Trial document




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  DRKS00017374

Trial Description

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Title

Bradykinine-associated angioedema and quality of life

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Trial Acronym

QOLA - Quality of Life with angioedema

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Overview concerning Patient cohort, disease types, Quality of life, disease acitivy and therapy

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Brief Summary in Scientific Language

1. Evaluation of demographical data and comorbidities in patients with hereditary or acquired angioedema
2. Evaluation of disease characteristics and disease activity (time of final diagnosis, Family history, common Triggers, influence of pregnancies and critical life Events).
3. Evaluation of preventive therapies and Management of acute attacks)
4. Influence of Quality of life and psychosocial factors

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Organizational Data

  •   DRKS00017374
  •   2019/05/28
  •   [---]*
  •   yes
  •   Approved
  •   115/19-ek, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   D84.1 -  Defects in the complement system
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Interventions/Observational Groups

  •   Paper based questionnaires

    - clinical questionnaire concerning private and professional life, therapy, leisure time
    - following validated questionnaires:
    Angioedema control score (ACS),
    The angioedema quality of life questionnaire (AE-QoL),
    Hospital Anxiety and depression scale (HADS), Generalized Anxiety Disorder (GAD-7),
    Lubben Social Network Scale (LSNS),
    Health Survey (SF-8),
    Disease severity score by Bygum
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

questionnaire-based study
Primary Goal: Evaluation of completed questionnaires concerning disease activity, therapy, Quality of life and psychosocialcomorbidities in patients suffering from hereditary and acquired angioedema

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Secondary Outcome

see above, method: questionnaire-based study

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/06/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Age >18 years, medically diagnosed hereditary or acquired angioedema, consent for data protection declaration

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Exclusion Criteria

Age <18 years, no signed consent of data protection declaration

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Addresses

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    • Universitätsklinikum Leipzig
    • Liebigstr. 18
    • 04103  Leipzig
    • Germany
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    • Klinik für Dermatologie, Venerologie und Allergologie des Universitätsklinikums Leipzig
    • Ms.  Prof. Dr.  Regina  Treudler 
    • Philipp-Rosenthal-Straße 23
    • 04103  Leipzig
    • Germany
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    • Klinik für Dermatologie, Venerologie und Allergologie des Universitätsklinikums Leipzig
    • Ms.  Julia  Zarnowski 
    • Philipp-Rosenthal-Straße 23
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Dermatologie, Venerologie und Allergologie des Universitätsklinikums Leipzig
    • Ms.  Prof. Dr.  Regina  Treudler 
    • Philipp-Rosenthal-Straße 23
    • 04103  Leipzig
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.