PROOF-Registry New and Extended Belgium -Luxembourg

NCT03732859 | Completed DMC

• 1 other identifier: BVPSBP01
• Study Type: observational
• Target: 575
• Locations: 2 countries
• Sites: 9

Brief Summary

A Prospective Observational Registry to describe the disease course and outcomes of Idiopathic Pulmonary Fibrosis patients in a real-world clinical setting.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

IPF

Outcome Measures

Primary Outcomes (6)

• The first occurrence of a decrease of ≥ 10% in percent predicted forced vital capacity (FVC) since baseline.

  FVC data will be retrieved from the medical file of the participant.

  overall duration of study (5 years)

• The first occurrence of a decrease of ≥ 15% in percent predicted diffusing capacity of the lung for carbon monoxide (DLCO) since baseline

  DLCO data will be retrieved from the medical file of the participant.

  overall duration of study (5 years)

• Number of participants alive

  Data on death will be retrieved from the medical file of the participant.

  overall duration of study (5 years)

• The evolution of percent predicted forced vital capacity (FVC)

  FVC data will be retrieved from the medical file of the participant.

  overall duration of study (5 years)

• The evolution of percent predicted diffusing capacity of the lung for carbon monoxide (DLCO)

  DLCO data will be retrieved from the medical file of the participant.

  overall duration of study (5 years)

• The number of acute exacerbations of IPF

  Acute exacerbations of IPF data will be retrieved from the medical file of the participant.

  overall duration of study (5 years)

Secondary Outcomes (14)

• The number of patients per IPF treatment drug

  overall duration of study (5 years)

• The mean initial dose per IPF treatment drug

  overall duration of study (5 years)

• The mean number of dose changes per IPF treatment drug

  overall duration of study (5 years)

• The number of participants who have discontinued the IPF treatment per IPF treatment drug

  overall duration of study (5 years)

• The mean duration of treatment in days per IPF treatment drug

  overall duration of study (5 years)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults diagnosed with an IPF diagnosis "definite" or "probable" (according to 2011 ATS/ERS guidelines definitions) which is confirmed by a multidisciplinary team (= minimum of pulmonologist, radiologist, pathologist, all with expertise in IPF).

You may qualify if:

• Patients \>18 years of age
• IPF diagnosis "definite" or "probable" (2011 ATS/ERS guidelines definitions) confirmed by a multidisciplinary team (= minimum of pulmonologist, radiologist, pathologist, all with expertise in IPF).
• Patients who agreed to participate in the registry and have completed and signed the Informed Consent Form

You may not qualify if:

• Patients incapable of giving informed consent

Sponsors & Collaborators

• Belgian Thoracic Society: lead
• Boehringer Ingelheim: collaborator
• Roche Farma, S.A: collaborator

Study Sites (9)

Ziekenhuisnetwerk Antwerpen vzw

Antwerp, 2000, Belgium

Location

Cliniques Universitaires de Bruxelles - Hôpital Erasme

Brussels, 1070, Belgium

Location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire Sart Tilman

Liège, 4000, Belgium

Location

CHR de la Citadelle

Liège, 4000, Belgium

Location

CHU UCL Namur asbl - site Godinne

Yvoir, 5530, Belgium

Location

Centre Hospitalier de Luxembourg (CHL)/ Luxembourg Institute of Health (LIH)

Luxembourg, 1210, Luxembourg

Location

Related Publications (18)

• Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.

  PMID: 21471066 BACKGROUND

• Collard HR, King TE Jr, Bartelson BB, Vourlekis JS, Schwarz MI, Brown KK. Changes in clinical and physiologic variables predict survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2003 Sep 1;168(5):538-42. doi: 10.1164/rccm.200211-1311OC. Epub 2003 May 28.

  PMID: 12773325 BACKGROUND

• Flaherty KR, Mumford JA, Murray S, Kazerooni EA, Gross BH, Colby TV, Travis WD, Flint A, Toews GB, Lynch JP 3rd, Martinez FJ. Prognostic implications of physiologic and radiographic changes in idiopathic interstitial pneumonia. Am J Respir Crit Care Med. 2003 Sep 1;168(5):543-8. doi: 10.1164/rccm.200209-1112OC. Epub 2003 May 28.

  PMID: 12773329 BACKGROUND

• Latsi PI, du Bois RM, Nicholson AG, Colby TV, Bisirtzoglou D, Nikolakopoulou A, Veeraraghavan S, Hansell DM, Wells AU. Fibrotic idiopathic interstitial pneumonia: the prognostic value of longitudinal functional trends. Am J Respir Crit Care Med. 2003 Sep 1;168(5):531-7. doi: 10.1164/rccm.200210-1245OC. Epub 2003 Jun 5.

  PMID: 12791580 BACKGROUND

• Fernandez Perez ER, Daniels CE, Schroeder DR, St Sauver J, Hartman TE, Bartholmai BJ, Yi ES, Ryu JH. Incidence, prevalence, and clinical course of idiopathic pulmonary fibrosis: a population-based study. Chest. 2010 Jan;137(1):129-37. doi: 10.1378/chest.09-1002. Epub 2009 Sep 11.

