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

June 24, 2016 updated by: Boehringer Ingelheim

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

515

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia
        • 1199.32.61001 Boehringer Ingelheim Investigational Site
      • Concord, New South Wales, Australia
        • 1199.32.61002 Boehringer Ingelheim Investigational Site
    • South Australia
      • Daw Park, South Australia, Australia
        • 1199.32.61003 Boehringer Ingelheim Investigational Site
    • Victoria
      • Frankston, Victoria, Australia
        • 1199.32.61005 Boehringer Ingelheim Investigational Site
      • Prahran, Victoria, Australia
        • 1199.32.61004 Boehringer Ingelheim Investigational Site
  • Belgium
      • Bruxelles, Belgium
        • 1199.32.32004 Boehringer Ingelheim Investigational Site
      • Jette, Belgium
        • 1199.32.32005 Boehringer Ingelheim Investigational Site
      • Leuven, Belgium
        • 1199.32.32001 Boehringer Ingelheim Investigational Site
      • Yvoir, Belgium
        • 1199.32.32002 Boehringer Ingelheim Investigational Site
  • China
      • Beijing, China
        • 1199.32.86001 Boehringer Ingelheim Investigational Site
      • Beijing, China
        • 1199.32.86002 Boehringer Ingelheim Investigational Site
      • Changsha, China
        • 1199.32.86005 Boehringer Ingelheim Investigational Site
      • Chengdu, China
        • 1199.32.86004 Boehringer Ingelheim Investigational Site
      • Nanchang, China
        • 1199.32.86003 Boehringer Ingelheim Investigational Site
      • Xi'An, China
        • 1199.32.86006 Boehringer Ingelheim Investigational Site
  • Czech Republic
      • Prague 4, Czech Republic
        • 1199.32.42003 Boehringer Ingelheim Investigational Site
      • Prague 8, Czech Republic
        • 1199.32.42002 Boehringer Ingelheim Investigational Site
      • Usti nad Labem, Czech Republic
        • 1199.32.42001 Boehringer Ingelheim Investigational Site
  • France
      • Bobigny, France
        • 1199.32.33002 Boehringer Ingelheim Investigational Site
      • Nice Cedex 1, France
        • 1199.32.33003 Boehringer Ingelheim Investigational Site
      • Paris Cedex 15, France
        • 1199.32.33006 Boehringer Ingelheim Investigational Site
      • Paris Cedex 18, France
        • 1199.32.33001 Boehringer Ingelheim Investigational Site
      • Paris cedex 20, France
        • 1199.32.33005 Boehringer Ingelheim Investigational Site
      • Reims cedex, France
        • 1199.32.33007 Boehringer Ingelheim Investigational Site
      • Rennes Cedex 9, France
        • 1199.32.33004 Boehringer Ingelheim Investigational Site
  • Germany
      • Bamberg, Germany
        • 1199.32.49008 Boehringer Ingelheim Investigational Site
      • Donaustauf, Germany
        • 1199.32.49005 Boehringer Ingelheim Investigational Site
      • Essen, Germany
        • 1199.32.49001 Boehringer Ingelheim Investigational Site
      • Freiburg/Breisgau, Germany
        • 1199.32.49002 Boehringer Ingelheim Investigational Site
      • Gießen, Germany
        • 1199.32.49006 Boehringer Ingelheim Investigational Site
      • Großhansdorf, Germany
        • 1199.32.49003 Boehringer Ingelheim Investigational Site
      • Heidelberg, Germany
        • 1199.32.49007 Boehringer Ingelheim Investigational Site
      • Mainz, Germany
        • 1199.32.49004 Boehringer Ingelheim Investigational Site
  • India
      • Ahmedabad, India
        • 1199.32.91003 Boehringer Ingelheim Investigational Site
      • Coimbatore, India
        • 1199.32.91002 Boehringer Ingelheim Investigational Site
      • Jaipur, India
        • 1199.32.91006 Boehringer Ingelheim Investigational Site
      • Kolkatta, India
        • 1199.32.91005 Boehringer Ingelheim Investigational Site
      • Mumbai, India
        • 1199.32.91001 Boehringer Ingelheim Investigational Site
  • Ireland
      • Dublin, Ireland
        • 1199.32.35301 Boehringer Ingelheim Investigational Site
  • Israel
      • Haifa, Israel
        • 1199.32.97004 Boehringer Ingelheim Investigational Site
      • Petah Tiqwa, Israel
        • 1199.32.97001 Boehringer Ingelheim Investigational Site
      • Rehovot, Israel
        • 1199.32.97002 Boehringer Ingelheim Investigational Site
  • Italy
      • Catania, Italy
        • 1199.32.39012 Boehringer Ingelheim Investigational Site
      • Chieti Scalo, Italy
        • 1199.32.39004 Boehringer Ingelheim Investigational Site
      • Forli', Italy
        • 1199.32.39008 Boehringer Ingelheim Investigational Site
      • Milano, Italy
        • 1199.32.39005 Boehringer Ingelheim Investigational Site
      • Modena, Italy
        • 1199.32.39001 Boehringer Ingelheim Investigational Site
      • Monza, Italy
        • 1199.32.39007 Boehringer Ingelheim Investigational Site
      • Napoli, Italy
        • 1199.32.39011 Boehringer Ingelheim Investigational Site
      • Padova, Italy
        • 1199.32.39002 Boehringer Ingelheim Investigational Site
      • Pisa, Italy
        • 1199.32.39006A Boehringer Ingelheim Investigational Site
      • Pisa, Italy
        • 1199.32.39006B Boehringer Ingelheim Investigational Site
      • Roma, Italy
        • 1199.32.39010 Boehringer Ingelheim Investigational Site
      • Siena, Italy
        • 1199.32.39009 Boehringer Ingelheim Investigational Site
  • Japan
      • Bunkyo-ku,Tokyo, Japan
        • 1199.32.81005 Boehringer Ingelheim Investigational Site
      • Bunkyo-ku,Tokyo, Japan
        • 1199.32.81006 Boehringer Ingelheim Investigational Site
      • Kiyose, Tokyo, Japan
        • 1199.32.81007 Boehringer Ingelheim Investigational Site
      • Kumagaya, Saitama, Japan
        • 1199.32.81004 Boehringer Ingelheim Investigational Site
      • Minato-ku, Tokyo, Japan
        • 1199.32.81009 Boehringer Ingelheim Investigational Site
      • Naka-gun, Ibaraki, Japan
        • 1199.32.81003 Boehringer Ingelheim Investigational Site
      • Ota-ku, Tokyo, Japan
        • 1199.32.81011 Boehringer Ingelheim Investigational Site
      • Sendai, Miyagi, Japan
        • 1199.32.81001 Boehringer Ingelheim Investigational Site
      • Shibuya-ku, Tokyo, Japan
        • 1199.32.81010 Boehringer Ingelheim Investigational Site
      • Shimotsuke,Tochigi, Japan
        • 1199.32.81002 Boehringer Ingelheim Investigational Site
      • Shinjuku-ku, Tokyo, Japan
        • 1199.32.81008 Boehringer Ingelheim Investigational Site
      • Yokohama, Kanagawa, Japan
        • 1199.32.81012 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Aberdeen, United Kingdom
        • 1199.32.44006 Boehringer Ingelheim Investigational Site
      • Birmingham, United Kingdom
        • 1199.32.44003 Boehringer Ingelheim Investigational Site
      • Birmingham, United Kingdom
        • 1199.32.44005 Boehringer Ingelheim Investigational Site
      • Leeds, United Kingdom
        • 1199.32.44009 Boehringer Ingelheim Investigational Site
      • Liverpool, United Kingdom
        • 1199.32.44004 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 1199.32.44002 Boehringer Ingelheim Investigational Site
      • Oxford, United Kingdom
        • 1199.32.44008 Boehringer Ingelheim Investigational Site
      • Westbury on Trym, United Kingdom
        • 1199.32.44001 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 1199.32.10007 Boehringer Ingelheim Investigational Site
      • Jasper, Alabama, United States
        • 1199.32.10029 Boehringer Ingelheim Investigational Site
    • Arizona
      • Phoenix, Arizona, United States
        • 1199.32.10013 Boehringer Ingelheim Investigational Site
    • California
      • Los Angeles, California, United States
        • 1199.32.10005 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Danbury, Connecticut, United States
        • 1199.32.10022 Boehringer Ingelheim Investigational Site
    • Delaware
      • Newark, Delaware, United States
        • 1199.32.10025 Boehringer Ingelheim Investigational Site
    • Florida
      • Weston, Florida, United States
        • 1199.32.10023 Boehringer Ingelheim Investigational Site
    • Iowa
      • Council Bluffs, Iowa, United States
        • 1199.32.10001 Boehringer Ingelheim Investigational Site
    • Kansas
      • Wichita, Kansas, United States
        • 1199.32.10028 Boehringer Ingelheim Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • 1199.32.10016 Boehringer Ingelheim Investigational Site
    • New Jersey
      • New Brunswich, New Jersey, United States
        • 1199.32.10024 Boehringer Ingelheim Investigational Site
    • New York
      • New York, New York, United States
        • 1199.32.10019 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • 1199.32.10004 Boehringer Ingelheim Investigational Site
    • Oregon
      • Portland, Oregon, United States
        • 1199.32.10020 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • 1199.32.10002 Boehringer Ingelheim Investigational Site
      • Pittsburgh, Pennsylvania, United States
        • 1199.32.10033 Boehringer Ingelheim Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States
        • 1199.32.10008 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States
        • 1199.32.10015 Boehringer Ingelheim Investigational Site
      • Shelbyville, Tennessee, United States
        • 1199.32.10034 Boehringer Ingelheim Investigational Site
    • Texas
      • Dallas, Texas, United States
        • 1199.32.10009 Boehringer Ingelheim Investigational Site
      • McKinney, Texas, United States
        • 1199.32.10018 Boehringer Ingelheim Investigational Site
    • Virginia
      • Falls Church, Virginia, United States
        • 1199.32.10021 Boehringer Ingelheim Investigational Site
      • Lynchburg, Virginia, United States
        • 1199.32.10003 Boehringer Ingelheim Investigational Site
    • Washington
      • Tacoma, Washington, United States
        • 1199.32.10038 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks
Time Frame: 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
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks
Time Frame: baseline and 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).
baseline and 52 weeks
Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
Time Frame: 52 weeks

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 .
52 weeks
Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks
Time Frame: Baseline and 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).
Baseline and 52 weeks
Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks
Time Frame: Baseline and 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).
Baseline and 52 weeks
Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks
Time Frame: Baseline and 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).
Baseline and 52 weeks
Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks
Time Frame: Baseline and 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).
Baseline and 52 weeks
Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold
Time Frame: Baseline and 52 weeks
Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 5% threshold (decrease by >5%, increase by >5%, and change within ≤5%).
Baseline and 52 weeks
Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold
Time Frame: Baseline and 52 weeks
Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 10% threshold (decrease by 10%, increase by >10%, and change within ≤10%)
Baseline and 52 weeks
FVC Responders Using 10% Threshold at 52 Weeks
Time Frame: 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.
52 weeks
Proportion of FVC Responders Using 5% Threshold at 52 Weeks
Time Frame: 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.
52 weeks
Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)
Time Frame: Baseline and 52 weeks

Proportion of SGRQ responders at 52 weeks

Responders defined as <= -4 points change in change from baseline in SGRQ total score at 52 weeks.
Baseline and 52 weeks
Change From Baseline in SGRQ Symptom Score at 52 Weeks: Patient Reported Outcomes (PROs)
Time Frame: Baseline and 52 weeks

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).
Baseline and 52 weeks
Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)
Time Frame: Baseline and 52 weeks

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).
Baseline and 52 weeks
Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)
Time Frame: baseline and 52 weeks

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).
baseline and 52 weeks
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

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.
Baseline and 52 weeks
Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)
Time Frame: baseline and 52 weeks

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).
baseline and 52 weeks
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

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).
Baseline and 52 weeks
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

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).
Baseline and 52 weeks
Proportion of Patient's Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)
Time Frame: 52 weeks
Patient's Global Impression of Change (PGI-C) responders are defined as 'Very much better'/ 'Much better'/ 'A little better'/ 'No change'.
52 weeks
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
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.
baseline, 12 weeks, 24 weeks and 52 weeks
Risk of an Acute IPF Exacerbation Over 52 Weeks
Time Frame: 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)
52 weeks
Time to Death Over 52 Weeks
Time Frame: 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) .
52 weeks
Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated)
Time Frame: 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 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).
52 weeks
Time to On-treatment Death
Time Frame: 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 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.
52 weeks
Time to Death or Lung Transplant Over 52 Weeks
Time Frame: 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).
52 weeks
Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.
Time Frame: 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).
52 weeks
Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks
Time Frame: Baseline and 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)
Baseline and 52 weeks
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks
Time Frame: Baseline and 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).
Baseline and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

April 13, 2011

First Submitted That Met QC Criteria

April 13, 2011

First Posted (Estimate)

April 14, 2011

Study Record Updates

Last Update Posted (Estimate)

July 25, 2016

Last Update Submitted That Met QC Criteria

June 24, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1199.32
  • 2010-024251-87 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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