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Completed

NCT Number: NCT01110694

Prospective Observation of Fibrosis in the Lung Clinical Endpoints Study

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Idiopathic Non-specific Interstitial Pneumonitis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals over the age of 18 with a diagnosis of definite or probable IPF or definite or probable fibrotic NSIP as defined by the ATS/ERS consensus classification

Exclusion criteria

  • Patients with co-existent conditions known to be associated with the development of fibrotic lung disease will be excluded.
  • This includes
  • connective tissue disease
  • suspected drug-induced lung disease
  • asbestosis or other asbestos related disease (pleural plaques, mesothelioma, asbestos pleural effusions)
  • granulomatous disease including sarcoidosis.
  • Patients with an auto-immune profile considered diagnostic for a specific connective tissue disease will be excluded, even in the absence of systemic symptoms.
  • Non-specific rises in auto antibodies e.g. rheumatoid factor, anti-nuclear antibody etc. will not be used to exclude individuals from the study.
  • Patients with co-morbid disease that in the opinion of the investigators gives them an expected life expectancy of less than one year will be excluded from the study.
  • Patients involved in clinical trials assessing novel IPF therapies will be excluded from enrolment in this study.

Treatment and study plan

Primary outcomes

  1. Biomarker discovery

    Time frame: 3 years

    Discover and validate novel biomarkers and gene expression profiles for use in subsequent clinical studies in patients with idiopathic pulmonary fibrosis.

Secondary outcomes

  1. Study disease behaviour

    Time frame: 3 years

    Prospectively evaluate longitudinal disease behavior in patients with IPF and other fibrotic lung diseases of unknown cause with a view to developing composite clinical endpoints for subsequent use in clinical studies in patients with pulmonary fibrosis.

  2. Differentiate IPF from NSIP

    Time frame: 3 years

    Identify differences in the pathogenetic mechanisms involved in the development of different types of fibrosis in patients with fibrotic lung disease of unknown cause.

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Collaborators

  • GlaxoSmithKline
  • University College, London
  • University of Nottingham

Registry information

Official study title

Prospective Observation of Fibrosis in the Lung Clinical Endpoints (PROFILE_Brompton)Study

Acronym: PROFILE

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Apr 27, 2010
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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