NCT02803580 is a clinical trial in Idiopathic Pulmonary Fibrosis, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT02803580?

NCT02803580 is sponsored by Boehringer Ingelheim.

What condition does NCT02803580 study?

NCT02803580 studies Idiopathic Pulmonary Fibrosis.

Is NCT02803580 still recruiting?

NCT02803580 is currently completed. Last updated 13 September 2019.

Are results published for NCT02803580?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-09-13 · How we verify

NCT02803580

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

IPF Italian Observational Study (FIBRONET) in Idiopathic Pulmonary Fibrosis

Completed Results posted Last updated 13 September 2019

What this trial tests

trial in Idiopathic Pulmonary Fibrosis in 209 participants. Completed in 15 May 2018.

Timeline

17 November 2015

Primary endpoint
15 May 2018

15 May 2018

Quick facts

Lead sponsor	Boehringer Ingelheim
Status	Completed
Study type	OBSERVATIONAL
Enrollment	209
Start date	17 November 2015
Primary completion	15 May 2018
Estimated completion	15 May 2018
Sites	18 locations across Italy

Conditions studied

Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 40 to 99, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With IPF Symptoms Primary · 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).

More than 1 IPF symptom - V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	88.0

More than 1 IPF symptom - V2

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	51.8

More than 1 IPF symptom - V3

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	49.4

More than 1 IPF symptom - V4

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	42.9

More than 1 IPF symptom - V5

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	45.4

Cough - V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	59.8

Cough - V2

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	38.7

Cough - V3

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	36.6

Change From Baseline to Follow-up Visits in Lung Function: Vital Capacity Primary · 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.

V2-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	0.08	± 0.47

V3-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	0.07	± 0.55

V4-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	0.07	± 0.58

V5-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	0.03	± 0.58

Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Actual) Primary · 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.

V2-V1 Actual

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.02	± 0.27

V3-V1 Actual

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.02	± 0.34

V4-V1 Actual

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.02	± 0.31

V5-V1 Actual

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.05	± 0.33

Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Predicted) Primary · Baseline, 3 months, 6 months, 9 months and 12 months

V2-V1 Predicted

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	0.31	± 8.82

V3-V1 Predicted

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	1.59	± 8.20

V4-V1 Predicted

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	1.36	± 9.39

V5-V1 Predicted

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	0.01	± 10.17

Change From Baseline to Follow-up Visits in Lung Function: Forced Expiratory Volume in the 1st Second Primary · 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.

V2-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	0.01	± 0.21

V3-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.02	± 0.22

V4-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.01	± 0.24

V5-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.02	± 0.28

Change From Baseline to Follow-up Visits in Lung Function: Total Lung Capacity Primary · 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.

V2-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.07	± 0.62

V3-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.05	± 0.72

V4-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.03	± 0.65

V5-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.11	± 0.65

Change From Baseline to Follow-up Visits in Lung Function: Diffusion Capacity for Carbon Monoxide Primary · 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/minut

V2-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.41	± 2.52

V3-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.46	± 2.27

V4-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.34	± 2.97

V5-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.25	± 3.03

Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen Primary · 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.

V2-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.06	± 6.22

V3-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	2.13	± 9.56

V4-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	1.11	± 9.88

V5-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.47	± 14.05

Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide Primary · 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.

V2-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	1.03	± 3.63

V3-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	1.59	± 5.36

V4-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	1.24	± 4.42

V5-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	1.12	± 3.75

Change From Baseline to Follow-up Visits in Lung Function: Oxygen Saturation Primary · 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.

V2-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.05	± 2.05

V3-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.33	± 2.23

V4-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.02	± 2.27

V5-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.13	± 2.56

Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen in Arterial Blood at Rest Primary · 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.

V2-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.03	± 6.78

V3-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	2.74	± 5.44

V4-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	-0.60	± 4.48

V5-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	1.43	± 4.86

Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide in Arterial Blood at Rest Primary · 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.

V2-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	1.12	± 2.98

V3-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	1.61	± 2.63

V4-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	0.65	± 2.99

V5-V1

Group	Value	95% CI
Participants With Idiopathic Pulmonary Fibrosis	1.27	± 4.20

Adverse events — posted to ClinicalTrials.gov

Time frame: For serious adverse event (SAE) and Non-SAE: From IPF diagnosis until the end of observation period, up to 12 months. For All-cause mortality: From signing informed consent until the end of observation period, up to 493 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Participants With Idiopathic Pulmonary Fibrosis

Serious: 16/209 (8%)

Deaths: 13/209

Serious adverse events (11 terms)

Reaction	System	Participants With Idiopath…
Cardiac arrest	Cardiac disorders	—
Death	General disorders	—
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—
Angina pectoris	Cardiac disorders	—
Cardiac failure	Cardiac disorders	—
Myocardial infarction	Cardiac disorders	—
Pneumonia	Infections and infestations	—
Epilepsy	Nervous system disorders	—
Syncope	Nervous system disorders	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	Participants With Idiopath…
Diarrhoea	Gastrointestinal disorders	—
Rash	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Cardiac arrest, Death, Idiopathic pulmonary fibrosis, Respiratory failure, Angina pectoris, Cardiac failure, Myocardial infarction, Pneumonia.

Data from ClinicalTrials.gov NCT02803580 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Patient Registries in Idiopathic Pulmonary Fibrosis.
Culver DA, Behr J, Belperio JA, Corte TJ, et al · · 2019 · cited 39× · PMID 31034241 · DOI 10.1164/rccm.201902-0431ci
Clinical course of IPF in Italian patients during 12 months of observation: results from the FIBRONET observational study.
Poletti V, Vancheri C, Albera C, Harari S, et al · · 2021 · cited 8× · PMID 33627105 · DOI 10.1186/s12931-021-01643-w

Verify or expand the search:

Other recruiting trials for Idiopathic Pulmonary Fibrosis

Currently open trials in the same condition.

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NCT07225296 — A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics o · Phase 1 · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

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NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
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NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02803580 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 13 September 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02803580.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02803580

Quick facts

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (11 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Idiopathic Pulmonary Fibrosis

Other Boehringer Ingelheim trials

Verify against primary sources