Early Diagnosis of Asthma in Young Children

This study has been completed.
Sponsor:
Collaborators:
The Netherlands Asthma Foundation
Stichting Astma Bestrijding, The Netherlands
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00422747
First received: January 15, 2007
Last updated: June 17, 2013
Last verified: June 2013

January 15, 2007
June 17, 2013
April 2007
June 2011   (final data collection date for primary outcome measure)
- definite asthma diagnosis - biomarkers in exhaled breath [ Time Frame: 6 years of age ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00422747 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Early Diagnosis of Asthma in Young Children
Early Diagnosis of Asthma in Young Children

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Asthma
Drug: beclomethasondipropionate
2 x 100 ug dd for two months, via aerochamber
Other Name: Qvar Extra Fijn
Experimental: beclomethasondipropionate
2 x 100 ug dd for two months, via aerochamber
Intervention: Drug: beclomethasondipropionate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
202
August 2012
June 2011   (final data collection date for primary outcome measure)

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
Both
2 Years to 4 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00422747
NL17407.000.07/2007-001817-40
No
Maastricht University Medical Center
Maastricht University Medical Center
  • The Netherlands Asthma Foundation
  • Stichting Astma Bestrijding, The Netherlands
Principal Investigator: Edward Dompeling, PhD MD Dept. of Paediatric Pulmonology, Maastricht University Medical Centre
Maastricht University Medical Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP