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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Cultural Foundation of Finland, Helsinki, Finland
Maud Kuistila Foundation, Helsinki, Finland
Foundation for Paediatric Research, 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
The Paulo Foundation
Juselius Foundation, Helsinki, Finland
Information provided by:
University of Turku
ClinicalTrials.gov Identifier:
NCT00731575
First received: August 6, 2008
Last updated: August 11, 2011
Last verified: August 2011
  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.

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. The investigators 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, the investigators 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.


Condition Intervention
Asthma
Drug: prednisolone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Viral Inception of Asthma: Prospective Study From Infancy to School-age.

Resource links provided by NLM:


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.
    Other Name: Prednisolon®, 5 mg tablets, Oy Leiras Finland Ab, Helsinki, Finland.
  Show Detailed Description

  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
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: NCT00731575

Locations
Finland
Dept of Pediatrics, Turku University Hospital
Turku, Finland
Sponsors and Collaborators
University of Turku
Cultural Foundation of Finland, Helsinki, Finland
Maud Kuistila Foundation, Helsinki, Finland
Foundation for Paediatric Research, 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
The Paulo Foundation
Juselius Foundation, Helsinki, Finland
  More Information

Additional Information:
No publications provided

Responsible Party: Tuomas Jartti, Dept of Pediatrics, Turku University Hospital, Turku, Finland
ClinicalTrials.gov Identifier: NCT00731575     History of Changes
Other Study ID Numbers: VINKU2
Study First Received: August 6, 2008
Last Updated: August 11, 2011
Health Authority: Finland: Finnish Medicines Agency

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014