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Pediatric Arm of DZL All Age Asthma Cohort (ALLIANCE)

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ClinicalTrials.gov Identifier: NCT02496468
Recruitment Status : Recruiting
First Posted : July 14, 2015
Last Update Posted : April 5, 2018
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
German Center for Lung Research
Comprehensive Pulmonary Center Munich
Airway Research Center North
Biomedical Research in Endstage and Obstructive Lung Disease Hannover
Translational Lung Research Center Heidelberg
Universities of Giessen and Marburg Lung Center
Information provided by (Responsible Party):
Erika von Mutius, Klinikum der Universitaet Muenchen

Brief Summary:
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).

Condition or disease
Asthma Wheeze Hypersensitivity Endophenotype

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The All Age Asthma Cohort (ALLIANCE) of the German Center for Lung Research (DZL), Pediatric Arm
Study Start Date : January 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
new-onset wheeze/asthma
children with inhaled or systemic corticosteroid-/leukotriene receptor antagonist-naïve wheeze/asthma, will undergo follow-up after initial recruitment
wheeze/asthma under controller therapy
children with wheeze/asthma, already under controller (inhaled or systemic corticosteroids or leukotriene receptor antagonist) therapy, will undergo follow-up after initial recruitment
healthy controls
healthy age- and sex-matched controls, will not undergo follow-up after initial recruitment



Primary Outcome Measures :
  1. Prevalence of asthma [ Time Frame: At baseline and during yearly follow-ups up to 2 years ]
    Study participants will be assessed with regard to their development of asthma.

  2. Prevalence of transient preschool wheeze [ Time Frame: At baseline and during yearly follow-ups up to 2 years ]
    Study participants will be assessed with regard to their development of transient preschool wheeze.


Secondary Outcome Measures :
  1. Prevalence of atopic sensitization [ Time Frame: At baseline and during yearly follow-ups up to 2 years ]
    The prevalence of atopic sensitization will be measured by the detection of specific immunoglobin E against common aeroallergens.

  2. Lung function [ Time Frame: At baseline and during yearly follow-ups up to 2 years ]
    Study participants will be assessed with regard to lung function parameters (as measured by spirometry/bodyplethysmography and multiple-breath washouts (MBW)).

  3. Levels of exhaled nitric oxide [ Time Frame: At baseline and during yearly follow-ups up to 2 years ]
    Levels of exhaled nitric oxide (eNO) will be measured by chemoluminescence analyzers in combination with ultrasound-based flow measurement.

  4. Frequency of acute exacerbations during previous 12 months [ Time Frame: At baseline and during yearly follow-ups up to 2 years ]
    The frequency of acute exacerbations during previous 12 months will be assessed by questionnaires.


Biospecimen Retention:   Samples With DNA
whole blood (EDTA), serum, stool samples, whole blood cell pellets, primary nasal epithelial cells, induced sputum cells


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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
preschool children with wheeze and school children as well as adolescents with asthma
Criteria

Inclusion Criteria:

  • 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
  • age 6 months - < 6 years: preschool wheeze (more than two episodes of wheeze during 12 months prior to inclusion)
  • age at least 6 years: doctor diagnosed asthma (according to current guidelines)

Exclusion Criteria:

  • 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
  • diagnoses of cystic fibrosis; primary ciliary dyskinesia
  • heart failure diagnosed after birth affecting pulmonary circulation
  • major respiratory diseases such as e.g. interstitial lung disease
  • any current non-atopic comorbidity
  • fever of at least 38.5°C during the last two weeks prior to the planned first visit

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): NCT02496468


Contacts
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Contact: Claudia Liebl, Dr. rer. nat. +49894400 ext 57787 claudia.liebl@med.uni-muenchen.de
Contact: Erika von Mutius, MD MSc +49894400 ext 57897 erika.von.mutius@med.lmu.de

Locations
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Germany
University Children's Hospital Cologne, Department of Paediatric Allergology and Pneumology Recruiting
Cologne, Germany, 50937
Contact: Ernst Rietschel, MD    +49 221 478- ext 3798    ernst.rietschel@uk-koeln.de   
Contact: Silke van Koningsbruggen-Rietschel, MD    0221-478 ext 3798    Silke.vanKoningsbruggen@uk-koeln.de   
Medizinische Hochschule Hannover, Biomedical Research in Endstage and Obstructive Lung Disease Recruiting
Hannover, Germany, 30625
Contact: Gesine Hansen, MD    ++49511532 ext 9138    Hansen.Gesine@mh-hannover.de   
Contact: Anna-Maria Dittrich, MD    ++49511532 ext 9138    Dittrich.Anna-Maria@mh-hannover.de   
Principal Investigator: Gesine Hansen, MD         
Principal Investigator: Anna-Maria Dittrich, MD         
Universitaetsklinikum Schleswig-Holstein, Klinik für Kinder- und Jugendmedizin, Airway Research Center North Recruiting
Luebeck, Germany, 23528
Contact: Matthias Kopp, MD    ++49451500 ext 2550    Matthias.Kopp@uksh.de   
Contact: Markus Weckmann, PhD    ++49451500 ext 2550    Markus.Weckmann@uksh.dea   
Principal Investigator: Matthias Kopp, MD         
Principal Investigator: Markus Weckmann, PhD         
Klinik für Kinder- und Jugendmedizin, Universitaetsklinikum Giessen und Marburg GmbH, Universities of Giessen and Marburg Lung Center Recruiting
Marburg, Germany, 35033
Contact: Michael Zemlin, MD    +4964215866 ext 651    zemlin@staff.uni-marburg.de   
Sub-Investigator: Michael Zemlin, MD         
Klinikum der Universitaet Muenchen, Comprehensive Pulmonary Center Munich Recruiting
Munich, Germany, 80337
Contact: Markus Ege, MD    +49894400 ext 57709    markus.ege@med.uni-muenchen.de   
Contact: Erika von Mutius, MD MSc    +49894400 ext 57897    erika.von.mutius@med.lmu.de   
Principal Investigator: Markus Ege, MD         
Principal Investigator: Erika von Mutius, MD MSc         
Principal Investigator: Bianca Schaub, MD         
Sponsors and Collaborators
Klinikum der Universitaet Muenchen
German Federal Ministry of Education and Research
German Center for Lung Research
Comprehensive Pulmonary Center Munich
Airway Research Center North
Biomedical Research in Endstage and Obstructive Lung Disease Hannover
Translational Lung Research Center Heidelberg
Universities of Giessen and Marburg Lung Center
Investigators
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Principal Investigator: Erika von Mutius, MD MSc Klinikum der Universitaet Muenchen, Comprehensive Pulmonary Center Munich
Principal Investigator: Gesine Hansen, MD Biomedical Research in Endstage and Obstructive Lung Disease Hannover
Principal Investigator: Matthias Kopp, MD Airway Research Center North

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Erika von Mutius, Prof. Dr. Erika von Mutius, MSc, Klinikum der Universitaet Muenchen
ClinicalTrials.gov Identifier: NCT02496468     History of Changes
Other Study ID Numbers: DZL_DA_AA-1
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Keywords provided by Erika von Mutius, Klinikum der Universitaet Muenchen:
childhood asthma
preschool wheeze
adult asthma
transition
phenotype
endotype
trajectory

Additional relevant MeSH terms:
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Asthma
Hypersensitivity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents