |
Additional relevant MeSH terms:
|
Respiratory Sounds Signs and Symptoms, Respiratory Signs and Symptoms Methylprednisolone acetate Prednisolone acetate Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013