  PMID: 19749005 BACKGROUND

• Marshall RP, Puddicombe A, Cookson WO, Laurent GJ. Adult familial cryptogenic fibrosing alveolitis in the United Kingdom. Thorax. 2000 Feb;55(2):143-6. doi: 10.1136/thorax.55.2.143.

  PMID: 10639533 BACKGROUND

• Baumgartner KB, Samet JM, Stidley CA, Colby TV, Waldron JA. Cigarette smoking: a risk factor for idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 1997 Jan;155(1):242-8. doi: 10.1164/ajrccm.155.1.9001319.

  PMID: 9001319 BACKGROUND

• American Thoracic Society; European Respiratory Society. American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias. This joint statement of the American Thoracic Society (ATS), and the European Respiratory Society (ERS) was adopted by the ATS board of directors, June 2001 and by the ERS Executive Committee, June 2001. Am J Respir Crit Care Med. 2002 Jan 15;165(2):277-304. doi: 10.1164/ajrccm.165.2.ats01. No abstract available.

  PMID: 11790668 BACKGROUND

• Raghu G, Freudenberger TD, Yang S, Curtis JR, Spada C, Hayes J, Sillery JK, Pope CE 2nd, Pellegrini CA. High prevalence of abnormal acid gastro-oesophageal reflux in idiopathic pulmonary fibrosis. Eur Respir J. 2006 Jan;27(1):136-42. doi: 10.1183/09031936.06.00037005.

  PMID: 16387946 BACKGROUND

• Meltzer EB, Noble PW. Idiopathic pulmonary fibrosis. Orphanet J Rare Dis. 2008 Mar 26;3:8. doi: 10.1186/1750-1172-3-8.

  PMID: 18366757 BACKGROUND

• Nathan SD, Basavaraj A, Reichner C, Shlobin OA, Ahmad S, Kiernan J, Burton N, Barnett SD. Prevalence and impact of coronary artery disease in idiopathic pulmonary fibrosis. Respir Med. 2010 Jul;104(7):1035-41. doi: 10.1016/j.rmed.2010.02.008. Epub 2010 Mar 2.

  PMID: 20199856 BACKGROUND

• Hubbard RB, Smith C, Le Jeune I, Gribbin J, Fogarty AW. The association between idiopathic pulmonary fibrosis and vascular disease: a population-based study. Am J Respir Crit Care Med. 2008 Dec 15;178(12):1257-61. doi: 10.1164/rccm.200805-725OC. Epub 2008 Aug 28.

  PMID: 18755924 BACKGROUND

• Panos RJ, Mortenson RL, Niccoli SA, King TE Jr. Clinical deterioration in patients with idiopathic pulmonary fibrosis: causes and assessment. Am J Med. 1990 Apr;88(4):396-404. doi: 10.1016/0002-9343(90)90495-y.

  PMID: 2183601 BACKGROUND

• Lancaster LH, Mason WR, Parnell JA, Rice TW, Loyd JE, Milstone AP, Collard HR, Malow BA. Obstructive sleep apnea is common in idiopathic pulmonary fibrosis. Chest. 2009 Sep;136(3):772-778. doi: 10.1378/chest.08-2776. Epub 2009 Jun 30.

  PMID: 19567497 BACKGROUND

• Hubbard R, Venn A, Lewis S, Britton J. Lung cancer and cryptogenic fibrosing alveolitis. A population-based cohort study. Am J Respir Crit Care Med. 2000 Jan;161(1):5-8. doi: 10.1164/ajrccm.161.1.9906062.

  PMID: 10619790 BACKGROUND

• Collard HR, Ryerson CJ, Corte TJ, Jenkins G, Kondoh Y, Lederer DJ, Lee JS, Maher TM, Wells AU, Antoniou KM, Behr J, Brown KK, Cottin V, Flaherty KR, Fukuoka J, Hansell DM, Johkoh T, Kaminski N, Kim DS, Kolb M, Lynch DA, Myers JL, Raghu G, Richeldi L, Taniguchi H, Martinez FJ. Acute Exacerbation of Idiopathic Pulmonary Fibrosis. An International Working Group Report. Am J Respir Crit Care Med. 2016 Aug 1;194(3):265-75. doi: 10.1164/rccm.201604-0801CI.

  PMID: 27299520 BACKGROUND

• Martinez FJ, Safrin S, Weycker D, Starko KM, Bradford WZ, King TE Jr, Flaherty KR, Schwartz DA, Noble PW, Raghu G, Brown KK; IPF Study Group. The clinical course of patients with idiopathic pulmonary fibrosis. Ann Intern Med. 2005 Jun 21;142(12 Pt 1):963-7. doi: 10.7326/0003-4819-142-12_part_1-200506210-00005.

  PMID: 15968010 BACKGROUND

• Gan Y, Herzog EL, Gomer RH. Pirfenidone treatment of idiopathic pulmonary fibrosis. Ther Clin Risk Manag. 2011 Feb 8;7:39-47. doi: 10.2147/TCRM.S12209.

  PMID: 21339942 BACKGROUND

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wim Wuyts, Phd, MD

  Universitaire Ziekenhuizen KU Leuven

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: November 7, 2018
• Study Start: January 9, 2018
• Primary Completion: November 1, 2021
• Study Completion: January 9, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

LU (1); BE (8)