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Idiopathic Pulmonary FibrosisNCT02803580

IPF Italian Observational Study (FIBRONET) in Idiopathic Pulmonary Fibrosis

An observational study of Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 18 sites in Italy.

Completed

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

Official record
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Trial summary

The purpose of the present study is to evaluate the characteristics, management and clinical course of patients with IPF as treated under real-world in Italian Pulmonary Centres, in terms of symptoms, lung function and exercise tolerance during 12 months of observation. Read more about this study

Who is it for?
Ages 40 to 99 years
Conditions the study is for
Idiopathic Pulmonary Fibrosis
How many people
209 participants
Where
18 sitesItaly
Study dates
17 Nov 2015to 15 May 2018
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 40 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: IPF pts

Who may be able to join

  • Patients aged>=40 years
  • Written informed consent to both participation in the study and privacy
  • Physician diagnosed IPF during the last 3 months based upon recent American Thoracic Society/European Resp. Society/Japanese Resp. Society/Latin American Thoracic Association guidelines 2011 (see Tables A1-A2 for High Resolution Chest Computer Tomography and histology criteria):
  • Exclusion of other known causes of Interstitial Lung Disease (e.g. domestic and occupational environmental exposures, connective tissue disease and drug toxicity)
  • Assessment of Idiopathic Pulmonary Fibrosis based on High Resolution Computed Tomography (HRCT) or HRCT and surgical lung biopsy if available.
  • Patient with further follow-up possible with enrolling investigator during planned study period
  • Patients capable of discernment and able to read or write in Italian language.

Who cannot join

  • Inclusion in clinical trials or other IPF/ILD registries
  • Lung transplantation expected within the next 6 months
  • Pregnancy or breast feeding

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Italy18 sites

  • A.O.U. Policlinico Vittorio Emanuele

    Catania, 95124

  • Osp. Clin. SS. Anunziata

    Chieti, 66100

  • Ospedale Colonnello D Avanzo

    Foggia, 71100

  • Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli

    Forlì, 47121

  • Osp. S. Giuseppe Fatebenefratelli

    Milan, 20123

  • Azienda Ospedaliera Policlinico di Modena

    Modena, 41124

  • A.O. San Gerardo di Monza

    Monza, 20900

  • Azienda Ospedaliera Universitaria "Federico II"

    Naples, 80138

  • Azienda Sanitaria Ospedale S. Luigi Gonzaga

    Orbassano, 10043

  • Azienda Ospedaliera Universitaria di Padova

    Padova, 35128

  • Fondazione IRCCS Policlinico S. Matteo

    Pavia, 27100

  • Ospedale di Cisanello

    Pisa, 56124

  • Pol. Universitario Tor Vergata

    Roma, 00133

  • A.O. San Camillo Forlanini

    Roma, 00149

  • Policlinico Gemelli

    Roma, 00168

  • Policlinico Universitario di Sassari

    Sassari, 07100

  • A.O.U. Senese Policlinico Santa Maria alle Scotte

    Siena, 53100

  • Ospedale Riuniti di Ancona

    Torrette-Ancona, 60126

Other trials in Italy

About this study

Official title: IPF Italian Observational Study (FIBRONET)

The purpose of the present study is to evaluate the characteristics, management and clinical course of patients with IPF as treated under real-world in Italian Pulmonary Centres, in terms of symptoms, lung function and exercise tolerance during 12 months of observation.

Medical subject headings
Idiopathic Pulmonary Fibrosis

What is being measured

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

  1. Percentage of Participants With IPF Symptoms

    Percentage of participants with IPF symptoms such as cough, fatigue, dizziness, chest pain or any other symptom at 12-month follow up visit. The symptoms in the class 'other' reported upon specific visits were dyspnea, hemoptysis, post-nasal drip, sputum, weight loss, worsening of fatigue and lack of appetite.

    Baseline (V1), 3 months (V2), 6 months (V3), 9 months (V4) and 12 months (V5).

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months

  2. Change From Baseline to Follow-up Visits in Lung Function: Vital Capacity

    In calculating the change from baseline to all follow-up visits (3 months, 6 months, 9 months and 12 months) in lung function: Vital Capacity (VC), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:

    Change in parameter VC = value of parameter VC at follow up visit - value of parameter VC at baseline visit.

