NCT03747627

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
475

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Jan 2019Jan 2028

First Submitted

Initial submission to the registry

November 14, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 19, 2019

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Expected
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

6 years

First QC Date

November 14, 2018

Last Update Submit

April 22, 2025

Conditions

Keywords

Interstitial Lung Disease (ILD)Hypersensitivity PneumonitisIdiopathic Pulmonary Fibrosis (IPF)Extrinsic Allergic Alveolitis (EAA)Bird Fancier's LungGenetics

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Genetic profilingDIAGNOSTIC_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)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants in the sport of Pigeon racing

You may qualify if:

  • regular exposure to racing pigeons

You may not qualify if:

  • Unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Scottish Homing Union

Lanark, Lanark, ML11 9AX, United Kingdom

Location

Royal Pigeon Racing Association Meeting

Blackpool, FY1 1HL, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be prepared for DNA analysis

MeSH Terms

Conditions

DiseaseAlveolitis, Extrinsic AllergicBird Fancier's LungIdiopathic Interstitial PneumoniasLung Diseases, InterstitialIdiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesOccupational DiseasesPulmonary Fibrosis

Study Officials

  • Mark Spears, PhD, FRCP

    NHS Tayside & University of Dundee

    PRINCIPAL INVESTIGATOR
  • Louise Wain, PhD

    University of Leicester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Mark Spears, Consultant in Respiratory Medicine

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 20, 2018

Study Start

January 19, 2019

Primary Completion

January 19, 2025

Study Completion (Estimated)

January 1, 2028

Last Updated

April 25, 2025

Record last verified: 2025-04

Locations