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NCT00422747 Clinical Trial

Early Diagnosis of Asthma in Young Children

Asthma Clinical Trial

Official title:
Early Diagnosis of Asthma in Young Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00422747
Other study ID # NL17407.000.07/2007-001817-40
Secondary ID
Status Completed
Phase N/A
First received January 15, 2007
Last updated June 17, 2013
Start date April 2007
Est. completion date August 2012

Study information
Verified date June 2013
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: Ministry of Health, Welfare and Sport
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 202
Est. completion date August 2012
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Years to 4 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• beclomethasondipropionate
2 x 100 ug dd for two months, via aerochamber

Locations
Country Name City State
Netherlands Maastricht University Medical Centre Maastricht Limburg

Sponsors (3)
Lead Sponsor Collaborator
Maastricht University Medical Center Stichting Astma Bestrijding, The Netherlands, The Netherlands Asthma Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary - definite asthma diagnosis - biomarkers in exhaled breath 6 years of age Yes
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