Research for Specific Proteins of Interest for the Serological Diagnosis of Bird Fancier's Lung (HYPERSENS)

November 19, 2019 updated by: Centre Hospitalier Universitaire de Besancon
This study aims at identifying bird proteins useful for diagnostic tests to determine the cause of Bird Fancier's Lung (BFL).

Study Overview

Detailed Description

Allergic diseases are an important part of health concerns in Europe and in countries "industrialized". Among them are distinguished from hypersensitivity pneumonitis (HP), consecutive to repeated inhalation of organic substances (bacteria, fungi, avian proteins ...).

As with other HP, the BFL is a invalidating disease, but usually not lethal if the patient reduced sufficiently early exposure to antigens.

Associated symptoms include breathing difficulties a dry cough, a general fatigued state accompanied by a fever and a rapid and pronounced weight loss.

These clinical signs may be similar to a flu-like condition, difficult to discern from other respiratory disease. Diagnosis is based on a set of clinical, radiological and biological arguments that are often discussed.

Using these criteria as predictors would increase opportunities to diagnose HP without using invasive clinical examinations such as biopsy and bronchoalveolar lavage.

Although serology is a useful argument for the diagnosis, its value is often criticized.

Thus, significant variations in performance of serological tests are observed from one provider to another and, for the same supplier, from one batch to another.

This issue could be raised by the use of recombinant antigens. The principle is to use only to the reaction the purified protein of interest produced by genetic engineering.

The Parasitology-Mycology department has acquired expertise in the research of proteins of interest for serology allergic diseases and in the manufacture of recombinant antigens. Thus the work of the team have identified proteins of interest for the diagnosis of two HP of occupational origin and translates this expertise to identify pigeon's proteins and study the feasibility of this research.

For this project, the pigeon droppings (Columba livia), collected from different breeders in the region were identified as antigenic source.

The objective of the HYPERSENS project is to extend the problematic to other species of birds and understand the specific species of antigenic proteins. The aim is also to identify and produce recombinant proteins that will identify the cause of avian hypersensitivity pneumonitis.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

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

      • Besançon, France, 25030
        • Centre hospitalier régional universitaire

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Exposure known about birds
  • Non-smoker
  • Absence of compatible respiratory symptoms with a HP

Exclusion Criteria:

  • Farmer,
  • smoker,
  • pregnancy and feeding,
  • minor subject,
  • known immunizing deficit

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: control subject
additional blood sample and 15 control subjects will be seen in consultations in the service of pneumology. The visit will include an auscultation, a respiratory functional exploration and a blood test (2 tubes of 7 ml of total blood). A questionnaire of exhibition will be realized to collect the species of birds and the times of exhibition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of protein of interest
Time Frame: 24 months
5 and 15 proteins for all selected birds
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Selection and identification of protein of interest specific for each selected bird
Time Frame: 24 months
Identifying at least three specific proteins for each bird species by 2D-Electrophoresis and Western blotting (based on previous study).
24 months
Selection and identification of proteins of interest common to all selected bird'droppings
Time Frame: 24 months
Identifying at least one common protein to all droppings of selected bird species by 2D-Electrophoresis and Western blotting. This protein will be recognized by the antibodies of all patients regardless of their exposure and not recognized by controls. It would make the diagnosis of BFL for any avian exposure.
24 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Laurence Millon, lmillon@chu-besancon.fr

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

June 20, 2016

Primary Completion (Actual)

September 28, 2016

Study Completion (Actual)

September 28, 2016

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

February 14, 2017

First Posted (Actual)

February 17, 2017

Study Record Updates

Last Update Posted (Actual)

November 21, 2019

Last Update Submitted That Met QC Criteria

November 19, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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