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

Avian Hypersensitivity Pneumonitis Clinical Trial

— HYPERSENS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056404
• Other study ID #: API/2015/66
• Status: Completed
• Phase: N/A
• Start date: June 20, 2016
• Est. completion date: September 28, 2016

Study information

• Verified date: November 2019
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 28, 2016
• Est. primary completion date: September 28, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolitis, Extrinsic Allergic
• Avian Hypersensitivity Pneumonitis
• Bird Fancier's Lung
• Hypersensitivity
• Pneumonia

Intervention

Other:
• additional blood sample

• respiratory functional exploration

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of protein of interest	5 and 15 proteins for all selected birds	24 months
Secondary	Selection and identification of protein of interest specific for each selected bird	Identifying at least three specific proteins for each bird species by 2D-Electrophoresis and Western blotting (based on previous study).	24 months
Secondary	Selection and identification of proteins of interest common to all selected bird'droppings	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