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: July 10, 2013
Last verified: July 2013

August 9, 2007
July 10, 2013
August 2007
June 2010   (final data collection date for primary outcome measure)
The primary endpoint is the rate of decline in FVC (expressed in mL per year), evaluated from baseline until 12 month of treatment, compared to placebo. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
The primary endpoint is the rate of decline in FVC (expressed in mL per year), evaluated from baseline until 12 month of treatment, compared to placebo.
Complete list of historical versions of study NCT00514683 on ClinicalTrials.gov Archive Site
  • FVC changes [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Survival (all causes of death and lung-transplant free) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • SpO2 (oxygen saturation) at rest [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • DLCO changes [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • 6 minutes walking test changes [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Patient reported outcomes [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • PaO2, PaCO2 and calculated P(A-a)O2 changes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • FEV1/FVC actual change [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Total lung capacity (TLC) change [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Residual volume (RV) change [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Total gas volume (TGV) change [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Vital capacity (VC) change [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Inspiratory capacity (IC) change [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Incidence of IPF exacerbations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Occurrences of IPF exacerbations per patient per year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Time to first occurrence of IPF exacerbation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Survival (death due to respiratory cause, and lung-transplant free) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis
A 12 Month, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of BIBF 1120 Administered at Oral Doses of 50 mg qd, 50 mg Bid, 100 mg Bid and 150 mg Bid on Forced Vital Capacity Decline During One Year, in Patients With Idiopathic Pulmonary Fibrosis, With Optional Active Treatment Extension Until Last Patient Out.

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pulmonary Fibrosis
  • Drug: low dose BIBF1120 once daily
    low dose BIBF1120 once daily
  • Drug: low dose BIBF 1120 twice daily
    low dose BIBF 1120 twice daily
  • Drug: intermediate dose BIBF 1120 twice daily
    intermediate dose BIBF 1120 twice daily
  • Drug: high dose BIBF 1120 twice daily
    high dose BIBF 1120 twice daily
  • Drug: placebo
    placebo
  • Experimental: dose 1
    low dose BIBF1120 once daily
    Intervention: Drug: low dose BIBF1120 once daily
  • Experimental: dose 2
    low dose BIBF 1120 twice daily
    Intervention: Drug: low dose BIBF 1120 twice daily
  • Experimental: dose 3
    intermediate dose BIBF 1120 twice daily
    Intervention: Drug: intermediate dose BIBF 1120 twice daily
  • Experimental: dose 4
    high dose BIBF 1120 twice daily
    Intervention: Drug: high dose BIBF 1120 twice daily
  • Placebo Comparator: placebo
    placebo
    Intervention: Drug: placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
432
Not Provided
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

  6. 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

  7. PaO2 >= 55 mmHg (sea level to 1500 m) or 50 mmHg (above 1500 m) room air

Exclusion Criteria:

  1. AST, ALT > 1.5 x ULN ;
  2. Bilirubin > 1.5 x ULN
  3. Relevant airways obstruction
  4. Continuous oxygen supplementation at randomisation (defined as > 15 hours supplemental oxygen per day).
  5. Active infection at screening or randomisation.
  6. Neutrophils < 1500 / mm3
  7. International normalised ratio (INR) > 1.5 and/or Partial thromboplastin time (PTT) > 1.5 x ULN ;
  8. Platelets < 100 000 /mL
  9. Haemoglobin < 9.0 g/dL
  10. In the opinion of the Investigator, patient is likely to have lung transplantation during study
  11. Life expectancy for disease other than IPF < 2.5 years (Investigator assessment).
  12. 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
  13. Other investigational therapy received within 8 weeks prior to screening visit.
  14. 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.
  15. Sexually active males not committing to using condoms during the course of the study (except if their partner is not of childbearing potential).
  16. Known or suspected active alcohol or drug abuse.
  17. 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
  18. Thrombotic risk
  19. Surgical procedures planned to occur during trial period.
  20. Coagulopathy
  21. Uncontrolled systemic arterial hypertension
  22. known hypersensitivity to lactose or any component of the study medication
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Czech Republic,   France,   Germany,   Greece,   Hungary,   Ireland,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Portugal,   Russian Federation,   South Africa,   Spain,   Taiwan,   Turkey,   United Kingdom
 
NCT00514683
1199.30
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP