Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis

Phase 2

Completed

Conditions: Pulmonary Fibrosis

Interventions: Drug: placebo
Drug: low dose BIBF 1120 twice daily
Drug: intermediate dose BIBF 1120 twice daily
Drug: high dose BIBF 1120 twice daily
Drug: low dose BIBF1120 once daily

Registration Number: NCT00514683

Lead Sponsor: Boehringer Ingelheim

Brief Summary: The general purpose of this trial is to investigate the efficacy and safety of 4 dose strategies of BIBF 1120 treatment for 12 months, compared to placebo in patients with idiopathic pulmonary fibrosis.

The primary objective of this study is to demonstrate whether at least one dose strategy is superior to placebo in patients with IPF, in modifying the rate of decline of Forced Vital Capacity (FVC).

As a secondary objective, additional parameters will be assessed in order to differentiate between dose strategies on the basis of safety and efficacy

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 432

Inclusion Criteria

Patient >40 years
Written informed consent signed prior to entry into the study
IPF diagnosed (according to ATS / ERS criteria) less than 5 years prior to screening visit.
HRCT within 12 months of randomisation and biopsy (the latter if needed to fulfil ATS/ERS criteria) centrally reviewed and consistent with diagnosis.
FVC>50 % of predicted value

Predicted normal values will be calculated according to ESCS (R94-1408):

Males :

FVC predicted (L) = 5.76 x height (meters)- 0.026 x age (years) -4.34

Females :

FVC predicted (L) = 4.43 x height (meters)- 0.026 x age (years) -2.89
Single breath DLCO (corrected for Hb) 30 - 79% inclusive of predicted .

Different sites may use different prediction formulas, based on the method used to measure DLco. In any case, the method used must be in compliance with the ATS/ERS guideline on DLCO measurements (R06-2002), and the prediction formula appropriate for that method. Raw data (gas mixture, equation used for prediction of normal, further adjustments made if so) must be traced.

Adjustment for haemoglobin (R06-2002):

Males :

DLCO predicted for Hb = DLCO predicted x (1.7Hb/[10.22+Hb])

Females :

DLCO predicted for Hb = DLCO predicted x (1.7Hb/[9.38+Hb]) where Hb is expressed in g/dL-1
PaO2 >= 55 mmHg (sea level to 1500 m) or 50 mmHg (above 1500 m) room air

Exclusion Criteria

AST, ALT > 1.5 x ULN ;
Bilirubin > 1.5 x ULN
Relevant airways obstruction
Continuous oxygen supplementation at randomisation (defined as > 15 hours supplemental oxygen per day).
Active infection at screening or randomisation.
Neutrophils < 1500 / mm3
International normalised ratio (INR) > 1.5 and/or Partial thromboplastin time (PTT) > 1.5 x ULN ;
Platelets < 100 000 /mL
Haemoglobin < 9.0 g/dL
In the opinion of the Investigator, patient is likely to have lung transplantation during study
Life expectancy for disease other than IPF < 2.5 years (Investigator assessment).
Other disease that may interfere with testing procedures or in judgement of Investigator may interfere with trial participation or may put the patient at risk when participating to this trial.
- Myocardial infarction during the previous 6 months
- Unstable angina during the previous month
Other investigational therapy received within 8 weeks prior to screening visit.
Pregnant women or women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to enrolment.
Sexually active males not committing to using condoms during the course of the study (except if their partner is not of childbearing potential).
Known or suspected active alcohol or drug abuse.
Bleeding risk : Known inherited predisposition to bleeding, patients who require full-dose anticoagulation, Patients who require full-dose antiplatelet therapy, History of hemorrhagic CNS event within 12 months prior to screening , Any of the following within 3 months prior to screening : Gross / frank haemoptysis or haematuria, Active gastro-intestinal bleeding or ulcers, Major injury or surgery
Thrombotic risk
Surgical procedures planned to occur during trial period.
Coagulopathy
Uncontrolled systemic arterial hypertension
known hypersensitivity to lactose or any component of the study medication

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo
dose 2	low dose BIBF 1120 twice daily	low dose BIBF 1120 twice daily
dose 3	intermediate dose BIBF 1120 twice daily	intermediate dose BIBF 1120 twice daily
dose 4	high dose BIBF 1120 twice daily	high dose BIBF 1120 twice daily
dose 1	low dose BIBF1120 once daily	low dose BIBF1120 once daily

Primary Outcome Measures

Name	Time	Method
Rate of Decline in FVC	Baseline until 52 weeks	Rate of decline in Forced Vital Capacity (FVC) evaluated from baseline until 52 weeks of treatment. The means presents actually the adjusted rate based on a MMRM with fixed terms for treatment\time, gender\height, gender\age and random terms for patient effect, patient\time.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Change From Baseline in FVC by Categories	Baseline and 52 weeks	Change from baseline in percentage of Forced Vital Capacity (FVC) at 52 weeks in below mentioned categories: 1. Decrease \> 10% or 200mL 2. Change within \<= 10% or \<=200 mL 3. Increase \> 10% or 200mL
Absolute Change From Baseline in PaCO2	Baseline and 52 weeks	Absolute change from baseline in Arterial carbon dioxyde partial pressure (PaCO2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Absolute Change From Baseline in P(A-a) O2 by Categories	Baseline and 52 weeks	Absolute change from baseline in Alveolo-arterial oxygen gradient (P(A-a) O2) by below mentioned categories: 1. Decrease \> 4 mmHg 2. Change within +/- 4 mmHg 3. Increase \> 4 mmHg
Relative Change From Baseline in FVC%Pred	Baseline and 52 weeks	Percent change from baseline in percentage of predicted Forced Vital Capacity (FVC%pred) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region.
Absolute Change From Baseline in FVC%Pred	Baseline and 52 weeks	Change from baseline in percentage of predicted Forced Vital Capacity (FVC%pred) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region.
Absolute Change From Baseline in SpO2 at Rest by Categories	Baseline and 52 weeks	Absolute change from baseline in oxygen saturation (SpO2) at rest by below mentioned categories: SpO2 (non-invasive) at 52 weeks: 1. Decrease \> 4% SpO2 2. Change within +/- 4% SpO2 3. Increase \> 4% SpO2
Absolute Change From Baseline in FEV1/FVC	Baseline and 52 weeks	Change from baseline of percentage of FVC expelled in the first second of a forced expiration (FEV1/FVC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Change From Baseline in SGRQ Domain Score Symptoms	Baseline and 52 weeks	Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score symptoms. Scores range from 0 to 100, with higher scores indicating more limitations. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
St George's Respiratory Questionnaire (SGRQ) Responder	52 weeks	St George's Respiratory Questionnaire (SGRQ) responder (\<= -4 points change) (%) at 52 weeks-worst case
Change From Baseline in TLC	Baseline and 52 weeks	Change from Baseline in Total Lung Capacity (TLC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Change From Baseline in TGV	Baseline and 52 weeks	Change from Baseline in Thoracic gas volume (TGV) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Absolute Change From Baseline in SpO2 at Rest	Baseline and 52 weeks	Absolute change from baseline in oxygen saturation (SpO2) at rest. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Absolute Change From Baseline in Distance Walk (6-MWT)	Baseline and 52 weeks	Absolute change from baseline in distance walk (6-MWT) at 52 weeks. The 6-Minutes Walk Test (6-MWT) was conducted according to the American Thoracic Society (ATS) Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Change From Baseline in SGRQ Total Score	Baseline and 52 weeks	Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) total score. Total score is defined as sum of the three domain scores symptoms, activities and impacts. Scores range from 0 to 100, with higher scores indicating worst possible health status. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Occurrences of IPF Exacerbations Per Patient Per Year	52 weeks	Occurrences of Idiopathic Pulmonary Fibrosis (IPF) exacerbations per patient per year at 52 weeks
Absolute Change From Baseline in FVC	Baseline and 52 weeks	Change from baseline in percentage of absolute Forced Vital Capacity (FVC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region.
Relative Change From Baseline in FVC	Baseline and 52 weeks	Percent change from baseline in absolute Forced Vital Capacity (FVC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region
Survival (All Causes of Death and Lung-transplant Free)	52 weeks	Survival (all causes of death and lung-transplant free) at 52 weeks, based on overall mortality and on-treatment survival. Failure means participants with event and Censored means participants with no event.
Absolute Change From Baseline in PaO2	Baseline and 52 weeks	Absolute change from baseline in Arterial oxygen partial pressure (PaO2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Absolute Change From Baseline in P(A-a)O2	Baseline and 52 weeks	Absolute change from baseline in Alveolo-arterial oxygen gradient (P(A-a)O2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Absolute Change From Baseline in DLCO	Baseline and 52 weeks	Absolute change from Baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Absolute Change From Baseline in PaO2 by Categories	Baseline and 52 weeks	Absolute change from baseline in Arterial oxygen partial pressure (PaO2) by below mentioned categories: 1. Decrease \> 4 mmHg 2. Change within +/- 4 mmHg 3. Increase \> 4 mmHg
Absolute Change From Baseline in DLCO by Categories	Baseline and 52 weeks	Absolute change from baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) by below mentioned categories: 1. Decrease \> 15% or \> 1 2. Change \<= 15% or \<= 1 3. Increase \> 15% or \> 1
Absolute Change From Baseline in Dyspnoea Rating on Borg Scale Before Exercise (6-MWT)	Baseline and 52 weeks	Absolute change from baseline in Dyspnoea rating before exercise (6-MWT) at 52 weeks based on Borg scale as mentioned below : 0: Nothing at all, 0.5: Very, very slight (just noticable), 1: Very slight, 2: Slight (light), 3: Moderate, 4: Somewhat severe, 5: Severe (heavy), 6, 7:Very severe, 8, 9, 10: Very, very severe (Maximal). The 6-Minutes Walk Test (6-MWT) was conducted according to the ATS Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Change From Baseline in SGRQ Domain Score Impacts	Baseline and 52 weeks	Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score impacts. Scores range from 0 to 100, with higher scores indicating worst possible health status. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Domain Score Activities	Baseline and 52 weeks	Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score activities. Scores range from 0 to 100, with higher scores indicating worst possible health status. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Change From Baseline in IC	Baseline and 52 weeks	Change from Baseline in Inspiratory Capacity (IC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Survival (Death Due to Respiratory Cause, and Lung-transplant Free)	52 weeks	Survival (death due to respiratory cause, and lung-transplant free) at 52 weeks. Failure means participants with event and Censored means participants with no event.
Time to Progression	52 weeks	Time to progression. Progression was defined as at least one of the following: 5mmHg increase in the alveolo-arterial pressure difference in oxygen (P(A-a)O2), 10% decrease in FVC (FVC(baseline)-FVC(progression) \>= 10%) or Death. Failure means participants with event and Censored means participants with no event.
Change From Baseline in Dyspnoea Rating on Borg Scale After Exercise (6-MWT)	Baseline and 52 weeks	Change from baseline in Dyspnoea rating after exercise (6-MWT) at 52 weeks based on Borg scale as mentioned below : 0: Nothing at all, 0.5: Very, very slight (just noticable), 1: Very slight, 2: Slight (light), 3: Moderate, 4: Somewhat severe, 5: Severe (heavy), 6, 7:Very severe, 8, 9, 10: Very, very severe (Maximal). The 6-Minutes Walk Test (6-MWT) was conducted according to the ATS Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Absolute Change From Baseline in MRC Dyspnea Scale by Categories	Baseline and 52 weeks	Absolute change from baseline in Medical Research Council (MRC) dyspnea scale by below mentioned categories: 1. Decrease 2. No Change 3. Increase
Change From Baseline in RV	Baseline and 52 weeks	Change from Baseline in Residual volume (RV) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Number of Patients With at Least One IPF Exacerbation	52 weeks	Number of patients with at least one Idiopathic Pulmonary Fibrosis (IPF) exacerbation at 52 weeks
Time to First Occurrence of IPF Exacerbation	52 weeks	This endpoint is called time to first occurrence of IPF exacerbation however it was actually analysed as the proportion of patients having occurrence of Idiopathic Pulmonary Fibrosis (IPF) exacerbation at 52 weeks. Failure means participants with event and Censored means participants with no event.
Change From Baseline in VC	Baseline and 52 weeks	Change from baseline in Vital capacity (VC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Pre-dose Plasma Concentration of Nintedanib in Plasma at Steady State on Day 365 (Cpre,ss,365) and Day 729 (Cpre,ss,729).	day 365 and day 729	Cpre,ss,729 represents the pre-dose plasma concentration of nintedanib in plasma at steady state on Day 729 and Cpre,ss,365 represents the pre-dose plasma concentration of nintedanib in plasma at steady state on Day 365. At day 365, values only for Nintedanib 50 qd group are presented as no values reported for other groups and at day 729, values are presented for all group except for Nintedanib 50 qd group as no values reported for it.

