Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
Condition:	Pulmonary Fibrosis
Interventions:	Drug: low dose BIBF1120 once daily; Drug: low dose BIBF 1120 twice daily; Drug: intermediate dose BIBF 1120 twice daily; Drug: high dose BIBF 1120 twice daily; Drug: placebo

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Patients were treated with matching Placebo.
Nintedanib 50 qd	Patients were treated with 50mg nintedanib once daily
Nintedanib 50 Bid	Patients were treated with 50mg nintedanib twice daily
Nintedanib 100 Bid	Patients were treated with 100mg nintedanib twice daily
Nintedanib 150 Bid	Patients were treated with 150mg nintedanib twice daily

Participant Flow:   Overall Study

	Placebo	Nintedanib 50 qd	Nintedanib 50 Bid	Nintedanib 100 Bid	Nintedanib 150 Bid
STARTED	87 [1]	87 [1]	86 [1]	86 [1]	86 [1]
COMPLETED	61	62	68	72	53
NOT COMPLETED	26	25	18	14	33
Not treated	2	1	0	0	1
Adverse Event	21	20	15	13	27
Protocol Violation	1	1	0	1	0
Withdrawal by Subject	2	2	1	0	4
Reason other than listed above	0	1	2	0	1

[1]	Randomised

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set: This patient set includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.

Reporting Groups

	Description
Placebo	Patients were treated with matching Placebo.
Nintedanib 50 qd	Patients were treated with 50mg nintedanib once daily
Nintedanib 50 Bid	Patients were treated with 50mg nintedanib twice daily
Nintedanib 100 Bid	Patients were treated with 100mg nintedanib twice daily
Nintedanib 150 Bid	Patients were treated with 150mg nintedanib twice daily
Total	Total of all reporting groups

Baseline Measures

	Placebo	Nintedanib 50 qd	Nintedanib 50 Bid	Nintedanib 100 Bid	Nintedanib 150 Bid	Total
Overall Participants Analyzed; [Units: Participants]	85	86	86	86	85	428
Age; [Units: Years]; Mean (Standard Deviation)	64.8 (8.57)	65.3 (9.42)	64.9 (8.48)	65.1 (8.63)	65.4 (7.82)	65.1 (8.56)
Gender; [Units: Participants]
Female	22	21	24	21	20	108
Male	63	65	62	65	65	320

  Outcome Measures

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1. Primary:

Rate of Decline in FVC [ Time Frame: Baseline until 52 weeks ]

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2. Secondary:

Absolute Change From Baseline in FVC%Pred [ Time Frame: Baseline and 52 weeks ]

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3. Secondary:

Absolute Change From Baseline in FVC [ Time Frame: Baseline and 52 weeks ]

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4. Secondary:

Relative Change From Baseline in FVC%Pred [ Time Frame: Baseline and 52 weeks ]

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5. Secondary:

Relative Change From Baseline in FVC [ Time Frame: Baseline and 52 weeks ]

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6. Secondary:

Number of Participants With Change From Baseline in FVC by Categories [ Time Frame: Baseline and 52 weeks ]

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7. Secondary:

Survival (All Causes of Death and Lung-transplant Free) [ Time Frame: 52 weeks ]

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8. Secondary:

Absolute Change From Baseline in SpO2 at Rest [ Time Frame: Baseline and 52 weeks ]

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9. Secondary:

Absolute Change From Baseline in SpO2 at Rest by Categories [ Time Frame: Baseline and 52 weeks ]

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10. Secondary:

Absolute Change From Baseline in PaO2 [ Time Frame: Baseline and 52 weeks ]

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11. Secondary:

Absolute Change From Baseline in P(A-a)O2 [ Time Frame: Baseline and 52 weeks ]

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12. Secondary:

Absolute Change From Baseline in PaCO2 [ Time Frame: Baseline and 52 weeks ]

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13. Secondary:

Absolute Change From Baseline in PaO2 by Categories [ Time Frame: Baseline and 52 weeks ]

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14. Secondary:

Absolute Change From Baseline in P(A-a) O2 by Categories [ Time Frame: Baseline and 52 weeks ]

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15. Secondary:

