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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01335477
First received: April 13, 2011
Last updated: January 29, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention Phase
Pulmonary Fibrosis
Drug: placebo
Drug: BIBF 1120
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]

    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) [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]

    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) [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]

    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) [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]

    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) [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]

    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) [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]

    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) [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]

    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) [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]

    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) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline, 12 weeks, 24 weeks and 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

    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) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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 52 Weeks. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 551
Study Start Date: May 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
patient receives capsules identical to those containing active drug
Drug: placebo
placebo matching BIBF 1120 BID
Experimental: BIBF 1120
patient receives capsules containing BIBF 1120 twice a day
Drug: BIBF 1120
BIBF 1120 BID (twice daily)

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Age >= 40 years;
  2. 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;
  3. 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
  4. Dlco (corrected for Hb): 30%-79% predicted of normal; 5.FVC>= 50% predicted of normal

Exclusion criteria:

  1. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit of Normal (ULN)
  2. Bilirubin > 1.5 x ULN;
  3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7);
  4. Patient likely to have lung transplantation during study (being on transplantation list is acceptable for participation);
  5. Myocardial infarction within 6 months;
  6. Unstable angina within 1 month;
  7. 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);
  8. Thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months;
  9. International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by > 50% of institutional ULN);
  10. N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit 1;
  11. Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of visit 1;
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01335477

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Locations
United States, Arizona
1199.34.10078 Boehringer Ingelheim Investigational Site
Scottsdale, Arizona, United States
United States, California
1199.34.10086 Boehringer Ingelheim Investigational Site
San Francisco, California, United States
1199.34.10093 Boehringer Ingelheim Investigational Site
Santa Barbara, California, United States
1199.34.10077 Boehringer Ingelheim Investigational Site
Stanford, California, United States
1199.34.10083 Boehringer Ingelheim Investigational Site
Torrance, California, United States
United States, Connecticut
1199.34.10080 Boehringer Ingelheim Investigational Site
Stamford, Connecticut, United States
United States, Florida
1199.34.10087 Boehringer Ingelheim Investigational Site
South Miami, Florida, United States
United States, Georgia
1199.34.10100 Boehringer Ingelheim Investigational Site
Austell, Georgia, United States
United States, Illinois
1199.34.10075 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
United States, Kansas
1199.34.10069 Boehringer Ingelheim Investigational Site
Olathe, Kansas, United States
United States, Kentucky
1199.34.10090 Boehringer Ingelheim Investigational Site
Lexington, Kentucky, United States
United States, Minnesota
1199.34.10079 Boehringer Ingelheim Investigational Site
Rochester, Minnesota, United States
United States, Missouri
1199.34.10067 Boehringer Ingelheim Investigational Site
Chesterfield, Missouri, United States
United States, New Hampshire
1199.34.10066 Boehringer Ingelheim Investigational Site
Lebanon, New Hampshire, United States
United States, New York
1199.34.10085 Boehringer Ingelheim Investigational Site
Albany, New York, United States
1199.34.10092 Boehringer Ingelheim Investigational Site
Jamaica, New York, United States
United States, North Carolina
1199.34.10074 Boehringer Ingelheim Investigational Site
Durham, North Carolina, United States
United States, Ohio
1199.34.10088 Boehringer Ingelheim Investigational Site
Toledo, Ohio, United States
United States, Oregon
1199.34.10070 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
United States, Pennsylvania
1199.34.10064 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
1199.34.10089 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
United States, South Carolina
1199.34.10082 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
United States, Texas
1199.34.10095 Boehringer Ingelheim Investigational Site
Longview, Texas, United States
1199.34.10060 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
United States, Utah
1199.34.10084 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah, United States
United States, Vermont
1199.34.10101 Boehringer Ingelheim Investigational Site
Colchester, Vermont, United States
United States, Wisconsin
1199.34.10073 Boehringer Ingelheim Investigational Site
Madison, Wisconsin, United States
Canada, Alberta
1199.34.02001 Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
Canada, Nova Scotia
1199.34.02003 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia, Canada
Canada, Ontario
1199.34.02002 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
Chile
1199.34.56001 Boehringer Ingelheim Investigational Site
Santiago de Chile, Chile
China
1199.34.86056 Boehringer Ingelheim Investigational Site
Beijing, China
1199.34.86054 Boehringer Ingelheim Investigational Site
Shanghai, China
1199.34.86052 Boehringer Ingelheim Investigational Site
Shanghai, China
1199.34.86055 Boehringer Ingelheim Investigational Site
Shanghai, China
1199.34.86058 Boehringer Ingelheim Investigational Site
Shanghai, China
1199.34.86051 Boehringer Ingelheim Investigational Site
Shenyang, China
1199.34.86053 Boehringer Ingelheim Investigational Site
Shenyang, China
1199.34.86057 Boehringer Ingelheim Investigational Site
Yinchuan, China
Finland
1199.34.35801 Boehringer Ingelheim Investigational Site
Helsinki, Finland
France
1199.34.33004 Boehringer Ingelheim Investigational Site
Dijon Cedex, France
1199.34.33003 Boehringer Ingelheim Investigational Site
Lille Cedex, France
1199.34.33005 Boehringer Ingelheim Investigational Site
Lyon Cedex, France
1199.34.33007 Boehringer Ingelheim Investigational Site
Marseille, France
1199.34.33002 Boehringer Ingelheim Investigational Site
Montpellier cedex 5, France
1199.34.33006 Boehringer Ingelheim Investigational Site
Toulouse cedex 9, France
Germany
1199.34.49003 Boehringer Ingelheim Investigational Site
Bad Berka, Germany
1199.34.49002 Boehringer Ingelheim Investigational Site
Berlin, Germany
1199.34.49010 Boehringer Ingelheim Investigational Site
Berlin-Buch, Germany
1199.34.49005 Boehringer Ingelheim Investigational Site
Coswig, Germany
1199.34.49001 Boehringer Ingelheim Investigational Site
Essen, Germany
1199.34.49007 Boehringer Ingelheim Investigational Site
Greifswald, Germany
1199.34.49009 Boehringer Ingelheim Investigational Site
Immenhausen, Germany
1199.34.49011 Boehringer Ingelheim Investigational Site
Köln, Germany
1199.34.49006 Boehringer Ingelheim Investigational Site
München, Germany
1199.34.49004 Boehringer Ingelheim Investigational Site
Münster, Germany
Greece
1199.34.30005 Boehringer Ingelheim Investigational Site
Athens, Greece
1199.34.30001 Boehringer Ingelheim Investigational Site
Heraklion, Greece
1199.34.30004 Boehringer Ingelheim Investigational Site
Larisa, Greece
1199.34.30002 Boehringer Ingelheim Investigational Site
Maroussi, Athens, Greece
1199.34.30003 Boehringer Ingelheim Investigational Site
Nikaia, Greece
India
1199.34.91051 Boehringer Ingelheim Investigational Site
Ahmedabad, India
1199.34.91053 Boehringer Ingelheim Investigational Site
Banglore, India
1199.34.91056 Boehringer Ingelheim Investigational Site
Jaipur, India
1199.34.91054 Boehringer Ingelheim Investigational Site
Pune, India
1199.34.91055 Boehringer Ingelheim Investigational Site
Pune, India
Japan
1199.34.81059 Boehringer Ingelheim Investigational Site
Himeji, Hyogo, Japan
1199.34.81063 Boehringer Ingelheim Investigational Site
Kawasaki, Kanagawa, Japan
1199.34.81060 Boehringer Ingelheim Investigational Site
Kobe, Hyogo, Japan
1199.34.81051 Boehringer Ingelheim Investigational Site
Minato-ku, Tokyo, Japan
1199.34.81054 Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan
1199.34.81055 Boehringer Ingelheim Investigational Site
Ogaki, Gifu, Japan
1199.34.81058 Boehringer Ingelheim Investigational Site
Osaka-Sayama, Osaka, Japan
1199.34.81057 Boehringer Ingelheim Investigational Site
Sakai, Osaka, Japan
1199.34.81053 Boehringer Ingelheim Investigational Site
Seto, Aichi, Japan
1199.34.81052 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan
1199.34.81056 Boehringer Ingelheim Investigational Site
Tenri, Nara, Japan
1199.34.81062 Boehringer Ingelheim Investigational Site
Tokushima, Tokushima, Japan
1199.34.81061 Boehringer Ingelheim Investigational Site
Yonago, Tottori, Japan
Korea, Republic of
1199.34.82002 Boehringer Ingelheim Investigational Site
Bucheon, Korea, Republic of
1199.34.82004 Boehringer Ingelheim Investigational Site
Incheon, Korea, Republic of
1199.34.82007 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1199.34.82001 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1199.34.82006 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1199.34.82003 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Mexico
1199.34.52001 Boehringer Ingelheim Investigational Site
Mexico DF, Mexico
Netherlands
1199.34.31002 Boehringer Ingelheim Investigational Site
Amsterdam, Netherlands
1199.34.31001 Boehringer Ingelheim Investigational Site
Nieuwegein, Netherlands
1199.34.31003 Boehringer Ingelheim Investigational Site
Rotterdam, Netherlands
Portugal
1199.34.35107 Boehringer Ingelheim Investigational Site
Amadora, Portugal
1199.34.35105 Boehringer Ingelheim Investigational Site
Coimbra, Portugal
1199.34.35102 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1199.34.35103 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1199.34.35101 Boehringer Ingelheim Investigational Site
Porto, Portugal
1199.34.35106 Boehringer Ingelheim Investigational Site
Vila Nova de Gaia, Portugal
Russian Federation
1199.34.07001 Boehringer Ingelheim Investigational Site
Kazan, Russian Federation
1199.34.07003 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
Spain
1199.34.34001 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1199.34.34003 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1199.34.34004 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1199.34.34005 Boehringer Ingelheim Investigational Site
Hospitalet de Llobregat, Spain
1199.34.34009 Boehringer Ingelheim Investigational Site
Madrid, Spain
1199.34.34008 Boehringer Ingelheim Investigational Site
Sevilla, Spain
Turkey
1199.34.90003 Boehringer Ingelheim Investigational Site
Ankara, Turkey
1199.34.90001 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
1199.34.90005 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
1199.34.90002 Boehringer Ingelheim Investigational Site
Izmir, Turkey
1199.34.90004 Boehringer Ingelheim Investigational Site
Izmir, Turkey
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01335477     History of Changes
Other Study ID Numbers: 1199.34, 2010-024252-29
Study First Received: April 13, 2011
Results First Received: November 14, 2014
Last Updated: January 29, 2015
Health Authority: Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
India: Drugs Controller General of India
Japan: Ministry of Health, Labor and Welfare
Mexico: Ministry of Health
Netherlands: Central Committee Research Involving Human Subjects
Portugal: National Pharmacy and Medicines Institute
Russia: Pharmacological Committee, Ministry of Health
South Korea: Ministry of Food and Drug Safety (MFDS)
Spain: Spanish Agency of Medicines
Turkey: Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibrosis
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2015