BPF Genetics of ILD Study | NCT03747627

Studies
BPF Genetics of ILD Study

NCT03747627

Sponsor

University of Dundee

Status

Completed

Last Update Posted

May 27, 2026Actual

Enrollment

475Actual

Phase

Not provided

Conditions

Lung; Disease, Interstitial, With Fibrosis
Alveolitis, Extrinsic Allergic
Bird Fancier's Lung
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Idiopathic Pulmonary Fibrosis

Interventions

Genetic profiling

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 19, 2019Actual

Primary Completion Date

Jan 19, 2025Actual

Completion Date

Jan 19, 2025Actual

First Submitted Date

Nov 14, 2018

First Submission Date that Met QC Criteria

Nov 19, 2018

First Posted Date

Nov 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2026

Last Update Posted Date

May 27, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mark Spears, Dr Mark Spears, Consultant in Respiratory Medicine, University of DundeePrincipal Investigator

Lead Sponsor

University of DundeeOTHER

Collaborators

Name	Class
University of Leicester	OTHER
University of Glasgow	OTHER
Newcastle University	OTHER
British Lung Foundation

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators aim to examine the genetic determinants of interstitial lung disease in a cohort of subjects with regular exposure to pigeons, a known cause of one form of interstitial lung disease known as hypersensitivity pneumonitis. In addition we will examine immunological causes for hypersensitivity pneumonitis in this group.

We anticipate our work will provide insights of use to clinicians and patients with hypersensitivity pneumonitis and other interstitial lung diseases.

Detailed Description

The investigators aim to recruit participants with regular racing pigeon exposure at national (UK) and regional pigeon fancier meetings.

Consenting subjects will complete questionnaires, provide blood samples for genetic analysis and immunological testing and undertake lung function measurements.

Subjects will be observed, and encouraged to report referral to specialist respiratory services, and following this information will be sought on diagnosis (including supporting evidence). Where interstitial lung disease is detected this will be linked to subsequent unbiased analysis to detect potential predisposing genetic associations.

Conditions Module

Conditions

Lung; Disease, Interstitial, With Fibrosis
Alveolitis, Extrinsic Allergic
Bird Fancier's Lung
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Idiopathic Pulmonary Fibrosis

Keywords

Interstitial Lung Disease (ILD)
Hypersensitivity Pneumonitis
Idiopathic Pulmonary Fibrosis (IPF)
Extrinsic Allergic Alveolitis (EAA)
Bird Fancier's Lung
Genetics

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

475Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Genetic profiling	Diagnostic Test	All participating subjects will undergo detailed genetic analysis, with the aim of detecting novel genetic drivers for the development of interstitial lung disease in the context of known sensitising agent (pigeon antigen)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relationship of specific genetic markers to development of interstitial lung disease	Participants will be screened for MUC5B genetic profile to allow examination of MUC5B genetic profile relationship with risk of developing interstitial lung disease in this group	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

regular exposure to racing pigeons

Exclusion Criteria:

Unwilling to participate

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Participants in the sport of Pigeon racing

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Spears, PhD, FRCP	NHS Tayside & University of Dundee	Principal Investigator
Louise Wain, PhD	University of Leicester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Pigeon Racing Association Meeting		Blackpool		FY1 1HL	United Kingdom
Scottish Homing Union

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Will be considered, dependent on potential for increased power

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004194	Disease
D000542	Alveolitis, Extrinsic Allergic
D001716	Bird Fancier's Lung
D054988	Idiopathic Interstitial Pneumonias
D017563	Lung Diseases, Interstitial
D054990	Idiopathic Pulmonary Fibrosis

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided