COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056404
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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

Condition or disease Intervention/treatment Phase
Avian Hypersensitivity Pneumonitis Other: additional blood sample Other: respiratory functional exploration Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Research for Specific Proteins of Interest for the Serological Diagnosis of Bird Fancier's Lung
Actual Study Start Date : June 20, 2016
Actual Primary Completion Date : September 28, 2016
Actual Study Completion Date : September 28, 2016

Resource links provided by the National Library of Medicine


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.
Other: additional blood sample
Other: respiratory functional exploration



Primary Outcome Measures :
  1. number of protein of interest [ Time Frame: 24 months ]
    5 and 15 proteins for all selected birds


Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056404


Locations
Layout table for location information
France
Centre Hospitalier Régional Universitaire
Besançon, France, 25030
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
Layout table for investigator information
Principal Investigator: Laurence Millon lmillon@chu-besancon.fr
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03056404    
Other Study ID Numbers: API/2015/66
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia
Alveolitis, Extrinsic Allergic
Bird Fancier's Lung
Hypersensitivity
Immune System Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Interstitial
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Occupational Diseases