NCT00422747

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
202

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

4.2 years

First QC Date

January 15, 2007

Last Update Submit

June 17, 2013

Conditions

Asthma

Keywords

asthmatransient wheezingearly diagnosisexhaled airnitrogen monoxideairway resistance

Outcome Measures

Primary Outcomes (1)

  • - definite asthma diagnosis - biomarkers in exhaled breath

    6 years of age

Study Arms (1)

beclomethasondipropionate

EXPERIMENTAL

2 x 100 ug dd for two months, via aerochamber

Drug: beclomethasondipropionate

Interventions

beclomethasondipropionateDRUG

2 x 100 ug dd for two months, via aerochamber

Also known as: Qvar Extra Fijn
beclomethasondipropionate

Eligibility Criteria

Age2 Years - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 5800, Netherlands

Location

Related Publications (4)

  • 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.

    PMID: 25474185DERIVED

  • 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.

    PMID: 23277518DERIVED

  • 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.

    PMID: 21623968DERIVED

  • 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.

    PMID: 19563637DERIVED

MeSH Terms

Conditions

AsthmaDisease

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Edward Dompeling, PhD MD

    Dept. of Paediatric Pulmonology, Maastricht University Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2007

First Posted

January 17, 2007

Study Start

April 1, 2007

Primary Completion

June 1, 2011

Study Completion

August 1, 2012

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

NL(1)