Trial Locations

Locations (92): 1199.30.54002 Boehringer Ingelheim Investigational Site
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Mendoza, Argentina
1199.30.32001 Boehringer Ingelheim Investigational Site
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Leuven, Belgium
1199.30.32002 Boehringer Ingelheim Investigational Site
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Yvoir, Belgium
1199.30.06004 Boehringer Ingelheim Investigational Site
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Sofia, Bulgaria
1199.30.36002 Boehringer Ingelheim Investigational Site
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Budapest, Hungary
1199.30.32004 Boehringer Ingelheim Investigational Site
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Bruxelles, Belgium
1199.30.36003 Boehringer Ingelheim Investigational Site
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Budapest, Hungary
1199.30.01003 Division of Respirology
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Halifax, Nova Scotia, Canada
1199.30.56001 Boehringer Ingelheim Investigational Site
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Providencia, Chile
1199.30.30004 Boehringer Ingelheim Investigational Site
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Alexandroupolis, Greece
1199.30.30001 Boehringer Ingelheim Investigational Site
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Heraklion, Greece
1199.30.36001 Boehringer Ingelheim Investigational Site
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Pecs, Hungary
1199.30.36005 Boehringer Ingelheim Investigational Site
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Szekesfehervar, Hungary
1199.30.36004 Boehringer Ingelheim Investigational Site
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Deszk, Hungary
1199.30.35301 Mater Misericordiae Hospital
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Dublin 7, Ireland
1199.30.35105 Boehringer Ingelheim Investigational Site
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Coimbra, Portugal
1199.30.35109 Boehringer Ingelheim Investigational Site
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Lisboa, Portugal
1199.30.52001 Boehringer Ingelheim Investigational Site
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Distrito Federal, Mexico
1199.30.88606 Boehringer Ingelheim Investigational Site
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Taipei, Taiwan
1199.30.31002 Boehringer Ingelheim Investigational Site
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Nieuwegein, Netherlands
1199.30.35106 Boehringer Ingelheim Investigational Site
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Coimbra, Portugal
1199.30.35101 Boehringer Ingelheim Investigational Site
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Porto, Portugal
1199.30.07002 Boehringer Ingelheim Investigational Site
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Moscow, Russian Federation
1199.30.35107 Boehringer Ingelheim Investigational Site
🇵🇹
Lisboa, Portugal
1199.30.07003 Boehringer Ingelheim Investigational Site
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St. Petersburg, Russian Federation
1199.30.88605 Boehringer Ingelheim Investigational Site
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Taichung, Taiwan
1199.30.90001 Boehringer Ingelheim Investigational Site
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Ankara, Turkey
1199.30.90002 Boehringer Ingelheim Investigational Site
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Istanbul, Turkey
1199.30.88601 National Taiwan University
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Taipei, Taiwan
1199.30.88603 Tri-service General Hospital
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Taipei, Taiwan
1199.30.88604 Chang Gung Memorial Hosp-Linkou
🇨🇳
Taoyuan, Taiwan
1199.30.55002 Boehringer Ingelheim Investigational Site
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Porto Alegre, Brazil
1199.30.39013 Boehringer Ingelheim Investigational Site
🇮🇹
Busto Arsizio (va), Italy
1199.30.39003 Boehringer Ingelheim Investigational Site
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Terni, Italy
1199.30.39004 Boehringer Ingelheim Investigational Site
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Trieste, Italy
1199.30.3302A Boehringer Ingelheim Investigational Site
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Bobigny, France
1199.30.3305A Boehringer Ingelheim Investigational Site
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Lille Cedex, France
1199.30.49007 Boehringer Ingelheim Investigational Site
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Berlin, Germany
1199.30.42001 Boehringer Ingelheim Investigational Site
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Usti nad Labem, Czech Republic
1199.30.86005 Boehringer Ingelheim Investigational Site
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Nanjing, China
1199.30.86004 Boehringer Ingelheim Investigational Site
🇨🇳
Shenyang, China
1199.30.3305B Boehringer Ingelheim Investigational Site
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Lille Cedex, France
1199.30.3305C Boehringer Ingelheim Investigational Site
🇫🇷
Lille Cedex, France
1199.30.55001 Boehringer Ingelheim Investigational Site
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Vila Clementino, Brazil
1199.30.49008 Boehringer Ingelheim Investigational Site
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Bad Berka, Germany
1199.30.49001 Boehringer Ingelheim Investigational Site
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Essen, Germany
1199.30.3307A Boehringer Ingelheim Investigational Site
🇫🇷
