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
  Purpose

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 Intervention
Asthma
Drug: beclomethasondipropionate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Early Diagnosis of Asthma in Young Children

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • - definite asthma diagnosis - biomarkers in exhaled breath [ Time Frame: 6 years of age ] [ Designated as safety issue: Yes ]

Enrollment: 202
Study Start Date: April 2007
Study Completion Date: August 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years to 4 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Maastricht University Medical Center

Additional 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
Study First Received: January 15, 2007
Last Updated: June 17, 2013
Health Authority: Netherlands: Ministry of Health, Welfare and Sport

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

ClinicalTrials.gov processed this record on September 22, 2014