Adult Arm of DZL All Age Asthma Cohort (ALLIANCE) (ALLIANCE)

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ClinicalTrials.gov Identifier: NCT02419274

Recruitment Status : Unknown

Verified February 2021 by LungenClinic Grosshansdorf.
Recruitment status was: Recruiting

First Posted : April 17, 2015

Last Update Posted : March 1, 2021

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

German Center for Lung Research

Research Center Borstel

Information provided by (Responsible Party):

LungenClinic Grosshansdorf

Study Description

Brief Summary:

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

Condition or disease
Asthma

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.

Study Design

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Study Type :	Observational [Patient Registry]
Estimated Enrollment :	350 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Target Follow-Up Duration:	6 Years
Official Title:	The All Age Asthma Cohort (ALLIANCE) of the German Center for Lung Research (DZL), Adult Arm
Study Start Date :	March 2014
Estimated Primary Completion Date :	October 2022
Estimated Study Completion Date :	December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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

Biospecimen Retention: Samples With DNA

Collection of blood, nasal secretions, sputum and exhaled breath, such as pharyngeal and nasopharyngeal swabs

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 99 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Asthma of all severity grades, both allergic and non-allergic. Age of Onset childhood and adulthood. Smokers and non-smokers.

Proven Asthma according to current GINA Guidelines (2014)

Healthy Control Group.

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

Contacts and Locations

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): NCT02419274

Contacts

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Contact: Thomas J Bahmer, MD	+49 4102 601 2412	t.bahmer@lungenclinic.de
Contact: Joern Bullwinkel, PhD	+49 4102 601 2410	j.bullwinkel@lungenclinic.de

Locations

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Germany
Research Center Borstel	Recruiting
Borstel, Germany, 23845
Contact: Susanne Krauss-Etschmann, PhD +49 4537 188-5850 skrauss-etschmann@fz-borstel.de
Contact: Karoline I Gaede, PhD +49 4537-188-7050 kgaede@fz-borstel.de
LungenClinic Grosshansdorf	Recruiting
Grosshansdorf, Germany, 22927
Contact: Thomas J Bahmer, MD +49-4102-601-2412 t.bahmer@lungenclinic.de
Contact: Joern Bullwinkel, PhD +49-4102-601-2410 j.bullwinkel@lungenclinic.de

Sponsors and Collaborators

LungenClinic Grosshansdorf

German Center for Lung Research

Research Center Borstel

Investigators

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Principal Investigator:	Klaus F Rabe, MD PhD	LungenClinic Grosshansdorf, Grosshansdorf, Germany
Principal Investigator:	Susanne Krauss-Etschmann, PhD	Research Center Borstel, Borstel, Germany

More Information

Additional Information:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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. Erratum In: BMC Pulm Med. 2018 Nov 7;18(1):165.

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.

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Responsible Party:	LungenClinic Grosshansdorf
ClinicalTrials.gov Identifier:	NCT02419274
Other Study ID Numbers:	DZL-GHD-ERA
First Posted:	April 17, 2015 Key Record Dates
Last Update Posted:	March 1, 2021
Last Verified:	February 2021

Keywords provided by LungenClinic Grosshansdorf:


asthma phenotype childhood adulthood

Additional relevant MeSH terms:

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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases	Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases

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