    A positive value of change indicates a better outcome.

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months

  3. Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Actual)

    In calculating the change from baseline to follow-up visits in lung function: Forced Vital Capacity (FVC), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:

    Change in parameter FVC = value of parameter FVC at follow up visit - value of parameter FVC at baseline visit.

    A positive value of change indicates a better outcome.

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months

  4. Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Predicted)

    In calculating the change from baseline to follow-up visits in lung function: Forced Vital Capacity (FVC), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:

    Change in parameter FVC = value of parameter FVC at follow up visit - value of parameter FVC at baseline visit.

    A positive value of change indicates a better outcome.

    The value of FVC % of predicted is a relevant parameter to understand and classify the severity of the disease at the diagnosis and to follow up patients during the treatment (i.e. annual rate decline of FVC >10% is a predictor of high rate of mortality).

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months

  5. Change From Baseline to Follow-up Visits in Lung Function: Forced Expiratory Volume in the 1st Second

    In calculating the change from baseline to follow-up visits in lung function: Forced Expiratory Volume in the 1st second (FEV1), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:

    Change in parameter FEV1 = value of parameter FEV1 at follow up visit - value of parameter FEV1 at baseline visit.

    A positive value of change indicates a better outcome.

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months

  6. Change From Baseline to Follow-up Visits in Lung Function: Total Lung Capacity

    In calculating the change from baseline to follow-up visits in lung function: Total Lung Capacity (TLC), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:

    Change in parameter TLC = value of parameter TLC at follow up visit - value of parameter TLC at baseline visit.

    A positive value of change indicates a better outcome.

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months

  7. Change From Baseline to Follow-up Visits in Lung Function: Diffusion Capacity for Carbon Monoxide

    In calculating the change from baseline to follow-up visits in lung function: Diffusion capacity for carbon monoxide (DLCO), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:

    Change in parameter DLCO = value of parameter DLCO at follow up visit - value of parameter DLCO at baseline visit.

    A positive value of change indicates a better outcome.

    Values of DLCO with unit = milliliter/minute/millimeter mercury (ml/min/mmHg) were converted to micromole/minute/kilopascal (mmol/min/kPa) according to the following formula:

    DLCO (mmol/min/kPa) = DLCO (ml/min/mmHg)/2.986 [46].

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months

  8. Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen

    In calculating the change from baseline to follow-up visits in lung function: Partial Pressure of Oxygen (PO2), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:

    Change in parameter PO2 = value of parameter PO2 at follow up visit - value of parameter PO2 at baseline visit.

    A positive value of change indicates a better outcome.

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months

  9. Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide

    In calculating the change from baseline to follow-up visits in lung function: Partial Pressure of Carbon dioxide (PCO2), only patients with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:

    Change in parameter PCO2 = value of parameter PCO2 at follow up visit - value of parameter PCO2 at baseline visit.

    A positive value of change indicates a better outcome.

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months

  10. Change From Baseline to Follow-up Visits in Lung Function: Oxygen Saturation

    In calculating the change from baseline to follow-up visits in lung function: Oxygen Saturation (SaO2), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:

    Change in parameter SaO2 = value of parameter SaO2 at follow up visit - value of parameter SaO2 at baseline visit.

    A positive value of change indicates a better outcome.

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months

  11. Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen in Arterial Blood at Rest

    In calculating the change from baseline to follow-up visits in lung function: Partial Pressure of Oxygen in arterial blood at rest (PaO2), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:

    Change in parameter PaO2 = value of parameter PaO2 at follow up visit - value of parameter PaO2 at baseline visit.

    A positive value of change indicates a better outcome.

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months

  12. Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide in Arterial Blood at Rest

    In calculating the change from baseline to follow-up visits in lung function: Partial Pressure of Carbon dioxide in arterial blood at rest (PaCO2), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:

    Change in parameter PaCO2 = value of parameter PaCO2 at follow up visit - value of parameter PaCO2 at baseline visit.

    A positive value of change indicates a better outcome.

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months

  13. Change From Baseline to Follow-up Visits in Exercise Tolerance

    Change from baseline to follow-up visits in exercise tolerance was evaluated by means of change in 6 minute walked distance test.

