AzTrials
AzTrials

Idiopathic Pulmonary FibrosisPROOF-NEXTNCT03732859

PROOF-Registry New and Extended Belgium -Luxembourg

An observational study of Idiopathic Pulmonary Fibrosis, run by Belgian Thoracic Society at 9 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 19 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
How many people
575 participants
Where
9 sitesin 2 countries
Study dates
9 Jan 2018to 9 Jan 2022
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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

Who cannot join

  • Patients incapable of giving informed consent
  • Patients participating in a clinical trial at the time of inclusion in the registry and whose protocol does not allow participation in another trial

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

Belgium8 sites

  • Ziekenhuisnetwerk Antwerpen vzw

    Antwerp, 2000

  • Cliniques Universitaires de Bruxelles - Hôpital Erasme

    Brussels, 1070

  • Cliniques universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • University Hospitals Leuven

    Leuven, 3000

  • Centre Hospitalier Universitaire Sart Tilman

    Liège, 4000

  • CHR de la Citadelle

    Liège, 4000

  • CHU UCL Namur asbl - site Godinne

    Yvoir, 5530

Other trials in Belgium

Luxembourg1 site

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

    Luxembourg, 1210

Other trials in Luxembourg

About this study

Official title: A Prospective Observational Registry to Describe the Disease Course and Outcomes of Idiopathic Pulmonary Fibrosis Patients in a Real-world Clinical Setting. PROOF-Registry New and Extended Belgium -Luxembourg

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

Read the detailed description

Idiopathic pulmonary fibrosis (IPF) is a chronic disease of unknown etiology, characterized by scar tissue (fibrosis) within the lungs. IPF is one of the most common forms of interstitial lung disease and is associated with substantial morbidity and mortality (average survival of approximately three years from the time of diagnosis)).

The epidemiology and natural history of IPF is still not completely understood. Incidence and prevalence of IPF are difficult to determine because uniform diagnostic criteria have only recently been defined. Recent data among subjects aged 50 years or older suggests an age- and sex-adjusted incidence rate ranging from 8.8 cases to 17.4 cases per 100,000 person-years in the USA. In the same population, age- and sex- adjusted prevalence ranged from 27.9 cases to 63 cases per 100,000 persons.

Familial form of IPF accounts for 0.5 to 2% of all cases of IPF. Several environmental or occupational exposures seem to be prevalent in the medical histories of patients diagnosed with the disease.

The onset of IPF symptoms is slow, but symptoms become progressively worse over time. Breathlessness upon exertion and chronic dry cough are the major symptoms. Gastro-esophageal acid reflux is present in almost 90% of patients with IPF but often occurs without symptoms.

Auscultation of the lungs reveals early inspiratory crackles, predominantly located in the lower posterior lung zones upon physical exam. Clubbing is found in approximately 50% of patients with IPF.

Quality of life of patients with IPF is impacted by the disease.

Establishing an accurate diagnosis for the patient who presents with interstitial lung disease is an essential component of management. The recent ATS/ERS/JRS/ALAT recommendations on the diagnosis and management of IPF were developed from a systematic review of the published literature. High-resolution computed tomography (HRCT) scanning has a central role in the IPF diagnostic pathway with formal designation of criteria for an HRCT pattern of Usual Interstitial Pneumonia (UIP). In the correct clinical context, a UIP pattern on HRCT is indicative of a definite diagnosis of IPF without the need for a surgical lung biopsy.

IPF presents significant associations with other cardiopulmonary disorders including coronary artery disease, pulmonary embolism, sleep apnea, respiratory infections and lung cancer. In addition, patients with IPF are at risk for 'acute exacerbations'. Acute exacerbation is defined as an acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormality. Diagnostic criteria are: previous or concurrent diagnosis of IPF; acute worsening or development of dyspnea typically < 1 mo duration; computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia pattern; deterioration not fully explained by cardiac failure or fluid overload. These acute exacerbations are responsible for 50% of deaths in IPF and may affect previously stable patients.

The clinical course of IPF is highly variable and as a result, therapeutic strategies should be highly individualized, based upon the specific patients' medical history and co-morbidities.

Pirfenidone and Nintedanib are drugs approved for the treatment of adult patients with mild to moderate idiopathic pulmonary fibrosis in the European Union. In order to complement the data collected in previous studies, we implement a registry to describe the epidemiology and natural history of IPF, as well as the quality of life of IPF patients, and use of health care resources, in Belgium and Luxembourg. This registry will also enable the collection of clinical data of patients treated with Pirfenidone or Nintedanib and other therapies used in the treatment of IPF. The registry will be implemented in collaboration with pulmonologists and expert centers in order to enable the inclusion and follow up of recently diagnosed IPF patients.

Keywords
IPF
Medical subject headings
Idiopathic Pulmonary Fibrosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: overall duration of study (5 years)

  2. 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.

    Measured: overall duration of study (5 years)

  3. Number of participants alive

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

    Measured: overall duration of study (5 years)

  4. The evolution of percent predicted forced vital capacity (FVC)

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

    Measured: overall duration of study (5 years)

  5. 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.

    Measured: overall duration of study (5 years)

  6. The number of acute exacerbations of IPF

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

    Measured: overall duration of study (5 years)

Secondary outcomes (14)

  1. The number of patients per IPF treatment drug

    IPF treatment drug data will be retrieved from the medical file of the participant.

    Measured: overall duration of study (5 years)

  2. The mean initial dose per IPF treatment drug

    IPF treatment drug data will be retrieved from the medical file of the participant.

    Measured: overall duration of study (5 years)

  3. The mean number of dose changes per IPF treatment drug

    IPF treatment drug data will be retrieved from the medical file of the participant.

    Measured: overall duration of study (5 years)

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

    IPF treatment drug data will be retrieved from the medical file of the participant.

    Measured: overall duration of study (5 years)

  5. The mean duration of treatment in days per IPF treatment drug

    IPF treatment drug data will be retrieved from the medical file of the participant.

    Measured: overall duration of study (5 years)

  6. The mean duration of dose reduction in days per IPF treatment drug

    IPF treatment drug data will be retrieved from the medical file of the participant.

    Measured: overall duration of study (5 years)

  7. The mean duration of drug interruption in days per IPF treatment drug

    IPF treatment drug data will be retrieved from the medical file of the participant.

    Measured: overall duration of study (5 years)

  8. The number of participants with lung transplantation

    Lung transplantation data will be retrieved from the medical file of the participant.

    Measured: overall duration of study (5 years)

  9. The (S)ADRs per IPF treatment reported which are possibly or probably related to the IPF treatment drug.

    (S)ADR data will be retrieved from the medical file of the patient.

    Measured: overall duration of study (5 years)

  10. The utilisation of health care resources by participants

    The utilisation of health care resources will be retrieved from the medical file of the patient.

    Measured: overall duration of study (5 years)

  11. The impact of IPF and IPF treatment on the severity of cough measured with the Cough-Visual Analogue Scale.

    Cough severity in the last 2 weeks was assessed at inclusion and at every follow-up visit using the Cough-VAS, a linear visual scale with 0 mm representing 'no cough' and 100 mm.

    Measured: overall duration of study (5 years)

  12. The impact of IPF and IPF treatment on quality of life measured with the SGRQ.

    The St- George's Respiratory questionnaire (SGRQ) is a 50-item questionnaire consisting of two parts. The first part evaluates the symptoms (i.e. cough, sputum production, wheezing and breathlessness) and the second part evaluates the activities (i.e. activities causing breathlessness or limited by breathlessness) and the impacts (e.g. on employment, daily life, etc.). Each question is scored as positive (i.e. =1) or negative (i.e. =0) and the total score is expressed as a percentage where 0% represents the best possible health status and 100% the worst possible health status. A total score can be obtained as well as a score for each of the three components. Data are collected at inclusion and minimal twice a year during follow-up.

    Measured: overall duration of study (5 years)

  13. The impact of IPF and IPF treatment on quality of life measured with the EQ-5D-5L questionnaire.

    The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels, going from no problems to extreme problems. Only 1 option can be chosen by the patient. This decision results in a 1-digit number that expresses the level selected for that dimension: no problems (=1), slight problems(=2), moderate problems(=3), severe problems(=4) and extreme problems(=5). The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where 0 mm represents 'worst health imaginable' and 100 mm representing 'best health imaginable'.

    Data are collected at Inclusion and at every follow-up visit.

    Measured: overall duration of study (5 years)

  14. The impact of IPF and IPF treatment on quality of life measured with with the K-BILD questionnaire

    Patients will receive the K-BILD questionnaire measuring their health-related quality of life. The K-BILD is a 15-item self-completed questionnaire measuring the health-related quality of life (HRQL) of patients with interstitial lung disease. It consists of three domains: breathlessness and activities, psychological and chest symptoms. Each question has a seven-point response scale resulting in a total score ranging between 0 and 100 with a higher score reflecting a higher HRQL. Data are collected at inclusion and at every follow-up visit.

    Measured: overall duration of study (5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2018
  2. Study start9 Jan 2018
  3. Primary completion1 Nov 2021
  4. Study completion9 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
575 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03732859
Sponsor's protocol ID
BVPSBP01
Acronym
PROOF-NEXT
Status last verified
Feb 2022
First submitted
26 Jul 2018
Last updated
15 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21471066

  • 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.

    PubMed 12773325

  • 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.

    PubMed 12773329

  • 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.

    PubMed 12791580

  • 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.

    PubMed 19749005

  • 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.

    PubMed 10639533

  • 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.

    PubMed 9001319

  • 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.

    PubMed 11790668

  • 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.

    PubMed 16387946

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

    PubMed 18366757

  • 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.

    PubMed 20199856

  • 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.

    PubMed 18755924

  • 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.

    PubMed 2183601

  • 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.

    PubMed 19567497

  • 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.

    PubMed 10619790

Questions about this trial

What is this clinical trial studying?

An observational study of Idiopathic Pulmonary Fibrosis, run by Belgian Thoracic Society at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Belgium, Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The first occurrence of a decrease of ≥ 10% in percent predicted forced vital capacity (FVC) since baseline. (time frame: overall duration of study (5 years)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03732859, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in