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IPF Italian Observational Study (FIBRONET) in Idiopathic Pulmonary Fibrosis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02803580
Recruitment Status : Completed
First Posted : June 17, 2016
Results First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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.

Condition or disease
Idiopathic Pulmonary Fibrosis

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Study Type : Observational
Actual Enrollment : 209 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: IPF Italian Observational Study (FIBRONET)
Actual Study Start Date : November 17, 2015
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : May 15, 2018





Primary Outcome Measures :
  1. Percentage of Participants With IPF Symptoms [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ]

    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).


  2. Change From Baseline to Follow-up Visits in Lung Function: Vital Capacity [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ]

    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.


  3. Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Actual) [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ]

    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.


  4. Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Predicted) [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ]

    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).


  5. Change From Baseline to Follow-up Visits in Lung Function: Forced Expiratory Volume in the 1st Second [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ]

    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.


  6. Change From Baseline to Follow-up Visits in Lung Function: Total Lung Capacity [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ]

    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.


  7. Change From Baseline to Follow-up Visits in Lung Function: Diffusion Capacity for Carbon Monoxide [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ]

    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].


  8. Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ]

    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.


  9. Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ]

    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.


  10. Change From Baseline to Follow-up Visits in Lung Function: Oxygen Saturation [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ]

    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.


  11. Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen in Arterial Blood at Rest [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ]

    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.


  12. Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide in Arterial Blood at Rest [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ]

    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.


  13. Change From Baseline to Follow-up Visits in Exercise Tolerance [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ]

    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



Secondary Outcome Measures :
  1. Characteristic of Participants at Enrollment: Key Socio-demographic Data: Age [ Time Frame: Baseline ]
    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.

  2. Characteristic of Participants at Enrollment: Key Demographic Data: Gender [ Time Frame: Baseline ]
    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.

  3. Characteristic of Participants at Enrollment: Key Demographic Data: Race [ Time Frame: Baseline ]
    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.

  4. Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level [ Time Frame: Baseline ]
    IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their highest education level.

  5. Characteristic of Participants at Enrollment: Key Demographic Data: Employment Status [ Time Frame: Baseline ]
    IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their employment status are presented.

  6. Characteristic of IPF Patients at Enrollment: Key Demographic Data: Body Mass Index [ Time Frame: Baseline ]
    IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their Body mass index are presented.

  7. Characteristic of Participants at Enrollment: Key Demographic Data: Housing Situation [ Time Frame: Baseline ]
    IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their housing situation are presented.

  8. Characteristic of Participants at Enrollment: Key Demographic Data: Marital Status [ Time Frame: Baseline ]
    IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their marital status are presented.

  9. IPF Risk Factors: Smoking Habit [ Time Frame: Baseline ]
    IPF enrolled participants were described in terms of potential IPF risk factors; number of participants as per their smoking habits are presented.

  10. IPF Risk Factors: Environmental Exposure [ Time Frame: Baseline ]
    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.

  11. IPF Risk Factors: Exposure to Drugs Associated With IPF [ Time Frame: Baseline ]
    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.

  12. IPF Risk Factors: Family History [ Time Frame: Baseline ]
    IPF enrolled participants were described in terms of potential IPF risk factors; number of participants as per their family history for IPF are presented.

  13. Number of Participants With Comorbidity [ Time Frame: Baseline ]
    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.

  14. IPF Disease Severity and Manifestation [ Time Frame: Baseline ]
    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.

  15. Number of Participants With Different Methods Used for IPF Diagnosis [ Time Frame: Baseline ]
    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.

  16. IPF Treatment Modalities: Non-pharmacological Treatment [ Time Frame: Baseline, 3 months, 6 months and 12 months ]
    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.

  17. IPF Treatment Modalities: Lung Transplantation [ Time Frame: Baseline, 3 months, 6 months and 12 months ]
    Number of participants who had lung transplantation at baseline, 3-month, 6-month and 12-month follow up visits are presented.

  18. IPF Treatment Modalities: Prescribed Drugs and Dose [ Time Frame: Baseline, 3 months, 6 months and 12 months ]
    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.

  19. Number of Exacerbations During 12 Months of Observation [ Time Frame: Up to 12 months ]
    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).

  20. Health Related Quality of Life Variation Measured With Saint George's Respiratory Questionnaire [ Time Frame: Baseline, 6 months and 12 months ]
    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.

  21. HRQoL Variation Measured With EuroQol Descriptive System [ Time Frame: Baseline, 6 months and 12 months ]
    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.

  22. HRQoL Measured With EQ VAS [ Time Frame: Baseline, 6 months and 12 months ]
    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.

  23. Health Care Resource Consumption From Diagnosis up to End of 12 Months Follow-up According to the Italian National Health Service (INHS) [ Time Frame: Up to 12 months ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
IPF pts
Criteria

Inclusion criteria:

  1. Patients aged>=40 years
  2. Written informed consent to both participation in the study and privacy
  3. 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.
  4. Patient with further follow-up possible with enrolling investigator during planned study period
  5. Patients capable of discernment and able to read or write in Italian language.

Exclusion criteria:

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

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): NCT02803580


Locations
Show Show 18 study locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Statistical Analysis Plan  [PDF] January 30, 2018
Study Protocol  [PDF] June 26, 2015

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02803580    
Other Study ID Numbers: 1199.262
First Posted: June 17, 2016    Key Record Dates
Results First Posted: September 13, 2019
Last Update Posted: September 13, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases