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CompletedNCT02788474Updated Dec 21, 2023Results posted

Effect of Nintedanib on Biomarkers of Extracellular Matrix Turnover in Patients With Idiopathic Pulmonary Fibrosis and Limited Forced Vital Capacity Impairment

A Phase 4 interventional study of nintedanib and placebo in Idiopathic Pulmonary Fibrosis, sponsored by Boehringer Ingelheim. Completed at 86 sites in 13 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2023-12-21.

Sponsored by Boehringer Ingelheim · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
347
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

Identifying biomarkers to predict the clinical course and benefits of therapy early in the course of the disease remains one of the most urgent and relevant challenges to improve overall patient management, to prevent treatment delay or overtreatment. This study is conducted to examine the effect of nintedanib treatment on change in biomarkers indicative of extracellular matrix turnover which have been shown recently to correlate with disease progression. This study further aims to confirm the association of biomarker course during the first three months of treatment and disease progression.

02

Conditions studied

  • Idiopathic Pulmonary Fibrosis
03

In context

Pulmonary Fibrosis

680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.

This study's enrollment of 347 is above the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.

Browse Pulmonary Fibrosis studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Written informed consent consistent with International Conference on Harmonisation Good Clinical Practice and local laws, signed prior to participation in the trial including any study related procedures being performed;
  • Male or female patients aged >=40 years at Visit 1;
  • A clinical diagnosis of Idiopathic pulmonary fibrosis (IPF) within the last 3 years from visit 0, based upon the American Thoracic Society/ European Respiratory Society /Japanese Respiratory Society/ Latin American Thoracic Association 2011 guideline;
  • Chest high resolution computed tomography (HRCT) scan performed within 18 months of Visit 0;
  • Combination of HRCT pattern, and surgical lung biopsy pattern (the latter if available) as assessed by central review are consistent with the diagnosis of Idiopathic pulmonary fibrosis;
  • Forced vital capacity (FVC) >=80% of predicted normal at Visit 1.

Exclusion criteria

Exclusion criteria:

  • Alanine transaminase, Aspartate aminotransferase > 1.5 fold upper limit of normal (ULN) at Visit 1;
  • Total bilirubin > 1.5 fold ULN at Visit 1;
  • Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic impairment);
  • Relevant airways obstruction, i.e. pre-bronchodilator Forced expiratory volume in 1 second / Forced vital capacity \< 0.70;
  • History of myocardial infarction within 6 months of visit 1 or unstable angina within 1 month of Visit 1;

  • Bleeding Risk:

    • Known genetic predisposition to bleeding;
    • Patients who require fibrinolysis, full-dose therapeutic anticoagulation or high dose antiplatelet therapy;
    • History of haemorrhagic central nervous system (CNS) event within 12 months prior to Visit 1;
    • History of haemoptysis or haematuria, active gastro-intestinal bleeding or ulcers and/or major injury or surgery within 3 months prior to Visit 1;
    • International normalised ratio (INR) > 2 at Visit 1;
    • Prothrombin time (PT) and partial thromboplastin time (PTT) > 150% of ULN at Visit 1;
  • Planned major surgery during the trial participation, including lung transplantation, major abdominal or major intestinal surgery;
  • History of thrombotic event (including stroke and transient ischemic attack) within 12 months of Visit 1;
  • Creatinine clearance \< 30 mL/min calculated by Cockcroft-Gault formula at Visit 1;
  • Treatment with nintedanib, pirfenidone, azathioprine, cyclophosphamide, cyclosporine, any other investigational drug, n-acetylcysteine, prednisone/prednisolone >15 mg daily or >30 mg every 2 days OR use of other systemic corticosteroids as well as any investigational drugs within 4 weeks of Visit 2;
  • Known hypersensitivity to nintedanib, peanut, soya or to any other components of the study medication;
  • Prior discontinuation of nintedanib treatment due to intolerability/ adverse events considered drug related;
  • A disease or condition which in the opinion of the investigator may interfere with testing procedures or put the patient at risk when participating in this trial;
  • Alcohol or drug abuse which in the opinion of the treating physician would interfere with the treatment and would affect patient's ability to participate in this trial;
  • Patients not able to understand and follow any study procedures such as but not limited to home spirometry, including completion of self-administered questionnaires without help;
  • Women who are pregnant, nursing, who plan to become pregnant while in the trial or female patients with positive pregnancy (ß-HCG) test at Visit 1 and/or Visit 2;
  • Women of childbearing potential4 not willing or able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
  • Patients with acute IPF exacerbation or any respiratory tract infection in the four weeks prior to Visit 1 or during the screening period;
  • Patients who are or have been participating in another trial with investigational drug/s within one month prior to Visit 1 and patients who have previously been enrolled in this trial;
  • Further exclusion criteria apply.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
347 participants (actual)

Study arms

  • Placebo comparator
    placebo

    Drug: placebo

  • Experimental
    nintedanib

    Drug: nintedanib

Interventions

  • Drugnintedanib
  • Drugplacebo
06

What researchers measure

Primary outcomes

  1. The Rate of Change (Slope) in Blood C-reactive Protein Degraded by Matrix Metalloproteinase-1/8 (CRPM) From Baseline to Week 12.

    The rate of change (slope) in blood C-reactive protein degraded by matrix metalloproteinase-1/8 (CRPM) from baseline to week 12 is presented. The mean presented is the adjusted rate based on a random coefficient regression (CRPM log 10 transformed) with fixed effects for gender, age, height and random effect of patient specific intercept and time.

    Time frame: baseline and 12 weeks

Secondary outcomes

  1. Percentage of Patients With Disease Progression as Defined by Absolute Forced Vital Capacity (FVC) Decline >=10% or Death Until Week 52

    For this endpoint, disease progression was defined by absolute FVC (percentage of predicted) decline ≥10% or death up to Week 52 based on in-clinic supervised spirometry. This is a key secondary endpoint of the trial. This outcome measure is "percentage of patients with disease progression" and CRPM is included in the various models as a factor/covariate, and that this outcome measure, the percentage of progressors are displayed under "Measured values"

    Time frame: 52 weeks

  2. The Rate of Change in Blood Collagen 1 Degraded by Matrix Metalloproteinase-2/9/13 (C1M) From Baseline to Week 12

    The rate of change in blood Collagen 1 degraded by matrix metalloproteinase-2/9/13 (C1M) from baseline to week 12 is presented. The mean presented is the adjusted rate based on a random coefficient regression (C1M (negative reciprocal root transformation)) with fixed effects for gender, age, height and random effect of patient specific intercept and time.

    Time frame: baseline and 12 weeks

  3. The Rate of Change in Blood Collagen 3 Degraded by Matrix Metalloproteinase-9 (C3M) From Baseline to Week 12

    The rate of change in blood Collagen 3 degraded by matrix metalloproteinase-9 (C3M) from baseline to week 12 is presented. The mean presented is the adjusted rate based on a random coefficient regression (C3M- log 10 transformation) with fixed effects for gender, age, height and random effect of patient specific intercept and time.

    Time frame: baseline and 12 weeks

07

Results

Posted Aug 6, 2019

Participant flow

The trial comprised of 2 treatment periods (52 weeks). The first treatment period was a 12-week, randomised, double-blind, placebo-controlled, parallel-group period whereas the second treatment period was a 40-week, single-arm, open-label, active treatment (nintedanib 150 milligram (mg) twice daily (bid)) period.

Double Blind Treatment Period
Participant flow — Double Blind Treatment Period
MilestonePlacebo/ NintedanibNintedanib/ Nintedanib
Started231116
Treated230116
Completed221112
Not completed104
Withdrew: Not treated10
Withdrew: Patient's refusal30
Withdrew: Adverse event64
Open Label Treatment Period
Participant flow — Open Label Treatment Period
MilestonePlacebo/ NintedanibNintedanib/ Nintedanib
Started221112
Completed189100
Not completed3212
Withdrew: Adverse event299
Withdrew: Other than reason specified10
Withdrew: Patient's refusal13
Withdrew: Non-compliance10

Outcome measures

PrimaryThe Rate of Change (Slope) in Blood C-reactive Protein Degraded by Matrix Metalloproteinase-1/8 (CRPM) From Baseline to Week 12.

The rate of change (slope) in blood C-reactive protein degraded by matrix metalloproteinase-1/8 (CRPM) from baseline to week 12 is presented. The mean presented is the adjusted rate based on a random coefficient regression (CRPM log 10 transformed) with fixed effects for gender, age, height and random effect of patient specific intercept and time.

Time frame:
baseline and 12 weeks
Reported as:
Mean · nanogram/ millitre/ month (ng/ mL/ mth)
The Rate of Change (Slope) in Blood C-reactive Protein Degraded by Matrix Metalloproteinase-1/8 (CRPM) From Baseline to Week 12.
nanogram/ millitre/ month (ng/ mL/ mth)Placebo/ NintedanibNintedanib/ Nintedanib
The Rate of Change (Slope) in Blood C-reactive Protein Degraded by Matrix Metalloproteinase-1/8 (CRPM) From Baseline to Week 12.-0.00190 ± 0.00165-0.00257 ± 0.00232
Statistical analysis
  • Placebo/ Nintedanib vs Nintedanib/ Nintedanib · random coefficient regression · p = 0.8146 (random coefficient regression (random slopes and intercepts) model including sex, age and height as covariates (Due to the low number of measurements per patient, baseline CRPM was included as a response rather than as a covariate in the analysis)) · Adjusted mean difference: -0.00066 · 95% CI -0.00621 to 0.00488Difference calculated as Nintedanib minus Placebo
SecondaryPercentage of Patients With Disease Progression as Defined by Absolute Forced Vital Capacity (FVC) Decline >=10% or Death Until Week 52

For this endpoint, disease progression was defined by absolute FVC (percentage of predicted) decline ≥10% or death up to Week 52 based on in-clinic supervised spirometry. This is a key secondary endpoint of the trial. This outcome measure is "percentage of patients with disease progression" and CRPM is included in the various models as a factor/covariate, and that this outcome measure, the percentage of progressors are displayed under "Measured values"

Time frame:
52 weeks
Reported as:
Number · Percentage of participants
Percentage of Patients With Disease Progression as Defined by Absolute Forced Vital Capacity (FVC) Decline >=10% or Death Until Week 52
Percentage of participantsPlacebo/ NintedanibNintedanib/ Nintedanib
Percentage of Patients With Disease Progression as Defined by Absolute Forced Vital Capacity (FVC) Decline >=10% or Death Until Week 5230.43 (24.85 to 36.66)25.00 (18.01 to 33.60)
Statistical analysis
  • Placebo/ Nintedanib · Regression, Logistic · p = 0.2084 · Slope estimate: 22.001 · 95% CI -11.83 to 57.58Slope estimate is the monthly rate of change in CRPM up to week 12
  • Placebo/ Nintedanib vs Nintedanib/ Nintedanib · Regression, Logistic · p = 0.1537 · Slope estimate: -45.566 · 95% CI -109.55 to 16.37Slope estimate is the monthly rate of change in CRPM up to week 12
  • Placebo/ Nintedanib vs Nintedanib/ Nintedanib · Regression, Logistic · p = 0.3116 · Odds ratio (or): 0.769 · 95% CI 0.46 to 1.27
  • Placebo/ Nintedanib vs Nintedanib/ Nintedanib · Regression, Logistic · p = 0.3175 · Odds ratio (or): 0.772 · 95% CI 0.46 to 1.27
SecondaryThe Rate of Change in Blood Collagen 1 Degraded by Matrix Metalloproteinase-2/9/13 (C1M) From Baseline to Week 12

The rate of change in blood Collagen 1 degraded by matrix metalloproteinase-2/9/13 (C1M) from baseline to week 12 is presented. The mean presented is the adjusted rate based on a random coefficient regression (C1M (negative reciprocal root transformation)) with fixed effects for gender, age, height and random effect of patient specific intercept and time.

Time frame:
baseline and 12 weeks
Reported as:
Mean · ng/ml/mth
The Rate of Change in Blood Collagen 1 Degraded by Matrix Metalloproteinase-2/9/13 (C1M) From Baseline to Week 12
ng/ml/mthPlacebo/ NintedanibNintedanib/ Nintedanib
The Rate of Change in Blood Collagen 1 Degraded by Matrix Metalloproteinase-2/9/13 (C1M) From Baseline to Week 120.00041 ± 0.001270.00162 ± 0.00172
Statistical analysis
  • Placebo/ Nintedanib vs Nintedanib/ Nintedanib · random coefficient regression · p = 0.5469 (random coefficient regression model (C1M (negative reciprocal root-transformed)) with fixed effects for gender, age, height and random effect of patient specific intercept and time.) · Adjusted mean difference: 0.00121 · 95% CI -0.00273 to 0.00515Difference calculated as Nintedanib minus Placebo. Inter-individual variability is modelled by a Variance-Components variance-covariance matrix.
SecondaryThe Rate of Change in Blood Collagen 3 Degraded by Matrix Metalloproteinase-9 (C3M) From Baseline to Week 12

The rate of change in blood Collagen 3 degraded by matrix metalloproteinase-9 (C3M) from baseline to week 12 is presented. The mean presented is the adjusted rate based on a random coefficient regression (C3M- log 10 transformation) with fixed effects for gender, age, height and random effect of patient specific intercept and time.

Time frame:
baseline and 12 weeks
Reported as:
Mean · ng/ml/mth
The Rate of Change in Blood Collagen 3 Degraded by Matrix Metalloproteinase-9 (C3M) From Baseline to Week 12
ng/ml/mthPlacebo/ NintedanibNintedanib/ Nintedanib
The Rate of Change in Blood Collagen 3 Degraded by Matrix Metalloproteinase-9 (C3M) From Baseline to Week 12-0.00091 ± 0.00158-0.00398 ± 0.00219
Statistical analysis
  • Placebo/ Nintedanib vs Nintedanib/ Nintedanib · random coefficient regression · p = 0.2429 (random coefficient regression model (C3M (log10-transformed)) with fixed effects for gender, age, height and random effect of patient specific intercept and time.) · Adjusted mean difference: -0.00307 · 95% CI -0.00823 to 0.00209Difference calculated as Nintedanib minus Placebo. Inter-individual variability is modelled by a Variance-Components variance-covariance matrix.

Adverse events

Collected over Serious Adverse Event (SAE) & Non SAE: All adverse events (AEs) that occurred between first drug intake and 28 days after last drug intake (end of the Residual effect period (REP)); up to 53 weeks All cause mortality: All AEs during the course of the clinical trial; up to 56 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo (Double Blind Period)0/230 (0%)18/230 (7.8%)103/230 (44.8%)
Nintedanib (Double Blind Period)0/116 (0%)8/116 (6.9%)80/116 (69%)
Nintedanib (Open Label Period)9/333 (2.7%)65/333 (19.5%)277/333 (83.2%)
Most frequent serious events
Showing 10 of 79
Most frequent serious events
EventPlacebo (Double Blind Period)Nintedanib (Double Blind Period)Nintedanib (Open Label Period)
PneumoniaInfections and infestations1/2300/1165/333
Idiopathic pulmonary fibrosisRespiratory, thoracic and mediastinal disorders1/2301/1165/333
Lower respiratory tract infectionInfections and infestations2/2300/1162/333
Hypertensive crisisVascular disorders2/2301/1161/333
GlaucomaEye disorders1/2301/1162/333
Inguinal herniaGastrointestinal disorders0/2301/1160/333
ConcussionInjury, poisoning and procedural complications0/2301/1160/333
FallInjury, poisoning and procedural complications0/2301/1162/333
Jaw fractureInjury, poisoning and procedural complications0/2301/1160/333
Chondrocalcinosis pyrophosphateMusculoskeletal and connective tissue disorders0/2301/1160/333
Most frequent other events
Showing 10 of 17
Most frequent other events
EventPlacebo (Double Blind Period)Nintedanib (Double Blind Period)Nintedanib (Open Label Period)
DiarrhoeaGastrointestinal disorders42/23054/116215/333
NauseaGastrointestinal disorders15/23017/11657/333
NasopharyngitisInfections and infestations19/23010/11649/333
VomitingGastrointestinal disorders7/2309/11642/333
Decreased appetiteMetabolism and nutrition disorders10/23012/11639/333
CoughRespiratory, thoracic and mediastinal disorders16/2305/11638/333
Weight decreasedInvestigations2/2306/11626/333
Back painMusculoskeletal and connective tissue disorders5/2303/11624/333
BronchitisInfections and infestations5/2303/11623/333
Alanine aminotransferase increasedInvestigations2/2307/11617/333

Baseline characteristics

Treated Set (TS), consisting of participants who were randomised to a treatment group and received at least one dose of trial medication

Age, Continuous
Age, Continuous(years)Placebo/ NintedanibNintedanib/ NintedanibTotal
Mean70.2 ± 7.270.5 ± 7.770.3 ± 7.4
Sex: Female, Male
Sex: Female, Male(Participants)Placebo/ NintedanibNintedanib/ NintedanibTotal
Female612384
Male16993262
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo/ NintedanibNintedanib/ NintedanibTotal
Hispanic or Latino19928
Not Hispanic or Latino19396289
Unknown or Not Reported181129
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo/ NintedanibNintedanib/ NintedanibTotal
American Indian or Alaska Native000
Asian6835103
Native Hawaiian or Other Pacific Islander000
Black or African American000
White14470214
More than one race000
Unknown or Not Reported181129
08

Study locations

86 sites
  • Jasper Summit Research, LLC
    Jasper, Alabama 35501, United States
  • Western Connecticut Medical Group
    Danbury, Connecticut 06810, United States
  • St. Francis Medical Institute
    Clearwater, Florida 33765, United States
  • University of Florida College of Medicine
    Jacksonville, Florida 32209, United States
  • Minnesota Lung Center
    Minneapolis, Minnesota 55407, United States
  • The Lung Research Center, LLC
    Chesterfield, Missouri 63017, United States
  • Clinical Research Solutions
    Dayton, Ohio 45409, United States
  • Pulmonary Associates of Richmond, Inc.
    Richmond, Virginia 23225, United States
  • Royal Prince Alfred Hospital
    Camperdown, Sydney, New South Wales 2050, Australia
  • Concord General Repatriation Hospital -Ambulatory Care Unit
    Concord, New South Wales 2139, Australia
  • Royal Adelaide Hospital
    Adelaide, South Australia 5000, Australia
  • The Alfred Hospital
    Melbourne, Victoria 3004, Australia
  • ULB Hopital Erasme
    Bruxelles, 1070, Belgium
  • Edegem - UNIV UZ Antwerpen
    Edegem, 2650, Belgium
  • UZ Leuven
    Leuven, 3000, Belgium
  • Centre Hospitalier Universitaire de Liège
    Liège, 4000, Belgium
  • Yvoir - UNIV UCL de Mont-Godinne
    Yvoir, 5530, Belgium
  • University Hospital Olomouc
    Olomouc, 779 00, Czechia
  • University Hospital Plzen, Plzen-Bory
    Plzen, 30599, Czechia
  • Thomayer Hospital
    Praha 4, 14059, Czechia
  • University Hospital Na Bulovce, Prague
    Praha, 180 81, Czechia
  • Masaryk Hospital, Usti nad Labem
    Usti nad Labem, 401 13, Czechia
  • HYKS Keuhkosairauksien
    Helsinki, 00290, Finland
  • KYS, Keuhkosairauksien
    Kuopio, 70210, Finland
  • OYS, sisätautien klinikka
    Oulu, 90220, Finland
  • Tampere University Hospital
    Tampere, FI-33520, Finland
  • TYKS, Keuhkosairauksien klinikka, Turku
    Turku, 20520, Finland
  • HOP de la Cavale Blanche
    Brest, 29609, France
  • HOP Louis Pradel
    Bron, 69677, France
  • HOP Européen G. Pompidou
    Paris, 75015, France
  • HOP Maison Blanche
    Reims Cedex, 51092, France
  • HOP Pontchaillou
    Rennes, 35033, France
  • HOP Civil
    Strasbourg, 67091, France
  • HOP Bretonneau
    Tours, 37044, France
  • CIMS Studienzentrum Bamberg GmbH
    Bamberg, 96049, Germany
  • Helios Klinikum Emil von Behring
    Berlin, 14165, Germany
  • Universitätsklinikum Gießen und Marburg GmbH
    Gießen, 35392, Germany
  • Universitätsmedizin Greifswald
    Greifswald, 17475, Germany
  • Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
    Grosshansdorf, 22927, Germany
  • Medizinische Hochschule Hannover
    Hannover, 30625, Germany
  • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
    Heidelberg, 69126, Germany
  • Lungenfachklinik Immenhausen
    Immenhausen, 34376, Germany
  • Klinikum der Universität München - Campus Großhadern
    München, 81377, Germany
  • Universitätsklinikum Münster
    Münster, 48149, Germany
  • Semmelweis University
    Budapest, 1125, Hungary
  • Csongrad County's Hosp.
    Deszk, 6772, Hungary
  • Pulmonology Institute of Veszprem County, Farkasgyepu
    Farkasgyepu, 8582, Hungary
  • BAZ County Central Hospital and University Teaching Hospital
    Miskolc, 3526, Hungary
  • Tosei General Hospital
    Aichi, Seto, 489-8642, Japan
  • Kurume University Hospital
    Fukuoka, Kurume, 830-0011, Japan
  • Ibarakihigashi National Hospial
    Ibaraki, Naka-gun, 319-1113, Japan
  • Kanagawa Cardiovascular and Respiratory Center
    Kanagawa, Yokohama, 236-0051, Japan
  • Kindai University Hospital
    Osaka, Osakasayama, 589-8511, Japan
  • National Hospital Organization Kinki-Chuo Chest Medical Center
    Osaka, Sakai, 591-8555, Japan
  • Tokushima University Hospital
    Tokushima, Tokushima, 770-8503, Japan
  • Nippon Medical School Hospital
    Tokyo, Bunkyo-ku, 113-8603, Japan
  • Toho University Omori Medical Center
    Tokyo, Ota-ku, 143-8541, Japan
  • Global Health and Medicine Ctr
    Tokyo, Shinjuku-ku, 162-8655, Japan
  • Seoul National University Bundang Hospital
    Seongnam, 13620, Korea, Republic of
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
  • Asan Medical Center
    Seoul, 05505, Korea, Republic of
  • Our Doctor Clinical Trial Center, Department in Bydgoszcz
    Bydgoszcz, 85065, Poland
  • Non-pub.Health Care NZOZ Profilaktyka W. Pierzchala,Katowice
    Katowice, 40-752, Poland
  • Univ. Hospital in Krakow,Pulmonology Clinical Dept
    Krakow, 31-066, Poland
  • John Paul II Cracovian Hosp
    Krakow, 31-202, Poland
  • Norbert Barlicki University Clinical Hospital No.1, Lodz
    Lodz, 90-153, Poland
  • Practice of Internists "Nasz Lekarz", Torun
    Torun, 87-100, Poland
  • Hospital Clínic de Barcelona
    Barcelona, 08036, Spain
  • Hospital Santa Creu i Sant Pau
    Barcelona, 08041, Spain
  • Hospital de Galdakao
    Galdakao, 48960, Spain
  • Hospital de Bellvitge
    L'Hospitalet Llobregat (bcn), 08907, Spain
  • Hospital La Princesa
    Madrid, 28006, Spain
  • Fundación Jiménez Díaz
    Madrid, 28040, Spain
  • Hospital Clínico San Carlos
    Madrid, 28040, Spain
  • Hospital Puerta de Hierro
    Majadahonda (Madrid), 28220, Spain
  • Hospital Quirónsalud Madrid
    Pozuelo de Alarcón, 28223, Spain
  • CS Parc Taulí
    Sabadell, 08208, Spain
  • Hospital Virgen del Rocío
    Sevilla, 41013, Spain
  • Hospital Clínico de Valencia
    Valencia, 46010, Spain
  • Hospital Dr. Peset
    Valencia, 46017, Spain
  • Southmead Hospital
    Bristol, BS10 5NB, United Kingdom
  • Papworth Hospital
    Cambridge, CB23 3RE, United Kingdom
  • Royal Devon and Exeter Hospital
    Exeter, EX2 5DW, United Kingdom
  • Royal Brompton Hospital
    London, SW3 6NP, United Kingdom
  • Wythenshawe Hospital
    Manchester, M23 9LT, United Kingdom
  • Churchill Hospital
    Oxford, OX3 7LE, United Kingdom
09

References and documents

Publications

  • Glaspole I, Bonella F, Bargagli E, Glassberg MK, Caro F, Stansen W, Quaresma M, Orsatti L, Bendstrup E. Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities. Respir Res. 2021 Apr 26;22(1):125. doi: 10.1186/s12931-021-01695-y. PubMed 33902584 ↗
  • Noth I, Cottin V, Chaudhuri N, Corte TJ, Johannson KA, Wijsenbeek M, Jouneau S, Michael A, Quaresma M, Rohr KB, Russell AM, Stowasser S, Maher TM; INMARK trial investigators. Home spirometry in patients with idiopathic pulmonary fibrosis: data from the INMARK trial. Eur Respir J. 2021 Jul 8;58(1):2001518. doi: 10.1183/13993003.01518-2020. Print 2021 Jul. PubMed 33419890 ↗
  • Maher TM, Stowasser S, Nishioka Y, White ES, Cottin V, Noth I, Selman M, Rohr KB, Michael A, Ittrich C, Diefenbach C, Jenkins RG; INMARK trial investigators. Biomarkers of extracellular matrix turnover in patients with idiopathic pulmonary fibrosis given nintedanib (INMARK study): a randomised, placebo-controlled study. Lancet Respir Med. 2019 Sep;7(9):771-779. doi: 10.1016/S2213-2600(19)30255-3. Epub 2019 Jul 17. PubMed 31326319 ↗
  • Maher TM, Stowasser S, Nishioka Y, White ES, Cottin V, Noth I, Selman M, Blahova Z, Wachtlin D, Diefenbach C, Jenkins RG. Investigating the effects of nintedanib on biomarkers of extracellular matrix turnover in patients with IPF: design of the randomised placebo-controlled INMARK(R)trial. BMJ Open Respir Res. 2018 Aug 20;5(1):e000325. doi: 10.1136/bmjresp-2018-000325. eCollection 2018. PubMed 30167310 ↗

Study documents

  • Study protocol · Jul 9, 2018
  • Statistical analysis plan · Jul 19, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02788474
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jun 2, 2016
Start date
Jun 9, 2016
Primary completion
Aug 4, 2017
Completion
Jun 8, 2018
Results posted
Aug 6, 2019
Last update
Dec 21, 2023

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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Other studies from this sponsor

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