Nice Cedex 1, France
1199.30.49003 Boehringer Ingelheim Investigational Site
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Großhansdorf, Germany
1199.30.06005 Boehringer Ingelheim Investigational Site
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Sofia, Bulgaria
1199.30.86003 Boehringer Ingelheim Investigational Site
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Shanghai, China
1199.30.39008 Boehringer Ingelheim Investigational Site
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Ascoli Piceno, Italy
1199.30.39007 Boehringer Ingelheim Investigational Site
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Milano, Italy
1199.30.39009 Boehringer Ingelheim Investigational Site
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Pavia, Italy
1199.30.61005 Boehringer Ingelheim Investigational Site
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South Brisbane, Queensland, Australia
1199.30.49009 Boehringer Ingelheim Investigational Site
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Leipzig, Germany
1199.30.27002 Boehringer Ingelheim Investigational Site
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Tygerberg, South Africa
1199.30.82001 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republic of
1199.30.39012 Boehringer Ingelheim Investigational Site
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Napoli, Italy
1199.30.39010 Boehringer Ingelheim Investigational Site
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Siena, Italy
1199.30.34001 Boehringer Ingelheim Investigational Site
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Barcelona, Spain
1199.30.34002 Boehringer Ingelheim Investigational Site
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Valencia, Spain
1199.30.82002 Boehringer Ingelheim Investigational Site
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Gyunggido, Korea, Republic of
1199.30.49006 Boehringer Ingelheim Investigational Site
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Donaustauf, Germany
1199.30.49002 Boehringer Ingelheim Investigational Site
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Freiburg/Breisgau, Germany
1199.30.49004 Boehringer Ingelheim Investigational Site
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Mainz, Germany
1199.30.30002 Boehringer Ingelheim Investigational Site
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Larisa, Greece
1199.30.39001 Boehringer Ingelheim Investigational Site
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Modena, Italy
1199.30.44001 Boehringer Ingelheim Investigational Site
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Westbury on Trym, United Kingdom
1199.30.27001 Boehringer Ingelheim Investigational Site
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Bellville, South Africa
1199.30.82003 Boehringer Ingelheim Investigational Site
🇰🇷
Seoul, Korea, Republic of
1199.30.39011 Boehringer Ingelheim Investigational Site
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Roma, Italy
1199.30.82004 Boehringer Ingelheim Investigational Site
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Incheon, Korea, Republic of
1199.30.49005 Boehringer Ingelheim Investigational Site
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München, Germany
1199.30.35108 Boehringer Ingelheim Investigational Site
🇵🇹
Lisboa, Portugal
1199.30.44006 Boehringer Ingelheim Investigational Site
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Aberdeen, United Kingdom
1199.30.07001 Boehringer Ingelheim Investigational Site
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Moscow, Russian Federation
1199.30.27003 Boehringer Ingelheim Investigational Site
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Cape Town, South Africa
1199.30.82005 Boehringer Ingelheim Investigational Site
🇰🇷
Seoul, Korea, Republic of
1199.30.44003 Boehringer Ingelheim Investigational Site
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Birmingham, United Kingdom
1199.30.44005 Boehringer Ingelheim Investigational Site
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Birmingham, United Kingdom
1199.30.61001 Royal Perth Hospital
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Perth, Western Australia, Australia
1199.30.42002 Boehringer Ingelheim Investigational Site
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Prague 8, Czech Republic
1199.30.3306A Boehringer Ingelheim Investigational Site
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Dijon, France
1199.30.3303A Boehringer Ingelheim Investigational Site
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Grenoble, France
1199.30.3304C Boehringer Ingelheim Investigational Site
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Montpellier, France
1199.30.3301A Boehringer Ingelheim Investigational Site
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Paris Cedex 18, France
1199.30.61003 Boehringer Ingelheim Investigational Site
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Toorak Gardens, South Australia, Australia
1199.30.61004 Boehringer Ingelheim Investigational Site
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Woodville, South Australia, Australia
1199.30.01002 St. Joseph's Healthcare
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Hamilton, Ontario, Canada
1199.30.86001 Boehringer Ingelheim Investigational Site
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Beijing, China
1199.30.86002 Boehringer Ingelheim Investigational Site
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Beijing, China
1199.30.44007 Boehringer Ingelheim Investigational Site
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Manchester, United Kingdom