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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01110694
Recruitment Status : Completed
First Posted : April 27, 2010
Last Update Posted : March 27, 2019
Sponsor:
Collaborators:
GlaxoSmithKline
University College, London
University of Nottingham
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Tracking Information
First Submitted Date April 22, 2010
First Posted Date April 27, 2010
Last Update Posted Date March 27, 2019
Actual Study Start Date September 2010
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 26, 2010)		 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 26, 2010)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Observation of Fibrosis in the Lung Clinical Endpoints Study
Official Title Prospective Observation of Fibrosis in the Lung Clinical Endpoints (PROFILE_Brompton)Study
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood, serum, bronchoalveolar lavage, surgical lung biopsy (when clinically indicated)
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.
Condition
  • Idiopathic Pulmonary Fibrosis
  • Idiopathic Non-specific Interstitial Pneumonitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 19, 2017)		 230
Original Estimated Enrollment
 (submitted: April 26, 2010)		 210
Actual Study Completion Date September 2018
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01110694
Other Study ID Numbers PROFILE_RBH_001
10/H0720/12 ( Other Identifier: Royal Free Hospital REC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Royal Brompton & Harefield NHS Foundation Trust
Original Responsible Party Dr Toby Maher, Royal Brompton & Harefield NHS Foundation Trust
Current Study Sponsor Royal Brompton & Harefield NHS Foundation Trust
Original Study Sponsor Same as current
Collaborators
  • GlaxoSmithKline
  • University College, London
  • University of Nottingham
Investigators
Principal Investigator: Toby M Maher, MB PhD Royal Brompton and Harefield Foundation NHS Trust
PRS Account Royal Brompton & Harefield NHS Foundation Trust
Verification Date March 2019