Progressive Fibrosing Interstitial Lung DiseasePhase 3NCT05067517

Efficacy & Safety of Nintedanib in Patients With Progressive Fibrosing Coal Mine Dust-Induced Interstitial Lung Disease

A Phase 3 study testing Nintedanib in people with Progressive Fibrosing Interstitial Lung Disease, run by West Virginia University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Progressive Fibrosing Interstitial Lung Disease
What is being tested?: Nintedanib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: No sites listed yet
Study dates: Nov 2021to Jul 2024
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written Informed Consent consistent with International Conference on Harmonization Tripartite Guideline for Good Clinical Practice (ICH-GCP) and local laws signed prior to entry into the study (and prior to any study procedure including shipment of pre- existing High Resolution Computer Tomography (HRCT), spirometry or other medical records to reviewer).
Male or female patients aged >= 18 years at Visit 1.
Progressive Fibrosing Coal Mine Dust-Induced Interstitial Lung Disease (PF-CMD- ILD) based on a history of at least 5 years' work in surface or underground coal mining and presence of Progressive Massive Fibrosis (PMF) within 24 months of screening visit; or small opacity pneumoconiosis plus decline in percent predicted FVC of > 5% relative to high quality spirometry performed 12-24 months prior to screening visit, as assessed by the investigator.
Pneumoconiotic changes documented on screening chest HRCT. Must include large opacities consistent with PMF or small opacities consistent with pneumoconiosis (as described previously).
Carbon Monoxide Diffusion Capacity (DLCO) corrected for Hemoglobin (Hb) ≥ 30% and <80% predicted of normal at screening visit.
FVC >= 45% predicted at screening visit.

Who cannot join

For those with PMF and past spirometry data, stable lung function based on a fall in percent predicted FVC of < 5% relative to most recent high quality spirometry obtained at least 12 months but no more than 5 years prior to screening
Continued employment in a job such as active mining associated with ongoing coal mine dust or respirable crystalline silica dust exposure.
Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit of Normal (ULN) at screening visit.
Bilirubin > 1.5 x ULN at screening visit.
Creatinine clearance <30 mL/min calculated by Cockcroft-Gault formula at screening visit.
Patients with underlying chronic liver disease (Child Pugh B or C hepatic impairment). Child Pugh A patients may be enrolled and started at a dose of 100mg BID

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Previous treatment with nintedanib or pirfenidone.
Other investigational therapy received within 1 month or 6 half-lives (whichever was greater) prior to screening visit.
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 screening visit. The eligible patients with comorbid rheumatoid arthritis (RA) or other connective tissue diseases (CTD) is expected to be on disease- modifying anti-rheumatic drug (DMARD) e.g. methotrexate or TNF inhibitors. All approved RA/CTD medications are allowed at stable doses at baseline and during the study.
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
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, including 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 hemorrhagic central nervous system (CNS) event within 12 months of screening visit.
Any of the following within 3 months of screening visit:
Hemoptysis or hematuria
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 screening visit.
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. A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post- menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy
In the opinion of the Investigator, active alcohol or drug abuse that will preclude the patient from adhering to the protocol.
Patients not able to understand or follow trial procedures including completion of self- administered questionnaires without help.
A study subject may not participate in another research study while participating in this research study.

About this study

Official title: A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nintedanib Over 52 Weeks in Patients With Progressive Fibrosing Coal Mine Dust-Induced Interstitial Lung Disease (PF-CMD-ILD)

Assess efficacy (as measured by annual rate of decline in FVC) and safety. The hypothesis is that nintedanib will be safe and effective therapy for patients with progressive fibrosing CMD-ILD over a period of 52 weeks. Test Article - Nintedanib 150 mg administered PO twice daily or matching placebo. A total of 160 patients meeting inclusion/exclusion criteria will be randomized in a 1:1 ratio to either oral nintedanib 150 mg (n=80) or matching placebo (n=80) twice daily. A randomization scheme will be used that balances the group for potential confounders (proportion with PMF or small opacity-only PF-CMD_ILD and proportion of ever- or never-smokers). The dose of the study drug may be reduced to 100 mg twice daily or interrupted temporarily to manage adverse events (AEs).

