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Early Diagnosis of Asthma in Young Children

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ClinicalTrials.gov Identifier: NCT00422747
Recruitment Status : Completed
First Posted : January 17, 2007
Last Update Posted : June 18, 2013
Sponsor:
Collaborators:
The Netherlands Asthma Foundation
Stichting Astma Bestrijding, The Netherlands
Information provided by (Responsible Party):
Maastricht University Medical Center

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

Condition or disease Intervention/treatment Phase
Asthma Drug: beclomethasondipropionate Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Diagnosis of Asthma in Young Children
Study Start Date : April 2007
Actual Primary Completion Date : June 2011
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: beclomethasondipropionate
2 x 100 ug dd for two months, via aerochamber
Drug: beclomethasondipropionate
2 x 100 ug dd for two months, via aerochamber
Other Name: Qvar Extra Fijn




Primary Outcome Measures :
  1. - definite asthma diagnosis - biomarkers in exhaled breath [ Time Frame: 6 years of age ]


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Ages Eligible for Study:   2 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422747


Locations
Netherlands
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 5800
Sponsors and Collaborators
Maastricht University Medical Center
The Netherlands Asthma Foundation
Stichting Astma Bestrijding, The Netherlands
Investigators
Principal Investigator: Edward Dompeling, PhD MD Dept. of Paediatric Pulmonology, Maastricht University Medical Centre

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00422747     History of Changes
Other Study ID Numbers: NL17407.000.07/2007-001817-40
First Posted: January 17, 2007    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013

Keywords provided by Maastricht University Medical Center:
asthma
transient wheezing
early diagnosis
exhaled air
nitrogen monoxide
airway resistance

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases