Clinical trial NCT03056404: Research for Specific Proteins of Interest for the Serological Diagnosis of Bird Fancier's Lung
Official title: Research for Specific Proteins of Interest for the Serological Diagnosis of Bird Fancier's Lung
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Avian Hypersensitivity Pneumonitis
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims at identifying bird proteins useful for diagnostic tests to determine the cause of Bird Fancier's Lung (BFL).

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.

Eligibility criteria: 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

Primary outcomes:
measure: number of protein of interest
timeFrame: 24 months
Secondary outcomes:
measure: Selection and identification of protein of interest specific for each selected bird
timeFrame: 24 months
measure: Selection and identification of proteins of interest common to all selected bird'droppings
timeFrame: 24 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire
Study officials:
affiliation: lmillon@chu-besancon.fr
name: Laurence Millon
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rouzet A, Reboux G, Dalphin JC, Gondouin A, De Vuyst P, Balliau T, Millon L, Valot B, Roussel S. An immunoproteomic approach revealed antigenic proteins enhancing serodiagnosis performance of bird fancier's lung. J Immunol Methods. 2017 Nov;450:58-65. doi: 10.1016/j.jim.2017.07.012. Epub 2017 Jul 29.