Read the detailed description

This is a single center, prospective, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of nintedanib in patients with progressive fibrosing CMD-ILD over 52 weeks. The study will be led by and based at the West Virginia University School of Medicine and the West Virginia Clinical and Translational Science Institute (WVCTSI) and will recruit participants regionally, including from its associated Practice-Based Network of 24 healthcare systems and 94 individual clinics. Recruitment will also be sought in collaboration with Dr. Cohen from federally-funded Black Lung Clinics across the region and from partner CTSAs at the University of Kentucky and University of Virginia. It is planned to randomize a total of 160 patients in a 1:1 ratio to either oral nintedanib 150 mg (n=80) or matching placebo (n=80) twice daily. The dose of the study drug may be reduced to 100 mg twice daily with subsequent increase back to full dose or interrupted temporarily to manage adverse events (AEs). For each patient, the study will consist of two parts: part A and part B. The duration of part A, a randomized prospective controlled double-blinded trial, will be 52 weeks.

Following completion of the week 52 visit, patients will continue to have study visits every 16 weeks (Part B) until the last patient completes 52 weeks. In part B, patients will remain on blinded therapy with continued data collection.

In part A, patients will attend screening study visits (-4 to -2 weeks) and then at 0, 4, 8, 12, 24, 36, and 52 weeks. In addition, telehealth visits will be conducted at visits 2, 18, 30, 44, and 51 weeks via phone by the study coordinator. Part B visits will take place at 16 week intervals until study completion (last patient completes 52 weeks). To reduce the amount of missing data, patients who discontinue the trial drug (for any reason) prior to completing the 52-week treatment period will be asked to attend all visits and undergo all examinations as originally planned. In addition, for patients who prematurely discontinue trial medication and are unable to complete the scheduled visits, every attempt will be made to collect information on vital status at week 52 and at the time of data cut-off for the primary data analysis and at the conclusion of part B. It is estimated that patient recruitment will take up to 24 mos.

Conditions: Progressive Fibrosing Interstitial Lung Disease
Being tested: Nintedanib, Placebo
Keywords: Coal Mine Dust

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NintedanibDrug
Also called OFEV
Randomized in a 1:1 ratio to either oral nintedanib 150 mg (n=80) or matching placebo (n=80) twice daily.
PlaceboDrug
Randomized in a 1:1 ratio to either oral nintedanib 150 mg (n=80) or matching placebo (n=80) twice daily.

Study groups in NCT05067517
Study group	Role	What they receive
Nintedanib	Active comparator	Nintedanib 150 mg administered PO twice daily Receives: Drug: Nintedanib
Placebo	Placebo comparator	Placebo administered PO twice daily Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Annual rate of decline in FVC in mL (absolute)
Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Measured: Baseline after first drug intake (planned post visits with Spirometry test)
Annual rate of decline in FVC in mL (absolute)
Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Measured: 12 weeks after first drug intake (planned post visits with Spirometry test)
Annual rate of decline in FVC in mL (absolute)
Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Measured: 24 weeks after first drug intake (planned post visits with Spirometry test)
Annual rate of decline in FVC in mL (absolute)
Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Measured: 36 weeks after first drug intake (planned post visits with Spirometry test)
Annual rate of decline in FVC in mL (absolute)
Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Measured: 52 weeks after first drug intake (planned post visits with Spirometry test)

Secondary outcomes (33)

FVC change from baseline
Planned with post visit Spirometry test.
Measured: 52 weeks after first drug intake (planned post visits with Spirometry test)
FVC Change from baseline, relative decline % predicted
Planned with post visit Spirometry test.
Measured: 52 weeks after first drug intake (planned post visits with Spirometry test)
Absolute FEV1 annual rate of decline in mL
Planned with post visit Spirometry test
Measured: 52 weeks after first drug intake (planned post visits with Spirometry test)
Relative decline in FEV1 % predicted
Planned with post visit Spirometry test
Measured: 52 weeks after first drug intake (planned post visits with Spirometry test)
Change from baseline in FEV1 change % predicted
Planned with post visit Spirometry test
Measured: 52 weeks after first drug intake (planned post visits with Spirometry test)
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms cough domain score
Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms cough domain score (cough score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in cough score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline cough score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline cough score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analyzed participants in the model.
Measured: Baseline
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms cough domain score
Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms cough domain score (cough score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in cough score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline cough score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline cough score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analyzed participants in the model.
Measured: Week 2
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms cough domain score
Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms cough domain score (cough score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in cough score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline cough score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline cough score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analyzed participants in the model.
Measured: Week 18
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms cough domain score
Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms cough domain score (cough score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in cough score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline cough score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline cough score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analyzed participants in the model.
Measured: Week 30
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms cough domain score
Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms cough domain score (cough score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in cough score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline cough score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline cough score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analyzed participants in the model.
Measured: Week 44
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms cough domain score
Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms cough domain score (cough score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in cough score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline cough score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline cough score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analyzed participants in the model.
Measured: Week 51
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms dyspnea domain score
Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms dyspnea domain score (dyspnea score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in dyspnea score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline dyspnea score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline dyspnea score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analyzed participants in the model.
Measured: Baseline
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms dyspnea domain score
Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms dyspnea domain score (dyspnea score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in dyspnea score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline dyspnea score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline dyspnea score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analyzed participants in the model.
Measured: Week 2
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms dyspnea domain score
Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms dyspnea domain score (dyspnea score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in dyspnea score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline dyspnea score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline dyspnea score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analyzed participants in the model.
Measured: Week 18
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms dyspnea domain score
Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms dyspnea domain score (dyspnea score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in dyspnea score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline dyspnea score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline dyspnea score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analyzed participants in the model.
Measured: Week 30
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms dyspnea domain score
Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms dyspnea domain score (dyspnea score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in dyspnea score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline dyspnea score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline dyspnea score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analyzed participants in the model.
Measured: Week 44
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms dyspnea domain score
Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms dyspnea domain score (dyspnea score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in dyspnea score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline dyspnea score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline dyspnea score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analyzed participants in the model.
Measured: Week 51
Absolute change from baseline in King's Brief Interstitial Lung Disease Questionnaire (K- BILD) total score
King's Brief Interstitial Lung Disease questionnaire (K-BILD) consists of 15 items and 3 domains: breathlessness and activities, psychological, and chest symptoms. Possible score ranges from 0-100, score of 100 representing the best health status. If missing items were >50% per domain, the domain score was set to missing. If any of the domain scores were missing, the total score was set to missing. Absolute change from baseline in K-BILD Total score at week 52 in the overall population. Mild frustration may be experienced by the participant when completing the questionnaire over the phone with the study coordinator. The participant is allowed to skip questions and not complete the questionnaire if desired.
Measured: Baseline
Absolute change from baseline in King's Brief Interstitial Lung Disease Questionnaire (K- BILD) total score
King's Brief Interstitial Lung Disease questionnaire (K-BILD) consists of 15 items and 3 domains: breathlessness and activities, psychological, and chest symptoms. Possible score ranges from 0-100, score of 100 representing the best health status. If missing items were >50% per domain, the domain score was set to missing. If any of the domain scores were missing, the total score was set to missing. Absolute change from baseline in K-BILD Total score at week 52 in the overall population. Mild frustration may be experienced by the participant when completing the questionnaire over the phone with the study coordinator. The participant is allowed to skip questions and not complete the questionnaire if desired.
Measured: Week 2
Absolute change from baseline in King's Brief Interstitial Lung Disease Questionnaire (K- BILD) total score
King's Brief Interstitial Lung Disease questionnaire (K-BILD) consists of 15 items and 3 domains: breathlessness and activities, psychological, and chest symptoms. Possible score ranges from 0-100, score of 100 representing the best health status. If missing items were >50% per domain, the domain score was set to missing. If any of the domain scores were missing, the total score was set to missing. Absolute change from baseline in K-BILD Total score at week 52 in the overall population. Mild frustration may be experienced by the participant when completing the questionnaire over the phone with the study coordinator. The participant is allowed to skip questions and not complete the questionnaire if desired.
Measured: Week 18
Absolute change from baseline in King's Brief Interstitial Lung Disease Questionnaire (K- BILD) total score
King's Brief Interstitial Lung Disease questionnaire (K-BILD) consists of 15 items and 3 domains: breathlessness and activities, psychological, and chest symptoms. Possible score ranges from 0-100, score of 100 representing the best health status. If missing items were >50% per domain, the domain score was set to missing. If any of the domain scores were missing, the total score was set to missing. Absolute change from baseline in K-BILD Total score at week 52 in the overall population. Mild frustration may be experienced by the participant when completing the questionnaire over the phone with the study coordinator. The participant is allowed to skip questions and not complete the questionnaire if desired.
Measured: Week 30
Absolute change from baseline in King's Brief Interstitial Lung Disease Questionnaire (K- BILD) total score
King's Brief Interstitial Lung Disease questionnaire (K-BILD) consists of 15 items and 3 domains: breathlessness and activities, psychological, and chest symptoms. Possible score ranges from 0-100, score of 100 representing the best health status. If missing items were >50% per domain, the domain score was set to missing. If any of the domain scores were missing, the total score was set to missing. Absolute change from baseline in K-BILD Total score at week 52 in the overall population. Mild frustration may be experienced by the participant when completing the questionnaire over the phone with the study coordinator. The participant is allowed to skip questions and not complete the questionnaire if desired.
Measured: Week 44
Absolute change from baseline in King's Brief Interstitial Lung Disease Questionnaire (K- BILD) total score
King's Brief Interstitial Lung Disease questionnaire (K-BILD) consists of 15 items and 3 domains: breathlessness and activities, psychological, and chest symptoms. Possible score ranges from 0-100, score of 100 representing the best health status. If missing items were >50% per domain, the domain score was set to missing. If any of the domain scores were missing, the total score was set to missing. Absolute change from baseline in K-BILD Total score at week 52 in the overall population. Mild frustration may be experienced by the participant when completing the questionnaire over the phone with the study coordinator. The participant is allowed to skip questions and not complete the questionnaire if desired.
Measured: Week 51
Progression of chest HRCT findings graded according to the International Classification of High-Resolution Computed Tomography for Occupational and Environmental Respiratory Diseases (ICOERD) system
Change in chest HRCT findings graded according to the International Classification of High-Resolution Computed Tomography for Occupational and Environmental Respiratory Diseases (ICOERD) system
Measured: Week 52
6 Minute Walk Test
Change in distance walked from baseline.
Measured: Week 52
Time to all-cause mortality
Time to death over 52 weeks defined as the time from date of first drug intake until date of death from any cause for participants with known date of death (from any cause).
Measured: 52 weeks after first drug intake
Time to respiratory mortality over 52 weeks
Time to death due to respiratory cause over 52 weeks is defined as the time from date of first drug intake until date of death attributed to respiratory causes.
Measured: 52 weeks after first drug intake
Time to progression (defined a ≥10 %absolute decline in Forced Vital Capacity (FVC) % predicted) or death
Time to progression or death over 52 weeks is defined as the time from date of first drug intake to date of progression, or date of death (from any cause) if a participant died earlier. Date of progression is defined as the date when ≥ 10% of absolute decline in FVC percent predicted compared to baseline occurred for the first time as measured by Spirometry test
Measured: Over 52 weeks
Proportion of patients with a relative decline from baseline in FEV1 and/or FVC % predicted of more than 10 percent at week 52
Measured with Spirometry test over the course of study
Measured: Up to 52 weeks after first drug intake
Proportion of patients with a relative decline from baseline in FEV1 and/or FVC % predicted of more than 5 percent at week 52
Measured with Spirometry test over the course of study
Measured: Up to 52 weeks after first drug intake
Proportion of patients with an absolute decline from baseline in FVC % predicted of >10% at week 52
Measured with Spirometry test over the course of study
Measured: Week 52
Proportion of patients with an absolute decline from baseline in FVC % predicted of >5% at week 52
Measured with Spirometry test over the course of study
Measured: Week 52
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Total score at week 52
The cough symptom score will be calculated using the living with pulmonary fibrosis questionnaire (L-PF). L-PF cough symptom score ranges from 0 to 92; the higher the score, the greater the impairment.
Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2021Jul 2024

