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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01335464
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 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 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: 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 Symptoms 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. [ 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: 515
Study Start Date: April 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIBF 1120
patient receives capsules containing BIBF 1120 twice a day
Drug: BIBF 1120
BIBF1120 BID (twice daily)
Placebo Comparator: placebo
patient receives capsules identical to those containing active drug
Drug: placebo
placebo matching BIBF1120, BID

  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: NCT01335464

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Locations
United States, Alabama
1199.32.10007 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
1199.32.10029 Boehringer Ingelheim Investigational Site
Jasper, Alabama, United States
United States, Arizona
1199.32.10013 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
United States, California
1199.32.10005 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
United States, Connecticut
1199.32.10022 Boehringer Ingelheim Investigational Site
Danbury, Connecticut, United States
United States, Delaware
1199.32.10025 Boehringer Ingelheim Investigational Site
Newark, Delaware, United States
United States, Florida
1199.32.10023 Boehringer Ingelheim Investigational Site
Weston, Florida, United States
United States, Iowa
1199.32.10001 Boehringer Ingelheim Investigational Site
Council Bluffs, Iowa, United States
United States, Kansas
1199.32.10028 Boehringer Ingelheim Investigational Site
Wichita, Kansas, United States
United States, Minnesota
1199.32.10016 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota, United States
United States, New Jersey
1199.32.10024 Boehringer Ingelheim Investigational Site
New Brunswich, New Jersey, United States
United States, New York
1199.32.10019 Boehringer Ingelheim Investigational Site
New York, New York, United States
United States, Ohio
1199.32.10004 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
United States, Oregon
1199.32.10020 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
United States, Pennsylvania
1199.32.10033 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania, United States
1199.32.10002 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania, United States
United States, Rhode Island
1199.32.10008 Boehringer Ingelheim Investigational Site
Providence, Rhode Island, United States
United States, Tennessee
1199.32.10015 Boehringer Ingelheim Investigational Site
Nashville, Tennessee, United States
1199.32.10034 Boehringer Ingelheim Investigational Site
Shelbyville, Tennessee, United States
United States, Texas
1199.32.10009 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1199.32.10018 Boehringer Ingelheim Investigational Site
McKinney, Texas, United States
United States, Virginia
1199.32.10021 Boehringer Ingelheim Investigational Site
Falls Church, Virginia, United States
1199.32.10003 Boehringer Ingelheim Investigational Site
Lynchburg, Virginia, United States
United States, Washington
1199.32.10038 Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States
Australia, New South Wales
1199.32.61001 Boehringer Ingelheim Investigational Site
Camperdown, New South Wales, Australia
1199.32.61002 Boehringer Ingelheim Investigational Site
Concord, New South Wales, Australia
Australia, South Australia
1199.32.61003 Boehringer Ingelheim Investigational Site
Daw Park, South Australia, Australia
Australia, Victoria
1199.32.61005 Boehringer Ingelheim Investigational Site
Frankston, Victoria, Australia
1199.32.61004 Boehringer Ingelheim Investigational Site
Prahran, Victoria, Australia
Belgium
1199.32.32004 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1199.32.32005 Boehringer Ingelheim Investigational Site
Jette, Belgium
1199.32.32001 Boehringer Ingelheim Investigational Site
Leuven, Belgium
1199.32.32002 Boehringer Ingelheim Investigational Site
Yvoir, Belgium
China
1199.32.86002 Boehringer Ingelheim Investigational Site
Beijing, China
1199.32.86001 Boehringer Ingelheim Investigational Site
Beijing, China
1199.32.86005 Boehringer Ingelheim Investigational Site
Changsha, China
1199.32.86004 Boehringer Ingelheim Investigational Site
Chengdu, China
1199.32.86003 Boehringer Ingelheim Investigational Site
Nanchang, China
1199.32.86006 Boehringer Ingelheim Investigational Site
Xi'An, China
Czech Republic
1199.32.42003 Boehringer Ingelheim Investigational Site
Prague 4, Czech Republic
1199.32.42002 Boehringer Ingelheim Investigational Site
Prague 8, Czech Republic
1199.32.42001 Boehringer Ingelheim Investigational Site
Usti nad Labem, Czech Republic
France
1199.32.33002 Boehringer Ingelheim Investigational Site
Bobigny, France
1199.32.33003 Boehringer Ingelheim Investigational Site
Nice Cedex 1, France
1199.32.33006 Boehringer Ingelheim Investigational Site
Paris Cedex 15, France
1199.32.33001 Boehringer Ingelheim Investigational Site
Paris Cedex 18, France
1199.32.33005 Boehringer Ingelheim Investigational Site
Paris cedex 20, France
1199.32.33007 Boehringer Ingelheim Investigational Site
Reims cedex, France
1199.32.33004 Boehringer Ingelheim Investigational Site
Rennes Cedex 9, France
Germany
1199.32.49008 Boehringer Ingelheim Investigational Site
Bamberg, Germany
1199.32.49005 Boehringer Ingelheim Investigational Site
Donaustauf, Germany
1199.32.49001 Boehringer Ingelheim Investigational Site
Essen, Germany
1199.32.49002 Boehringer Ingelheim Investigational Site
Freiburg/Breisgau, Germany
1199.32.49006 Boehringer Ingelheim Investigational Site
Gießen, Germany
1199.32.49003 Boehringer Ingelheim Investigational Site
Großhansdorf, Germany
1199.32.49007 Boehringer Ingelheim Investigational Site
Heidelberg, Germany
1199.32.49004 Boehringer Ingelheim Investigational Site
Mainz, Germany
India
1199.32.91003 Boehringer Ingelheim Investigational Site
Ahmedabad, India
1199.32.91002 Boehringer Ingelheim Investigational Site
Coimbatore, India
1199.32.91006 Boehringer Ingelheim Investigational Site
Jaipur, India
1199.32.91005 Boehringer Ingelheim Investigational Site
Kolkatta, India
1199.32.91001 Boehringer Ingelheim Investigational Site
Mumbai, India
Ireland
1199.32.35301 Boehringer Ingelheim Investigational Site
Dublin, Ireland
Israel
1199.32.97004 Boehringer Ingelheim Investigational Site
Haifa, Israel
1199.32.97001 Boehringer Ingelheim Investigational Site
Petah Tiqwa, Israel
1199.32.97002 Boehringer Ingelheim Investigational Site
Rehovot, Israel
Italy
1199.32.39012 Boehringer Ingelheim Investigational Site
Catania, Italy
1199.32.39004 Boehringer Ingelheim Investigational Site
Chieti Scalo, Italy
1199.32.39008 Boehringer Ingelheim Investigational Site
Forli', Italy
1199.32.39005 Boehringer Ingelheim Investigational Site
Milano, Italy
1199.32.39001 Boehringer Ingelheim Investigational Site
Modena, Italy
1199.32.39007 Boehringer Ingelheim Investigational Site
Monza, Italy
1199.32.39011 Boehringer Ingelheim Investigational Site
Napoli, Italy
1199.32.39002 Boehringer Ingelheim Investigational Site
Padova, Italy
1199.32.39006A Boehringer Ingelheim Investigational Site
Pisa, Italy
1199.32.39006B Boehringer Ingelheim Investigational Site
Pisa, Italy
1199.32.39010 Boehringer Ingelheim Investigational Site
Roma, Italy
1199.32.39009 Boehringer Ingelheim Investigational Site
Siena, Italy
Japan
1199.32.81005 Boehringer Ingelheim Investigational Site
Bunkyo-ku,Tokyo, Japan
1199.32.81006 Boehringer Ingelheim Investigational Site
Bunkyo-ku,Tokyo, Japan
1199.32.81007 Boehringer Ingelheim Investigational Site
Kiyose, Tokyo, Japan
1199.32.81004 Boehringer Ingelheim Investigational Site
Kumagaya, Saitama, Japan
1199.32.81009 Boehringer Ingelheim Investigational Site
Minato-ku, Tokyo, Japan
1199.32.81003 Boehringer Ingelheim Investigational Site
Naka-gun, Ibaraki, Japan
1199.32.81011 Boehringer Ingelheim Investigational Site
Ota-ku, Tokyo, Japan
1199.32.81001 Boehringer Ingelheim Investigational Site
Sendai, Miyagi, Japan
1199.32.81010 Boehringer Ingelheim Investigational Site
Shibuya-ku, Tokyo, Japan
1199.32.81002 Boehringer Ingelheim Investigational Site
Shimotsuke,Tochigi, Japan
1199.32.81008 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan
1199.32.81012 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa, Japan
United Kingdom
1199.32.44006 Boehringer Ingelheim Investigational Site
Aberdeen, United Kingdom
1199.32.44005 Boehringer Ingelheim Investigational Site
Birmingham, United Kingdom
1199.32.44003 Boehringer Ingelheim Investigational Site
Birmingham, United Kingdom
1199.32.44009 Boehringer Ingelheim Investigational Site
Leeds, United Kingdom
1199.32.44004 Boehringer Ingelheim Investigational Site
Liverpool, United Kingdom
1199.32.44002 Boehringer Ingelheim Investigational Site
London, United Kingdom
1199.32.44008 Boehringer Ingelheim Investigational Site
Oxford, United Kingdom
1199.32.44001 Boehringer Ingelheim Investigational Site
Westbury on Trym, United Kingdom
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: NCT01335464     History of Changes
Other Study ID Numbers: 1199.32, 2010-024251-87
Study First Received: April 13, 2011
Results First Received: November 14, 2014
Last Updated: January 29, 2015
Health Authority: Australia: Dept of Health and Ageing Therapeutic Goods Admin
Belgium: Federal Agency for Medicinal and Health Products
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
India: Drugs Controller General of India
Ireland: Medical Ethics Research Committee
Israel: Ministry of Health
Italy: Ethics Committee
Japan: Ministry of Health, Labor and Welfare
United Kingdom: Medicines and Healthcare Products Regulatory Agency
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 23, 2015