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Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients

Primary Purpose

Pulmonary Fibrosis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

placebo

BIBF 1120

About this trial

This is an interventional treatment trial for Pulmonary Fibrosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Age >= 40 years;
IPF diagnosed, according to most recent American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) IPF guideline for diagnosis and management, within 5 years;
Combination of High Resolution Computerized Tomography (HRCT) pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF
Dlco (corrected for Hb): 30%-79% predicted of normal;
FVC>= 50% predicted of normal

Exclusion criteria:

Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit of Normal (ULN)
Bilirubin > 1.5 x ULN;
Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7);
Patient likely to have lung transplantation during study (being on transplantation list is acceptable for participation);
Myocardial infarction within 6 months;
Unstable angina within 1 month;
Bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or ulcers or major injury or surgery within 3 months);
Thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months;
International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by > 50% of institutional ULN);
N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit 1;
Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of visit 1;

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BIBF 1120

placebo

Arm Description

patient receives capsules containing BIBF 1120 twice a day

patient receives capsules identical to those containing active drug

Outcomes

Primary Outcome Measures

Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks

Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate

Secondary Outcome Measures

Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks

This is a key secondary endpoint. SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact. The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status. Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52).

Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation

Due to rare events, the median of time to event is not calculable, thus the percentages of patients with (IPF) exacerbation are reported and represented as a key secondary endpoint. An acute exacerbation (reported as an AE by the investigator) was defined as follows: Otherwise unexplained clinical features including all of the following: Unexplained worsening or development of dyspnoea within 30 days New diffuse pulmonary infiltrates on chest X-ray, and/or new HRCT parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit Exclusion of infection as per routine clinical practice and microbiological studies Exclusion of alternative causes as per routine clinical practice including left heart failure, pulmonary embolism and identifiable cause of acute lung injury. Failure is the proportion of patients with at least one acute IPF exacerbation over 52 weeks, based on all investigator-reported AEs .

Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks

Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).

Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks

Percentage change from baseline in FVC over 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).

Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks

Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).

Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks

Percentage change from baseline in FVC (% predicted) at 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).

Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold

Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 5% threshold (decrease by >5%, increase by >5%, and change within ≤5%).

Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold

Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 10% threshold (decrease by 10%, increase by >10%, and change within ≤10%)

FVC Responders Using 10% Threshold at 52 Weeks

FVC responders using 10% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 10% and with an FVC evaluation at 52 weeks.

Proportion of FVC Responders Using 5% Threshold at 52 Weeks

Proportion of FVC responders using 5% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 5% and with an FVC evaluation at 52 weeks.

Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)

Proportion of SGRQ responders at 52 weeks Responders defined as <= -4 points change in change from baseline in SGRQ total score at 52 weeks.

Change From Baseline in SGRQ Symptom Score at 52 Weeks: Patient Reported Outcomes (PROs)

SGRQ Symptom score is a sub-component of SGRQ total score and is concerned with the effect of respiratory symptoms, their frequency and severity. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better symptom-related quality of life. Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52).

Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)

SGRQ Impact score is a sub-component of SGRQ total score and covers a range of aspects concerned with social functioning and psychological disturbances resulting from airway disease. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better impact-related quality of life. Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52).

Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)

SGRQ Activity score is a sub-component of SGRQ total score and concerned with activities that cause or are limited by breathlessness. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better activity-related quality of life. Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52).

Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)

SGRQ-I is the IPF specific version of SGRQ comprises of selected items from the SGRQ divided into three components, Symptoms, Activity and Impact. Each component is scored separately. The weights for all items with a positive responses are summed and the weights from missed items are deducted from the maximum possible weight for the total score. The total score is calculated by dividing the summed weights from positive items in the questionnaire by maximum possible weight for all items in the questionnaire. The total score can range from 0 to 100 with a lower score denoting a better health-related quality of life. Change from baseline is calculated as the difference between total score at week 52 and total score at baseline as measured by the scale.

Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)

Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome). Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52).

Change From Baseline in Cough Symptoms Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)

The cough domains of the Cough and Sputum Assessment Questionnaire (CASAQ(CD)) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome). Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52).

Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks : Patient Reported Outcomes (PROs)

The cough domains of the Cough and Sputum Assessment Questionnaire (CASA-Q) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome). Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52).

Proportion of Patient's Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)

Patient's Global Impression of Change (PGI-C) responders are defined as 'Very much better'/ 'Much better'/ 'A little better'/ 'No change'.

Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs)

The EuroQol 5-dimensional Health State is based on a visual analog scale (EQ-VAS) representing the general patient's health state labelled from 100 (best imaginable health state) to 0 (worst imaginable health state). A higher score indicating a better health state. Change from baseline is calculated as the difference between health state at week 12, 24 and 52 respectively and health state at baseline as measured by the scale.

Risk of an Acute IPF Exacerbation Over 52 Weeks

The incidence rate of exacerbations (calculated as the number of patients with at least 1 acute IPF exacerbation divided by the total number of years at risk in years*100)

Time to Death Over 52 Weeks

Due to rare events, the median of time to event is not calculable, thus the percentages of patients who did or did not experienced death before or at 372 days after randomisation or last contact date (whichever occurs first) are reported. Failure is the proportion of patients who died over 52 weeks (373 days time-period) .

Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated)

Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death due to respiratory causes before or at 372 days after randomisation or last contact date (whichever occurs first) are reported. Failure is the the proportion of patients who died due to respiratory causes over 52 weeks (373 days time-period).

Time to On-treatment Death

Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not die before or at last trial medication intake + 28 days were censored at last trial medication intake + 28 days and reported. Failure is the the proportion of patients who died on-treatment.

Time to Death or Lung Transplant Over 52 Weeks

Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experience event (death or lung transplant) before or at 372 days after randomisation or last contact date (whichever occurs first) are reported. Failure is the proportion of patients who died or had lung transplant over 52 weeks (373 days time-period).

Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.

Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death or lung transplant or qualifying for lung transplant over 52 weeks are reported. A patient was considered qualifying for lung transplant by the investigator if he or she fulfilled the following criteria: FVC <45% predicted or Carbon monoxide diffusion capacity (DL(CO)) <30% pred or Oxygen saturation on pulse oximetry (SpO2) <88% at rest, at sea level (to be adapted for other heights). These criteria were evaluated by investigators judgement. Failure is the proportion of patients who died or had lung transplant or qualified for lung transplant over 52 weeks (373 days time-period).

Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks

Means presented are the adjusted means. Adjusted mean is based on all analyzed patients in the model (not only patients with a change from baseline to week 52)

Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks

Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).

Full Information

NCT ID

NCT01335464

First Posted

April 13, 2011

Last Updated

June 24, 2016

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01335464

Brief Title

Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients

Official Title

A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate. In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo. Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data. Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

515 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BIBF 1120

Arm Type

Experimental

Arm Description

patient receives capsules containing BIBF 1120 twice a day

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

patient receives capsules identical to those containing active drug

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo matching BIBF1120, BID

Intervention Type

Drug

Intervention Name(s)

BIBF 1120

Intervention Description

BIBF1120 BID (twice daily)

Primary Outcome Measure Information:

Title

Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks

Description

Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks

Description

Time Frame

baseline and 52 weeks

Title

Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation

Description

Time Frame

52 weeks

Title

Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks

Description

Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).

Time Frame

Baseline and 52 weeks

Title

Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks

Description

Time Frame

Baseline and 52 weeks

Title

Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks

Description

Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).

Time Frame

Baseline and 52 weeks

Title

Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks

Description

Time Frame

Baseline and 52 weeks

Title

Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold

Description

Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 5% threshold (decrease by >5%, increase by >5%, and change within ≤5%).

Time Frame

Baseline and 52 weeks

Title

Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold

Description

Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 10% threshold (decrease by 10%, increase by >10%, and change within ≤10%)

Time Frame

Baseline and 52 weeks

Title

FVC Responders Using 10% Threshold at 52 Weeks

Description

FVC responders using 10% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 10% and with an FVC evaluation at 52 weeks.

Time Frame

52 weeks

Title

Proportion of FVC Responders Using 5% Threshold at 52 Weeks

Description

Proportion of FVC responders using 5% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 5% and with an FVC evaluation at 52 weeks.

Time Frame

52 weeks

Title

Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)

Description

Proportion of SGRQ responders at 52 weeks Responders defined as <= -4 points change in change from baseline in SGRQ total score at 52 weeks.

