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

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; 5.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

Placebo Comparator

Experimental

Arm Label

placebo

BIBF 1120

Arm Description

patient receives capsules identical to those containing active drug

patient receives capsules containing BIBF 1120 twice a day

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 From Baseline 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 From Baseline 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 (Points): 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 Symptom 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

NCT01335477

First Posted

April 13, 2011

Last Updated

June 24, 2016

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01335477

Brief Title

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

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

May 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

551 (Actual)

8. Arms, Groups, and Interventions

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

patient receives capsules identical to those containing active drug

Arm Title

BIBF 1120

Arm Type

Experimental

Arm Description

patient receives capsules containing BIBF 1120 twice a day

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo matching BIBF 1120 BID

Intervention Type

Drug

Intervention Name(s)

BIBF 1120

Intervention Description

BIBF 1120 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 From Baseline 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 From Baseline 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 (Points): 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 Symptom 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; 5.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

1199.34.10078 Boehringer Ingelheim Investigational Site

City

Scottsdale

State/Province

Arizona

Country

United States

Facility Name

1199.34.10086 Boehringer Ingelheim Investigational Site

City

San Francisco

State/Province

California

Country

United States

Facility Name

1199.34.10093 Boehringer Ingelheim Investigational Site

City

Santa Barbara

State/Province

California

Country

United States

Facility Name

1199.34.10077 Boehringer Ingelheim Investigational Site

City

Stanford

State/Province

California

Country

United States

Facility Name

1199.34.10083 Boehringer Ingelheim Investigational Site

City

Torrance

State/Province

California

Country

United States

Facility Name

1199.34.10080 Boehringer Ingelheim Investigational Site

City

Stamford

State/Province

Connecticut

Country

United States

Facility Name

1199.34.10087 Boehringer Ingelheim Investigational Site

City

South Miami

State/Province

Florida

Country

United States

Facility Name

1199.34.10100 Boehringer Ingelheim Investigational Site

City

Austell

State/Province

Georgia

Country

United States

Facility Name

1199.34.10075 Boehringer Ingelheim Investigational Site

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

1199.34.10069 Boehringer Ingelheim Investigational Site

City

Olathe

State/Province

Kansas

Country

United States

Facility Name

1199.34.10090 Boehringer Ingelheim Investigational Site

City

Lexington

State/Province

Kentucky

Country

United States

Facility Name

1199.34.10079 Boehringer Ingelheim Investigational Site

City

Rochester

State/Province

Minnesota

Country

United States

Facility Name

1199.34.10067 Boehringer Ingelheim Investigational Site

City

Chesterfield

State/Province

Missouri

Country

United States

Facility Name

1199.34.10066 Boehringer Ingelheim Investigational Site

City

Lebanon

State/Province

New Hampshire

Country

United States

Facility Name

1199.34.10085 Boehringer Ingelheim Investigational Site

City

Albany

State/Province

New York

Country

United States

Facility Name

1199.34.10092 Boehringer Ingelheim Investigational Site

City

Jamaica

State/Province

New York

Country

United States

Facility Name

1199.34.10074 Boehringer Ingelheim Investigational Site

City

Durham

State/Province

North Carolina

Country

United States

Facility Name

1199.34.10088 Boehringer Ingelheim Investigational Site

City

Toledo

State/Province

Ohio

Country

United States

Facility Name

1199.34.10070 Boehringer Ingelheim Investigational Site

City

Portland

State/Province

Oregon

Country

United States

Facility Name

1199.34.10064 Boehringer Ingelheim Investigational Site

City

Philadelphia

State/Province

Pennsylvania

Country

United States

Facility Name

1199.34.10089 Boehringer Ingelheim Investigational Site

City

Philadelphia

State/Province

Pennsylvania

Country

United States

Facility Name

1199.34.10082 Boehringer Ingelheim Investigational Site

City

Charleston

State/Province

South Carolina

Country

United States

Facility Name

1199.34.10095 Boehringer Ingelheim Investigational Site

City

Longview

State/Province

Texas

Country

United States

Facility Name

1199.34.10060 Boehringer Ingelheim Investigational Site

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

1199.34.10084 Boehringer Ingelheim Investigational Site

City

Salt Lake City

State/Province

Utah

Country

United States

Facility Name

1199.34.10101 Boehringer Ingelheim Investigational Site

City

Colchester

State/Province

Vermont

Country

United States

Facility Name

1199.34.10073 Boehringer Ingelheim Investigational Site

City

Madison

State/Province

Wisconsin

Country

United States

Facility Name

1199.34.02001 Boehringer Ingelheim Investigational Site

City

Calgary

State/Province

Alberta

Country

Canada

Facility Name

1199.34.02003 Boehringer Ingelheim Investigational Site

City

Halifax

State/Province

Nova Scotia

Country

Canada

Facility Name

1199.34.02002 Boehringer Ingelheim Investigational Site

City

Hamilton

State/Province

Ontario

Country

Canada

Facility Name

1199.34.56001 Boehringer Ingelheim Investigational Site

City

Santiago de Chile

Country

Chile

Facility Name

1199.34.86056 Boehringer Ingelheim Investigational Site

City

Beijing

Country

China

Facility Name

1199.34.86052 Boehringer Ingelheim Investigational Site

City

Shanghai

Country

China

Facility Name

1199.34.86054 Boehringer Ingelheim Investigational Site

City

Shanghai

Country

China

Facility Name

1199.34.86055 Boehringer Ingelheim Investigational Site

City

Shanghai

Country

China

Facility Name

1199.34.86058 Boehringer Ingelheim Investigational Site

City

Shanghai

Country

China

Facility Name

1199.34.86051 Boehringer Ingelheim Investigational Site

City

Shenyang

Country

China

Facility Name

1199.34.86053 Boehringer Ingelheim Investigational Site

City

Shenyang

Country

China

Facility Name

1199.34.86057 Boehringer Ingelheim Investigational Site

City

Yinchuan

Country

China

Facility Name

1199.34.35801 Boehringer Ingelheim Investigational Site

City

Helsinki

Country

Finland

Facility Name

1199.34.33004 Boehringer Ingelheim Investigational Site

City

Dijon Cedex

Country

France

Facility Name

1199.34.33003 Boehringer Ingelheim Investigational Site

City

Lille Cedex

Country

France

Facility Name

1199.34.33005 Boehringer Ingelheim Investigational Site

City

Lyon Cedex

Country

France

Facility Name

1199.34.33007 Boehringer Ingelheim Investigational Site

City

Marseille

Country

France

Facility Name

1199.34.33002 Boehringer Ingelheim Investigational Site

City

Montpellier cedex 5

Country

France

Facility Name

1199.34.33006 Boehringer Ingelheim Investigational Site

City

Toulouse cedex 9

Country

France

Facility Name

1199.34.49003 Boehringer Ingelheim Investigational Site

City

Bad Berka

Country

Germany

Facility Name

1199.34.49010 Boehringer Ingelheim Investigational Site

City

Berlin-Buch

Country

Germany

Facility Name

1199.34.49002 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1199.34.49005 Boehringer Ingelheim Investigational Site

