Viral Inception of Asthma: Prospective Study From Infancy to School-age (VINKU2)
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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. |
- Diagnosis of asthma [ Time Frame: 1-7 years ] [ Designated as safety issue: No ]
- 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) |
-
Drug: prednisolone
Show Detailed Description
Eligibility| Ages Eligible for Study: | 3 Months to 24 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| Finland | |
| Dept of Pediatrics, Turku University Hospital | |
| Turku, 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 Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Methylprednisolone acetate Prednisolone acetate Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone hemisuccinate |
Prednisolone phosphate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 21, 2013