Trial record 1 of 1 for:    NCT 01979952
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Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01979952
First received: November 4, 2013
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

This is an 12 month multi-centre, prospective, randomized, placebo controlled, double blind clinical trial designed to assess the effect of nintedanib 150mg BID on the progression of IPF measured by using HRCT, lung function, 6MWT, biomarkers, and PROs with continued treatment and assessments for up to 18 months.


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: Matching Placebo
Drug: Nintedanib
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 Double Blind Randomized Placebo Controlled Trial Evaluating the Effect of Oral Nintedanib 150 mg Twice Daily on High Resolution Computerized Tomography Quantitative Lung Fibrosis Score, Lung Function, Six Minute Walk Test Distance and St. George's Respiratory Questionnaire After Twelve Months of Treatment in Patients With Idiopathic Pulmonary Fibrosis With Continued Evaluations Over a Period of up to Eighteen Months

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Relative change from baseline in HRCT Quantitative Lung Fibrosis (QLF) score [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FVC absolute and relative change from baseline [ Time Frame: at 12 month ] [ Designated as safety issue: No ]
  • St. George's Respiratory Questionnaire (SGRQ) total score change from baseline [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • 6MWT total distance walked change from baseline [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • FVC categorical change from baseline [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) change from baseline [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
  • Occurrence of all cause mortality at the end of treatment period [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
  • Occurrence of respiratory hospitalizations at the end of treatment period [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
  • Occurrence of respiratory mortality at the end of treatment period [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
  • Risk ratio of an acute IPF exacerbation at the end of treatment [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 275
Study Start Date: November 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nintedanib
150 mg twice daily
Drug: Nintedanib
gelating capsule
Placebo Comparator: Placebo
twice daily dosing
Drug: Matching Placebo
twice daily dosing

  Eligibility

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

Inclusion criteria:

  1. Written Informed Consent consistent with International Conference on Harmonisation-Good Clinical Practice and local laws signed prior to entry into the study
  2. Patient aged = 40 years at visit 1
  3. IPF diagnosed, according to the 2011 American Thoracic Society (ATS)/European Respiratory Society (ERS) /Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) IPF guidelines for diagnosis Usual Interstitial Pneumonia (UIP) management, within 5 years of Visit 0. All HRCT found to be possible UIP must have confirmatory pathology
  4. Carbon Monoxide Diffusing Capacity (DLCO) (corrected for Hb): 30%-79% predicted of normal
  5. Full Vital Capacity (FVC) predicted of normal

Exclusion criteria:

  1. Aspartate Amino Transferase (AST), Alanine Amino Transferase (ALT) > 1.5 fold Upper Limit Normal (ULN)
  2. Bilirubin > 1.5 fold ULN
  3. Bleeding risk:

    1. Patients who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, dabigatran, heparin, hirudin), or high dose antiplatelet therapy. Exceptions: prophylactic low dose heparin or heparin flush as needed for maintenance of an indwelling intravenous device (e.g. enoxaparin 4000 IU s.c. per day) and prophylactic use of antiplatelet therapy (e.g. acetyl salicylic acid up to 325 mg/d, or clopidogrel at 75 mg/d, or equivalent doses of other antiplatelet therapy)
    2. History of hemorrhagic Central Nervous System (CNS) event within 12 months
    3. Any of the following within 3 months: Haemoptysis or haematuria, active gastro-intestinal bleeding or ulcers, major injury or surgery
    4. Coagulation parameters: International normalised ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 150% of institutional ULN
  4. Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery
  5. Thrombotic risk:

    1. Known inherited predisposition to thrombosis
    2. History of thrombotic event (including stroke and transient ischemic attacks) within 12 months
  6. Current or planned usage of any investigational drug during the course of this trial
  7. Previous treatment with nintedanib within a clinical trial in the previous 3 months and discontinuation of nintedanib study treatment due to an adverse event
  8. Known hypersensitivity to the trial drug or its component
  9. A disease or condition which in the opinion of investigator may put the patient at risk because of participation in this trial or limit the patient¿s ability to participate in this trial
  10. Alcohol or drug abuse which in the opinion of the investigator would interfere with trial participation
  11. Pregnant women or women who are breast feeding or of child bearing potential not using two effective methods of birth control (one barrier and one highly effective non-barrier) for at least 1 month prior to trial and/or not committing to using it until 3 months after end of treatment
  12. Women will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or postmenopausal for at least two years; Highly effective methods of birth control include established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS). A barrier method of contraception includes condom or occlusive cap with spermicidal (foam, gel, film, cream, suppository) or male sterilization (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate)
  13. Sexually active males not committing to using condoms during the course of the study (except if their partner is not of childbearing potential) and 3 months after end of treatment.
  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: NCT01979952

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Show 19 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01979952     History of Changes
Other Study ID Numbers: 1199.187
Study First Received: November 4, 2013
Last Updated: October 7, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014