Prospective Observation of Fibrosis in the Lung Clinical Endpoints Study

Idiopathic Pulmonary Fibrosis Clinical Trial

— PROFILE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110694
• Other study ID #: PROFILE_RBH_001
• Secondary ID: 10/H0720/12
• Status: Completed
• Start date: September 2010
• Est. completion date: September 2018

Study information

• Verified date: March 2019
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Non-specific Interstitial Pneumonitis
• Idiopathic Pulmonary Fibrosis
• Lung Diseases, Interstitial
• Pneumonia
• Pulmonary Fibrosis

Locations

Country	Name	City	State
United Kingdom	Royal Brompton Hospital	London

Sponsors (4)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust	GlaxoSmithKline, University College, London, University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

Gribbin J, Hubbard RB, Le Jeune I, Smith CJ, West J, Tata LJ. Incidence and mortality of idiopathic pulmonary fibrosis and sarcoidosis in the UK. Thorax. 2006 Nov;61(11):980-5. Epub 2006 Jul 14. — View Citation

Hubbard R, Johnston I, Britton J. Survival in patients with cryptogenic fibrosing alveolitis: a population-based cohort study. Chest. 1998 Feb;113(2):396-400. — View Citation

Maher TM, Wells AU, Laurent GJ. Idiopathic pulmonary fibrosis: multiple causes and multiple mechanisms? Eur Respir J. 2007 Nov;30(5):835-9. Review. — View Citation

Maher TM. The diagnosis of idiopathic pulmonary fibrosis and its complications. Expert Opin Med Diagn. 2008 Dec;2(12):1317-31. doi: 10.1517/17530050802549484. — View Citation

Maher TM. Understanding nonspecific interstitial pneumonia: the need for a diagnostic gold standard. Am J Respir Crit Care Med. 2009 Feb 1;179(3):255-6; author reply 256. — View Citation

Moeller A, Gilpin SE, Ask K, Cox G, Cook D, Gauldie J, Margetts PJ, Farkas L, Dobranowski J, Boylan C, O'Byrne PM, Strieter RM, Kolb M. Circulating fibrocytes are an indicator of poor prognosis in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2009 Apr 1;179(7):588-94. doi: 10.1164/rccm.200810-1534OC. Epub 2009 Jan 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarker discovery	Discover and validate novel biomarkers and gene expression profiles for use in subsequent clinical studies in patients with idiopathic pulmonary fibrosis.	3 years
Secondary	Study disease behaviour	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.	3 years
Secondary	Differentiate IPF from NSIP	Identify differences in the pathogenetic mechanisms involved in the development of different types of fibrosis in patients with fibrotic lung disease of unknown cause.	3 years