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Efficacy of Systemic Glucocorticoid in the Treatment of Wheezing in Children (VINKU)

This study is currently recruiting participants.
Verified by University of Turku, June 2007

Sponsors and Collaborators: University of Turku
Academy of Finland
Information provided by: University of Turku
ClinicalTrials.gov Identifier: NCT00494624
  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 IV

Drug Information available for:   Prednisolone    6-Methylprednisolone    Depo-medrol    Medrol veriderm    Methylprednisolone    Methylprednisolone hemisuccinate    Methylprednisolone Sodium Succinate    Prednisolone acetate    Prednisolone sodium phosphate    Prednisolone Sodium Succinate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further study details as provided by University of Turku:

Primary Outcome Measures:
  • The time until ready for discharge

Secondary Outcome Measures:
  • 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  Show Detailed Description

  Eligibility
Ages Eligible for Study:   3 Months to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494624

Contacts
Contact: Tuomas Jartti, MD     +358 2 313 0000     tuomas.jartti@utu.fi    
Contact: Olli Ruuskanen, MD     +358 2 313 0000     olli.ruuskanen@tyks.fi    

Locations
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            

Sponsors and Collaborators
University of Turku
Academy of Finland

Investigators
Principal Investigator:     Tuomas Jartti, MD     Turku University Hospital    
Principal Investigator:     Olli Ruuskanen, MD     Turku University Hospital    
  More Information


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

Keywords provided by University of Turku:
Wheezing  
virus  
child  

Study placed in the following topic categories:
Virus Diseases
Signs and Symptoms
Respiratory Sounds
Methylprednisolone
Prednisolone
Methylprednisolone acetate
Signs and Symptoms, Respiratory
Prednisolone acetate
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 06, 2008




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