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PROOF-Registry New and Extended Belgium -Luxembourg (PROOF-NEXT)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03732859
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborators:
Boehringer Ingelheim
Roche Farma, S.A
Information provided by (Responsible Party):
Belgian Thoracic Society

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

Condition or disease
Idiopathic Pulmonary Fibrosis

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
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
Actual Study Start Date : January 9, 2018
Estimated Primary Completion Date : January 9, 2021
Estimated Study Completion Date : January 9, 2023





Primary Outcome Measures :
  1. 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) ]
    FVC data will be retrieved from the medical file of the participant.

  2. The first occurrence of a decrease of ≥ 15% in percent predicted diffusing capacity of the lung for carbon monoxide (DLCO) since baseline [ Time Frame: overall duration of study (5 years) ]
    DLCO data will be retrieved from the medical file of the participant.

  3. Number of participants alive [ Time Frame: overall duration of study (5 years) ]
    Data on death will be retrieved from the medical file of the participant.

  4. The evolution of percent predicted forced vital capacity (FVC) [ Time Frame: overall duration of study (5 years) ]
    FVC data will be retrieved from the medical file of the participant.

  5. The evolution of percent predicted diffusing capacity of the lung for carbon monoxide (DLCO) [ Time Frame: overall duration of study (5 years) ]
    DLCO data will be retrieved from the medical file of the participant.

  6. The number of acute exacerbations of IPF [ Time Frame: overall duration of study (5 years) ]
    Acute exacerbations of IPF data will be retrieved from the medical file of the participant.


Secondary Outcome Measures :
  1. The number of patients per IPF treatment drug [ Time Frame: overall duration of study (5 years) ]
    IPF treatment drug data will be retrieved from the medical file of the participant.

  2. The mean initial dose per IPF treatment drug [ Time Frame: overall duration of study (5 years) ]
    IPF treatment drug data will be retrieved from the medical file of the participant.

  3. The mean number of dose changes per IPF treatment drug [ Time Frame: overall duration of study (5 years) ]
    IPF treatment drug data will be retrieved from the medical file of the participant.

  4. The number of participants who have discontinued the IPF treatment per IPF treatment drug [ Time Frame: overall duration of study (5 years) ]
    IPF treatment drug data will be retrieved from the medical file of the participant.

  5. The mean duration of treatment in days per IPF treatment drug [ Time Frame: overall duration of study (5 years) ]
    IPF treatment drug data will be retrieved from the medical file of the participant.

  6. The mean duration of dose reduction in days per IPF treatment drug [ Time Frame: overall duration of study (5 years) ]
    IPF treatment drug data will be retrieved from the medical file of the participant.

  7. The mean duration of drug interruption in days per IPF treatment drug [ Time Frame: overall duration of study (5 years) ]
    IPF treatment drug data will be retrieved from the medical file of the participant.

  8. The number of participants with lung transplantation [ Time Frame: overall duration of study (5 years) ]
    Lung transplantation data will be retrieved from the medical file of the participant.

  9. The (S)ADRs per IPF treatment reported which are possibly or probably related to the IPF treatment drug. [ Time Frame: overall duration of study (5 years) ]
    (S)ADR data will be retrieved from the medical file of the patient.

  10. The utilisation of health care resources by participants [ Time Frame: overall duration of study (5 years) ]
    The utilisation of health care resources will be retrieved from the medical file of the patient.

  11. The impact of IPF and IPF treatment on the severity of cough measured with the Cough-Visual Analogue Scale. [ Time Frame: overall duration of study (5 years) ]
    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.

  12. The impact of IPF and IPF treatment on quality of life measured with the SGRQ. [ Time Frame: overall duration of study (5 years) ]
    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.

  13. The impact of IPF and IPF treatment on quality of life measured with the EQ-5D-5L questionnaire. [ Time Frame: overall duration of study (5 years) ]

    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.


  14. The impact of IPF and IPF treatment on quality of life measured with with the K-BILD questionnaire [ Time Frame: overall duration of study (5 years) ]
    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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03732859


Contacts
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Contact: Lieve Bruggeman +32 (0)470557178 lieve.bruggeman@uzleuven.be
Contact: Agnes Tommeleyn +32 (0)2 518 18 18 info@bvp-sbp.org

Locations
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Belgium
Ziekenhuisnetwerk Antwerpen vzw Recruiting
Antwerp, Belgium, 2000
Contact: Maaike Viaene       maaike.viaene@zna.be   
Principal Investigator: Hans Slabbynck, MD         
Cliniques Universitaires de Bruxelles - Hôpital Erasme Recruiting
Brussels, Belgium, 1070
Contact: Liliane Collignon    +32 2 555 35 51    Liliane.Collignon@erasme.ulb.ac.be   
Principal Investigator: Benjamin Bondue, PhD MD         
Cliniques universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Sandra Koenig       sandra.koenig@uclouvain.be   
Principal Investigator: Antoine Froidure, PhD MD         
Universitair Ziekenhuis Gent Recruiting
Ghent, Belgium, 9000
Contact: Anja Delporte    +32(0)93320228    anja.delporte@uzgent.be   
Principal Investigator: Guy Joos, MD PhD         
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Lieve Bruggeman         
Principal Investigator: Wim Wuyts, PhD MD         
Sub-Investigator: Jonas Yserbiet, PhD MD         
Centre Hospitalier Universitaire Sart Tilman Recruiting
Liège, Belgium, 4000
Contact: Anne Chevremont, MD         
Principal Investigator: Julien Guiot, MD         
Sub-Investigator: Fanny Gester         
CHR de la Citadelle Recruiting
Liège, Belgium, 4000
Contact: Michel Crine    +32 4 225 70 47    Michel.crine@chrcitadelle.be   
Principal Investigator: Natacha Gusbin, MD         
CHU UCL Namur asbl - site Godinne Recruiting
Yvoir, Belgium, 5530
Contact: Emilie Collet    +32 81 42 30 28    emilie.collet@uclouvain.be   
Principal Investigator: Caroline Dahlqvist, MD         
Luxembourg
Centre Hospitalier de Luxembourg (CHL)/ Luxembourg Institute of Health (LIH) Recruiting
Luxembourg, Luxembourg, 1210
Contact: Gloria Montanes       Gloria.Montanes@lih.lu   
Principal Investigator: Marc Schlesser, MD         
Sponsors and Collaborators
Belgian Thoracic Society
Boehringer Ingelheim
Roche Farma, S.A
Investigators
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Study Director: Wim Wuyts, Phd, MD Universitaire Ziekenhuizen Leuven

Additional Information:

Publications:

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Responsible Party: Belgian Thoracic Society
ClinicalTrials.gov Identifier: NCT03732859     History of Changes
Other Study ID Numbers: BVPSBP01
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Belgian Thoracic Society:
IPF
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial