N/A N=209

IPF Italian Observational Study (FIBRONET) in Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis

Bottom Line

View on ClinicalTrials.gov: NCT02803580 ↗

Enrolled (actual)

209

Serious AEs

7.7%

Results posted

Sep 2019

Primary outcome: Primary: Percentage of Participants With IPF Symptoms — 88.0; 51.8; 49.4; 42.9 Percentage of participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With IPF Symptoms	88.0; 51.8; 49.4; 42.9; 45.4; 59.8	—
PRIMARY Change From Baseline to Follow-up Visits in Lung Function: Vital Capacity	0.08; 0.07; 0.07; 0.03	—
PRIMARY Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Actual)	-0.02; -0.02; -0.02; -0.05	—
PRIMARY Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Predicted)	0.31; 1.59; 1.36; 0.01	—
PRIMARY Change From Baseline to Follow-up Visits in Lung Function: Forced Expiratory Volume in the 1st Second	0.01; -0.02; -0.01; -0.02	—
PRIMARY Change From Baseline to Follow-up Visits in Lung Function: Total Lung Capacity	-0.07; -0.05; -0.03; -0.11	—
PRIMARY Change From Baseline to Follow-up Visits in Lung Function: Diffusion Capacity for Carbon Monoxide	-0.41; -0.46; -0.34; -0.25	—
PRIMARY Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen	-0.06; 2.13; 1.11; -0.47	—
PRIMARY Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide	1.03; 1.59; 1.24; 1.12	—
PRIMARY Change From Baseline to Follow-up Visits in Lung Function: Oxygen Saturation	-0.05; -0.33; -0.02; -0.13	—
PRIMARY Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen in Arterial Blood at Rest	-0.03; 2.74; -0.60; 1.43	—
PRIMARY Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide in Arterial Blood at Rest	1.12; 1.61; 0.65; 1.27	—
PRIMARY Change From Baseline to Follow-up Visits in Exercise Tolerance	0.11; 0.11; -0.04; 0.16; -0.52; -0.64	—
SECONDARY Characteristic of Participants at Enrollment: Key Socio-demographic Data: Age	69.54	—
SECONDARY Characteristic of Participants at Enrollment: Key Demographic Data: Gender	173; 36	—
SECONDARY Characteristic of Participants at Enrollment: Key Demographic Data: Race	0; 0; 0; 0; 209; 0	—
SECONDARY Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level	1; 34; 55; 45; 20; 54	—
SECONDARY Characteristic of Participants at Enrollment: Key Demographic Data: Employment Status	9; 51; 130; 14; 5	—
SECONDARY Characteristic of IPF Patients at Enrollment: Key Demographic Data: Body Mass Index	2; 34; 81; 50; 42	—
SECONDARY Characteristic of Participants at Enrollment: Key Demographic Data: Housing Situation	11; 182; 2; 14	—
SECONDARY Characteristic of Participants at Enrollment: Key Demographic Data: Marital Status	169; 9; 9; 22	—
SECONDARY IPF Risk Factors: Smoking Habit	138; 9; 62	—
SECONDARY IPF Risk Factors: Environmental Exposure	136; 70; 3	—
SECONDARY IPF Risk Factors: Exposure to Drugs Associated With IPF	2; 207	—
SECONDARY IPF Risk Factors: Family History	183; 25; 1	—
SECONDARY Number of Participants With Comorbidity	12; 103; 27; 9; 25; 13	—
SECONDARY IPF Disease Severity and Manifestation	4.1; 24.5; 41.3; 30.1	—
SECONDARY Number of Participants With Different Methods Used for IPF Diagnosis	209; 14; 40; 11; 58; 27	—
SECONDARY IPF Treatment Modalities: Non-pharmacological Treatment	7; 1; 15; 12; 2; 13	—
SECONDARY IPF Treatment Modalities: Lung Transplantation	0; 5; 2; 1	—
SECONDARY IPF Treatment Modalities: Prescribed Drugs and Dose	33; 138; 139; 146	—
SECONDARY Number of Exacerbations During 12 Months of Observation	7; 7; 4	—
SECONDARY Health Related Quality of Life Variation Measured With Saint George's Respiratory Questionnaire	39.82; 41.14; 39.60	—
SECONDARY HRQoL Variation Measured With EuroQol Descriptive System	74.6; 45.4; 49.3; 46.8; 46.8; 73.1	—
SECONDARY HRQoL Measured With EQ VAS	67.01; 68.92; 67.46	—
SECONDARY Health Care Resource Consumption From Diagnosis up to End of 12 Months Follow-up According to the Italian National Health Service (INHS)	14.92; 1	—

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

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):
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.
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.

Exclusion criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02803580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.