Trial Outcomes & Findings for IPF Italian Observational Study (FIBRONET) in Idiopathic Pulmonary Fibrosis (NCT NCT02803580)

NCT ID: NCT02803580

Last Updated: 2019-09-13

Results Overview

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).

• Recruitment status: COMPLETED
• Target enrollment: 209 participants
• Primary outcome timeframe: Baseline, 3 months, 6 months, 9 months and 12 months
• Results posted on: 2019-09-13

Participant Flow

This was an observational study based on participants newly diagnosed with Idiopathic Pulmonary Fibrosis (IPF) for less than 3 months, who enrolled in 20 Italian Pulmonary Centers highly experienced in the disease management of IPF. Data collection was performed between 30th November 2015 and 15th May 2018.

Data source for this study were medical records usually collected during routine clinical practice other than study-specific questionnaires.

Participant milestones

Measure	Participants With Idiopathic Pulmonary Fibrosis Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Overall Study STARTED	209
Overall Study COMPLETED	173
Overall Study NOT COMPLETED	36

Reasons for withdrawal

Measure	Participants With Idiopathic Pulmonary Fibrosis Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Overall Study Death	13
Overall Study Lost to Follow-up	19
Overall Study Withdrawal by Subject	3
Overall Study Inclusion in clinical trial	1

Baseline Characteristics

IPF Italian Observational Study (FIBRONET) in Idiopathic Pulmonary Fibrosis

Baseline characteristics by cohort

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Age, Continuous	69.54 Years STANDARD_DEVIATION 7.43 • n=209 Participants
Sex: Female, Male Female	36 Participants n=209 Participants
Sex: Female, Male Male	173 Participants n=209 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=209 Participants
Race (NIH/OMB) Asian	0 Participants n=209 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=209 Participants
Race (NIH/OMB) Black or African American	0 Participants n=209 Participants
Race (NIH/OMB) White	209 Participants n=209 Participants
Race (NIH/OMB) More than one race	0 Participants n=209 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=209 Participants
IPF symptoms More than 1 IPF symptom	88.0 Percentage of participants n=209 Participants
IPF symptoms Cough	59.8 Percentage of participants n=209 Participants
IPF symptoms Fatigue	54.1 Percentage of participants n=209 Participants
IPF symptoms Dizziness	1.4 Percentage of participants n=209 Participants
IPF symptoms Chest pain	4.8 Percentage of participants n=209 Participants
IPF symptoms Other	20.1 Percentage of participants n=209 Participants

PRIMARY outcome

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

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.

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).

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Percentage of Participants With IPF Symptoms Fatigue - V3	33.1 Percentage of participants
Percentage of Participants With IPF Symptoms Fatigue - V4	26.1 Percentage of participants
Percentage of Participants With IPF Symptoms Fatigue - V5	32.2 Percentage of participants
Percentage of Participants With IPF Symptoms Dizziness - V1	1.4 Percentage of participants
Percentage of Participants With IPF Symptoms Dizziness - V2	3.7 Percentage of participants
Percentage of Participants With IPF Symptoms Dizziness - V3	1.7 Percentage of participants
Percentage of Participants With IPF Symptoms Dizziness - V4	1.9 Percentage of participants
Percentage of Participants With IPF Symptoms Dizziness - V5	2.3 Percentage of participants
Percentage of Participants With IPF Symptoms Chest pain - V1	4.8 Percentage of participants
Percentage of Participants With IPF Symptoms Chest pain - V2	2.6 Percentage of participants
Percentage of Participants With IPF Symptoms Chest pain - V3	4.1 Percentage of participants
Percentage of Participants With IPF Symptoms Chest pain - V4	1.9 Percentage of participants
Percentage of Participants With IPF Symptoms Chest pain - V5	4.0 Percentage of participants
Percentage of Participants With IPF Symptoms Other - V1	20.1 Percentage of participants
Percentage of Participants With IPF Symptoms Other - V2	8.4 Percentage of participants
Percentage of Participants With IPF Symptoms Other - V3	5.2 Percentage of participants
Percentage of Participants With IPF Symptoms Other - V4	6.2 Percentage of participants
Percentage of Participants With IPF Symptoms Other - V5	5.2 Percentage of participants
Percentage of Participants With IPF Symptoms More than 1 IPF symptom - V1	88.0 Percentage of participants
Percentage of Participants With IPF Symptoms More than 1 IPF symptom - V2	51.8 Percentage of participants
Percentage of Participants With IPF Symptoms More than 1 IPF symptom - V3	49.4 Percentage of participants
Percentage of Participants With IPF Symptoms More than 1 IPF symptom - V4	42.9 Percentage of participants
Percentage of Participants With IPF Symptoms More than 1 IPF symptom - V5	45.4 Percentage of participants
Percentage of Participants With IPF Symptoms Cough - V1	59.8 Percentage of participants
Percentage of Participants With IPF Symptoms Cough - V2	38.7 Percentage of participants
Percentage of Participants With IPF Symptoms Cough - V3	36.6 Percentage of participants
Percentage of Participants With IPF Symptoms Cough - V4	29.2 Percentage of participants
Percentage of Participants With IPF Symptoms Cough - V5	30.5 Percentage of participants
Percentage of Participants With IPF Symptoms Fatigue - V1	54.1 Percentage of participants
Percentage of Participants With IPF Symptoms Fatigue - V2	35.1 Percentage of participants

PRIMARY outcome

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

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Change From Baseline to Follow-up Visits in Lung Function: Vital Capacity V2-V1	0.08 Liters (L) Standard Deviation 0.47
Change From Baseline to Follow-up Visits in Lung Function: Vital Capacity V3-V1	0.07 Liters (L) Standard Deviation 0.55
Change From Baseline to Follow-up Visits in Lung Function: Vital Capacity V4-V1	0.07 Liters (L) Standard Deviation 0.58
Change From Baseline to Follow-up Visits in Lung Function: Vital Capacity V5-V1	0.03 Liters (L) Standard Deviation 0.58

PRIMARY outcome

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

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Actual) V2-V1 Actual	-0.02 L Standard Deviation 0.27
Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Actual) V3-V1 Actual	-0.02 L Standard Deviation 0.34
Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Actual) V4-V1 Actual	-0.02 L Standard Deviation 0.31
Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Actual) V5-V1 Actual	-0.05 L Standard Deviation 0.33

PRIMARY outcome

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

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.

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).

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Predicted) V2-V1 Predicted	0.31 Percent Predicted Standard Deviation 8.82
Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Predicted) V3-V1 Predicted	1.59 Percent Predicted Standard Deviation 8.20
Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Predicted) V4-V1 Predicted	1.36 Percent Predicted Standard Deviation 9.39
Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Predicted) V5-V1 Predicted	0.01 Percent Predicted Standard Deviation 10.17

PRIMARY outcome

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

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Change From Baseline to Follow-up Visits in Lung Function: Forced Expiratory Volume in the 1st Second V3-V1	-0.02 L Standard Deviation 0.22
Change From Baseline to Follow-up Visits in Lung Function: Forced Expiratory Volume in the 1st Second V4-V1	-0.01 L Standard Deviation 0.24
Change From Baseline to Follow-up Visits in Lung Function: Forced Expiratory Volume in the 1st Second V5-V1	-0.02 L Standard Deviation 0.28
Change From Baseline to Follow-up Visits in Lung Function: Forced Expiratory Volume in the 1st Second V2-V1	0.01 L Standard Deviation 0.21

PRIMARY outcome

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

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Change From Baseline to Follow-up Visits in Lung Function: Total Lung Capacity V4-V1	-0.03 L Standard Deviation 0.65
Change From Baseline to Follow-up Visits in Lung Function: Total Lung Capacity V3-V1	-0.05 L Standard Deviation 0.72
Change From Baseline to Follow-up Visits in Lung Function: Total Lung Capacity V2-V1	-0.07 L Standard Deviation 0.62
Change From Baseline to Follow-up Visits in Lung Function: Total Lung Capacity V5-V1	-0.11 L Standard Deviation 0.65

PRIMARY outcome

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

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.

