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CompletedNCT02826356Updated Jul 11, 2016

Analysis of the Availability of the Treatments for ACE-I and ARB-induced Angioedema

An observational study in ACE-I and ARB-induced Angioedema., sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-11.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
38
Ages
18 Years and older
01

Study summary

Specific treatments for angiotensin-converting-enzyme inhibitor (ACE-I) and angiotensin-receptor-blocker (ARB)-induced angioedema exist. Early access to these treatments is challenging because they are expensive and have short shelf lives making it illusory that all emergency department (ED) stock them. The aim of this retrospective study was to define, for each patient with a confirmed ACE-I or ARB-induced angioedema, at which step of the care, the specific treatment was administered. The second objective was to analyse the availability of these treatment in the area around Lyon, France and the factors that may influence it.

02

Conditions studied

  • ACE-I and ARB-induced Angioedema.

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Keywords

  • Angioedema
  • Emergency treatment
  • Treatment availability
  • Health Equity
03

In context

Angioedema

165 studies on the registry are indexed under Angioedema; 19 are open to participants now.

This study's enrollment of 38 is below the median of 158 across 45 observational studies indexed under Angioedema.

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Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,856 studies on the registry; 442 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients treated with a specific treatment for bradykinin-mediated angioedema for a severe attack of angioedema due to ACE-inhibitors or ARB during the study period.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Every patient followed for the first time in our reference center for severe confirmed ACE-I or ARB-induced angioedema. Data were analyzed from patients attended either in a specialized angioedema consultation or during a hospitalization in our intensive care unit.
  • Severe attack was defined either by its localization over the shoulder or by an severe abdominal attack.

Exclusion criteria

Exclusion Criteria:

- Patients which received no specific treatment (icatibant, C1-inhibitor concentrate) were excluded.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
38 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Step of the care allowing the patients to benefit from a specific treatment.

    Three answers are possible. Patients were treated with the specific medication (icatibant or C1-inhibitor concentrate) either in the first ED or by the medical ambulance team, or by the investigators reference center's intensive care unit.

    Time frame: October 2010 to December 2014

Secondary outcomes

  1. Epidemiological characteristics

    The investigators collect data such as age, sex, localization of the angioedema.

    Time frame: October 2010 to December 2014

  2. Triggering treatments

    The investigators detail which ACE-inhibitor, which ARB and eventually which co-medication was taken and triggered the angioedema.

    Time frame: October 2010 to December 2014

07

Study locations

1 site
  • Hospices Civils de Lyon, Département d'Anesthésie-Réanimation, Hôpital Edouard Herriot, Lyon, France.
    Lyon, 69003, France
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2016, a primary completion of Mar 2016 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 5, 2016
First posted
Jul 11, 2016
Start
Feb 2016
Primary completionActual
Mar 2016
CompletionActual
Mar 2016
Last update
Jul 11, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02826356
Responsible party
Sponsor
First posted
Jul 11, 2016
Start date
Feb 2016
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Jul 11, 2016

Study contacts

Bernard FLOCCARD, MD
principal investigator · Hospices Civils de Lyon, Département d'Anesthésie-Réanimation, Hôpital Edouard Herriot, Lyon, France.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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