Idiopathic Pulmonary Fibrosis Job Exposures Study

Idiopathic Pulmonary Fibrosis Clinical Trial

— IPFJES  

Official title:

Idiopathic Pulmonary Fibrosis Job Exposures Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03211507
• Other study ID #: 16SM3627
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: October 5, 2019

Study information

• Verified date: December 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 960
• Est. completion date: October 5, 2019
• Est. primary completion date: October 5, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• IPF
• Pulmonary Fibrosis

Intervention

Other:
• Computer-assisted telephone interview
Occupational history

Genetic:
• Genetic analysis
To include analysis of known susceptibility markers

Locations

Country	Name	City	State
United Kingdom	Imperial Healthcare NHS Trust	London

Sponsors (23)

Lead Sponsor

Collaborator

Imperial College London

Aberdeen Royal Infirmary, Aintree University Hospitals NHS Foundation Trust, Glasgow Royal Infirmary, Guy's and St Thomas' NHS Foundation Trust, Heart of England NHS Foundation Trust, Imperial College Healthcare NHS Trust, Morriston Hospital, Newcastle-upon-Tyne Hospitals NHS Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust, North Bristol NHS Trust, Nottingham University Hospitals NHS Trust, Papworth Hospital NHS Foundation Trust, Portsmouth Hospitals NHS Trust, Royal Devon and Exeter NHS Foundation Trust, Royal Infirmary of Edinburgh, Taunton and Somerset NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, University Hospital Birmingham NHS Foundation Trust, University Hospital of South Manchester, University Hospital Southampton NHS Foundation Trust, Wellcome Trust, Worcestershire Acute Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Gene-environment interaction (for MUC5B rs35705950 and asbestos exposure) odds ratio.	MUC5B rs35705950 and asbestos exposure odds ratio.	2 years

External Links

•   Full study documentation