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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02535793
Other study ID # UF 9410
Secondary ID
Status Completed
Phase N/A
First received August 20, 2015
Last updated April 11, 2016
Start date September 2014
Est. completion date February 2015

Study information

Verified date April 2016
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

Allergy is a very common problem and can be a handicap in everyday life, specially when symptoms occur at work place. Some persons working with drosophila developed respiratory symptoms. Investigators tried to analyze if these manifestations could be due to a specific allergy to drosophila.


Description:

To do so, investigators invited laboratory workers who presented any symptoms in presence of drosophila to undergo skin prick tests in order to determine if a specific sensibilization to drosophila exists. Then, a blood sample is taken from these persons to research specific IgE directed against drosophila. By this way, investigators hope determine if a specific allergy to drosophila exists, its characteristics as prevalence, symptoms, populations concerned...in order to better protect laboratory workers and prevent allergy incidence.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 68 Years
Eligibility Inclusion Criteria:

- major males or females (aged <68) who work in laboratory with drosophila in Montpellier (France)

- clinical symptoms in presence of drosophila

- The subject must be affiliated to a social security scheme

- Provision of informed consent prior to any study specific procedures

Exclusion Criteria:

- The patient has indicated against (or incompatible drug combination) concerning the implementation of a prick test

- antihistamine cure in progress

- Inability to understand the nature and goals of the study and / or communication difficulties with the investigator

- No affiliation to a French social security recipient or not such a scheme

- Major protected by law (guardianship, curator or under judicial protection)

- deprivation of liberty by judicial or administrative decision

- Increased likelihood of non compliance to the protocol or abandonment under study

- pregnancy or breastfeeding

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
blood test (four dry tubes 7ml) and prick tests


Locations

Country Name City State
France Hôpital Arnaud de Villeneuve Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with positive prick test to drosophila Prick tests : measuring the size of the skin reaction (wheal) after prick tests with drosophila. A wheal measuring more than 4 millimeters in diameter sign a sensitization to drosophila. Then, a blood sample is collected in order to measure specific drosophila IgE rate The day of inclusion Yes
Secondary Survey to analyse risk factors for allergy to drosophila analysis of professional (attended institute, time from start working with drosophila, type of animal manipulation (species, living, dead, DNA, protein) use of protection,) or personal factors (age, gender, others allergies, treatment used) which could lead to allergic reaction to drosophila The day of inclusion Yes