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Recruiting NCT02419274

Adult Arm of DZL All Age Asthma Cohort (ALLIANCE)

Observational Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Asthma. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The All Age Asthma Cohort (ALLIANCE) of the German Center for Lung Research (DZL), Adult Arm

Overview

Deep Phenotyping of adult asthma patients: * severity from mild to severe * both atopic and non-atopic * both childhood and adult onset * both smokers and non-smokers * corresponding pediatric cohort (Pediatric Arm of DZL All Age Asthma Cohort) with equivalent SOPs regarding collection of biomaterial and clinical data incl. lung function, further processing of biomaterial and further analyses

Detailed description

The clinical heterogeneity of asthma patients has been increasingly recognised within the last years. Recent studies and articles highlighted the idea of asthma not beeing a single disease but rather a unifying term for multiple phenotypes. Phenotype in this sense is defined as the combination of observable properties of an organism, that are produced by the interactions of a genotype and the environment. In contrast, endotype describes a specific underlying pathophysiological pathway. Linking asthma phenotypes and endotypes in a system biological approach is an important research goal in order to develop targeted therapy, especially for severe asthma.

The advantage the investigators' cohort provides is the collaboration with an equivalent pediatric cohort. In this setting questions regarding disease onset, exacerbation and chronicity can be posed and worked with in a comprehensive manner.

Primary outcome measures

  • Defining clinical asthma phenotypes by combining clinical, lung function and biomaterial data [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Proven Diagnosis according to current GINA Guideline (2014)
  • Ability to read and understand German
  • Ability to understand and agree to informed consent

Exclusion criteria

  • History of respiratory tract infection within the last 4 weeks before inclusion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • LungenClinic Grosshansdorf — Großhansdorf

Publications

  • Wenzel SE. Asthma phenotypes: the evolution from clinical to molecular approaches. Nat Med. 2012 May 4;18(5):716-25. doi: 10.1038/nm.2678. PMID 22561835
  • Anderson GP. Endotyping asthma: new insights into key pathogenic mechanisms in a complex, heterogeneous disease. Lancet. 2008 Sep 20;372(9643):1107-19. doi: 10.1016/S0140-6736(08)61452-X. PMID 18805339
  • Lagally L, Ullemeyer L, Omony J, Gottschau K, Foppiano F, Abdo M, Veith V, Tholken C, Hose A, Maison N, Grychtol R, Dittrich AM, Riemann L, Weckmann M, Konig I, Kronziel L, Illi S, van Koningsbruggen-Rietschel S, Rabe KF, Renz H, Hansen G, Brinkmann F, Kopp MV, von Mutius E, Bahmer T, Ege M, Skevaki C, Schaub B; ALLIANCE Study Group. Increased high sensitivity C-reactive protein in more severe whe PMID 42509549
  • Habener A, Grychtol R, Gaedcke S, DeLuca D, Dittrich AM, Happle C, Abdo M, Watz H, Pedersen F, Konig IR, Thiele D, Kopp MV, von Mutius E, Bahmer T, Rabe KF, Meyer-Bahlburg A, Hansen G; ALLIANCE Study Group as part of the German Center for Lung Research (DZL); Fuchs O, Roesler B, Welchering N, Kohistani-Greif N, Kurz J, Landgraf-Rauf K, Laubhahn K, Maison N, Liebl C, Schaub B, Ege M, Illi S, Hose A PMID 35595320
  • Ronnow SR, Sand JMB, Staunstrup LM, Bahmer T, Wegmann M, Lunding L, Burgess J, Rabe K, Sorensen GL, Fuchs O, Mutius EV, Hansen G, Kopp MV, Karsdal M, Leeming DJ, Weckmann M; ALLIANCE Study Group as part of the German Center of Lung Research (DZL). A serological biomarker of type I collagen degradation is related to a more severe, high neutrophilic, obese asthma subtype. Asthma Res Pract. 2022 Apr PMID 35418159
  • 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, PMID 35210326
  • 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 f PMID 34326188
  • Holz O, Waschki B, Watz H, Kirsten A, Abdo M, Pedersen F, Weckmann M, Fuchs O, Dittrich AM, Hansen G, Kopp MV, von Mutius E, Rabe KF, Hohlfeld JM, Bahmer T; ALLIANCE Study Group. Breath volatile organic compounds and inflammatory markers in adult asthma patients: negative results from the ALLIANCE cohort. Eur Respir J. 2021 Feb 11;57(2):2002127. doi: 10.1183/13993003.02127-2020. Print 2021 Feb. PMID 33008938

Identifiers

NCT: NCT02419274 · DZL-GHD-ERA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