NCT00731575

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2008

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

August 12, 2011

Status Verified

August 1, 2011

Enrollment Period

8.9 years

First QC Date

August 6, 2008

Last Update Submit

August 11, 2011

Conditions

Asthma

Keywords

asthmachildpathogenesisrhinovirusprednisolonePreventionpediatric

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of asthma

    1-7 years

Secondary Outcomes (1)

  • Home diary recordings for airway symptoms

    12 months

Interventions

prednisoloneDRUG

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.

Also known as: Prednisolon®, 5 mg tablets, Oy Leiras Finland Ab, Helsinki, Finland.

Eligibility Criteria

Age3 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Pediatrics, Turku University Hospital

Turku, Finland

Location

Related Publications (5)

  • Forsstrom V, Toivonen L, Homil K, Waris M, Pedersen CT, Bonnelykke K, Jartti T, Peltola V. Association of Asthma Risk Alleles With Acute Respiratory Tract Infections and Wheezing Illnesses in Young Children. J Infect Dis. 2023 Oct 18;228(8):990-998. doi: 10.1093/infdis/jiad075.

    PMID: 36967681DERIVED

  • Erkkola RA, Virta LJ, Vahlberg T, Jartti T. Prednisolone for the first rhinovirus induced wheezing reduces use of respiratory medication. Pediatr Allergy Immunol. 2022 Jan;33(1):e13668. doi: 10.1111/pai.13668. Epub 2021 Sep 29. No abstract available.

    PMID: 34536305DERIVED

  • Hurme P, Homil K, Lehtinen P, Turunen R, Vahlberg T, Vuorinen T, Camargo CA Jr, Gern JE, Jartti T. Efficacy of inhaled salbutamol with and without prednisolone for first acute rhinovirus-induced wheezing episode. Clin Exp Allergy. 2021 Sep;51(9):1121-1132. doi: 10.1111/cea.13960. Epub 2021 Jun 19.

    PMID: 34062027DERIVED

  • Koistinen A, Lukkarinen M, Turunen R, Vuorinen T, Vahlberg T, Camargo CA Jr, Gern J, Ruuskanen O, Jartti T. Prednisolone for the first rhinovirus-induced wheezing and 4-year asthma risk: A randomized trial. Pediatr Allergy Immunol. 2017 Sep;28(6):557-563. doi: 10.1111/pai.12749. Epub 2017 Aug 6.

    PMID: 28660720DERIVED

  • Lukkarinen M, Koistinen A, Turunen R, Lehtinen P, Vuorinen T, Jartti T. Rhinovirus-induced first wheezing episode predicts atopic but not nonatopic asthma at school age. J Allergy Clin Immunol. 2017 Oct;140(4):988-995. doi: 10.1016/j.jaci.2016.12.991. Epub 2017 Mar 25.

    PMID: 28347734DERIVED

Related Links

MeSH Terms

Conditions

Asthma

Interventions

PrednisoloneTablets

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 6, 2008

First Posted

August 11, 2008

Study Start

June 1, 2007

Primary Completion

May 1, 2016

Last Updated

August 12, 2011

Record last verified: 2011-08

Locations

FI(1)