    Change versus baseline was calculated as parameter at follow up - parameter at baseline.

    A positive value of change indicates a better outcome. The 6-minute walked distance test was carried out using two parameters start of peripheral capillary oxygen saturation (SpO2) and SpO2 at the end of the test. Only participants with values available at baseline and at follow up were considered

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months

Secondary outcomes (23)

  1. Characteristic of Participants at Enrollment: Key Socio-demographic Data: Age

    IPF enrolled participants were described in terms of socio-demographic variables (e.g. age, gender, race, body mass index, educational degree, and employment status) at baseline.

    Measured: Baseline

  2. Characteristic of Participants at Enrollment: Key Demographic Data: Gender

    IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their gender are presented. The data is provided in baseline section.

    Measured: Baseline

  3. Characteristic of Participants at Enrollment: Key Demographic Data: Race

    IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their race are presented. The data is provided in baseline section.

    Measured: Baseline

  4. Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level

    IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their highest education level.

    Measured: Baseline

  5. Characteristic of Participants at Enrollment: Key Demographic Data: Employment Status

    IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their employment status are presented.

    Measured: Baseline

  6. Characteristic of IPF Patients at Enrollment: Key Demographic Data: Body Mass Index

    IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their Body mass index are presented.

    Measured: Baseline

  7. Characteristic of Participants at Enrollment: Key Demographic Data: Housing Situation

    IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their housing situation are presented.

    Measured: Baseline

  8. Characteristic of Participants at Enrollment: Key Demographic Data: Marital Status

    IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their marital status are presented.

    Measured: Baseline

  9. IPF Risk Factors: Smoking Habit

    IPF enrolled participants were described in terms of potential IPF risk factors; number of participants as per their smoking habits are presented.

    Measured: Baseline

  10. IPF Risk Factors: Environmental Exposure

    IPF enrolled participants were described in terms of potential IPF risk factors; number of participants as per their environmental exposure (such as bricklayer, building material dust, cement dust, chemical gas, coal dust, factory food, marble dust, masonry dust, mold, paint, powdered detergent and textile material) are presented.

    Measured: Baseline

  11. IPF Risk Factors: Exposure to Drugs Associated With IPF

    IPF enrolled participants were described in terms of potential IPF risk factors; number of participants as per their exposure to drugs associated with IPF are presented.

    Measured: Baseline

  12. IPF Risk Factors: Family History

    IPF enrolled participants were described in terms of potential IPF risk factors; number of participants as per their family history for IPF are presented.

    Measured: Baseline

  13. Number of Participants With Comorbidity

    Number of participants with ongoing comorbidities (such as gastroesophageal reflux disease, pulmonary hypertension, emphysema, lung cancer, coronary heart disease, depression) are provided. Some participants reported more than one comorbidity at enrollment.

    Measured: Baseline

  14. IPF Disease Severity and Manifestation

    IPF disease severity and manifestation (including lung function, cardiopulmonary exercise testing and/or exercise capacity if available, laboratory values) is measured by the FVC. Percentages are calculated out of the total number of evaluable participants with available FVC of the predicted at baseline.

    Measured: Baseline

  15. Number of Participants With Different Methods Used for IPF Diagnosis

    Several diagnostic approaches were used to detect IPF, the main ones being High Resolution chest Computer Tomography (HRCT), surgical lung biopsy, Bronchoalveolar lavage (BAL), transbronchial biopsy and spirometry.

    Measured: Baseline

  16. IPF Treatment Modalities: Non-pharmacological Treatment

    Number of participants with ≥1 non-pharmacological therapy for IPF ongoing at baseline (visit 1), 3-month (visit 2), 6-month (visit 3) and 12-month (visit 5) follow up visits are presented.

    Measured: Baseline, 3 months, 6 months and 12 months

  17. IPF Treatment Modalities: Lung Transplantation

    Number of participants who had lung transplantation at baseline, 3-month, 6-month and 12-month follow up visits are presented.

    Measured: Baseline, 3 months, 6 months and 12 months

  18. IPF Treatment Modalities: Prescribed Drugs and Dose

    IPF Patients with ≥1 pharmacological therapy for IPF ongoing at baseline, 3-month, 6-month and 12-month follow up visits are presented. The pharmacological therapies used for IPF treatment are Nintedanib and Pirfenidone.

