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AsthmaALLIANCENCT02419274

Adult Arm of DZL All Age Asthma Cohort (ALLIANCE)

An observational study of Asthma, run by LungenClinic Grosshansdorf at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Asthma
How many people
400 participants
Where
1 siteGermany
Study dates
Mar 2014to Dec 2030
How long will I take part?
6 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Thomas J Bahmer, MD contact

+49 4102 601 2412

thomas.bahmer@uksh.de

Germany1 site, 1 recruiting
  • LungenClinic Grosshansdorf

    Großhansdorf, 22927

    Thomas J Bahmer, MD, +49-4102-601-2412, thomas.bahmer@uksh.de

    Joern Bullwinkel, PhD, +49-4102-601-2410, j.bullwinkel@lungenclinic.de

    Recruiting

Other trials in Germany

About this study

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

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
Read the 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.

Conditions
Asthma
Keywords
asthma, phenotype, childhood, adulthood
Medical subject headings
Asthma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Defining clinical asthma phenotypes by combining clinical, lung function and biomaterial data

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2015 (estimated)
  2. Study startMar 2014
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
Target duration
6 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02419274
Sponsor's protocol ID
DZL-GHD-ERA
Acronym
ALLIANCE
Status last verified
Oct 2023
First submitted
14 Apr 2015
Last updated
12 Oct 2023
Results posted
No
Data monitoring committee
No

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.

    PubMed 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.

    PubMed 18805339
  • Jakwerth CA, Illi S, Charles H, Oelsner M, Gabr AA, Zissler UM, Erb A, Feuerherd M, Drost F, Buttner M, Schubert B, Maison N, Omony J, Weckmann M, Grychtol R, Dittrich AM, Foth S, Skevaki C, Trojan T, van Koningsbruggen-Rietschel S, Hansen G, Bahmer T, Rabe KF, Brinkmann F, Kopp MV, Protzer U, Chaker AM, Schaub B, von Mutius E, Schmidt-Weber CB; ALLIANCE Study Group as part of the German Center for Lung Research (DZL). Nasal Epithelial Immune Signatures Are Associated With Age-Dependent Asthma Trajectories in Early Life. Allergy. 2026 Sep 6. doi: 10.1111/all.70477. Online ahead of print.

    PubMed 42703035
  • 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 wheeze/asthma phenotypes in child- and adulthood in ALLIANCE. Respir Res. 2026 Jul 27;27(1):294. doi: 10.1186/s12931-026-03840-x.

    PubMed 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, 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.

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

    PubMed 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, 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.

    PubMed 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 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.

    PubMed 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.

    PubMed 33008938
  • 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.

    PubMed 30126401
  • 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.

    PubMed 28052957

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by LungenClinic Grosshansdorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Thomas J Bahmer, MD (+49 4102 601 2412, thomas.bahmer@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Defining clinical asthma phenotypes by combining clinical, lung function and biomaterial data (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02419274, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.

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