Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01335477
First received: April 13, 2011
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Pulmonary Fibrosis
Drug: placebo
Drug: BIBF 1120
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • annual rate of decline in FVC (expressed in mL over 52 weeks). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute categorical change of FVC% up to 52 weeks: decrease by > 5, increase by > 5, and change within <= 5. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Absolute categorical change of FVC% up to 52 weeks: decrease by > 10, increase by > 10, and change within <= 10. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • change from baseline in Shortness Of Breath Questionnaire (SOBQ) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • change from baseline in Cough And Sputum Assessment (CASAQ) score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of Patient's Global Impression of Change (PGIC) responders [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • change from baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ5D) total score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of SGRQ responders [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • change from baseline in SGRQ-I [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in SPO2 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • change from baseline in DLCO [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Saint-George Respiratory Questionnaire (SGRQ) total score at 52 weeks (expressed in points). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Respiratory mortality (adjudicated; all data collected based on randomized set, including vital status follow-up, censored at 52 weeks). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Absolute and relative change from baseline of FVC and FVC %pred up to 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Overall survival (all data collected based on randomized set, including vital status follow-up, censored at 52 weeks). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • time to first acute IPF exacerbation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • risk ratio of an IPF exacerbation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • On-treatment survival (on-treatment based on fatal adverse event + 28 days). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • changes from baseline in SGRQ domains [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to death or lung transplant. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 551
Study Start Date: May 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
patient receives capsules identical to those containing active drug
Drug: placebo
placebo matching BIBF 1120 BID
Experimental: BIBF 1120
patient receives capsules containing BIBF 1120 twice a day
Drug: BIBF 1120
BIBF 1120 BID (twice daily)

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335477

  Show 108 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01335477     History of Changes
Other Study ID Numbers: 1199.34, 2010-024252-29
Study First Received: April 13, 2011
Last Updated: March 28, 2014
Health Authority: Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
India: Drugs Controller General of India
Japan: Ministry of Health, Labor and Welfare
Mexico: Ministry of Health
Netherlands: Central Committee Research Involving Human Subjects
Portugal: National Pharmacy and Medicines Institute
Russia: Pharmacological Committee, Ministry of Health
South Korea: Ministry of Food and Drug Safety (MFDS)
Spain: Spanish Agency of Medicines
Turkey: Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibrosis
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014