Adult Arm of DZL All Age Asthma Cohort (ALLIANCE)

NCT ID: NCT02419274

Last Updated: 2023-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2030-12-31

Brief Summary

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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

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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.

Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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German Center for Lung Research

OTHER

Sponsor Role collaborator

Research Center Borstel

OTHER

Sponsor Role collaborator

LungenClinic Grosshansdorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Klaus F Rabe, MD PhD

Role: PRINCIPAL_INVESTIGATOR

LungenClinic Grosshansdorf, Grosshansdorf, Germany

Susanne Krauss-Etschmann, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Center Borstel, Borstel, Germany

Locations

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LungenClinic Grosshansdorf

Großhansdorf, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Thomas J Bahmer, MD

Role: CONTACT

+49 4102 601 2412

Joern Bullwinkel, PhD

Role: CONTACT

+49 4102 601 2410

Facility Contacts

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Thomas J Bahmer, MD

Role: primary

+49-4102-601-2412

Joern Bullwinkel, PhD

Role: backup

+49-4102-601-2410

References

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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.

Reference Type BACKGROUND
PMID: 22561835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18805339 (View on PubMed)

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, Zeitlmann E, Berbig M, Marzi C, Schauberger C, Zissler U, Schmidt-Weber C, Ricklefs I, Diekmann G, Liboschik L, Voigt G, Sultansei L, Weckmann M, Nissen G, Kirsten AM, Waschki B, Herzmann C, 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, Liu B, Calveron MR, Weber S, Foth S, Skevaki C, Renz H, Meyer M, Schildberg T, Rietschel E, van Koningsbruggen-Rietschel S, Alcazar M. IgA+ memory B-cells are significantly increased in patients with asthma and small airway dysfunction. Eur Respir J. 2022 Nov 3;60(5):2102130. doi: 10.1183/13993003.02130-2021. Print 2022 Nov.

Reference Type DERIVED
PMID: 35595320 (View on PubMed)

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 13;8(1):2. doi: 10.1186/s40733-022-00084-6.

Reference Type DERIVED
PMID: 35418159 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35210326 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34326188 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33008938 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30126401 (View on PubMed)

Bahmer T, Waschki B, Schatz F, Herzmann C, Zabel P, Kirsten AM, Rabe KF, Watz H; ERA-Study Group. Physical activity, airway resistance and small airway dysfunction in severe asthma. Eur Respir J. 2017 Jan 4;49(1):1601827. doi: 10.1183/13993003.01827-2016. Print 2017 Jan. No abstract available.

Reference Type DERIVED
PMID: 28052957 (View on PubMed)

Other Identifiers

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DZL-GHD-ERA

Identifier Type: -

Identifier Source: org_study_id

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