Back to resultsEarly Diagnosis of Asthma in Young Children
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
beclomethasondipropionate
Sponsored by
About this trial
This is an interventional diagnostic trial for Asthma focused on measuring asthma, transient wheezing, early diagnosis, exhaled air, nitrogen monoxide, airway resistance
Eligibility Criteria
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
Sites / Locations
- Maastricht University Medical Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
beclomethasondipropionate
Arm Description
2 x 100 ug dd for two months, via aerochamber
Outcomes
Primary Outcome Measures
- definite asthma diagnosis - biomarkers in exhaled breath
Secondary Outcome Measures
Full Information
NCT ID
NCT00422747
First Posted
January 15, 2007
Last Updated
June 17, 2013
Sponsor
Maastricht University Medical Center
Collaborators
The Netherlands Asthma Foundation, Stichting Astma Bestrijding, The Netherlands
1. Study Identification
Unique Protocol Identification Number
NCT00422747
Brief Title
Early Diagnosis of Asthma in Young Children
Official Title
Early Diagnosis of Asthma in Young Children
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
The Netherlands Asthma Foundation, Stichting Astma Bestrijding, The Netherlands
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, transient wheezing, early diagnosis, exhaled air, nitrogen monoxide, airway resistance
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
beclomethasondipropionate
Arm Type
Experimental
Arm Description
2 x 100 ug dd for two months, via aerochamber
Intervention Type
Drug
Intervention Name(s)
beclomethasondipropionate
Other Intervention Name(s)
Qvar Extra Fijn
Intervention Description
2 x 100 ug dd for two months, via aerochamber
Primary Outcome Measure Information:
Title
- definite asthma diagnosis - biomarkers in exhaled breath
Time Frame
6 years of age
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Dompeling, PhD MD
Organizational Affiliation
Dept. of Paediatric Pulmonology, Maastricht University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
5800
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
25474185
Citation
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.
Results Reference
derived
PubMed Identifier
23277518
Citation
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.
Results Reference
derived
PubMed Identifier
21623968
Citation
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.
Results Reference
derived
PubMed Identifier
19563637
Citation
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.
Results Reference
derived
Learn more about this trial
Early Diagnosis of Asthma in Young Children
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