AngioedemaQUALANGIONCT03240991
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)
An observational study of Angioedema, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study aims to describe quality of life in hereditary or acquired non drug-related bradykinin-mediated angioedema patients, using validated questionnaires Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angioedema
- What is being tested?
- Quality of life
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jul 2016to 1 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hereditary or Acquired non drug-induced bradykinin-mediated angioedema patients
Who may be able to join
- 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)
Who cannot join
- Acquired angioedema with normal C1 inhibitor activity (former "drug-induced")
- Minor subjects
- Vulnerable subjects (under guardianship/curatorship/tutorship)
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to describe quality of life in hereditary or acquired non drug-related bradykinin-mediated angioedema patients, using validated questionnaires
- Conditions
- Angioedema
- Being tested
- Quality of life
- Keywords
- bradykinin-mediated angiodema, quality of life
- Medical subject headings
- Angioedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of lifeOther
Dermatology Life Quality Index, Angioedema Quality of Life Questionnaire, Angioedema Activity Score
| Study group | Role | What they receive |
|---|---|---|
| Quality of life questionnaires | Data will be collected retrospectively and prospectively. Receives: Other: Quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermatology Life Quality Index (DLQI)
Description of Quality of Life (QoL) using DLQI
Measured: 6 months
Angioedema Quality of Life (AE-QoL) Questionnaire
Description of QoL using AE-QOL questionnnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start11 Jul 2016
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngioedemaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240991
- Sponsor's protocol ID
- P/2016/302
- Acronym
- QUALANGIO
- Status last verified
- Apr 2018
- First submitted
- 27 Jul 2017
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03240991
- Acronym / sponsor ID
- QUALANGIO / P/2016/302
- Conditions
- Angioedema
- Keywords
- bradykinin-mediated angiodema, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 11 Jul 2016 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to describe quality of life in hereditary or acquired non drug-related bradykinin-mediated angioedema patients, using validated questionnaires
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality of life questionnaires | – | Other: Quality of lifeData will be collected retrospectively and prospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hereditary or Acquired non drug-induced bradykinin-mediated angioedema patients
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- Acquired angioedema with normal C1 inhibitor activity (former "drug-induced")
- Minor subjects
- Vulnerable subjects (under guardianship/curatorship/tutorship)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of lifeDermatology Life Quality Index, Angioedema Quality of Life Questionnaire, Angioedema Activity Score | Other | Quality of life questionnaires |
Primary outcome
Dermatology Life Quality Index (DLQI)
Time frame: 6 months
Description of Quality of Life (QoL) using DLQI
Angioedema Quality of Life (AE-QoL) Questionnaire
Time frame: 6 months
Description of QoL using AE-QOL questionnnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angioedema, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 17 Apr 2018. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermatology Life Quality Index (DLQI) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2018.