Pediatric Arm of DZL All Age Asthma Cohort

NCT02496468 | Recruiting

• 1 other identifier: DZL_DA_AA-1
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 5

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).

Conditions

Asthma; Wheeze; Hypersensitivity; Endophenotype

Keywords

childhood asthma; preschool wheeze; adult asthma; transition; phenotype; endotype; trajectory

Outcome Measures

Primary Outcomes (2)

• Prevalence of asthma

  Study participants will be assessed with regard to their development of asthma.

  At baseline and during yearly follow-ups up to 2 years

• Prevalence of transient preschool wheeze

  Study participants will be assessed with regard to their development of transient preschool wheeze.

  At baseline and during yearly follow-ups up to 2 years

Secondary Outcomes (4)

• Prevalence of atopic sensitization

  At baseline and during yearly follow-ups up to 2 years

• Lung function

  At baseline and during yearly follow-ups up to 2 years

• Levels of exhaled nitric oxide

  At baseline and during yearly follow-ups up to 2 years

• Frequency of acute exacerbations during previous 12 months

  At baseline and during yearly follow-ups up to 2 years

Study Arms (3)

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

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

preschool children with wheeze and school children as well as adolescents with asthma

You may qualify if:

• 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 at least 6 years: doctor diagnosed asthma (according to current guidelines)

You may not qualify if:

• 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

Sponsors & Collaborators

• LMU Klinikum: lead
• 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

Study Sites (5)

University Children's Hospital Cologne, Department of Paediatric Allergology and Pneumology

Cologne, 50937, Germany

RECRUITING

Medizinische Hochschule Hannover, Biomedical Research in Endstage and Obstructive Lung Disease

Hanover, 30625, Germany

RECRUITING

Universitaetsklinikum Schleswig-Holstein, Klinik für Kinder- und Jugendmedizin, Airway Research Center North

Lübeck, 23528, Germany

RECRUITING

Klinik für Kinder- und Jugendmedizin, Universitaetsklinikum Giessen und Marburg GmbH, Universities of Giessen and Marburg Lung Center

Marburg, 35033, Germany

RECRUITING

Klinikum der Universitaet Muenchen, Comprehensive Pulmonary Center Munich

Munich, 80337, Germany

RECRUITING

Related Publications (6)

• 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.

  PMID: 38064241 DERIVED

• 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.

  PMID: 37604132 DERIVED

• 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.

  PMID: 35210326 DERIVED

• 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.

  PMID: 34326188 DERIVED

• 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.

  PMID: 34128558 DERIVED

• 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.

  PMID: 30126401 DERIVED

Related Links

• 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)

Biospecimen

Retention: SAMPLES WITH DNA

whole blood (EDTA), serum, stool samples, whole blood cell pellets, primary nasal epithelial cells, induced sputum cells

MeSH Terms

Conditions

Asthma; Respiratory Sounds; Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bianca Schaub, MD

  Klinikum der Universitaet Muenchen, Comprehensive Pulmonary Center Munich

  PRINCIPAL INVESTIGATOR

• Gesine Hansen, MD

  Biomedical Research in Endstage and Obstructive Lung Disease Hannover

  PRINCIPAL INVESTIGATOR

• Folke Brinkmann, MD

  Airway Research Center North

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esther Zeitlmann, Diplom

CONTACT

+49894400; esther.zeitlmann@med.uni-muenchen.de

Bianca Schaub, MD

CONTACT

+49894400; bianca.schaub@med.uni-muenchen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Bianca Schaub

Study Record Dates

• First Submitted: July 3, 2015
• First Posted: July 14, 2015
• Study Start: January 1, 2013
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

DE (5)