Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00514683
First received: August 9, 2007
Last updated: January 5, 2015
Last verified: January 2015
Results First Received: November 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Show All Outcome Measures

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

36.  Secondary:   Time to Progression   [ Time Frame: 52 weeks ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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 )


  More Information
  Hide More Information

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:
unchecked 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.
unchecked 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.


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


No publications provided by Boehringer Ingelheim

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00514683     History of Changes
Other Study ID Numbers: 1199.30
Study First Received: August 9, 2007
Results First Received: November 14, 2014
Last Updated: January 5, 2015
Health Authority: Argentina: A.N.M.A.T. (Administración Nacional de Medicamentos, Alimentos y Tecnologia Médica)
Australia: Dept of Health and Ageing Therapeutic Goods Admin
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: ANVISA
Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia
Canada: Therapeutic Products Directorate
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
France: AGENCE FRANCAISE DE SECURITE SANITAIRE DES PRODUITS DE SANTE
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte, Fachregistratur Z 14.02.06, Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn
Great Britain: MHRA
Greece: National Organization for Medicines (EOF) National Ethics Committee
Hungary: National Institute of Pharmacy, H-1051 Budapest
Ireland: Irish Medicines Board
Italy: Comitato Etico Provinciale di Modena - MODENA
Korea, Republic of: Korea Food and Drug Administration (KFDA)
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Portugal: National Pharmacy and Medicines Institute
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
South Africa: Medicines Control Council
Spain: Spanish Agency for Medicines and Health Products
Taiwan: Department of Health, Executive Yuan, Taiwan
Turkey: Ministry of Health Central Ethics Committee