Study Results
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Basic Information
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RECRUITING
1500 participants
OBSERVATIONAL
2013-01-31
2027-12-31
Brief Summary
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Detailed Description
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In order to do so, a clinical cohort for childhood asthma has been set up with identical, standardized instruments (quality assurance plan: standard operating procedures (SOPs) for clinical and lab modules, shipment, biobanking and analysis as well as quality control measures via audits and site visits have been developed) across the participating 'German Center for Lung Research' (DZL) sites. Here, new-onset steroid/leukotriene receptor antagonist (LTRA) naïve wheeze/asthma patients and wheeze/asthma patients under controller therapy are being recruited in addition to healthy controls. Following recruitment, regularly follow-ups and exacerbation visits of included patients are being performed with identical study instruments and meticulous quality control checks as at baseline.
PROJECT HYPOTHESES:
1. Specific molecular phenotypes are associated with distinct wheeze/asthma phenotypes and trajectories. Thereby, underlying mechanisms as well as predictors and biomarkers for persistent asthma will be identified.
2. Individuals at risk for exacerbations can be identified by clinical and molecular biomarkers, which will become novel targets for therapy and secondary prevention.
WORK PROGRAM:
Identification of molecular phenotypes, predictors and biomarkers for distinct wheeze/asthma phenotypes and trajectories.
The investigators aim to recruit over 1000 cases and controls to ensure sufficient statistical power for multivariate statistical analyses. Recruitment of study participants will be continued and cases will undergo 'deep phenotyping' as described below. In addition, healthy age and sex matched controls will be recruited. Cases and controls undergo a comprehensive clinical assessment including questionnaires (browser-based online data entry into extensive database with audit trail, plausibility and quality control checks implemented, data dictionary accessible), physical examination and lung function tests (spirometry and bodyplethysmography including bronchodilator response, multiple breath washout, exhaled nitric oxide). Biomaterials will be collected for analyses: i) blood samples; ii) nasal secretions; iii) pharyngeal swabs; iv) induced sputum; v) stool samples. Furthermore, epithelial cells will be collected by nasal brushings. Breath samples will be collected for analyses of volatile organic compounds. The cases will be followed up regularly using the same clinical tools and collecting the same biomaterials as at the initial visit to assess trajectories over time. Two closely interacting working groups have been established for all aims described: one lab and one data management/analysis group, each headed by expert members of the participating sites. The lab group will initiate and supervise all measurements of biomaterials; the data management/analysis group will expand the combined and shared data base and coordinate statistical analyses across sites. A common publication policy has already been developed. Using advanced bioinformatics, systems biology and machine learning approaches, the investigators will develop predictive (diagnostic) algorithms including clinical and molecular biomarkers for transient and persistent wheeze/asthma phenotypes and their trajectories. These analyses will also identify underlying mechanisms and thereby potential targets for future personalized therapy comparing childhood and adult findings. During data collection. The investigators attempt to minimize missing data. In all cases where missing data will reduce power for subsequent analyses, imputation will be used in order to omit power loss.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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new-onset wheeze/asthma
children with inhaled or systemic corticosteroid-/leukotriene receptor antagonist-naïve wheeze/asthma, will undergo follow-up after initial recruitment
No interventions assigned to this group
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
No interventions assigned to this group
healthy controls
healthy age- and sex-matched controls, will not undergo follow-up after initial recruitment
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Months
18 Years
ALL
Yes
Sponsors
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German Federal Ministry of Education and Research
OTHER_GOV
German Center for Lung Research
OTHER
Comprehensive Pulmonary Center Munich
UNKNOWN
Airway Research Center North
UNKNOWN
Biomedical Research in Endstage and Obstructive Lung Disease Hannover
UNKNOWN
Translational Lung Research Center Heidelberg
UNKNOWN
Universities of Giessen and Marburg Lung Center
UNKNOWN
LMU Klinikum
OTHER
Responsible Party
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Erika von Mutius
Prof. Dr. Bianca Schaub
Principal Investigators
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Bianca Schaub, MD
Role: PRINCIPAL_INVESTIGATOR
Klinikum der Universitaet Muenchen, Comprehensive Pulmonary Center Munich
Gesine Hansen, MD
Role: PRINCIPAL_INVESTIGATOR
Biomedical Research in Endstage and Obstructive Lung Disease Hannover
Folke Brinkmann, MD
Role: PRINCIPAL_INVESTIGATOR
Airway Research Center North
Locations
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University Children's Hospital Cologne, Department of Paediatric Allergology and Pneumology
Cologne, , Germany
Medizinische Hochschule Hannover, Biomedical Research in Endstage and Obstructive Lung Disease
Hanover, , Germany
Universitaetsklinikum Schleswig-Holstein, Klinik für Kinder- und Jugendmedizin, Airway Research Center North
Lübeck, , Germany
Klinik für Kinder- und Jugendmedizin, Universitaetsklinikum Giessen und Marburg GmbH, Universities of Giessen and Marburg Lung Center
Marburg, , Germany
Klinikum der Universitaet Muenchen, Comprehensive Pulmonary Center Munich
Munich, , Germany
Countries
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Central Contacts
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Facility Contacts
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Stefanie Weber, PD
Role: primary
References
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Jakwerth CA, Weckmann M, Illi S, Charles H, Zissler UM, Oelsner M, Guerth F, Omony J, Nemani SSP, Grychtol R, Dittrich AM, Skevaki C, Foth S, Weber S, Alejandre Alcazar MA, van Koningsbruggen-Rietschel S, Brock R, Blau S, Hansen G, Bahmer T, Rabe KF, Brinkmann F, Kopp MV, Chaker AM, Schaub B, von Mutius E, Schmidt-Weber CB; ALLIANCE Study Group as part of the German Center for Lung Research. 17q21 Variants Disturb Mucosal Host Defense in Childhood Asthma. Am J Respir Crit Care Med. 2024 Apr 15;209(8):947-959. doi: 10.1164/rccm.202305-0934OC.