Time Frame

Baseline and 52 weeks

Title

Change From Baseline in SGRQ Symptom Score at 52 Weeks: Patient Reported Outcomes (PROs)

Description

Time Frame

Baseline and 52 weeks

Title

Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)

Description

Time Frame

Baseline and 52 weeks

Title

Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)

Description

Time Frame

baseline and 52 weeks

Title

Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)

Description

Time Frame

Baseline and 52 weeks

Title

Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)

Description

Time Frame

baseline and 52 weeks

Title

Change From Baseline in Cough Symptoms Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)

Description

Time Frame

Baseline and 52 weeks

Title

Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks : Patient Reported Outcomes (PROs)

Description

Time Frame

Baseline and 52 weeks

Title

Proportion of Patient's Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)

Description

Patient's Global Impression of Change (PGI-C) responders are defined as 'Very much better'/ 'Much better'/ 'A little better'/ 'No change'.

Time Frame

52 weeks

Title

Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs)

Description

Time Frame

baseline, 12 weeks, 24 weeks and 52 weeks

Title

Risk of an Acute IPF Exacerbation Over 52 Weeks

Description

The incidence rate of exacerbations (calculated as the number of patients with at least 1 acute IPF exacerbation divided by the total number of years at risk in years*100)

Time Frame

52 weeks

Title

Time to Death Over 52 Weeks

Description

Time Frame

52 weeks

Title

Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated)

Description

Time Frame

52 weeks

Title

Time to On-treatment Death

Description

Time Frame

52 weeks

Title

Time to Death or Lung Transplant Over 52 Weeks

Description

Time Frame

52 weeks

Title

Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.

Description

Time Frame

52 weeks

Title

Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks

Description

Means presented are the adjusted means. Adjusted mean is based on all analyzed patients in the model (not only patients with a change from baseline to week 52)

Time Frame

Baseline and 52 weeks

Title

Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks

Description

Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).

Time Frame

Baseline and 52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Age >= 40 years; IPF diagnosed, according to most recent American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) IPF guideline for diagnosis and management, within 5 years; Combination of High Resolution Computerized Tomography (HRCT) pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF Dlco (corrected for Hb): 30%-79% predicted of normal; FVC>= 50% predicted of normal Exclusion criteria: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit of Normal (ULN) Bilirubin > 1.5 x ULN; Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7); Patient likely to have lung transplantation during study (being on transplantation list is acceptable for participation); Myocardial infarction within 6 months; Unstable angina within 1 month; Bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or ulcers or major injury or surgery within 3 months); Thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months; International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by > 50% of institutional ULN); N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit 1; Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of visit 1;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

1199.32.10007 Boehringer Ingelheim Investigational Site

City

Birmingham

State/Province

Alabama

Country

United States

Facility Name

1199.32.10029 Boehringer Ingelheim Investigational Site

City

Jasper

State/Province

Alabama

Country

United States

Facility Name

1199.32.10013 Boehringer Ingelheim Investigational Site

City

Phoenix

State/Province

Arizona

Country

United States

Facility Name

1199.32.10005 Boehringer Ingelheim Investigational Site

City

Los Angeles

State/Province

California

Country

United States

Facility Name

1199.32.10022 Boehringer Ingelheim Investigational Site

City

Danbury

State/Province

Connecticut

Country

United States

Facility Name

1199.32.10025 Boehringer Ingelheim Investigational Site

City

Newark

State/Province

Delaware

Country

United States

Facility Name

1199.32.10023 Boehringer Ingelheim Investigational Site

City

Weston

State/Province

Florida

Country

United States

Facility Name

1199.32.10001 Boehringer Ingelheim Investigational Site

City

Council Bluffs

State/Province

Iowa

Country

United States

Facility Name

1199.32.10028 Boehringer Ingelheim Investigational Site

City

Wichita

State/Province

Kansas

Country

United States

Facility Name

1199.32.10016 Boehringer Ingelheim Investigational Site

City

Minneapolis

State/Province

Minnesota

Country

United States

Facility Name

1199.32.10024 Boehringer Ingelheim Investigational Site

City

New Brunswich

State/Province

New Jersey

Country

United States

Facility Name

1199.32.10019 Boehringer Ingelheim Investigational Site

City

New York

State/Province

New York

Country

United States

Facility Name

1199.32.10004 Boehringer Ingelheim Investigational Site

City

Cincinnati

State/Province

Ohio

Country

United States

Facility Name

1199.32.10020 Boehringer Ingelheim Investigational Site

City

Portland

State/Province

Oregon

Country

United States

Facility Name

1199.32.10002 Boehringer Ingelheim Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

Country

United States

Facility Name

1199.32.10033 Boehringer Ingelheim Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

Country

United States

Facility Name

1199.32.10008 Boehringer Ingelheim Investigational Site

City

Providence

State/Province

Rhode Island

Country

United States

Facility Name

1199.32.10015 Boehringer Ingelheim Investigational Site

City

Nashville

State/Province

Tennessee

Country

United States

Facility Name

1199.32.10034 Boehringer Ingelheim Investigational Site

City

Shelbyville

State/Province

Tennessee

Country

United States

Facility Name

1199.32.10009 Boehringer Ingelheim Investigational Site

City

Dallas

State/Province

Texas

Country

United States

Facility Name

1199.32.10018 Boehringer Ingelheim Investigational Site

City

McKinney

State/Province

Texas

Country

United States

Facility Name

1199.32.10021 Boehringer Ingelheim Investigational Site

City

Falls Church

State/Province

Virginia

Country

United States

Facility Name

1199.32.10003 Boehringer Ingelheim Investigational Site

City

Lynchburg

State/Province

Virginia

Country

United States

Facility Name

1199.32.10038 Boehringer Ingelheim Investigational Site

City

Tacoma

State/Province

Washington

Country

United States

Facility Name

1199.32.61001 Boehringer Ingelheim Investigational Site

City

Camperdown

State/Province

New South Wales

Country

Australia

Facility Name

1199.32.61002 Boehringer Ingelheim Investigational Site

City

Concord

State/Province

New South Wales

Country

Australia

Facility Name

1199.32.61003 Boehringer Ingelheim Investigational Site

City

Daw Park

State/Province

South Australia

Country

Australia

Facility Name

1199.32.61005 Boehringer Ingelheim Investigational Site

City

Frankston

State/Province

Victoria

Country

Australia

Facility Name

1199.32.61004 Boehringer Ingelheim Investigational Site

City

Prahran

State/Province

Victoria

Country

Australia

Facility Name

1199.32.32004 Boehringer Ingelheim Investigational Site

City

Bruxelles

Country

Belgium

Facility Name

