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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Royal Brompton & Harefield NHS Foundation Trust
Sponsor:
Collaborators:
GlaxoSmithKline
University College, London
University of Nottingham
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01110694
First received: April 22, 2010
Last updated: November 12, 2014
Last verified: November 2014
  Purpose

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.


Condition
Idiopathic Pulmonary Fibrosis
Idiopathic Non-specific Interstitial Pneumonitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observation of Fibrosis in the Lung Clinical Endpoints (PROFILE_Brompton)Study

Resource links provided by NLM:


Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • Biomarker discovery [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Discover and validate novel biomarkers and gene expression profiles for use in subsequent clinical studies in patients with idiopathic pulmonary fibrosis.


Secondary Outcome Measures:
  • Study disease behaviour [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.

  • Differentiate IPF from NSIP [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Identify differences in the pathogenetic mechanisms involved in the development of different types of fibrosis in patients with fibrotic lung disease of unknown cause.


Biospecimen Retention:   Samples With DNA

Whole blood, serum, bronchoalveolar lavage, surgical lung biopsy (when clinically indicated)


Estimated Enrollment: 210
Study Start Date: September 2010
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be recruited from patients refered to the Interstitial Lung Disease Unit of the Royal Brompton Hospital.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110694

Contacts
Contact: Toby M Maher, MB MSc PhD +44(0)20 7352 8121 ext 4188 t.maher@rbht.nhs.uk

Locations
United Kingdom
Royal Brompton Hospital Recruiting
London, United Kingdom, SW3 6NP
Contact: Toby M Maher, MB MSc PhD    +44(0)207 352 8121 ext 4188    t.maher@rbht.nhs.uk   
Contact: Anne-Marie Russell, RGN    +44(0)207 352 8121 ext 4923    a.russell@rbht.nhs.uk   
Principal Investigator: Toby M Maher, MB MSc PhD         
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
GlaxoSmithKline
University College, London
University of Nottingham
Investigators
Principal Investigator: Toby M Maher, MB PhD Royal Brompton and Harefield Foundation NHS Trust
  More Information

Publications:
Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01110694     History of Changes
Other Study ID Numbers: PROFILE_RBH_001, 10/H0720/12
Study First Received: April 22, 2010
Last Updated: November 12, 2014
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Idiopathic pulmonary fibrosis
Interstitial lung disease
Prognosis
Biomarkers
Mortality
Acute exacerbations

Additional relevant MeSH terms:
Fibrosis
Idiopathic Pulmonary Fibrosis
Lung Diseases, Interstitial
Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014