City

Coswig

Country

Germany

Facility Name

1199.34.49001 Boehringer Ingelheim Investigational Site

City

Essen

Country

Germany

Facility Name

1199.34.49007 Boehringer Ingelheim Investigational Site

City

Greifswald

Country

Germany

Facility Name

1199.34.49009 Boehringer Ingelheim Investigational Site

City

Immenhausen

Country

Germany

Facility Name

1199.34.49011 Boehringer Ingelheim Investigational Site

City

Köln

Country

Germany

Facility Name

1199.34.49006 Boehringer Ingelheim Investigational Site

City

München

Country

Germany

Facility Name

1199.34.49004 Boehringer Ingelheim Investigational Site

City

Münster

Country

Germany

Facility Name

1199.34.30005 Boehringer Ingelheim Investigational Site

City

Athens

Country

Greece

Facility Name

1199.34.30001 Boehringer Ingelheim Investigational Site

City

Heraklion

Country

Greece

Facility Name

1199.34.30004 Boehringer Ingelheim Investigational Site

City

Larisa

Country

Greece

Facility Name

1199.34.30002 Boehringer Ingelheim Investigational Site

City

Maroussi, Athens

Country

Greece

Facility Name

1199.34.30003 Boehringer Ingelheim Investigational Site

City

Nikaia

Country

Greece

Facility Name

1199.34.91051 Boehringer Ingelheim Investigational Site

City

Ahmedabad

Country

India

Facility Name

1199.34.91053 Boehringer Ingelheim Investigational Site

City

Banglore

Country

India

Facility Name

1199.34.91056 Boehringer Ingelheim Investigational Site

City

Jaipur

Country

India

Facility Name

1199.34.91054 Boehringer Ingelheim Investigational Site

City

Pune

Country

India

Facility Name

1199.34.91055 Boehringer Ingelheim Investigational Site

City

Pune

Country

India

Facility Name

1199.34.81059 Boehringer Ingelheim Investigational Site

City

Himeji, Hyogo

Country

Japan

Facility Name

1199.34.81063 Boehringer Ingelheim Investigational Site

City

Kawasaki, Kanagawa

Country

Japan

Facility Name

1199.34.81060 Boehringer Ingelheim Investigational Site

City

Kobe, Hyogo

Country

Japan

Facility Name

1199.34.81051 Boehringer Ingelheim Investigational Site

City

Minato-ku, Tokyo

Country

Japan

Facility Name

1199.34.81054 Boehringer Ingelheim Investigational Site

City

Nagoya, Aichi

Country

Japan

Facility Name

1199.34.81055 Boehringer Ingelheim Investigational Site

City

Ogaki, Gifu

Country

Japan

Facility Name

1199.34.81058 Boehringer Ingelheim Investigational Site

City

Osaka-Sayama, Osaka

Country

Japan

Facility Name

1199.34.81057 Boehringer Ingelheim Investigational Site

City

Sakai, Osaka

Country

Japan

Facility Name

1199.34.81053 Boehringer Ingelheim Investigational Site

City

Seto, Aichi

Country

Japan

Facility Name

1199.34.81052 Boehringer Ingelheim Investigational Site

City

Shinjuku-ku, Tokyo

Country

Japan

Facility Name

1199.34.81056 Boehringer Ingelheim Investigational Site

City

Tenri, Nara

Country

Japan

Facility Name

1199.34.81062 Boehringer Ingelheim Investigational Site

City

Tokushima, Tokushima

Country

Japan

Facility Name

1199.34.81061 Boehringer Ingelheim Investigational Site

City

Yonago, Tottori

Country

Japan

Facility Name

1199.34.82002 Boehringer Ingelheim Investigational Site

City

Bucheon

Country

Korea, Republic of

Facility Name

1199.34.82004 Boehringer Ingelheim Investigational Site

City

Incheon

Country

Korea, Republic of

Facility Name

1199.34.82001 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1199.34.82003 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1199.34.82006 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1199.34.82007 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1199.34.52001 Boehringer Ingelheim Investigational Site

City

Mexico DF

Country

Mexico

Facility Name

1199.34.31002 Boehringer Ingelheim Investigational Site

City

Amsterdam

Country

Netherlands

Facility Name

1199.34.31001 Boehringer Ingelheim Investigational Site

City

Nieuwegein

Country

Netherlands

Facility Name

1199.34.31003 Boehringer Ingelheim Investigational Site

City

Rotterdam

Country

Netherlands

Facility Name

1199.34.35107 Boehringer Ingelheim Investigational Site

City

Amadora

Country

Portugal

Facility Name

1199.34.35105 Boehringer Ingelheim Investigational Site

City

Coimbra

Country

Portugal

Facility Name

1199.34.35102 Boehringer Ingelheim Investigational Site

City

Lisboa

Country

Portugal

Facility Name

1199.34.35103 Boehringer Ingelheim Investigational Site

City

Lisboa

Country

Portugal

Facility Name

1199.34.35101 Boehringer Ingelheim Investigational Site

City

Porto

Country

Portugal

Facility Name

1199.34.35106 Boehringer Ingelheim Investigational Site

City

Vila Nova de Gaia

Country

Portugal

Facility Name

1199.34.07001 Boehringer Ingelheim Investigational Site

City

Kazan

Country

Russian Federation

Facility Name

1199.34.07003 Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

1199.34.34001 Boehringer Ingelheim Investigational Site

City

Barcelona

Country

Spain

Facility Name

1199.34.34003 Boehringer Ingelheim Investigational Site

City

Barcelona

Country

Spain

Facility Name

1199.34.34004 Boehringer Ingelheim Investigational Site

City

Barcelona

Country

Spain

Facility Name

1199.34.34005 Boehringer Ingelheim Investigational Site

City

Hospitalet de Llobregat

Country

Spain

Facility Name

1199.34.34009 Boehringer Ingelheim Investigational Site

City

Madrid

Country

Spain

Facility Name

1199.34.34008 Boehringer Ingelheim Investigational Site

City

Sevilla

Country

Spain

Facility Name

1199.34.90003 Boehringer Ingelheim Investigational Site

City

Ankara

Country

Turkey

Facility Name

1199.34.90001 Boehringer Ingelheim Investigational Site

City

Istanbul

Country

Turkey

Facility Name

1199.34.90005 Boehringer Ingelheim Investigational Site

City

Istanbul

Country

Turkey

Facility Name

1199.34.90002 Boehringer Ingelheim Investigational Site

City

Izmir

Country

Turkey

Facility Name

1199.34.90004 Boehringer Ingelheim Investigational Site

City

Izmir

Country

Turkey

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.

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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.

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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.

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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.

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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.

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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.

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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

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

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

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