1199.32.32005 Boehringer Ingelheim Investigational Site

City

Jette

Country

Belgium

Facility Name

1199.32.32001 Boehringer Ingelheim Investigational Site

City

Leuven

Country

Belgium

Facility Name

1199.32.32002 Boehringer Ingelheim Investigational Site

City

Yvoir

Country

Belgium

Facility Name

1199.32.86001 Boehringer Ingelheim Investigational Site

City

Beijing

Country

China

Facility Name

1199.32.86002 Boehringer Ingelheim Investigational Site

City

Beijing

Country

China

Facility Name

1199.32.86005 Boehringer Ingelheim Investigational Site

City

Changsha

Country

China

Facility Name

1199.32.86004 Boehringer Ingelheim Investigational Site

City

Chengdu

Country

China

Facility Name

1199.32.86003 Boehringer Ingelheim Investigational Site

City

Nanchang

Country

China

Facility Name

1199.32.86006 Boehringer Ingelheim Investigational Site

City

Xi'An

Country

China

Facility Name

1199.32.42003 Boehringer Ingelheim Investigational Site

City

Prague 4

Country

Czech Republic

Facility Name

1199.32.42002 Boehringer Ingelheim Investigational Site

City

Prague 8

Country

Czech Republic

Facility Name

1199.32.42001 Boehringer Ingelheim Investigational Site

City

Usti nad Labem

Country

Czech Republic

Facility Name

1199.32.33002 Boehringer Ingelheim Investigational Site

City

Bobigny

Country

France

Facility Name

1199.32.33003 Boehringer Ingelheim Investigational Site

City

Nice Cedex 1

Country

France

Facility Name

1199.32.33006 Boehringer Ingelheim Investigational Site

City

Paris Cedex 15

Country

France

Facility Name

1199.32.33001 Boehringer Ingelheim Investigational Site

City

Paris Cedex 18

Country

France

Facility Name

1199.32.33005 Boehringer Ingelheim Investigational Site

City

Paris cedex 20

Country

France

Facility Name

1199.32.33007 Boehringer Ingelheim Investigational Site

City

Reims cedex

Country

France

Facility Name

1199.32.33004 Boehringer Ingelheim Investigational Site

City

Rennes Cedex 9

Country

France

Facility Name

1199.32.49008 Boehringer Ingelheim Investigational Site

City

Bamberg

Country

Germany

Facility Name

1199.32.49005 Boehringer Ingelheim Investigational Site

City

Donaustauf

Country

Germany

Facility Name

1199.32.49001 Boehringer Ingelheim Investigational Site

City

Essen

Country

Germany

Facility Name

1199.32.49002 Boehringer Ingelheim Investigational Site

City

Freiburg/Breisgau

Country

Germany

Facility Name

1199.32.49006 Boehringer Ingelheim Investigational Site

City

Gießen

Country

Germany

Facility Name

1199.32.49003 Boehringer Ingelheim Investigational Site

City

Großhansdorf

Country

Germany

Facility Name

1199.32.49007 Boehringer Ingelheim Investigational Site

City

Heidelberg

Country

Germany

Facility Name

1199.32.49004 Boehringer Ingelheim Investigational Site

City

Mainz

Country

Germany

Facility Name

1199.32.91003 Boehringer Ingelheim Investigational Site

City

Ahmedabad

Country

India

Facility Name

1199.32.91002 Boehringer Ingelheim Investigational Site

City

Coimbatore

Country

India

Facility Name

1199.32.91006 Boehringer Ingelheim Investigational Site

City

Jaipur

Country

India

Facility Name

1199.32.91005 Boehringer Ingelheim Investigational Site

City

Kolkatta

Country

India

Facility Name

1199.32.91001 Boehringer Ingelheim Investigational Site

City

Mumbai

Country

India

Facility Name

1199.32.35301 Boehringer Ingelheim Investigational Site

City

Dublin

Country

Ireland

Facility Name

1199.32.97004 Boehringer Ingelheim Investigational Site

City

Haifa

Country

Israel

Facility Name

1199.32.97001 Boehringer Ingelheim Investigational Site

City

Petah Tiqwa

Country

Israel

Facility Name

1199.32.97002 Boehringer Ingelheim Investigational Site

City

Rehovot

Country

Israel

Facility Name

1199.32.39012 Boehringer Ingelheim Investigational Site

City

Catania

Country

Italy

Facility Name

1199.32.39004 Boehringer Ingelheim Investigational Site

City

Chieti Scalo

Country

Italy

Facility Name

1199.32.39008 Boehringer Ingelheim Investigational Site

City

Forli'

