Pediatric Arm of DZL All Age Asthma Cohort
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorLMU Klinikum
About this trial
Despite its common occurrence, still little is known about pathomechanisms determining different wheeze and asthma trajectories and phenotypes in children, and those beginning in adulthood. Therefore, deciphering underlying determinants for different childhood and adult asthma phenotypes is urgently needed to develop personalized treatment approaches targeting distinct underlying mechanisms. Thereby, secondary prevention early in the disease process can also be achieved. The decoding of such mechanisms and their translation to the individual patient is the aim of the Disease Area Asthma Allergy of the 'German Centre for Lung Research' (DZL).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
informed consent by parents (and by children if age > 8 years)
age 6 months to 18 years
term delivery (≥ 37 weeks)
active/passive understanding of German
Disqualifiers
known inborn or perinatal pulmonary disease
airway malformation
oxygen therapy after birth with a duration of more than 24 hours
ventilator support or mechanical ventilation after birth
Trial population
preschool children with wheeze and school children as well as adolescents with asthma
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,500 Participants
are grouped into 3 trial groupsGroup A: new-onset wheeze/asthma
Group B: wheeze/asthma under controller therapy
Group C: healthy controls
Trial outcomes
Primary outcomes
1
Prevalence of asthma
Study participants will be assessed with regard to their development of asthma.
Time frame
At baseline and during yearly follow-ups up to 2 years2
Prevalence of transient preschool wheeze
Study participants will be assessed with regard to their development of transient preschool wheeze.
Time frame
At baseline and during yearly follow-ups up to 2 yearsSecondary outcomes
1
Prevalence of atopic sensitization
The prevalence of atopic sensitization will be measured by the detection of specific immunoglobin E against common aeroallergens.
Time frame
At baseline and during yearly follow-ups up to 2 years2
Lung function
Study participants will be assessed with regard to lung function parameters (as measured by spirometry/bodyplethysmography and multiple-breath washouts (MBW)).
Time frame
At baseline and during yearly follow-ups up to 2 years3
Levels of exhaled nitric oxide
Levels of exhaled nitric oxide (eNO) will be measured by chemoluminescence analyzers in combination with ultrasound-based flow measurement.
Time frame
At baseline and during yearly follow-ups up to 2 years4
Frequency of acute exacerbations during previous 12 months
The frequency of acute exacerbations during previous 12 months will be assessed by questionnaires.
Time frame
At baseline and during yearly follow-ups up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
LMU Klinikum
Lead sponsor
German Federal Ministry of Education and Research
Collaborator
German Center for Lung Research
Collaborator
Comprehensive Pulmonary Center Munich
Collaborator
Airway Research Center North
Collaborator
Biomedical Research in Endstage and Obstructive Lung Disease Hannover
Collaborator
Translational Lung Research Center Heidelberg
Collaborator
Universities of Giessen and Marburg Lung Center
Collaborator
Source ClinicalTrials.gov