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Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)

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ClinicalTrials.gov Identifier: NCT01979952
Recruitment Status : Terminated
First Posted : November 8, 2013
Last Update Posted : June 14, 2017
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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 or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Matching Placebo Drug: Nintedanib Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Actual Study Start Date : November 26, 2013
Primary Completion Date : July 18, 2016
Study Completion Date : October 27, 2016

Arm Intervention/treatment
Experimental: Nintedanib
150 mg twice daily
Drug: Nintedanib
gelating capsule
Placebo Comparator: Placebo
twice daily dosing
Drug: Matching Placebo
twice daily dosing

Primary Outcome Measures :
  1. Relative change from baseline in HRCT Quantitative Lung Fibrosis (QLF) score [ Time Frame: at 6 months ]

Secondary Outcome Measures :
  1. Effect of six month delayed treatment onset: relative change from baseline in HRCT QLF score [ Time Frame: at 12 month ]
  2. FVC absolute, relative and categorical change from baseline [ Time Frame: at 6 months ]
  3. St. George's Respiratory Questionnaire (SGRQ) total score change from baseline [ Time Frame: at 6 months ]
  4. 6MWT total distance walked change from baseline [ Time Frame: at 6 months ]
  5. University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) change from baseline [ Time Frame: at 6 months ]
  6. Occurrence of all-cause mortality [ Time Frame: at 6 months ]
  7. Occurrence of respiratory hospitalizations [ Time Frame: at 6 months ]
  8. Occurrence of respiratory mortality [ Time Frame: at 6 months ]
  9. Occurence of acute exacerbations [ Time Frame: at 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01979952

  Show 26 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01979952     History of Changes
Other Study ID Numbers: 1199.187
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017

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