IPF Italian Observational Study (FIBRONET) in Idiopathic Pulmonary Fibrosis

NCT02803580 | Completed Results

• 1 other identifier: 1199.262
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 18

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (13)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (23)

• Characteristic of Participants at Enrollment: Key Socio-demographic Data: Age

  Baseline

• Characteristic of Participants at Enrollment: Key Demographic Data: Gender

  Baseline

• Characteristic of Participants at Enrollment: Key Demographic Data: Race

  Baseline

• Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level

  Baseline

• Characteristic of Participants at Enrollment: Key Demographic Data: Employment Status

  Baseline

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

IPF pts

You may qualify if:

• Patients aged\>=40 years
• Written informed consent to both participation in the study and privacy
• 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):
• Assessment of Idiopathic Pulmonary Fibrosis based on High Resolution Computed Tomography (HRCT) or HRCT and surgical lung biopsy if available.
• Patient with further follow-up possible with enrolling investigator during planned study period
• Patients capable of discernment and able to read or write in Italian language.

You may not qualify if:

• Lung transplantation expected within the next 6 months
• Pregnancy or breast feeding

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (18)

A.O.U. Policlinico Vittorio Emanuele

Catania, 95124, Italy

Location

Osp. Clin. SS. Anunziata

Chieti, 66100, Italy

Location

Ospedale Colonnello D Avanzo

Foggia, 71100, Italy

Location

Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli

Forlì, 47121, Italy

Location

Osp. S. Giuseppe Fatebenefratelli

Milan, 20123, Italy

Location

Azienda Ospedaliera Policlinico di Modena

Modena, 41124, Italy

Location

A.O. San Gerardo di Monza

Monza, 20900, Italy

Location

Azienda Ospedaliera Universitaria "Federico II"

Napoli, 80138, Italy

Location

Azienda Sanitaria Ospedale S. Luigi Gonzaga

Orbassano, 10043, Italy

Location

Azienda Ospedaliera Universitaria di Padova

Padua, 35128, Italy

Location

Fondazione IRCCS Policlinico S. Matteo

Pavia, 27100, Italy

Location

Ospedale di Cisanello

Pisa, 56124, Italy

Location

Pol. Universitario Tor Vergata

Roma, 00133, Italy

Location

A.O. San Camillo Forlanini

Roma, 00149, Italy

Location

Policlinico Gemelli

Roma, 00168, Italy

Location

Policlinico Universitario di Sassari

Sassari, 07100, Italy

Location

A.O.U. Senese Policlinico Santa Maria alle Scotte

Siena, 53100, Italy

Location

Ospedale Riuniti di Ancona

Torrette-Ancona, 60126, Italy

Location

Related Publications (1)

• 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.

  PMID: 33627105 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: June 17, 2016
• Study Start: November 17, 2015
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: September 13, 2019
• Results First Posted: September 13, 2019

Record last verified: 2019-08

Locations

IT (18)