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

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
551

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BIBF 1120
patient receives capsules containing BIBF 1120 twice a day
Drug: BIBF 1120
BIBF 1120 BID (twice daily)
Placebo Comparator: placebo
patient receives capsules identical to those containing active drug
Drug: placebo
placebo matching BIBF 1120 BID

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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 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
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 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 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 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 Categorical Change From Baseline 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 From Baseline 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
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 (Points): 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 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 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

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
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 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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1199.34
  • 2010-024252-29 (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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Conditions

Rare Diseases

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