Prospective Observation of Fibrosis in the Lung Clinical Endpoints Study

NCT01110694 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 230

Last updated 2019-03-27

No results posted yet for this study

Summary

Idiopathic pulmonary fibrosis (IPF) is a progressive scarring condition of the lungs the cause of which is unknown.There are currently no effective treatments for IPF and the condition tends to cause progressive disability and death with an average survival of 3.5 years from diagnosis. The condition is responsible for the deaths of 4000 people per year in the UK. At present the definite diagnosis of IPF rests on the identification of a specific pattern of fibrosis when a section of fibrotic lung tissue is examined under a microscope. Unfortunately, the process of obtaining a lung biopsy requires an operation and is not with out risk. The investigators hope to identify specific markers in the blood and lungs of patients with IPF that will enable the condition to be diagnosed without biopsy. Furthermore, the investigators hope to identify indicators(biomarkers) that will predict which patients have more aggressive and progressive disease and also to identify biomarkers that might be useful in identifying a response to treatment and might therefore be used in future clinical trials in IPF. As well as looking at markers in the blood and lungs the investigators also plan to assess the use of daily home lung function measurement and a computerised technique for analyzing lung sounds to see if these are investigations that are able to predict the development of worsening lung fibrosis.

Conditions

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY
  • University College, London

    collaborator OTHER
  • University of Nottingham

    collaborator OTHER
  • Royal Brompton & Harefield NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Toby M Maher, MB PhD · Royal Brompton and Harefield Foundation NHS Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01110694 on ClinicalTrials.gov