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

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ClinicalTrials.gov Identifier: NCT00494624
Recruitment Status : Unknown
Verified June 2007 by University of Turku.
Recruitment status was:  Recruiting
First Posted : July 2, 2007
Last Update Posted : July 2, 2007
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Wheezing Drug: prednisolone Phase 4

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : September 2000
Estimated Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. The time until ready for discharge

Secondary Outcome Measures :
  1. Oxygen saturation during hospital stay
  2. Wheeze and cough during two weeks after discharge from the hospital
  3. Readmission to the out-patient clinic or hospital for recurrent wheezing during a two-month period after discharge
  4. Blood eosinophil counts at discharge and two weeks later

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00494624     History of Changes
Other Study ID Numbers: VINKU
First Posted: July 2, 2007    Key Record Dates
Last Update Posted: July 2, 2007
Last Verified: June 2007

Keywords provided by University of Turku:
Wheezing
virus
child

Additional relevant MeSH terms:
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents