Efficacy and Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
NCT ID: NCT02999178
Last Updated: 2020-05-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
663 participants
INTERVENTIONAL
2017-01-17
2019-08-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Nintedanib
Nintedanib
Placebo
Placebo
Interventions
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Nintedanib
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female patients aged \>= 18 years at Visit 1.
* Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) based on American Thoracic Society (ATS)/ European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) 2011 Guidelines.
* Significant Pulmonary Arterial Hypertension (PAH) defined by any of the following:
* Previous clinical or echocardiographic evidence of significant right heart failure
* History of right heart catheterization showing a cardiac index \<= 2 l/min/m²
* PAH requiring parenteral therapy with epoprostenol/treprostinil
* Primary obstructive airway physiology (pre-bronchodilator FEV1/FVC \< 0.7 at Visit 1).
* In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
* Major extrapulmonary physiological restriction (e.g. chest wall abnormality, large pleural effusion)
* Cardiovascular diseases, any of the following:
* Severe hypertension, uncontrolled under treatment (≥160/100 mmHg), within 6 month of Visit 1
* Myocardial infarction within 6 months of Visit 1
* Unstable cardiac angina within 6 months of Visit 1
* Bleeding risk, any of the following:
* Known genetic predisposition to bleeding.
* Patients who require
* Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin)
* High dose antiplatelet therapy. \[Note: Prophylactic low dose heparin or heparin flush as needed for maintenance of an indwelling intravenous device (e.g. enoxaparin 4000 I.U. s.c. per day), as well as prophylactic use of antiplatelet therapy (e.g. acetyl salicylic acid up to 325 mg/day, or clopidogrel at 75 mg/day, or equivalent doses of other antiplatelet therapy) are not prohibited\].
* History of haemorrhagic central nervous system (CNS) event within 12 months of Visit 1.
* Any of the following within 3 months of Visit 1:
* Haemoptysis or haematuria
* Active gastro-intestinal (GI) bleeding or GI - ulcers
* Major injury or surgery (Investigators judgment).
* Coagulation parameters: International normalized ratio (INR) \>2, prolongation of prothrombin time (PT) and activated partial thromboplastin time (aPTT) by \>1.5 x ULN at Visit 1.
* History of thrombotic event (including stroke and transient ischemic attack) within 12 months of Visit 1.
* Known hypersensitivity to the trial medication or its components (i.e. soya lecithin)
* Patients with peanut allergy.
* Other disease that may interfere with testing procedures or in the judgment of the Investigator may interfere with trial participation or may put the patient at risk when participating in this trial.
* Life expectancy for disease other than ILD \< 2.5 years (Investigator assessment).
* Planned major surgical procedures.
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
* Women of childbearing potential\* not willing or able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly as well as one barrier method for 28 days prior to and 3 months after nintedanib administration. A list of contraception methods meeting these criteria is provided in the patient information.
* In the opinion of the Investigator, active alcohol or drug abuse.
* Patients not able to understand or follow trial procedures including completion of self-administered questionnaires without help. \*A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
Exclusion Criteria
* Marginal decline in FVC % pred based on a relative decline of .\>=5-\<10% combined with worsening of respiratory symptoms
* Marginal decline in FVC % pred based on a relative decline of \>=5-\<10% combined with increasing extent of fibrotic changes on chest imaging
* Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging \[Note: Changes attributable to comorbidities e.g. infection, heart failure must be excluded. Unapproved medications used in the clinical practice to treat ILD include but are not limited to corticosteroid, azathioprine, mycophenolate mofetil (MMF), n-acetylcysteine (NAC), rituximab, cyclophosphamide, cyclosporine, tacrolimus\].
* Fibrosing lung disease on HRCT, defined as reticular abnormality with traction bronchiectasis with or without honeycombing, with disease extent of \>10%, performed within 12 months of Visit 1 as confirmed by central readers.
* For patients with underlying Connective Tissue Disease (CTD): stable CTD as defined by no initiation of new therapy or withdrawal of therapy for CTD within 6 weeks prior to Visit 1.
* Carbon Monoxide Diffusion Capacity (DLCO) corrected for Haemoglobin (Hb) \[visit 1\] ≥ 30% and \<80% predicted of normal at Visit 2
* FVC \>= 45% predicted at Visit 2
* Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) \> 1.5 x Upper Limit of Normal (ULN) at Visit 1
* Bilirubin \> 1.5 x ULN at Visit 1
* Creatinine clearance \<30 mL/min calculated by Cockcroft-Gault formula at Visit 1 \[Note: Laboratory parameters from Visit 1 have to satisfy the laboratory threshold values as shown above. Visit 2 laboratory results will be available only after randomization. In case at Visit 2 the results do no longer satisfy the entry criteria, the Investigator has to decide whether it is justified that the patient remains on study drug. The justification for decision needs to be documented. Laboratory parameters that are found to be abnormal at Visit 1 are allowed to be re-tested (once) if it is thought to be a measurement error (i.e. there was no abnormal result of this test in the recent history of the patient and there is no related clinical sign) or the result of a temporary and reversible medical condition, once that condition is resolved\].
* Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic impairment).
* Previous treatment with nintedanib or pirfenidone.
* Other investigational therapy received within 1 month or 6 half-lives (whichever was greater) prior to screening visit (Visit 1).
* Use of any of the following medications for the treatment of Interstitial Lung Disease (ILD): azathioprine (AZA), cyclosporine, MMF, tacrolimus, oral corticosteroids (OCS) \>20mg/day and the combination of OCS+AZA+NAC within 4 weeks of Visit 2, cyclophosphamide within 8 weeks of Visit 2, rituximab within 6 months of Visit 2.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
University of California Davis
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
National Jewish Health
Denver, Colorado, United States
Pulmonary and Sleep Specialists
Danbury, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Pulmonary and Sleep of Tampa Bay
Brandon, Florida, United States
University of Florida College of Medicine
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Pulmonary and Critical Care Associates of Baltimore
Towson, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Pulmonary and Critical Care Medicine
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
The Lung Research Center, LLC
Chesterfield, Missouri, United States
Creighton University
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, United States
NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
The Oregon Clinic
Portland, Oregon, United States
The Oregon Clinic
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Temple University Hospital
Oaks, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of South Carolina
Columbia, South Carolina, United States
Baylor University Medical Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Texas Pul & Crit Care Conslt
Fort Worth, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
Medical Arts and Research Center (MARC)
San Antonio, Texas, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, United States
Centro Dr. Lazaro Langer S.R.L
Alberdi Sur, , Argentina
Centro de Investigaciones Metabólicas (CINME)
C.a.b.a, , Argentina
Sanatorio Güemes
Ciudad Autónoma de Bs As, , Argentina
CEMER-Centro Medico De Enfermedades Respiratorias
Florida, , Argentina
INSARES
Mendoza, , Argentina
Instituto Médico de la Fundación Estudios Clínicos
Rosario, , Argentina
Centre Hospitalier Universitaire de Liège
Angleur, , Belgium
ULB Hopital Erasme
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Yvoir - UNIV UCL de Mont-Godinne
Yvoir, , Belgium
Concordia Hospital
Winnipeg, Manitoba, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
CHUS Fleurimont
Sherbrooke, Quebec, Canada
Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"
Concepción, , Chile
Instituto Nacional del Tórax
Providencia, Santiago de Chile, , Chile
Centro de Investigación del Maule
Talca, , Chile
Peking Union Medical College Hospital
Beijing, , China
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
Nanjing Drum Tower Hospital
Nanjing, , China
The First Hospital of Chinese Medical University
Shenyang, , China
HOP Avicenne
Bobigny, , France
HOP Louis Pradel
Bron, , France
HOP Côte de Nacre
Caen, , France
HOP d'Instruction des Armées Percy
Clamart, , France
HOP Calmette
Lille, , France
HOP Nord
Marseille, , France
HOP Arnaud de Villeneuve
Montpellier, , France
HOP Pasteur
Nice, , France
HOP Bichat
Paris, , France
HOP Maison Blanche
Reims, , France
HOP Pontchaillou
Rennes, , France
HOP Civil
Strasbourg, , France
HOP Bretonneau
Tours, , France
Universitätsklinikum Bonn AöR
Bonn, , Germany
Fachkrankenhaus Coswig GmbH
Coswig, , Germany
Klinik Donaustauf
Donaustauf, , Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, , Germany
Wissenschaftliches Institut Bethanien
Solingen, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Petrus-Krankenhaus
Wuppertal, , Germany
A.O.U. Policlinico Vittorio Emanuele
Catania, , Italy
Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
Forlì, , Italy
Azienda Ospedaliera Policlinico di Modena
Modena, , Italy
A.O. San Gerardo di Monza
Monza, , Italy
Policlinico Gemelli
Roma, , Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, , Italy
Tosei General Hospital
Aichi, Seto, , Japan
Kurume University Hospital
Fukuoka, Kurume, , Japan
Sapporo Medical University Hospital
Hokkaido, Sapporo, , Japan
National Hospital Organization Himeji Medical Center
Hyogo, Himeji, , Japan
Kobe City Medical Center General Hospital
Hyogo, Kobe, , Japan
Ibarakihigashi National Hospial
Ibaraki, Naka-gun, , Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, , Japan
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, , Japan
Tohoku University Hospital
Miyagi, Sendai, , Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, , Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, , Japan
Osaka Medical College Hospital
Osaka, Takatsuki, , Japan
Hamamatsu University Hospital
Shizuoka, Hamamatsu, , Japan
Jichi Medical University Hospital
Tochigi, Shimotsuke, , Japan
Tokushima University Hospital
Tokushima, Tokushima, , Japan
Tokyo Medical and Dental University
Tokyo, Bunkyo-ku, , Japan
Nippon Medical School Hospital
Tokyo, Bunkyo-ku, , Japan
Toranomon Hospital
Tokyo, Minato-ku, , Japan
JR Tokyo General Hospital
Tokyo, Shibuya-ku, , Japan
Global Health and Medicine Ctr
Tokyo, Shinjuku-ku, , Japan
University Clinical Center, Gdansk
Gdansk, , Poland
Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.
Katowice, , Poland
Norbert Barlicki University Clinical Hospital No.1, Lodz
Lodz, , Poland
Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
Warsaw, , Poland
Clinical Hospital No. 1, n.a. Prof. Szyszko from Silesian MA
Zabrze, , Poland
Res.Inst.-Compl.Iss.Cardi.Dis.
Kemerovo, , Russia
Pulmonology Scientific Research Institute
Moscow, , Russia
Central Scientific Research Insitute of Tuberculosis
Moscow, , Russia
Moscow 1st State Med.Univ.n.a.I.M.Sechenov
Moscow, , Russia
Scientific Research Institute of Pulmonology
Saint Petersburg, , Russia
Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl
Yaroslavl, , Russia
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon-si, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Puerta del Mar
Cadiz, , Spain
Hospital de Galdakao
Galdakao, , Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, , Spain
Hospital La Princesa
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Central de Asturias
Oviedo, , Spain
Hospital Son Espases
Palma de Mallorca, , Spain
Hospital de Canarias
San Cristóbal de La Laguna, , Spain
Hospital Virgen del Rocío
Seville, , Spain
Hospital Politècnic La Fe
Valencia, , Spain
University Hospital Llandough
Cardiff, , United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
Countries
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References
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Kolb M, Flaherty KR, Silva RS, Prasse A, Vancheri C, Mueller H, Sroka-Saidi K, Wells AU; INBUILD trial investigators. Effect of Nintedanib in Patients with Progressive Pulmonary Fibrosis in Subgroups with Differing Baseline Characteristics. Adv Ther. 2023 Dec;40(12):5536-5546. doi: 10.1007/s12325-023-02668-x. Epub 2023 Sep 26.
Kreuter M, Bendstrup E, Jouneau S, Maher TM, Inoue Y, Miede C, Lievens D, Crestani B. Weight loss and outcomes in subjects with progressive pulmonary fibrosis: data from the INBUILD trial. Respir Res. 2023 Mar 9;24(1):71. doi: 10.1186/s12931-023-02371-z.
Inoue Y, Wells AU, Song JW, Xu Z, Kitamura H, Suda T, Okamoto M, Muller H, Coeck C, Rohr KB, Kolb M, Brown KK. Nintedanib in Asian patients with progressive fibrosing interstitial lung diseases: Results from the INBUILD trial. Respirology. 2023 May;28(5):465-474. doi: 10.1111/resp.14452. Epub 2023 Jan 15.
Ogura T, Suda T, Inase N, Nishioka Y, Azuma A, Okamoto M, Takizawa A, Ito T, Rohr KB, Inoue Y. Effects of nintedanib on disease progression and safety in Japanese patients with progressive fibrosing interstitial lung diseases: Further subset analysis from the whole INBUILD trial. Respir Investig. 2022 Nov;60(6):787-797. doi: 10.1016/j.resinv.2022.06.009. Epub 2022 Aug 1.
Cottin V, Martinez FJ, Jenkins RG, Belperio JA, Kitamura H, Molina-Molina M, Tschoepe I, Coeck C, Lievens D, Costabel U. Safety and tolerability of nintedanib in patients with progressive fibrosing interstitial lung diseases: data from the randomized controlled INBUILD trial. Respir Res. 2022 Apr 7;23(1):85. doi: 10.1186/s12931-022-01974-2.
Swigris JJ, Bushnell DM, Rohr K, Mueller H, Baldwin M, Inoue Y. Responsiveness and meaningful change thresholds of the Living with Pulmonary Fibrosis (L-PF) questionnaire Dyspnoea and Cough scores in patients with progressive fibrosing interstitial lung diseases. BMJ Open Respir Res. 2022 Mar;9(1):e001167. doi: 10.1136/bmjresp-2021-001167.
Inoue Y, Suda T, Kitamura H, Okamoto M, Azuma A, Inase N, Kuwana M, Makino S, Nishioka Y, Ogura T, Takizawa A, Ugai H, Stowasser S, Schlenker-Herceg R, Takeuchi T. Efficacy and safety of nintedanib in Japanese patients with progressive fibrosing interstitial lung diseases: Subgroup analysis of the randomised, double-blind, placebo-controlled, phase 3 INBUILD trial. Respir Med. 2021 Oct;187:106574. doi: 10.1016/j.rmed.2021.106574. Epub 2021 Aug 12.
Flaherty KR, Wells AU, Cottin V, Devaraj A, Inoue Y, Richeldi L, Walsh SLF, Kolb M, Koschel D, Moua T, Stowasser S, Goeldner RG, Schlenker-Herceg R, Brown KK; INBUILD Trial Investigators. Nintedanib in progressive interstitial lung diseases: data from the whole INBUILD trial. Eur Respir J. 2022 Mar 17;59(3):2004538. doi: 10.1183/13993003.04538-2020. Print 2022 Mar.
Maher TM, Brown KK, Kreuter M, Devaraj A, Walsh SLF, Lancaster LH, Belloli EA, Padilla M, Behr J, Goeldner RG, Tetzlaff K, Schlenker-Herceg R, Flaherty KR; INBUILD trial investigators. Effects of nintedanib by inclusion criteria for progression of interstitial lung disease. Eur Respir J. 2022 Feb 3;59(2):2004587. doi: 10.1183/13993003.04587-2020. Print 2022 Feb.
Cottin V, Richeldi L, Rosas I, Otaola M, Song JW, Tomassetti S, Wijsenbeek M, Schmitz M, Coeck C, Stowasser S, Schlenker-Herceg R, Kolb M; INBUILD Trial Investigators. Nintedanib and immunomodulatory therapies in progressive fibrosing interstitial lung diseases. Respir Res. 2021 Mar 16;22(1):84. doi: 10.1186/s12931-021-01668-1.
Brown KK, Martinez FJ, Walsh SLF, Thannickal VJ, Prasse A, Schlenker-Herceg R, Goeldner RG, Clerisme-Beaty E, Tetzlaff K, Cottin V, Wells AU. The natural history of progressive fibrosing interstitial lung diseases. Eur Respir J. 2020 Jun 25;55(6):2000085. doi: 10.1183/13993003.00085-2020. Print 2020 Jun.
Wells AU, Flaherty KR, Brown KK, Inoue Y, Devaraj A, Richeldi L, Moua T, Crestani B, Wuyts WA, Stowasser S, Quaresma M, Goeldner RG, Schlenker-Herceg R, Kolb M; INBUILD trial investigators. Nintedanib in patients with progressive fibrosing interstitial lung diseases-subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial. Lancet Respir Med. 2020 May;8(5):453-460. doi: 10.1016/S2213-2600(20)30036-9. Epub 2020 Mar 5.
Flaherty KR, Wells AU, Cottin V, Devaraj A, Walsh SLF, Inoue Y, Richeldi L, Kolb M, Tetzlaff K, Stowasser S, Coeck C, Clerisme-Beaty E, Rosenstock B, Quaresma M, Haeufel T, Goeldner RG, Schlenker-Herceg R, Brown KK; INBUILD Trial Investigators. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases. N Engl J Med. 2019 Oct 31;381(18):1718-1727. doi: 10.1056/NEJMoa1908681. Epub 2019 Sep 29.
Flaherty KR, Brown KK, Wells AU, Clerisme-Beaty E, Collard HR, Cottin V, Devaraj A, Inoue Y, Le Maulf F, Richeldi L, Schmidt H, Walsh S, Mezzanotte W, Schlenker-Herceg R. Design of the PF-ILD trial: a double-blind, randomised, placebo-controlled phase III trial of nintedanib in patients with progressive fibrosing interstitial lung disease. BMJ Open Respir Res. 2017 Sep 17;4(1):e000212. doi: 10.1136/bmjresp-2017-000212. eCollection 2017.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-003360-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1199.247
Identifier Type: -
Identifier Source: org_study_id
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