Country

Italy

Facility Name

1199.32.39005 Boehringer Ingelheim Investigational Site

City

Milano

Country

Italy

Facility Name

1199.32.39001 Boehringer Ingelheim Investigational Site

City

Modena

Country

Italy

Facility Name

1199.32.39007 Boehringer Ingelheim Investigational Site

City

Monza

Country

Italy

Facility Name

1199.32.39011 Boehringer Ingelheim Investigational Site

City

Napoli

Country

Italy

Facility Name

1199.32.39002 Boehringer Ingelheim Investigational Site

City

Padova

Country

Italy

Facility Name

1199.32.39006A Boehringer Ingelheim Investigational Site

City

Pisa

Country

Italy

Facility Name

1199.32.39006B Boehringer Ingelheim Investigational Site

City

Pisa

Country

Italy

Facility Name

1199.32.39010 Boehringer Ingelheim Investigational Site

City

Roma

Country

Italy

Facility Name

1199.32.39009 Boehringer Ingelheim Investigational Site

City

Siena

Country

Italy

Facility Name

1199.32.81005 Boehringer Ingelheim Investigational Site

City

Bunkyo-ku,Tokyo

Country

Japan

Facility Name

1199.32.81006 Boehringer Ingelheim Investigational Site

City

Bunkyo-ku,Tokyo

Country

Japan

Facility Name

1199.32.81007 Boehringer Ingelheim Investigational Site

City

Kiyose, Tokyo

Country

Japan

Facility Name

1199.32.81004 Boehringer Ingelheim Investigational Site

City

Kumagaya, Saitama

Country

Japan

Facility Name

1199.32.81009 Boehringer Ingelheim Investigational Site

City

Minato-ku, Tokyo

Country

Japan

Facility Name

1199.32.81003 Boehringer Ingelheim Investigational Site

City

Naka-gun, Ibaraki

Country

Japan

Facility Name

1199.32.81011 Boehringer Ingelheim Investigational Site

City

Ota-ku, Tokyo

Country

Japan

Facility Name

1199.32.81001 Boehringer Ingelheim Investigational Site

City

Sendai, Miyagi

Country

Japan

Facility Name

1199.32.81010 Boehringer Ingelheim Investigational Site

City

Shibuya-ku, Tokyo

Country

Japan

Facility Name

1199.32.81002 Boehringer Ingelheim Investigational Site

City

Shimotsuke,Tochigi

Country

Japan

Facility Name

1199.32.81008 Boehringer Ingelheim Investigational Site

City

Shinjuku-ku, Tokyo

Country

Japan

Facility Name

1199.32.81012 Boehringer Ingelheim Investigational Site

City

Yokohama, Kanagawa

Country

Japan

Facility Name

1199.32.44006 Boehringer Ingelheim Investigational Site

City

Aberdeen

Country

United Kingdom

Facility Name

1199.32.44003 Boehringer Ingelheim Investigational Site

City

Birmingham

Country

United Kingdom

Facility Name

1199.32.44005 Boehringer Ingelheim Investigational Site

City

Birmingham

Country

United Kingdom

Facility Name

1199.32.44009 Boehringer Ingelheim Investigational Site

City

Leeds

Country

United Kingdom

Facility Name

1199.32.44004 Boehringer Ingelheim Investigational Site

City

Liverpool

Country

United Kingdom

Facility Name

1199.32.44002 Boehringer Ingelheim Investigational Site

City

London

Country

United Kingdom

Facility Name

1199.32.44008 Boehringer Ingelheim Investigational Site

City

Oxford

Country

United Kingdom

Facility Name

1199.32.44001 Boehringer Ingelheim Investigational Site

City

Westbury on Trym

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

33902584

Citation

Glaspole I, Bonella F, Bargagli E, Glassberg MK, Caro F, Stansen W, Quaresma M, Orsatti L, Bendstrup E. Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities. Respir Res. 2021 Apr 26;22(1):125. doi: 10.1186/s12931-021-01695-y.

Results Reference

derived

PubMed Identifier

33239000

Citation

Jouneau S, Crestani B, Thibault R, Lederlin M, Vernhet L, Valenzuela C, Wijsenbeek M, Kreuter M, Stansen W, Quaresma M, Cottin V. Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis. Respir Res. 2020 Nov 25;21(1):312. doi: 10.1186/s12931-020-01528-4.

Results Reference

derived

PubMed Identifier

32217654

Citation

Brown KK, Martinez FJ, Walsh SLF, Thannickal VJ, Prasse A, Schlenker-Herceg R, Goeldner RG, Clerisme-Beaty E, Tetzlaff K, Cottin V, Wells AU. The natural history of progressive fibrosing interstitial lung diseases. Eur Respir J. 2020 Jun 25;55(6):2000085. doi: 10.1183/13993003.00085-2020. Print 2020 Jun.

Results Reference

derived

PubMed Identifier

31914963

Citation

Richeldi L, Kolb M, Jouneau S, Wuyts WA, Schinzel B, Stowasser S, Quaresma M, Raghu G. Efficacy and safety of nintedanib in patients with advanced idiopathic pulmonary fibrosis. BMC Pulm Med. 2020 Jan 8;20(1):3. doi: 10.1186/s12890-019-1030-4.

Results Reference

derived

PubMed Identifier

30971229

Citation

Kreuter M, Koegler H, Trampisch M, Geier S, Richeldi L. Differing severities of acute exacerbations of idiopathic pulmonary fibrosis (IPF): insights from the INPULSIS(R) trials. Respir Res. 2019 Apr 11;20(1):71. doi: 10.1186/s12931-019-1037-7.

