Clinical trial NCT02803580: IPF Italian Observational Study (FIBRONET) in Idiopathic Pulmonary Fibrosis
Official title: IPF Italian Observational Study (FIBRONET)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-06-17
Enrollment: 209
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: IPF pts

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.


Eligibility criteria: Inclusion criteria:

1. Patients aged\>=40 years
2. Written informed consent to both participation in the study and privacy
3. Physician diagnosed IPF during the last 3 months based upon recent American Thoracic Society/European Resp. Society/Japanese Resp. Society/Latin American Thoracic Association guidelines 2011 (see Tables A1-A2 for High Resolution Chest Computer Tomography and histology criteria):

   * Exclusion of other known causes of Interstitial Lung Disease (e.g. domestic and occupational environmental exposures, connective tissue disease and drug toxicity)
   * Assessment of Idiopathic Pulmonary Fibrosis based on High Resolution Computed Tomography (HRCT) or HRCT and surgical lung biopsy if available.
4. Patient with further follow-up possible with enrolling investigator during planned study period
5. Patients capable of discernment and able to read or write in Italian language.

Exclusion criteria:

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

Primary outcomes:
measure: Percentage of Participants With IPF Symptoms
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months
measure: Change From Baseline to Follow-up Visits in Lung Function: Vital Capacity
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months
measure: Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Actual)
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months
measure: Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Predicted)
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months
measure: Change From Baseline to Follow-up Visits in Lung Function: Forced Expiratory Volume in the 1st Second
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months
measure: Change From Baseline to Follow-up Visits in Lung Function: Total Lung Capacity
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months
measure: Change From Baseline to Follow-up Visits in Lung Function: Diffusion Capacity for Carbon Monoxide
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months
measure: Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months
measure: Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months
measure: Change From Baseline to Follow-up Visits in Lung Function: Oxygen Saturation
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months
measure: Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen in Arterial Blood at Rest
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months
measure: Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide in Arterial Blood at Rest
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months
measure: Change From Baseline to Follow-up Visits in Exercise Tolerance
timeFrame: Baseline, 3 months, 6 months, 9 months and 12 months
Secondary outcomes:
measure: Characteristic of Participants at Enrollment: Key Socio-demographic Data: Age
timeFrame: Baseline
measure: Characteristic of Participants at Enrollment: Key Demographic Data: Gender
timeFrame: Baseline
measure: Characteristic of Participants at Enrollment: Key Demographic Data: Race
timeFrame: Baseline
measure: Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level
timeFrame: Baseline
measure: Characteristic of Participants at Enrollment: Key Demographic Data: Employment Status
timeFrame: Baseline
measure: Characteristic of IPF Patients at Enrollment: Key Demographic Data: Body Mass Index
timeFrame: Baseline
measure: Characteristic of Participants at Enrollment: Key Demographic Data: Housing Situation
timeFrame: Baseline
measure: Characteristic of Participants at Enrollment: Key Demographic Data: Marital Status
timeFrame: Baseline
measure: IPF Risk Factors: Smoking Habit
timeFrame: Baseline
measure: IPF Risk Factors: Environmental Exposure
timeFrame: Baseline
measure: IPF Risk Factors: Exposure to Drugs Associated With IPF
timeFrame: Baseline
measure: IPF Risk Factors: Family History
timeFrame: Baseline
measure: Number of Participants With Comorbidity
timeFrame: Baseline
measure: IPF Disease Severity and Manifestation
timeFrame: Baseline
measure: Number of Participants With Different Methods Used for IPF Diagnosis
timeFrame: Baseline
measure: IPF Treatment Modalities: Non-pharmacological Treatment
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: IPF Treatment Modalities: Lung Transplantation
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: IPF Treatment Modalities: Prescribed Drugs and Dose
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Number of Exacerbations During 12 Months of Observation
timeFrame: Up to 12 months
measure: Health Related Quality of Life Variation Measured With Saint George's Respiratory Questionnaire
timeFrame: Baseline, 6 months and 12 months
measure: HRQoL Variation Measured With EuroQol Descriptive System
timeFrame: Baseline, 6 months and 12 months
measure: HRQoL Measured With EQ VAS
timeFrame: Baseline, 6 months and 12 months
measure: Health Care Resource Consumption From Diagnosis up to End of 12 Months Follow-up According to the Italian National Health Service (INHS)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Catania
country: Italy
facility: A.O.U. Policlinico Vittorio Emanuele
city: Chieti
country: Italy
facility: Osp. Clin. SS. Anunziata
city: Foggia
country: Italy
facility: Ospedale Colonnello D Avanzo
city: Forli
country: Italy
facility: Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
city: Milano
country: Italy
facility: Osp. S. Giuseppe Fatebenefratelli
city: Modena
country: Italy
facility: Azienda Ospedaliera Policlinico di Modena
city: Monza
country: Italy
facility: A.O. San Gerardo di Monza
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria "Federico II"
city: Orbassano
country: Italy
facility: Azienda Sanitaria Ospedale S. Luigi Gonzaga
city: Padova
country: Italy
facility: Azienda Ospedaliera Universitaria di Padova
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico S. Matteo
city: Pisa
country: Italy
facility: Ospedale di Cisanello
city: Roma
country: Italy
facility: Pol. Universitario Tor Vergata
city: Roma
country: Italy
facility: A.O. San Camillo Forlanini
city: Roma
country: Italy
facility: Policlinico Gemelli
city: Sassari
country: Italy
facility: Policlinico Universitario di Sassari
city: Siena
country: Italy
facility: A.O.U. Senese Policlinico Santa Maria alle Scotte
city: Torrette-Ancona
country: Italy
facility: Ospedale Riuniti di Ancona
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Poletti V, Vancheri C, Albera C, Harari S, Pesci A, Metella RR, Campolo B, Crespi G, Rizzoli S; FIBRONET study group. Clinical course of IPF in Italian patients during 12 months of observation: results from the FIBRONET observational study. Respir Res. 2021 Feb 24;22(1):66. doi: 10.1186/s12931-021-01643-w.