    Measured: Baseline, 3 months, 6 months and 12 months

  19. Number of Exacerbations During 12 Months of Observation

    Number of participants with mild, moderate and severe exacerbations during the observation period are presented. An exacerbation was considered occurred during observation period if onset date ≥ date of first IPF diagnosis and onset date ≤ last available visit date (for participants who completed the study) or date of drop out or date of death (for participants who did not complete the study).

    Measured: Up to 12 months

  20. Health Related Quality of Life Variation Measured With Saint George's Respiratory Questionnaire

    Health Related Quality of Life (HRQoL) variation measured with Saint George's Respiratory Questionnaire (SGRQ), developed to measure health in chronic airflow limitation. It is a disease-specific instrument designed to measure health impairment in terms of impact on overall health, daily life, and perceived well-being in participants with obstructive airways disease. Three component scores (symptoms, activity and impacts on daily life) and a total score were calculated, with lower scores corresponding to better health. The Total score is calculated by summing all positive responses in the questionnaire and expressing the result as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.

    Measured: Baseline, 6 months and 12 months

  21. HRQoL Variation Measured With EuroQol Descriptive System

    The quality of life was evaluated by the EuroQol 5-dimension 5-level (EQ-5D-5L) a standardized measure of health status developed by EuroQol Group to provide a simple generic measure of health status for clinical and economic evaluation. EQ-5D-5L was filled in by participants, it was easy from a cognitive point of view, since it took only few minutes for filling. EQ-5D-5L consists of 2 sections: "EQ-5D descriptive system" and EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

    Measured: Baseline, 6 months and 12 months

  22. HRQoL Measured With EQ VAS

    The quality of life was evaluated by the EQ-5D-5L a standardized measure of health status developed by EuroQol Group to provide a simple generic measure of health status for clinical and economic evaluation. EQ-5D-5L consists of 2 sections: "EQ-5D descriptive system" and EQ VAS. The EQ VAS indicate the health status self-assessed by the participants on a visual analogue scale from 0 to 100, where 100 is the "best imaginable health state" and 0 the "worst imaginable health state". It can be used as a quantitative measure of health as judged by participants.

    Measured: Baseline, 6 months and 12 months

  23. Health Care Resource Consumption From Diagnosis up to End of 12 Months Follow-up According to the Italian National Health Service (INHS)

    The health care sector-related costs at diagnosis and from diagnosis up to the end of 12-month follow-up according to the INHS point of view, was carried out in a two-step approach:

    (i)First of all the resource consumption exclusively related to both IPF, IPF exacerbations and IPF-related adverse events since diagnosis was collected or estimated and then (ii) A monetary value was assigned to the collected or estimated resource consumption.

    Health care resource consumption was computed during observational period in terms of number of (inward and day-hospital) hospitalizations and number of Intensive Care Unit (ICU) admissions.

    Measured: Up to 12 months

Timeline

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

  1. First posted17 Jun 2016 (estimated)
  2. Study start17 Nov 2015
  3. Primary completion15 May 2018
  4. Study completion15 May 2018

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
Cohort
Time perspective
Prospective
Enrolment
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02803580
Sponsor's protocol ID
1199.262
Status last verified
Aug 2019
First submitted
30 Nov 2015
Last updated
13 Sep 2019

Publications

  • Poletti V, Vancheri C, Albera C, Harari S, Pesci A, Metella RR, Campolo B, Crespi G, Rizzoli S; FIBRONET study group. Clinical course of IPF in Italian patients during 12 months of observation: results from the FIBRONET observational study. Respir Res. 2021 Feb 24;22(1):66. doi: 10.1186/s12931-021-01643-w.

    PubMed 33627105

Questions about this trial

What is this clinical trial studying?

An observational study of Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 18 sites in Italy.

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 7 inclusion and 3 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 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Italy. 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?

Yes. Results are posted in the registry (first posted 13 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With IPF Symptoms (time frame: Baseline, 3 months, 6 months, 9 months and 12 months). The study lists 13 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 NCT02803580, which also lists 1 linked publication.

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 13 Sep 2019.

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