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Viral Inception of Asthma: Prospective Study From Infancy to School-Age. (VINKU2)

This study is currently recruiting participants.
Verified by University of Turku, August 2008

Sponsors and Collaborators: University of Turku
Cultural Foundation of Finland, Helsinki, Finland
Turku University Foundation, Turku, Finland
Maud Kuistila Foundation, Helsinki, Finland
Foundation for Pediatric Research, Helsinki, Finland
University of Turku, Foundation of Emil and Blida Maunula, Turku, Finland
Foundation for outpatient Research, Helsinki, Finland
Research Support, Turku University Hospital, Turku, Finland
Paulo Foundation, Helsinki, Finland
Juselius Foundation, Helsinki, Finland
Information provided by: University of Turku
ClinicalTrials.gov Identifier: NCT00731575
  Purpose

The purpose of this study is to study prospectively the early clinical and immunological events in children susceptible to rhinovirus induced early wheezing (i.e. recently found highest risk factor for recurrent wheezing/asthma) and the efficacy of systemic corticosteroid to modify these events.


Condition Intervention
Asthma
Drug: prednisolone

MedlinePlus related topics:   Asthma   

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:   Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Viral Inception of Asthma: Prospective Study From Infancy to School-Age.

Further study details as provided by University of Turku:

Primary Outcome Measures:
  • Diagnosis of asthma [ Time Frame: 1-7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Home diary recordings for airway symptoms [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   200
Study Start Date:   June 2007
Estimated Primary Completion Date:   May 2016 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: prednisolone
    First dose 2 mg/kg (max 60 mg) p.o., then 2 mg/kg/d (max 60 mg/d) p.o. in 3 divided doses for 3 days.
Detailed Description:

Up to 50% of children suffer from acute wheezing before school-age. The prevalence of childhood asthma is 5-7%. Although pediatric asthma is mainly allergic, the exacerbations are associated with respiratory viral infections in 95% of cases. The means to predict asthma from environmental factors have been limited mainly to sensitization to aeroallergens (3-fold risk), which start to develop usually at 2-3 years of age. VINKU 1-study (orig. VINKU-study) discovered simultaneously with two other groups, that early wheezing associated with rhinovirus, the "common cold" virus, is the strongest predictor of recurrent wheezing/asthma (up to 10-fold risky). Noteworthily, viral infections work as risk markers already during infancy, a lot earlier than the sensitization to aeroallergens. We also found retrospectively that early wheezers affected by rhinovirus responded to 3 day course of oral prednisolone (inexpensive and widely available treatment): recurrent wheezing decreased by 50% during following 12 months and the difference appeared to continue. VINKU 5V-study is currently investigating the clinical history, prevalence of asthma and airway hyperreactivity of these same children at school-age. The mechanism of rhinovirus associated risk or why they respond to prednisolone are largely unknown. However, the susceptibility to rhinovirus infections is associated with atopy and therefore it is possible these children may have impaired anti-inflammatory (Treg) responses and more likely to wheeze with any pro-inflammatory response (Th1 or Th2). Moreover, they may not effectively clear viruses, because they can not limit rhinovirus to nose and it spreads to lower airways and causes wheezing. VINKU 2-study will prospectively investigate the immunological events in young first-time wheezers affected by rhinovirus, and prospectively study the clinical efficacy of systemic corticosteroid in them. Most likely these children will benefit from the drug in terms of less recurrent wheezing, we will also explore immunological effects of the drug and their link to clinical efficacy. The results are expected to give basis for the prevention of asthma and for the development of new treatment strategies and they can be directly applied to clinical medicine.

  Eligibility
Ages Eligible for Study:   3 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • age 3-23 months
  • be delivered at >=37 weeks
  • first wheezing episode
  • written informed consent from guardian

Exclusion Criteria:

  • chronic illness other than atopy
  • previous systemic or inhaled corticosteroid treatment
  • participation to another study
  • varicella contact if previously intact
  • need for intensive care unit treatment, or
  • poor understanding of Finnish
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731575

Contacts
Contact: Tuomas Jartti, M.D.     +358 40 7270 284     tuomas.jartti@utu.fi    
Contact: Olli Ruuskanen, M.D.     +358 2 313 2415     olli.ruuskanen@tyks.fi    

Locations
Finland
Dept of Pediatrics, Turku University Hospital     Recruiting
      Turku, Finland

Sponsors and Collaborators
University of Turku
Cultural Foundation of Finland, Helsinki, Finland
Turku University Foundation, Turku, Finland
Maud Kuistila Foundation, Helsinki, Finland
Foundation for Pediatric Research, Helsinki, Finland
University of Turku, Foundation of Emil and Blida Maunula, Turku, Finland
Foundation for outpatient Research, Helsinki, Finland
Research Support, Turku University Hospital, Turku, Finland
Paulo Foundation, Helsinki, Finland
Juselius Foundation, Helsinki, Finland
  More Information


home page of the VINKU study group  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Dept of Pediatrics, Turku University Hospital, Turku, Finland ( Tuomas Jartti )
Study ID Numbers:   VINKU2
First Received:   August 6, 2008
Last Updated:   August 8, 2008
ClinicalTrials.gov Identifier:   NCT00731575
Health Authority:   Finland: National Agency for Medicines

Keywords provided by University of Turku:
asthma  
child  
pathogenesis  
rhinovirus  
prednisolone
Prevention
pediatric

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Methylprednisolone
Lung Diseases
Prednisolone
Hypersensitivity, Immediate
Methylprednisolone acetate
Asthma
Prednisolone acetate
Methylprednisolone Hemisuccinate
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Bronchial Diseases
Immune System Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Protective Agents
Neuroprotective Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 31, 2008




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