Trial record 1 of 1 for:    NCT01979952
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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 August 2015 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01979952
First received: November 4, 2013
Last updated: August 4, 2015
Last verified: August 2015
  Purpose

This is an 6 month multi-centre, prospective, randomized, placebo controlled, double blind clinical trial followed by conversion of each arm to active nintedanib for an additional 6 months comparing 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 Six Month Double Blind Randomized Placebo Controlled Trial Followed by Each Arm Being Converted to Oral Nintedanib 150 mg Twice Daily Comparing the Effect on High Resolution Computerized Tomography Quantitative Lung Fibrosis Score, Lung Function, Six Minute Walk Test Distance and St. George¿s Respiratory Questionnaire After Six 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 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of six month delayed treatment onset: relative change from baseline in HRCT QLF score [ Time Frame: at 12 month ] [ Designated as safety issue: No ]
  • FVC absolute, relative and categorical change from baseline [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • St. George's Respiratory Questionnaire (SGRQ) total score change from baseline [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • 6MWT total distance walked change from baseline [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) change from baseline [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Occurrence of all-cause mortality [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Occurrence of respiratory hospitalizations [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Occurrence of respiratory mortality [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Occurence of acute exacerbations [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: November 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: December 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 (ICH-GCP) 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 ATS/ERS/JRS/ALAT IPF guidelines for diagnosis and management, within 5 years and reaffirmed applying 2011 Guidelines (P11-07084) if diagnosed >2 years and up to 5 year from Visit 1,. Diagnosis must be confirmed by chest HRCT taken within 24 months of Visit 1. All HRCT results reported to be possible or inconsistent usual interstitial pneumonia (UIP) must have confirmatory pathology.
  4. DLCO (corrected for Hb): 30%-79% predicted of normal
  5. FVC = 50% predicted of normal at Visit 1 and Visit 2

Exclusion criteria:

  1. AST, ALT > 1.5 fold 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. Patients will be excluded if they require greater than 12L/min oxygen, are not ambulatory or require use of a walker or cane during the 6 Minute Titration Walk Test. Patients who cannot complete the 6 Minute Titration Walk Test are excluded from participation.
  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.
  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 26 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: August 4, 2015
Health Authority: Canada: Health Canada
Taiwan : Food and Drug Administration
Turkey: Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibrosis
Idiopathic Interstitial Pneumonias
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
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 September 01, 2015