Idiopathic Pulmonary Fibrosis
Conditions
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.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With IPF Symptoms | 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). |
| Change From Baseline to Follow-up Visits in Lung Function: Vital Capacity | 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. |
| Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Actual) | 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. |
| Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Predicted) | 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). |
| Change From Baseline to Follow-up Visits in Lung Function: Forced Expiratory Volume in the 1st Second | 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. |
| Change From Baseline to Follow-up Visits in Lung Function: Total Lung Capacity | 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. |
| Change From Baseline to Follow-up Visits in Lung Function: Diffusion Capacity for Carbon Monoxide | 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 \[46\]. |
| Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen | 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. |
| Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide | 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. |
| Change From Baseline to Follow-up Visits in Lung Function: Oxygen Saturation | 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. |
| Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen in Arterial Blood at Rest | 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. |
| Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide in Arterial Blood at Rest | 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. |
| Change From Baseline to Follow-up Visits in Exercise Tolerance | 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
| Measure | Time frame | Description |
|---|---|---|
| IPF Disease Severity and Manifestation | 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. |
| Number of Participants With Different Methods Used for IPF Diagnosis | 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. |
| IPF Treatment Modalities: Non-pharmacological Treatment | 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. |
| IPF Treatment Modalities: Lung Transplantation | 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. |
| IPF Treatment Modalities: Prescribed Drugs and Dose | 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. |
| Characteristic of Participants at Enrollment: Key Socio-demographic Data: Age | 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. |
| Health Related Quality of Life Variation Measured With Saint George's Respiratory Questionnaire | 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. |
| HRQoL Variation Measured With EuroQol Descriptive System | 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. |
| HRQoL Measured With EQ VAS | 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. |
| Health Care Resource Consumption From Diagnosis up to End of 12 Months Follow-up According to the Italian National Health Service (INHS) | 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. |
| Number of Exacerbations During 12 Months of Observation | 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). |
| Characteristic of Participants at Enrollment: Key Demographic Data: Gender | 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. |
| Characteristic of Participants at Enrollment: Key Demographic Data: Race | 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. |
| Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level | Baseline | IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their highest education level. |
| Characteristic of Participants at Enrollment: Key Demographic Data: Employment Status | Baseline | IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their employment status are presented. |
| Characteristic of IPF Patients at Enrollment: Key Demographic Data: Body Mass Index | Baseline | IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their Body mass index are presented. |
| Characteristic of Participants at Enrollment: Key Demographic Data: Housing Situation | Baseline | IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their housing situation are presented. |
| Characteristic of Participants at Enrollment: Key Demographic Data: Marital Status | Baseline | IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their marital status are presented. |
| IPF Risk Factors: Smoking Habit | Baseline | IPF enrolled participants were described in terms of potential IPF risk factors; number of participants as per their smoking habits are presented. |
| IPF Risk Factors: Environmental Exposure | 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. |
| IPF Risk Factors: Exposure to Drugs Associated With IPF | 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. |
| IPF Risk Factors: Family History | 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. |
| Number of Participants With Comorbidity | 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. |
Countries
Italy
Participant flow
Recruitment details
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.
Pre-assignment details
Data source for this study were medical records usually collected during routine clinical practice other than study-specific questionnaires.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 209 |
| Total | 209 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 13 |
| Overall Study | Inclusion in clinical trial | 1 |
| Overall Study | Lost to Follow-up | 19 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Participants With Idiopathic Pulmonary Fibrosis |
|---|---|
| Age, Continuous | 69.54 Years STANDARD_DEVIATION 7.43 |
| IPF symptoms Chest pain | 4.8 Percentage of participants |
| IPF symptoms Cough | 59.8 Percentage of participants |
| IPF symptoms Dizziness | 1.4 Percentage of participants |
| IPF symptoms Fatigue | 54.1 Percentage of participants |
| IPF symptoms More than 1 IPF symptom | 88.0 Percentage of participants |
| IPF symptoms Other | 20.1 Percentage of participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 209 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 173 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 13 / 209 |
| other Total, other adverse events | 38 / 209 |
| serious Total, serious adverse events | 16 / 209 |
Outcome results
Primary
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
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
Primary
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 \[46\].
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Actual) | V3-V1 Actual | -0.02 L | Standard Deviation 0.34 |
| Participants With Idiopathic Pulmonary Fibrosis | Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Actual) | V2-V1 Actual | -0.02 L | Standard Deviation 0.27 |
| Participants With Idiopathic Pulmonary Fibrosis | Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Actual) | V4-V1 Actual | -0.02 L | Standard Deviation 0.31 |
| Participants With Idiopathic Pulmonary Fibrosis | 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
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Predicted) | V3-V1 Predicted | 1.59 Percent Predicted | Standard Deviation 8.2 |
| Participants With Idiopathic Pulmonary Fibrosis | 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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | Change From Baseline to Follow-up Visits in Lung Function: Oxygen Saturation | V2-V1 | -0.05 Percentage (%) of SaO2 | Standard Deviation 2.05 |
| Participants With Idiopathic Pulmonary Fibrosis | Change From Baseline to Follow-up Visits in Lung Function: Oxygen Saturation | V3-V1 | -0.33 Percentage (%) of SaO2 | Standard Deviation 2.23 |
| Participants With Idiopathic Pulmonary Fibrosis | Change From Baseline to Follow-up Visits in Lung Function: Oxygen Saturation | V4-V1 | -0.02 Percentage (%) of SaO2 | Standard Deviation 2.27 |
| Participants With Idiopathic Pulmonary Fibrosis | Change From Baseline to Follow-up Visits in Lung Function: Oxygen Saturation | V5-V1 | -0.13 Percentage (%) of SaO2 | Standard Deviation 2.56 |
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide | V2-V1 | 1.03 mmHg | Standard Deviation 3.63 |
| Participants With Idiopathic Pulmonary Fibrosis | Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide | V3-V1 | 1.59 mmHg | Standard Deviation 5.36 |
| Participants With Idiopathic Pulmonary Fibrosis | Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide | V4-V1 | 1.24 mmHg | Standard Deviation 4.42 |
| Participants With Idiopathic Pulmonary Fibrosis | 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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 4.2 |
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | Change From Baseline to Follow-up Visits in Lung Function: Total Lung Capacity | V5-V1 | -0.11 L | Standard Deviation 0.65 |
| Participants With Idiopathic Pulmonary Fibrosis | Change From Baseline to Follow-up Visits in Lung Function: Total Lung Capacity | V2-V1 | -0.07 L | Standard Deviation 0.62 |
| Participants With Idiopathic Pulmonary Fibrosis | Change From Baseline to Follow-up Visits in Lung Function: Total Lung Capacity | V3-V1 | -0.05 L | Standard Deviation 0.72 |
| Participants With Idiopathic Pulmonary Fibrosis | Change From Baseline to Follow-up Visits in Lung Function: Total Lung Capacity | V4-V1 | -0.03 L | Standard Deviation 0.65 |
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | Change From Baseline to Follow-up Visits in Lung Function: Vital Capacity | V2-V1 | 0.08 Liters (L) | Standard Deviation 0.47 |
| Participants With Idiopathic Pulmonary Fibrosis | Change From Baseline to Follow-up Visits in Lung Function: Vital Capacity | V3-V1 | 0.07 Liters (L) | Standard Deviation 0.55 |
| Participants With Idiopathic Pulmonary Fibrosis | Change From Baseline to Follow-up Visits in Lung Function: Vital Capacity | V4-V1 | 0.07 Liters (L) | Standard Deviation 0.58 |
| Participants With Idiopathic Pulmonary Fibrosis | Change From Baseline to Follow-up Visits in Lung Function: Vital Capacity | V5-V1 | 0.03 Liters (L) | Standard Deviation 0.58 |
Primary
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | More than 1 IPF symptom - V1 | 88.0 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | More than 1 IPF symptom - V2 | 51.8 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | More than 1 IPF symptom - V3 | 49.4 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | More than 1 IPF symptom - V4 | 42.9 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | More than 1 IPF symptom - V5 | 45.4 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Cough - V1 | 59.8 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Cough - V2 | 38.7 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Cough - V3 | 36.6 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Cough - V4 | 29.2 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Cough - V5 | 30.5 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Fatigue - V1 | 54.1 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Fatigue - V2 | 35.1 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Fatigue - V3 | 33.1 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Chest pain - V1 | 4.8 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Fatigue - V4 | 26.1 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Fatigue - V5 | 32.2 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Dizziness - V1 | 1.4 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Dizziness - V2 | 3.7 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Dizziness - V3 | 1.7 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Dizziness - V4 | 1.9 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Dizziness - V5 | 2.3 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Chest pain - V2 | 2.6 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Chest pain - V3 | 4.1 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Chest pain - V4 | 1.9 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Chest pain - V5 | 4.0 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Other - V1 | 20.1 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Other - V2 | 8.4 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Other - V3 | 5.2 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Other - V4 | 6.2 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | Percentage of Participants With IPF Symptoms | Other - V5 | 5.2 Percentage of participants |
Secondary
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.
Time frame: Baseline
Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of IPF Patients at Enrollment: Key Demographic Data: Body Mass Index | Normal weight | 34 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of IPF Patients at Enrollment: Key Demographic Data: Body Mass Index | Overweight | 81 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of IPF Patients at Enrollment: Key Demographic Data: Body Mass Index | Obese | 50 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of IPF Patients at Enrollment: Key Demographic Data: Body Mass Index | Not Reported | 42 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of IPF Patients at Enrollment: Key Demographic Data: Body Mass Index | Underweight | 2 Participants |
Secondary
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.
Time frame: Baseline
Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Employment Status | Unemployed | 9 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Employment Status | Employed | 51 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Employment Status | Retired | 130 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Employment Status | Housewife / househusband | 14 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Employment Status | Unknown | 5 Participants |
Secondary
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.
Time frame: Baseline
Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Gender | Female | 36 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Gender | Male | 173 Participants |
Secondary
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.
Time frame: Baseline
Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level | None | 1 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level | Primary School | 34 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level | Middle school | 55 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level | High school | 45 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level | Academic degree | 20 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level | Unknown | 54 Participants |
Secondary
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.
Time frame: Baseline
Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Housing Situation | Home (alone) | 11 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Housing Situation | Home (with family) | 182 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Housing Situation | Institution | 2 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Housing Situation | Unknown | 14 Participants |
Secondary
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.
Time frame: Baseline
Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Marital Status | Married | 169 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Marital Status | Single | 9 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Marital Status | Widow / Widowed | 9 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Marital Status | Unknown | 22 Participants |
Secondary
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.
Time frame: Baseline
Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Race | American Indian or Alaska Native | 0 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Race | Asian | 0 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Race | Native Hawaiian or Other Pacific Islander | 0 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Race | Black or African American | 0 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Race | White | 209 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Race | More than one race | 0 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Demographic Data: Race | Unknown or Not Reported | 0 Participants |
Secondary
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.
Time frame: Baseline
Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | Characteristic of Participants at Enrollment: Key Socio-demographic Data: Age | 69.54 Years | Standard Deviation 7.43 |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | 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 |
| Participants With Idiopathic Pulmonary Fibrosis | 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 | — |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | Health Related Quality of Life Variation Measured With Saint George's Respiratory Questionnaire | V1 | 39.82 Unit on scale |
| Participants With Idiopathic Pulmonary Fibrosis | Health Related Quality of Life Variation Measured With Saint George's Respiratory Questionnaire | V3 | 41.14 Unit on scale |
| Participants With Idiopathic Pulmonary Fibrosis | Health Related Quality of Life Variation Measured With Saint George's Respiratory Questionnaire | V5 | 39.60 Unit on scale |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | HRQoL Measured With EQ VAS | V5 | 67.46 Unit on scale | Standard Deviation 17.75 |
| Participants With Idiopathic Pulmonary Fibrosis | HRQoL Measured With EQ VAS | V1 | 67.01 Unit on scale | Standard Deviation 18.29 |
| Participants With Idiopathic Pulmonary Fibrosis | HRQoL Measured With EQ VAS | V3 | 68.92 Unit on scale | Standard Deviation 16.12 |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | HRQoL Variation Measured With EuroQol Descriptive System | Not to be anxious - V1 | 46.8 Percentage (%) of participants |
| Participants With Idiopathic Pulmonary Fibrosis | HRQoL Variation Measured With EuroQol Descriptive System | Autonomous in self care - V1 | 74.6 Percentage (%) of participants |
| Participants With Idiopathic Pulmonary Fibrosis | HRQoL Variation Measured With EuroQol Descriptive System | Walk without difficulties - V1 | 45.4 Percentage (%) of participants |
| Participants With Idiopathic Pulmonary Fibrosis | HRQoL Variation Measured With EuroQol Descriptive System | Perform daily activies easily - V1 | 49.3 Percentage (%) of participants |
| Participants With Idiopathic Pulmonary Fibrosis | HRQoL Variation Measured With EuroQol Descriptive System | Not to have pain - V1 | 46.8 Percentage (%) of participants |
| Participants With Idiopathic Pulmonary Fibrosis | HRQoL Variation Measured With EuroQol Descriptive System | Autonomous in self care - V3 | 73.1 Percentage (%) of participants |
| Participants With Idiopathic Pulmonary Fibrosis | HRQoL Variation Measured With EuroQol Descriptive System | Walk without difficulties - V3 | 46.9 Percentage (%) of participants |
| Participants With Idiopathic Pulmonary Fibrosis | HRQoL Variation Measured With EuroQol Descriptive System | Perform daily activies easily - V3 | 51.3 Percentage (%) of participants |
| Participants With Idiopathic Pulmonary Fibrosis | HRQoL Variation Measured With EuroQol Descriptive System | Not to have pain - V3 | 51.9 Percentage (%) of participants |
| Participants With Idiopathic Pulmonary Fibrosis | HRQoL Variation Measured With EuroQol Descriptive System | Not to be anxious - V3 | 40.0 Percentage (%) of participants |
| Participants With Idiopathic Pulmonary Fibrosis | HRQoL Variation Measured With EuroQol Descriptive System | Autonomous in self care - V5 | 65.0 Percentage (%) of participants |
| Participants With Idiopathic Pulmonary Fibrosis | HRQoL Variation Measured With EuroQol Descriptive System | Walk without difficulties - V5 | 49.0 Percentage (%) of participants |
| Participants With Idiopathic Pulmonary Fibrosis | HRQoL Variation Measured With EuroQol Descriptive System | Perform daily activies easily - V5 | 45.2 Percentage (%) of participants |
| Participants With Idiopathic Pulmonary Fibrosis | HRQoL Variation Measured With EuroQol Descriptive System | Not to have pain - V5 | 52.2 Percentage (%) of participants |
| Participants With Idiopathic Pulmonary Fibrosis | HRQoL Variation Measured With EuroQol Descriptive System | Not to be anxious - V5 | 46.5 Percentage (%) of participants |
Secondary
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.
Time frame: Baseline
Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | IPF Disease Severity and Manifestation | FVC <50% | 4.1 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Disease Severity and Manifestation | FVC between 50%-70% | 24.5 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Disease Severity and Manifestation | FVC between 70%-90% | 41.3 Percentage of participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Disease Severity and Manifestation | FVC >=90% | 30.1 Percentage of participants |
Secondary
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.
Time frame: Baseline
Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | IPF Risk Factors: Environmental Exposure | No | 136 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Risk Factors: Environmental Exposure | Yes | 70 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Risk Factors: Environmental Exposure | Unknown | 3 Participants |
Secondary
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.
Time frame: Baseline
Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | IPF Risk Factors: Exposure to Drugs Associated With IPF | Drug Exposure - Amiodarone | 2 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Risk Factors: Exposure to Drugs Associated With IPF | No drug exposure | 207 Participants |
Secondary
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.
Time frame: Baseline
Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | IPF Risk Factors: Family History | No | 183 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Risk Factors: Family History | Yes | 25 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Risk Factors: Family History | Unknown | 1 Participants |
Secondary
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.
Time frame: Baseline
Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | IPF Risk Factors: Smoking Habit | Former smokers | 138 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Risk Factors: Smoking Habit | Current smokers | 9 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Risk Factors: Smoking Habit | No smokers | 62 Participants |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | IPF Treatment Modalities: Lung Transplantation | V1 | 0 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Treatment Modalities: Lung Transplantation | V2 | 5 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Treatment Modalities: Lung Transplantation | V3 | 2 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Treatment Modalities: Lung Transplantation | V5 | 1 Participants |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | IPF Treatment Modalities: Non-pharmacological Treatment | V3: LtOT-Cardiopulmonary exercise training | 2 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Treatment Modalities: Non-pharmacological Treatment | V5: LtOT | 13 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Treatment Modalities: Non-pharmacological Treatment | V1: Long-term oxygen therapy (LtOT) | 7 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Treatment Modalities: Non-pharmacological Treatment | V2: LtOT-Cardiopulmonary exercise training | 1 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Treatment Modalities: Non-pharmacological Treatment | V2: LtOT | 15 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Treatment Modalities: Non-pharmacological Treatment | V3: LtOT | 12 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Treatment Modalities: Non-pharmacological Treatment | V5: LtOT-Cardiopulmonary exercise training | 2 Participants |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | IPF Treatment Modalities: Prescribed Drugs and Dose | V1 | 33 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Treatment Modalities: Prescribed Drugs and Dose | V2 | 138 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Treatment Modalities: Prescribed Drugs and Dose | V3 | 139 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | IPF Treatment Modalities: Prescribed Drugs and Dose | V5 | 146 Participants |
Secondary
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).
Time frame: Up to 12 months
Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | Number of Exacerbations During 12 Months of Observation | Severe exacerbation | 4 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Exacerbations During 12 Months of Observation | Mild exacerbation | 7 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Exacerbations During 12 Months of Observation | Moderate exacerbation | 7 Participants |
Secondary
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.
Time frame: Baseline
Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Comorbidity | Anxiety/Depression | 12 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Comorbidity | Arterial hypertension | 103 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Comorbidity | Atherothrombotic disease | 27 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Comorbidity | Atrial fibrillation | 9 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Comorbidity | Benign Prostatic Hypertrophy | 25 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Comorbidity | Cerebrovascular disease (Carotid stenosis, stroke) | 13 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Comorbidity | Deep venous thrombosis | 1 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Comorbidity | Diabetes mellitus | 45 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Comorbidity | Emphysema | 8 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Comorbidity | Gastroesophageal reflux disease | 49 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Comorbidity | Hypercholesterolemia | 17 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Comorbidity | Lung cancer | 1 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Comorbidity | Peripheral arterial disease | 2 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Comorbidity | Pulmonary hypertension | 6 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Comorbidity | Renal insufficiency | 5 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Comorbidity | Other | 80 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Comorbidity | Previous myocardial infarction | 23 Participants |
Secondary
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.
Time frame: Baseline
Population: All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Different Methods Used for IPF Diagnosis | HRCT | 209 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Different Methods Used for IPF Diagnosis | Surgical lung biopsy | 14 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Different Methods Used for IPF Diagnosis | BAL | 40 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Different Methods Used for IPF Diagnosis | Transbronchial Biopsy | 11 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Different Methods Used for IPF Diagnosis | Spirometry | 58 Participants |
| Participants With Idiopathic Pulmonary Fibrosis | Number of Participants With Different Methods Used for IPF Diagnosis | Other | 27 Participants |