IPF Italian Observational Study (FIBRONET) in Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

IPF Italian Observational Study (FIBRONET)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803580
• Other study ID #: 1199.262
• Status: Completed
• Start date: November 17, 2015
• Est. completion date: May 15, 2018

Study information

• Verified date: August 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: May 15, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Locations

Country	Name	City	State
Italy	A.O.U. Policlinico Vittorio Emanuele	Catania
Italy	Osp. Clin. SS. Anunziata	Chieti
Italy	Ospedale Colonnello D Avanzo	Foggia
Italy	Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli	Forli
Italy	Osp. S. Giuseppe Fatebenefratelli	Milano
Italy	Azienda Ospedaliera Policlinico di Modena	Modena
Italy	A.O. San Gerardo di Monza	Monza
Italy	Azienda Ospedaliera Universitaria "Federico II"	Napoli
Italy	Azienda Sanitaria Ospedale S. Luigi Gonzaga	Orbassano
Italy	Azienda Ospedaliera Universitaria di Padova	Padova
Italy	Fondazione IRCCS Policlinico S. Matteo	Pavia
Italy	Ospedale di Cisanello	Pisa
Italy	A.O. San Camillo Forlanini	Roma
Italy	Pol. Universitario Tor Vergata	Roma
Italy	Policlinico Gemelli	Roma
Italy	Policlinico Universitario di Sassari	Sassari
Italy	A.O.U. Senese Policlinico Santa Maria alle Scotte	Siena
Italy	Ospedale Riuniti di Ancona	Torrette-Ancona

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline, 3 months, 6 months, 9 months and 12 months
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.	Baseline, 3 months, 6 months, 9 months and 12 months
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.	Baseline, 3 months, 6 months, 9 months and 12 months
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).	Baseline, 3 months, 6 months, 9 months and 12 months
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.	Baseline, 3 months, 6 months, 9 months and 12 months
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.	Baseline, 3 months, 6 months, 9 months and 12 months
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].	Baseline, 3 months, 6 months, 9 months and 12 months
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.	Baseline, 3 months, 6 months, 9 months and 12 months
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.	Baseline, 3 months, 6 months, 9 months and 12 months
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.	Baseline, 3 months, 6 months, 9 months and 12 months
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.	Baseline, 3 months, 6 months, 9 months and 12 months
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.	Baseline, 3 months, 6 months, 9 months and 12 months
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	Baseline, 3 months, 6 months, 9 months and 12 months
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline, 3 months, 6 months and 12 months
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.	Baseline, 3 months, 6 months and 12 months
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.	Baseline, 3 months, 6 months and 12 months
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).	Up to 12 months
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.	Baseline, 6 months and 12 months
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.	Baseline, 6 months and 12 months
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.	Baseline, 6 months and 12 months
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.	Up to 12 months

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