NCT02419274

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Mar 2014Dec 2030

Study Start

First participant enrolled

March 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Expected
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

11.8 years

First QC Date

April 14, 2015

Last Update Submit

October 11, 2023

Conditions

Keywords

asthmaphenotypechildhoodadulthood

Outcome Measures

Primary Outcomes (1)

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

    2 years

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LungenClinic Grosshansdorf

Großhansdorf, 22927, Germany

RECRUITING

Related Publications (9)

  • 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: 22561835BACKGROUND
  • 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: 18805339BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Klaus F Rabe, MD PhD

    LungenClinic Grosshansdorf, Grosshansdorf, Germany

    PRINCIPAL INVESTIGATOR
  • Susanne Krauss-Etschmann, PhD

    Research Center Borstel, Borstel, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 17, 2015

Study Start

March 1, 2014

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2030

Last Updated

October 12, 2023

Record last verified: 2023-10

Locations