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].

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Change From Baseline to Follow-up Visits in Lung Function: Diffusion Capacity for Carbon Monoxide V2-V1	-0.41 mmol/min/kPa Standard Deviation 2.52
Change From Baseline to Follow-up Visits in Lung Function: Diffusion Capacity for Carbon Monoxide V3-V1	-0.46 mmol/min/kPa Standard Deviation 2.27
Change From Baseline to Follow-up Visits in Lung Function: Diffusion Capacity for Carbon Monoxide V4-V1	-0.34 mmol/min/kPa Standard Deviation 2.97
Change From Baseline to Follow-up Visits in Lung Function: Diffusion Capacity for Carbon Monoxide V5-V1	-0.25 mmol/min/kPa Standard Deviation 3.03

PRIMARY outcome

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

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen V2-V1	-0.06 Millimeter mercury (mmHg) Standard Deviation 6.22
Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen V3-V1	2.13 Millimeter mercury (mmHg) Standard Deviation 9.56
Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen V4-V1	1.11 Millimeter mercury (mmHg) Standard Deviation 9.88
Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen V5-V1	-0.47 Millimeter mercury (mmHg) Standard Deviation 14.05

PRIMARY outcome

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

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide V2-V1	1.03 mmHg Standard Deviation 3.63
Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide V3-V1	1.59 mmHg Standard Deviation 5.36
Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide V4-V1	1.24 mmHg Standard Deviation 4.42
Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide V5-V1	1.12 mmHg Standard Deviation 3.75

PRIMARY outcome

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

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Change From Baseline to Follow-up Visits in Lung Function: Oxygen Saturation V5-V1	-0.13 Percentage (%) of SaO2 Standard Deviation 2.56
Change From Baseline to Follow-up Visits in Lung Function: Oxygen Saturation V2-V1	-0.05 Percentage (%) of SaO2 Standard Deviation 2.05
Change From Baseline to Follow-up Visits in Lung Function: Oxygen Saturation V3-V1	-0.33 Percentage (%) of SaO2 Standard Deviation 2.23
Change From Baseline to Follow-up Visits in Lung Function: Oxygen Saturation V4-V1	-0.02 Percentage (%) of SaO2 Standard Deviation 2.27

PRIMARY outcome

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

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen in Arterial Blood at Rest V2-V1	-0.03 mmHg Standard Deviation 6.78
Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen in Arterial Blood at Rest V3-V1	2.74 mmHg Standard Deviation 5.44
Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen in Arterial Blood at Rest V4-V1	-0.60 mmHg Standard Deviation 4.48
Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen in Arterial Blood at Rest V5-V1	1.43 mmHg Standard Deviation 4.86

PRIMARY outcome

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

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide in Arterial Blood at Rest V2-V1	1.12 mmHg Standard Deviation 2.98
Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide in Arterial Blood at Rest V3-V1	1.61 mmHg Standard Deviation 2.63
Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide in Arterial Blood at Rest V4-V1	0.65 mmHg Standard Deviation 2.99
Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide in Arterial Blood at Rest V5-V1	1.27 mmHg Standard Deviation 4.20

PRIMARY outcome

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

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.

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

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Change From Baseline to Follow-up Visits in Exercise Tolerance SpO2 at start of the test - V2-V1	0.11 Percentage (%) of SpO2 Standard Deviation 1.99
Change From Baseline to Follow-up Visits in Exercise Tolerance SpO2 at start of the test - V3-V1	0.11 Percentage (%) of SpO2 Standard Deviation 1.96
Change From Baseline to Follow-up Visits in Exercise Tolerance SpO2 at start of the test - V4-V1	-0.04 Percentage (%) of SpO2 Standard Deviation 2.03
Change From Baseline to Follow-up Visits in Exercise Tolerance SpO2 at start of the test - V5-V1	0.16 Percentage (%) of SpO2 Standard Deviation 1.69
Change From Baseline to Follow-up Visits in Exercise Tolerance SpO2 at the end of the test - V2-V1	-0.52 Percentage (%) of SpO2 Standard Deviation 3.23
Change From Baseline to Follow-up Visits in Exercise Tolerance SpO2 at the end of the test - V3-V1	-0.64 Percentage (%) of SpO2 Standard Deviation 2.88
Change From Baseline to Follow-up Visits in Exercise Tolerance SpO2 at the end of the test - V4-V1	0.07 Percentage (%) of SpO2 Standard Deviation 5.32
Change From Baseline to Follow-up Visits in Exercise Tolerance SpO2 at the end of the test - V5-V1	0.19 Percentage (%) of SpO2 Standard Deviation 3.21

SECONDARY outcome

Timeframe: Baseline

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Characteristic of Participants at Enrollment: Key Socio-demographic Data: Age	69.54 Years Standard Deviation 7.43

SECONDARY outcome

Timeframe: Baseline

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Characteristic of Participants at Enrollment: Key Demographic Data: Gender Male	173 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Gender Female	36 Participants

SECONDARY outcome

Timeframe: Baseline

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Characteristic of Participants at Enrollment: Key Demographic Data: Race American Indian or Alaska Native	0 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Race Asian	0 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Race Native Hawaiian or Other Pacific Islander	0 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Race Black or African American	0 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Race White	209 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Race More than one race	0 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Race Unknown or Not Reported	0 Participants

SECONDARY outcome

Timeframe: Baseline

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.

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

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level None	1 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level Primary School	34 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level Middle school	55 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level High school	45 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level Academic degree	20 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level Unknown	54 Participants

SECONDARY outcome

Timeframe: Baseline

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.

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

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Characteristic of Participants at Enrollment: Key Demographic Data: Employment Status Unemployed	9 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Employment Status Employed	51 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Employment Status Retired	130 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Employment Status Housewife / househusband	14 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Employment Status Unknown	5 Participants

SECONDARY outcome

Timeframe: Baseline

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.

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

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Characteristic of IPF Patients at Enrollment: Key Demographic Data: Body Mass Index Not Reported	42 Participants
Characteristic of IPF Patients at Enrollment: Key Demographic Data: Body Mass Index Underweight	2 Participants
Characteristic of IPF Patients at Enrollment: Key Demographic Data: Body Mass Index Normal weight	34 Participants
Characteristic of IPF Patients at Enrollment: Key Demographic Data: Body Mass Index Overweight	81 Participants
Characteristic of IPF Patients at Enrollment: Key Demographic Data: Body Mass Index Obese	50 Participants

SECONDARY outcome

Timeframe: Baseline

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.

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

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Characteristic of Participants at Enrollment: Key Demographic Data: Housing Situation Home (alone)	11 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Housing Situation Home (with family)	182 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Housing Situation Institution	2 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Housing Situation Unknown	14 Participants

SECONDARY outcome

Timeframe: Baseline

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.

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

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Characteristic of Participants at Enrollment: Key Demographic Data: Marital Status Married	169 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Marital Status Single	9 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Marital Status Widow / Widowed	9 Participants
Characteristic of Participants at Enrollment: Key Demographic Data: Marital Status Unknown	22 Participants

SECONDARY outcome

Timeframe: Baseline

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.

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

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
IPF Risk Factors: Smoking Habit Former smokers	138 Participants
IPF Risk Factors: Smoking Habit Current smokers	9 Participants
IPF Risk Factors: Smoking Habit No smokers	62 Participants

SECONDARY outcome

Timeframe: Baseline

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
IPF Risk Factors: Environmental Exposure No	136 Participants
IPF Risk Factors: Environmental Exposure Yes	70 Participants
IPF Risk Factors: Environmental Exposure Unknown	3 Participants

SECONDARY outcome

Timeframe: Baseline

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
IPF Risk Factors: Exposure to Drugs Associated With IPF Drug Exposure - Amiodarone	2 Participants
IPF Risk Factors: Exposure to Drugs Associated With IPF No drug exposure	207 Participants

SECONDARY outcome

Timeframe: Baseline

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.

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

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
IPF Risk Factors: Family History No	183 Participants
IPF Risk Factors: Family History Yes	25 Participants
IPF Risk Factors: Family History Unknown	1 Participants

SECONDARY outcome

Timeframe: Baseline

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Number of Participants With Comorbidity Peripheral arterial disease	2 Participants
Number of Participants With Comorbidity Pulmonary hypertension	6 Participants
Number of Participants With Comorbidity Renal insufficiency	5 Participants
Number of Participants With Comorbidity Anxiety/Depression	12 Participants
Number of Participants With Comorbidity Arterial hypertension	103 Participants
Number of Participants With Comorbidity Atherothrombotic disease	27 Participants
Number of Participants With Comorbidity Atrial fibrillation	9 Participants
Number of Participants With Comorbidity Benign Prostatic Hypertrophy	25 Participants
Number of Participants With Comorbidity Cerebrovascular disease (Carotid stenosis, stroke)	13 Participants
Number of Participants With Comorbidity Deep venous thrombosis	1 Participants
Number of Participants With Comorbidity Diabetes mellitus	45 Participants
Number of Participants With Comorbidity Emphysema	8 Participants
Number of Participants With Comorbidity Gastroesophageal reflux disease	49 Participants
Number of Participants With Comorbidity Hypercholesterolemia	17 Participants
Number of Participants With Comorbidity Lung cancer	1 Participants
Number of Participants With Comorbidity Other	80 Participants
Number of Participants With Comorbidity Previous myocardial infarction	23 Participants

SECONDARY outcome

Timeframe: Baseline

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=196 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
IPF Disease Severity and Manifestation FVC <50%	4.1 Percentage of participants
IPF Disease Severity and Manifestation FVC between 50%-70%	24.5 Percentage of participants
IPF Disease Severity and Manifestation FVC between 70%-90%	41.3 Percentage of participants
IPF Disease Severity and Manifestation FVC >=90%	30.1 Percentage of participants

SECONDARY outcome

Timeframe: Baseline

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Number of Participants With Different Methods Used for IPF Diagnosis HRCT	209 Participants
Number of Participants With Different Methods Used for IPF Diagnosis Surgical lung biopsy	14 Participants
Number of Participants With Different Methods Used for IPF Diagnosis BAL	40 Participants
Number of Participants With Different Methods Used for IPF Diagnosis Transbronchial Biopsy	11 Participants
Number of Participants With Different Methods Used for IPF Diagnosis Spirometry	58 Participants
Number of Participants With Different Methods Used for IPF Diagnosis Other	27 Participants

SECONDARY outcome

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

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
IPF Treatment Modalities: Non-pharmacological Treatment V2: LtOT	15 Participants
IPF Treatment Modalities: Non-pharmacological Treatment V1: Long-term oxygen therapy (LtOT)	7 Participants
IPF Treatment Modalities: Non-pharmacological Treatment V2: LtOT-Cardiopulmonary exercise training	1 Participants
IPF Treatment Modalities: Non-pharmacological Treatment V3: LtOT	12 Participants
IPF Treatment Modalities: Non-pharmacological Treatment V3: LtOT-Cardiopulmonary exercise training	2 Participants
IPF Treatment Modalities: Non-pharmacological Treatment V5: LtOT	13 Participants
IPF Treatment Modalities: Non-pharmacological Treatment V5: LtOT-Cardiopulmonary exercise training	2 Participants

SECONDARY outcome

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

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.

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

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
IPF Treatment Modalities: Lung Transplantation V1	0 Participants
IPF Treatment Modalities: Lung Transplantation V2	5 Participants
IPF Treatment Modalities: Lung Transplantation V3	2 Participants
IPF Treatment Modalities: Lung Transplantation V5	1 Participants

SECONDARY outcome

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

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
IPF Treatment Modalities: Prescribed Drugs and Dose V1	33 Participants
IPF Treatment Modalities: Prescribed Drugs and Dose V2	138 Participants
IPF Treatment Modalities: Prescribed Drugs and Dose V3	139 Participants
IPF Treatment Modalities: Prescribed Drugs and Dose V5	146 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.

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).

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Number of Exacerbations During 12 Months of Observation Mild exacerbation	7 Participants
Number of Exacerbations During 12 Months of Observation Moderate exacerbation	7 Participants
Number of Exacerbations During 12 Months of Observation Severe exacerbation	4 Participants

SECONDARY outcome

Timeframe: Baseline, 6 months and 12 months

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Health Related Quality of Life Variation Measured With Saint George's Respiratory Questionnaire V1	39.82 Unit on scale Interval 23.4 to 56.79
Health Related Quality of Life Variation Measured With Saint George's Respiratory Questionnaire V3	41.14 Unit on scale Interval 24.48 to 55.79
Health Related Quality of Life Variation Measured With Saint George's Respiratory Questionnaire V5	39.60 Unit on scale Interval 23.8 to 56.77

SECONDARY outcome

Timeframe: Baseline, 6 months and 12 months

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
HRQoL Variation Measured With EuroQol Descriptive System Autonomous in self care - V1	74.6 Percentage (%) of participants
HRQoL Variation Measured With EuroQol Descriptive System Walk without difficulties - V1	45.4 Percentage (%) of participants
HRQoL Variation Measured With EuroQol Descriptive System Perform daily activies easily - V1	49.3 Percentage (%) of participants
HRQoL Variation Measured With EuroQol Descriptive System Not to have pain - V1	46.8 Percentage (%) of participants
HRQoL Variation Measured With EuroQol Descriptive System Walk without difficulties - V5	49.0 Percentage (%) of participants
HRQoL Variation Measured With EuroQol Descriptive System Perform daily activies easily - V5	45.2 Percentage (%) of participants
HRQoL Variation Measured With EuroQol Descriptive System Not to have pain - V5	52.2 Percentage (%) of participants
HRQoL Variation Measured With EuroQol Descriptive System Not to be anxious - V1	46.8 Percentage (%) of participants
HRQoL Variation Measured With EuroQol Descriptive System Autonomous in self care - V3	73.1 Percentage (%) of participants
HRQoL Variation Measured With EuroQol Descriptive System Walk without difficulties - V3	46.9 Percentage (%) of participants
HRQoL Variation Measured With EuroQol Descriptive System Perform daily activies easily - V3	51.3 Percentage (%) of participants
HRQoL Variation Measured With EuroQol Descriptive System Not to have pain - V3	51.9 Percentage (%) of participants
HRQoL Variation Measured With EuroQol Descriptive System Not to be anxious - V3	40.0 Percentage (%) of participants
HRQoL Variation Measured With EuroQol Descriptive System Autonomous in self care - V5	65.0 Percentage (%) of participants
HRQoL Variation Measured With EuroQol Descriptive System Not to be anxious - V5	46.5 Percentage (%) of participants

SECONDARY outcome

Timeframe: Baseline, 6 months and 12 months

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=157 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
HRQoL Measured With EQ VAS V1	67.01 Unit on scale Standard Deviation 18.29
HRQoL Measured With EQ VAS V3	68.92 Unit on scale Standard Deviation 16.12
HRQoL Measured With EQ VAS V5	67.46 Unit on scale Standard Deviation 17.75

SECONDARY outcome

Timeframe: Up to 12 months

Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.

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.

Outcome measures

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 Participants Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Health Care Resource Consumption From Diagnosis up to End of 12 Months Follow-up According to the Italian National Health Service (INHS) Overall duration of inward hospitalization	14.92 Days Standard Deviation 9.07
Health Care Resource Consumption From Diagnosis up to End of 12 Months Follow-up According to the Italian National Health Service (INHS) Overall duration of ICU admissions	1 Days Standard Deviation NA Only one participant is involved.

Adverse Events

Participants With Idiopathic Pulmonary Fibrosis

Serious events: 16 serious events

Other events: 38 other events

Deaths: 13 deaths

Serious adverse events

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 participants at risk Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Cardiac disorders Angina pectoris	0.48% 1/209 • For serious adverse event (SAE) and Non-SAE: From IPF diagnosis until the end of observation period, up to 12 months. For All-cause mortality: From signing informed consent until the end of observation period, up to 493 days. All patients who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
Cardiac disorders Cardiac arrest	1.4% 3/209 • For serious adverse event (SAE) and Non-SAE: From IPF diagnosis until the end of observation period, up to 12 months. For All-cause mortality: From signing informed consent until the end of observation period, up to 493 days. All patients who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
Cardiac disorders Cardiac failure	0.48% 1/209 • For serious adverse event (SAE) and Non-SAE: From IPF diagnosis until the end of observation period, up to 12 months. For All-cause mortality: From signing informed consent until the end of observation period, up to 493 days. All patients who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
Cardiac disorders Myocardial infarction	0.48% 1/209 • For serious adverse event (SAE) and Non-SAE: From IPF diagnosis until the end of observation period, up to 12 months. For All-cause mortality: From signing informed consent until the end of observation period, up to 493 days. All patients who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
General disorders Death	1.4% 3/209 • For serious adverse event (SAE) and Non-SAE: From IPF diagnosis until the end of observation period, up to 12 months. For All-cause mortality: From signing informed consent until the end of observation period, up to 493 days. All patients who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
Infections and infestations Pneumonia	0.48% 1/209 • For serious adverse event (SAE) and Non-SAE: From IPF diagnosis until the end of observation period, up to 12 months. For All-cause mortality: From signing informed consent until the end of observation period, up to 493 days. All patients who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
Nervous system disorders Epilepsy	0.48% 1/209 • For serious adverse event (SAE) and Non-SAE: From IPF diagnosis until the end of observation period, up to 12 months. For All-cause mortality: From signing informed consent until the end of observation period, up to 493 days. All patients who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
Nervous system disorders Syncope	0.48% 1/209 • For serious adverse event (SAE) and Non-SAE: From IPF diagnosis until the end of observation period, up to 12 months. For All-cause mortality: From signing informed consent until the end of observation period, up to 493 days. All patients who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.96% 2/209 • For serious adverse event (SAE) and Non-SAE: From IPF diagnosis until the end of observation period, up to 12 months. For All-cause mortality: From signing informed consent until the end of observation period, up to 493 days. All patients who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.48% 1/209 • For serious adverse event (SAE) and Non-SAE: From IPF diagnosis until the end of observation period, up to 12 months. For All-cause mortality: From signing informed consent until the end of observation period, up to 493 days. All patients who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.96% 2/209 • For serious adverse event (SAE) and Non-SAE: From IPF diagnosis until the end of observation period, up to 12 months. For All-cause mortality: From signing informed consent until the end of observation period, up to 493 days. All patients who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.

Other adverse events

Measure	Participants With Idiopathic Pulmonary Fibrosis n=209 participants at risk Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
Gastrointestinal disorders Diarrhoea	12.0% 25/209 • For serious adverse event (SAE) and Non-SAE: From IPF diagnosis until the end of observation period, up to 12 months. For All-cause mortality: From signing informed consent until the end of observation period, up to 493 days. All patients who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
Skin and subcutaneous tissue disorders Rash	6.7% 14/209 • For serious adverse event (SAE) and Non-SAE: From IPF diagnosis until the end of observation period, up to 12 months. For All-cause mortality: From signing informed consent until the end of observation period, up to 493 days. All patients who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER