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Study of Clinical, Biological Characteristics and Quality of Life of Patients With Hereditary or Acquired Non Drug-induced Bradykinin-mediated Angioedema, Monitored in Besançon's Partner Site Reference Center for Studies of Kinin-mediated Angioedema (CREAK) (QUALANGIO)

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ClinicalTrials.gov Identifier: NCT03240991
Recruitment Status : Completed
First Posted : August 7, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:
This study aims to describe quality of life in hereditary or acquired non drug-related bradykinin-mediated angioedema patients, using validated questionnaires

Condition or disease Intervention/treatment
Angioedema Other: Quality of life

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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Prospective
Actual Study Start Date : July 11, 2016
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016

Group/Cohort Intervention/treatment
Quality of life questionnaires
Data will be collected retrospectively and prospectively.
Other: Quality of life
Dermatology Life Quality Index, Angioedema Quality of Life Questionnaire, Angioedema Activity Score




Primary Outcome Measures :
  1. Dermatology Life Quality Index (DLQI) [ Time Frame: 6 months ]
    Description of Quality of Life (QoL) using DLQI

  2. Angioedema Quality of Life (AE-QoL) Questionnaire [ Time Frame: 6 months ]
    Description of QoL using AE-QOL questionnnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hereditary or Acquired non drug-induced bradykinin-mediated angioedema patients
Criteria

Inclusion Criteria:

  • Clinically documented angioedema due to C1 inhibitor deficiency, hereditary (type I et II) or acquired
  • Clinically documented angioedema with normal C1 inhibitor activity (hereditary type III)

Exclusion Criteria:

  • Acquired angioedema with normal C1 inhibitor activity (former "drug-induced")
  • Minor subjects
  • Vulnerable subjects (under guardianship/curatorship/tutorship)
  • Pregnant women

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): NCT03240991


Locations
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France
CHU Besançon
Besançon, France, 25000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03240991     History of Changes
Other Study ID Numbers: P/2016/302
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Keywords provided by Centre Hospitalier Universitaire de Besancon:
bradykinin-mediated angiodema
quality of life

Additional relevant MeSH terms:
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Angioedema
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bradykinin
Vasodilator Agents