Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by University of Turku.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Academy of Finland
Information provided by:
University of Turku
ClinicalTrials.gov Identifier:
NCT00494624
First received: June 29, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  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

Resource links provided by NLM:


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by University of Turku

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

ClinicalTrials.gov processed this record on November 25, 2014