Idiopathic Pulmonary Fibrosis Job Exposures Study

Completed

• Conditions: Idiopathic Pulmonary Fibrosis; IPF
• Interventions: Other: Computer-assisted telephone interview; Genetic: Genetic analysis

• Registration Number: NCT03211507
• Lead Sponsor: Imperial College London

Brief Summary

A case-control study to investigate whether job exposures are an under-recognized cause of idiopathic pulmonary fibrosis (IPF) using an interview to collect information about previous jobs and a blood test to investigate genetic susceptibility.

Detailed Description

Idiopathic pulmonary fibrosis (IPF) is a scarring lung disease. It damages the air sacs that allow oxygen to be transferred into the blood and transported to vital organs. These changes make people with IPF cough and feel short of breath. It not known what causes the damage. People who get IPF are usually older than 40; it's a very serious illness that cannot be cured and gets worse over time. Statistics show that IPF is becoming more common in the UK but it's not known why. It can be difficult for doctors to tell if someone has IPF or another disease called asbestosis.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-07-05
• Study First Posted: 2017-07-07
• Primary Completion: 2019-10-05
• Study Completion: 2019-10-05
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-10
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 960

Inclusion Criteria

• New diagnosis of IPF between February 2017 and October 2019

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Exclusion Criteria

• Unable to give informed consent
• Ever worked outside of the UK

For controls

Inclusion Criteria:

• New outpatient department attendee between February 2017 and October 2019

Exclusion Criteria:

• Unable to give informed consent
• Ever worked outside of the UK (does not include work outside the UK by members of the armed forces or merchant navy)
• Diagnosis of IPF

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case	Computer-assisted telephone interview	Males with an incident diagnosis of IPF made between the 1st of February 2017 and the 5th of October 2019.
Controls	Computer-assisted telephone interview	Males with an incident hospital outpatient attendance between the 1st of February 2017 and the 5th of October 2019 who do not have a diagnosis of IPF. At each participating centre a control clinic is randomly selected from all control clinics that the research team is able to recruit from; this clinic is the source clinic for controls for the duration of the study.
Controls	Genetic analysis	Males with an incident hospital outpatient attendance between the 1st of February 2017 and the 5th of October 2019 who do not have a diagnosis of IPF. At each participating centre a control clinic is randomly selected from all control clinics that the research team is able to recruit from; this clinic is the source clinic for controls for the duration of the study.
Case	Genetic analysis	Males with an incident diagnosis of IPF made between the 1st of February 2017 and the 5th of October 2019.

Primary Outcome Measures

Name	Time	Method
Association between asbestos exposure and IPF	2 years	estimated using logistic regression for any vs no asbestos exposure and adjusting for age and smoking status

Secondary Outcome Measures

Name	Time	Method
Dose-response relationship between asbestos exposure and IPF	2 years	estimated using logistic regression for categories of cumulative exposure and adjusting for age and smoking status
Gene-environment interaction (for MUC5B rs35705950 and asbestos exposure) odds ratio.	2 years	MUC5B rs35705950 and asbestos exposure odds ratio.

Trial Locations

Locations (1)

Imperial Healthcare NHS Trust; 🇬🇧 London, United Kingdom