Skip to main content
OpenTrials
Completed

NCT Number: NCT03056404

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Régional Universitaire

Besançon, 25030, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

additional blood sample

Other

respiratory functional exploration

Other

Primary outcomes

  1. number of protein of interest

    Time frame: 24 months

    5 and 15 proteins for all selected birds

Secondary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: HYPERSENS

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 17, 2017
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.