Results Reference

derived

PubMed Identifier

30729456

Citation

Xu Z, Li H, Wen F, Bai C, Chen P, Fan F, Hu N, Stowasser S, Kang J. Subgroup Analysis for Chinese Patients Included in the INPULSIS(R) Trials on Nintedanib in Idiopathic Pulmonary Fibrosis. Adv Ther. 2019 Mar;36(3):621-631. doi: 10.1007/s12325-019-0887-1. Epub 2019 Feb 7.

Results Reference

derived

PubMed Identifier

30176872

Citation

Costabel U, Behr J, Crestani B, Stansen W, Schlenker-Herceg R, Stowasser S, Raghu G. Anti-acid therapy in idiopathic pulmonary fibrosis: insights from the INPULSIS(R) trials. Respir Res. 2018 Sep 3;19(1):167. doi: 10.1186/s12931-018-0866-0.

Results Reference

derived

PubMed Identifier

28526798

Citation

Collard HR, Richeldi L, Kim DS, Taniguchi H, Tschoepe I, Luisetti M, Roman J, Tino G, Schlenker-Herceg R, Hallmann C, du Bois RM. Acute exacerbations in the INPULSIS trials of nintedanib in idiopathic pulmonary fibrosis. Eur Respir J. 2017 May 19;49(5):1601339. doi: 10.1183/13993003.01339-2016. Print 2017 May.

Results Reference

derived

PubMed Identifier

28388260

Citation

Paterniti MO, Bi Y, Rekic D, Wang Y, Karimi-Shah BA, Chowdhury BA. Acute Exacerbation and Decline in Forced Vital Capacity Are Associated with Increased Mortality in Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2017 Sep;14(9):1395-1402. doi: 10.1513/AnnalsATS.201606-458OC.

Results Reference

derived

PubMed Identifier

28039616

Citation

Rinciog C, Watkins M, Chang S, Maher TM, LeReun C, Esser D, Diamantopoulos A. A Cost-Effectiveness Analysis of Nintedanib in Idiopathic Pulmonary Fibrosis in the UK. Pharmacoeconomics. 2017 Apr;35(4):479-491. doi: 10.1007/s40273-016-0480-2.

Results Reference

derived

PubMed Identifier

27672117

Citation

Kolb M, Richeldi L, Behr J, Maher TM, Tang W, Stowasser S, Hallmann C, du Bois RM. Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume. Thorax. 2017 Apr;72(4):340-346. doi: 10.1136/thoraxjnl-2016-208710. Epub 2016 Sep 26.

Results Reference

derived

PubMed Identifier

26400368

Citation

Corte T, Bonella F, Crestani B, Demedts MG, Richeldi L, Coeck C, Pelling K, Quaresma M, Lasky JA. Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis. Respir Res. 2015 Sep 24;16:116. doi: 10.1186/s12931-015-0276-5.

Results Reference

derived

PubMed Identifier

24836310

Citation

Richeldi L, du Bois RM, Raghu G, Azuma A, Brown KK, Costabel U, Cottin V, Flaherty KR, Hansell DM, Inoue Y, Kim DS, Kolb M, Nicholson AG, Noble PW, Selman M, Taniguchi H, Brun M, Le Maulf F, Girard M, Stowasser S, Schlenker-Herceg R, Disse B, Collard HR; INPULSIS Trial Investigators. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2071-82. doi: 10.1056/NEJMoa1402584. Epub 2014 May 18. Erratum In: N Engl J Med. 2015 Aug 20;373(8):782.

Results Reference

derived

PubMed Identifier

24834811

Citation

Richeldi L, Cottin V, Flaherty KR, Kolb M, Inoue Y, Raghu G, Taniguchi H, Hansell DM, Nicholson AG, Le Maulf F, Stowasser S, Collard HR. Design of the INPULSIS trials: two phase 3 trials of nintedanib in patients with idiopathic pulmonary fibrosis. Respir Med. 2014 Jul;108(7):1023-30. doi: 10.1016/j.rmed.2014.04.011. Epub 2014 Apr 29.

Results Reference

derived

Links:

URL

http://trials.boehringer-ingelheim.com

Description

Related Info

Learn more about this trial

Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients

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Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients

Pulmonary Fibrosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial