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)

April 13, 2018 updated by: Centre Hospitalier Universitaire de Besancon
This study aims to describe quality of life in hereditary or acquired non drug-related bradykinin-mediated angioedema patients, using validated questionnaires

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • CHU Besançon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hereditary or Acquired non drug-induced bradykinin-mediated angioedema patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dermatology Life Quality Index (DLQI)
Time Frame: 6 months
Description of Quality of Life (QoL) using DLQI
6 months
Angioedema Quality of Life (AE-QoL) Questionnaire
Time Frame: 6 months
Description of QoL using AE-QOL questionnnaire
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 27, 2017

First Submitted That Met QC Criteria

August 4, 2017

First Posted (Actual)

August 7, 2017

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 13, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2016/302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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