Early Diagnosis of Asthma in Young Children

NCT ID: NCT00422747

Last Updated: 2013-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2012-08-31

Brief Summary

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The overall aim of the study is an early asthma diagnosis in young children by the use of non-invasive biomarkers of airway inflammation /oxidative stress in exhaled air, and early lung function measurements

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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beclomethasondipropionate

2 x 100 ug dd for two months, via aerochamber

Group Type EXPERIMENTAL

beclomethasondipropionate

Intervention Type DRUG

2 x 100 ug dd for two months, via aerochamber

Interventions

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beclomethasondipropionate

2 x 100 ug dd for two months, via aerochamber

Intervention Type DRUG

Other Intervention Names

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Qvar Extra Fijn

Eligibility Criteria

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Inclusion Criteria

* Children aged 2-3 years, with recurrent respiratory symptoms suggestive of asthma
* Children aged 2-3 years, with no or minor respiratory symptoms

Exclusion Criteria

* Mental retardation
* Cardiac anomalies
* Congenital malformations
* Other diseases of the lungs/airways
* Chronic systemic inflammatory diseases like M. Crohn
* The inability to perform lung function measurements and/or exhaled air collection
Minimum Eligible Age

2 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Netherlands Asthma Foundation

OTHER

Sponsor Role collaborator

Stichting Astma Bestrijding, The Netherlands

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edward Dompeling, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Paediatric Pulmonology, Maastricht University Medical Centre

Locations

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Maastricht University Medical Centre

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

References

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Klaassen EM, van de Kant KD, Jobsis Q, van Schayck OC, Smolinska A, Dallinga JW, van Schooten FJ, den Hartog GJ, de Jongste JC, Rijkers GT, Dompeling E. Exhaled biomarkers and gene expression at preschool age improve asthma prediction at 6 years of age. Am J Respir Crit Care Med. 2015 Jan 15;191(2):201-7. doi: 10.1164/rccm.201408-1537OC.

Reference Type DERIVED
PMID: 25474185 (View on PubMed)

van de Kant KD, van Berkel JJ, Jobsis Q, Lima Passos V, Klaassen EM, van der Sande L, van Schayck OC, de Jongste JC, van Schooten FJ, Derks E, Dompeling E, Dallinga JW. Exhaled breath profiling in diagnosing wheezy preschool children. Eur Respir J. 2013 Jan;41(1):183-8. doi: 10.1183/09031936.00122411.

Reference Type DERIVED
PMID: 23277518 (View on PubMed)

van de Kant KD, Koers K, Rijkers GT, Lima Passos V, Klaassen EM, Mommers M, Dagnelie PC, van Schayck CP, Dompeling E, Jobsis Q. Can exhaled inflammatory markers predict a steroid response in wheezing preschool children? Clin Exp Allergy. 2011 Aug;41(8):1076-83. doi: 10.1111/j.1365-2222.2011.03774.x. Epub 2011 May 30.

Reference Type DERIVED
PMID: 21623968 (View on PubMed)

van de Kant KD, Klaassen EM, Jobsis Q, Nijhuis AJ, van Schayck OC, Dompeling E. Early diagnosis of asthma in young children by using non-invasive biomarkers of airway inflammation and early lung function measurements: study protocol of a case-control study. BMC Public Health. 2009 Jun 29;9:210. doi: 10.1186/1471-2458-9-210.

Reference Type DERIVED
PMID: 19563637 (View on PubMed)

Other Identifiers

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NL17407.000.07/2007-001817-40

Identifier Type: -

Identifier Source: org_study_id

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