Absolute Change From Baseline in DLCO [ Time Frame: Baseline and 52 weeks ]

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16. Secondary:

Absolute Change From Baseline in DLCO by Categories [ Time Frame: Baseline and 52 weeks ]

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17. Secondary:

Absolute Change From Baseline in Distance Walk (6-MWT) [ Time Frame: Baseline and 52 weeks ]

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18. Secondary:

Absolute Change From Baseline in Dyspnoea Rating on Borg Scale Before Exercise (6-MWT) [ Time Frame: Baseline and 52 weeks ]

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19. Secondary:

Change From Baseline in Dyspnoea Rating on Borg Scale After Exercise (6-MWT) [ Time Frame: Baseline and 52 weeks ]

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20. Secondary:

Absolute Change From Baseline in MRC Dyspnea Scale by Categories [ Time Frame: Baseline and 52 weeks ]

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21. Secondary:

Absolute Change From Baseline in FEV1/FVC [ Time Frame: Baseline and 52 weeks ]

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22. Secondary:

Change From Baseline in SGRQ Total Score [ Time Frame: Baseline and 52 weeks ]

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23. Secondary:

Change From Baseline in SGRQ Domain Score Symptoms [ Time Frame: Baseline and 52 weeks ]

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24. Secondary:

Change From Baseline in SGRQ Domain Score Impacts [ Time Frame: Baseline and 52 weeks ]

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25. Secondary:

Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Domain Score Activities [ Time Frame: Baseline and 52 weeks ]

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26. Secondary:

St George's Respiratory Questionnaire (SGRQ) Responder [ Time Frame: 52 weeks ]

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27. Secondary:

Change From Baseline in TLC [ Time Frame: Baseline and 52 weeks ]

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28. Secondary:

Change From Baseline in RV [ Time Frame: Baseline and 52 weeks ]

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29. Secondary:

Change From Baseline in TGV [ Time Frame: Baseline and 52 weeks ]

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30. Secondary:

Change From Baseline in VC [ Time Frame: Baseline and 52 weeks ]

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31. Secondary:

Change From Baseline in IC [ Time Frame: Baseline and 52 weeks ]

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32. Secondary:

Number of Patients With at Least One IPF Exacerbation [ Time Frame: 52 weeks ]

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33. Secondary:

Occurrences of IPF Exacerbations Per Patient Per Year [ Time Frame: 52 weeks ]

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34. Secondary:

Time to First Occurrence of IPF Exacerbation [ Time Frame: 52 weeks ]

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35. Secondary:

Survival (Death Due to Respiratory Cause, and Lung-transplant Free) [ Time Frame: 52 weeks ]

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36. Secondary:

Time to Progression [ Time Frame: 52 weeks ]

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37. Secondary:

Pre-dose Plasma Concentration of Nintedanib in Plasma at Steady State on Day 365 (Cpre,ss,365) and Day 729 (Cpre,ss,729). [ Time Frame: day 365 and day 729 ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There were numerous additional pre-specified endpoints. Full results are available under the BI Transparency web page ( http://trials.boehringer-ingelheim.com/trial_results.html )

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is: The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights

Results Point of Contact:  

Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Paterniti MO, Bi Y, Rekić D, Wang Y, Karimi-Shah BA, Chowdhury BA. Acute Exacerbation and Decline in Forced Vital Capacity Are Associated with Increased Mortality in Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2017 Sep;14(9):1395-1402. doi: 10.1513/AnnalsATS.201606-458OC.

Richeldi L, Costabel U, Selman M, Kim DS, Hansell DM, Nicholson AG, Brown KK, Flaherty KR, Noble PW, Raghu G, Brun M, Gupta A, Juhel N, Klüglich M, du Bois RM. Efficacy of a tyrosine kinase inhibitor in idiopathic pulmonary fibrosis. N Engl J Med. 2011 Sep 22;365(12):1079-87. doi: 10.1056/NEJMoa1103690.

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00514683 History of Changes
Other Study ID Numbers:	1199.30
First Submitted:	August 9, 2007
First Posted:	August 10, 2007
Results First Submitted:	November 14, 2014
Results First Posted:	January 6, 2015
Last Update Posted:	January 6, 2015