NCT03056404

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 17, 2017

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

August 10, 2016

Last Update Submit

November 19, 2019

Conditions

Avian Hypersensitivity Pneumonitis

Outcome Measures

Primary Outcomes (1)

  • number of protein of interest

    5 and 15 proteins for all selected birds

    24 months

Secondary Outcomes (2)

  • Selection and identification of protein of interest specific for each selected bird

    24 months

  • Selection and identification of proteins of interest common to all selected bird'droppings

    24 months

Study Arms (1)

control subject

EXPERIMENTAL

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 sampleOther: respiratory functional exploration

Interventions

additional blood sampleOTHER
control subject
respiratory functional explorationOTHER
control subject

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Régional Universitaire

Besançon, 25030, France

Location

Related Publications (1)

  • 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.

    PMID: 28760669DERIVED

MeSH Terms

Conditions

Bird Fancier's Lung

Condition Hierarchy (Ancestors)

Alveolitis, Extrinsic AllergicLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesOccupational Diseases

Study Officials

  • Laurence Millon

    lmillon@chu-besancon.fr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2016

First Posted

February 17, 2017

Study Start

June 20, 2016

Primary Completion

September 28, 2016

Study Completion

September 28, 2016

Last Updated

November 21, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)