Idiopathic Pulmonary Fibrosis Job Exposures Study (IPFJES)

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis; IPF
• Intervention / Treatment: Other: Computer-assisted telephone interview; Genetic: Genetic analysis

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.

• Study Type: Observational
• Enrollment (Actual): 960

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Imperial Healthcare NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Hospital based

Description

For cases

Inclusion Criteria:

• New diagnosis of IPF between February 2017 and October 2019

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case; Males with an incident diagnosis of IPF made between the 1st of February 2017 and the 5th of October 2019.	Other: Computer-assisted telephone interview; Occupational history; Genetic: Genetic analysis; To include analysis of known susceptibility markers
Controls; 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.	Other: Computer-assisted telephone interview; Occupational history; Genetic: Genetic analysis; To include analysis of known susceptibility markers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between asbestos exposure and IPF	estimated using logistic regression for any vs no asbestos exposure and adjusting for age and smoking status	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: The Leeds Teaching Hospitals NHS Trust; Norfolk and Norwich University Hospitals NHS Foundation Trust; Wellcome Trust; Nottingham University Hospitals NHS Trust; Guy's and St Thomas' NHS Foundation Trust; Liverpool University Hospitals NHS Foundation Trust; University Hospital Birmingham NHS Foundation Trust; University Hospital Southampton NHS Foundation Trust; Papworth Hospital NHS Foundation Trust; Newcastle-upon-Tyne Hospitals NHS Trust; Portsmouth Hospitals NHS Trust; Imperial College Healthcare NHS Trust; North Bristol NHS Trust; Royal Devon and Exeter NHS Foundation Trust; Royal Infirmary of Edinburgh; Heart of England NHS Foundation Trust; Somerset NHS Foundation Trust; Worcestershire Acute Hospitals NHS Trust; Glasgow Royal Infirmary; Aberdeen Royal Infirmary; University Hospital of South Manchester; Morriston Hospital
• Investigators: Study Director: Carl Reynolds, Imperial College London

Publications and helpful links

Helpful Links

• Full study documentation

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ACTUAL): October 5, 2019
• Study Completion (ACTUAL): October 5, 2019

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (ACTUAL): July 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 12, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Idiopathic Pulmonary Fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: 16SM3627

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No