Shahrokny P, Maison N, Riemann L, Ehrmann M, DeLuca D, Schuchardt S, Thiele D, Weckmann M, Dittrich AM, Schaub B, Brinkmann F, Hansen G, Kopp MV, von Mutius E, Rabe KF, Bahmer T, Hohlfeld JM, Grychtol R, Holz O. Increased breath naphthalene in children with asthma and wheeze of the All Age Asthma Cohort (ALLIANCE). J Breath Res. 2023 Oct 12;18(1). doi: 10.1088/1752-7163/acf23e.
Maison N, Omony J, Illi S, Thiele D, Skevaki C, Dittrich AM, Bahmer T, Rabe KF, Weckmann M, Happle C, Schaub B, Meyer M, Foth S, Rietschel E, Renz H, Hansen G, Kopp MV, von Mutius E, Grychtol R; ALLIANCE Study Group; ALLIANCE Study Group; Fuchs O, Roesler B, Welchering N, Kohistani-Greif N, Kurz J, Landgraf-Rauf K, Laubhahn K, Liebl C, Ege M, Hose A, Zeitlmann E, Berbig M, Marzi C, Schauberger C, Zissler U, Schmidt-Weber C, Ricklefs I, Diekmann G, Liboschik L, Voigt G, Sultansei L, Nissen G, Konig IR, Kirsten AM, Pedersen F, Watz H, Waschki B, Herzmann C, Abdo M, Biller H, Gaede KI, Bovermann X, Steinmetz A, Husstedt BL, Nitsche C, Veith V, Szewczyk M, Brinkmann F, Malik A, Schwerk N, Dopfer C, Price M, Jirmo AC, Habener A, DeLuca DS, Gaedcke S, Liu B, Calveron MR, Weber S, Schildberg T, van Koningsbruggen-Rietschel S, Alcazar M. T2-high asthma phenotypes across lifespan. Eur Respir J. 2022 Sep 29;60(3):2102288. doi: 10.1183/13993003.02288-2021. Print 2022 Sep.
Weckmann M, Bahmer T, Sand JM, Rank Ronnow S, Pech M, Vermeulen C, Faiz A, Leeming DJ, Karsdal MA, Lunding L, Oliver BGG, Wegmann M, Ulrich-Merzenich G, Juergens UR, Duhn J, Laumonnier Y, Danov O, Sewald K, Zissler U, Jonker M, Konig I, Hansen G, von Mutius E, Fuchs O, Dittrich AM, Schaub B, Happle C, Rabe KF, van de Berge M, Burgess JK, Kopp MV; ALLIANCE Study Group as part of the German Centre for Lung Research (DZL). COL4A3 is degraded in allergic asthma and degradation predicts response to anti-IgE therapy. Eur Respir J. 2021 Dec 9;58(6):2003969. doi: 10.1183/13993003.03969-2020. Print 2021 Dec.
Skevaki C, Tafo P, Eiringhaus K, Timmesfeld N, Weckmann M, Happle C, Nelson PP, Maison N, Schaub B, Ricklefs I, Fuchs O, von Mutius E, Kopp MV, Renz H, Hansen G, Dittrich AM; ALLIANCE Study Group. Allergen extract- and component-based diagnostics in children of the ALLIANCE asthma cohort. Clin Exp Allergy. 2021 Oct;51(10):1331-1345. doi: 10.1111/cea.13964. Epub 2021 Jun 26.
Fuchs O, Bahmer T, Weckmann M, Dittrich AM, Schaub B, Rosler B, Happle C, Brinkmann F, Ricklefs I, Konig IR, Watz H, Rabe KF, Kopp MV, Hansen G, von Mutius E; ALLIANCE Study Group as part of the German Centre for Lung Research (DZL). The all age asthma cohort (ALLIANCE) - from early beginnings to chronic disease: a longitudinal cohort study. BMC Pulm Med. 2018 Aug 20;18(1):140. doi: 10.1186/s12890-018-0705-6.
Related Links
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Click here for more information about the German Center for Lung Research (DZL)
Click here for more information about the Disease Area Asthma and Allergy (DA AA) as part of the German Center for Lung Research (DZL)
Other Identifiers
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DZL_DA_AA-1
Identifier Type: -
Identifier Source: org_study_id
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