First posted5 Oct 2021
Study startNov 2021 (estimated)
Primary completionJul 2024 (estimated)
Study completionJul 2024 (estimated)

Why it stopped: Unable to enroll any subjects. IRB closed study in agreement with PI.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Progressive Fibrosing Interstitial Lung DiseaseStudies of the same condition, open and under way.
More trials run by West Virginia UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05067517
Sponsor's protocol ID: 2012199067
Status last verified: Feb 2025
First submitted: 22 Jul 2021
Last updated: 24 Feb 2025
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Progressive Fibrosing Interstitial Lung Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nintedanib Over 52 Weeks in Patients With Progressive Fibrosing Coal Mine Dust-Induced Interstitial Lung Disease (PF-CMD-ILD)
ClinicalTrials.gov ID: NCT05067517
Acronym / sponsor ID: 2012199067
Conditions: Progressive Fibrosing Interstitial Lung Disease
Keywords: Coal Mine Dust
Phase: Phase 3
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Unable to enroll any subjects. IRB closed study in agreement with PI.
Enrolment: 0 participants (actual)
Lead sponsor: West Virginia UniversityUniversity, hospital or other
Study start: Nov 2021 (estimated)
Primary completion: Jul 2024 (estimated)
Study completion: Jul 2024 (estimated)
First posted: 5 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Nintedanib	Active comparator	Drug: NintedanibNintedanib 150 mg administered PO twice daily
Placebo	Placebo comparator	Drug: PlaceboPlacebo administered PO twice daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Written Informed Consent consistent with International Conference on Harmonization Tripartite Guideline for Good Clinical Practice (ICH-GCP) and local laws signed prior to entry into the study (and prior to any study procedure including shipment of pre- existing High Resolution Computer Tomography (HRCT), spirometry or other medical records to reviewer).
Male or female patients aged >= 18 years at Visit 1.
Progressive Fibrosing Coal Mine Dust-Induced Interstitial Lung Disease (PF-CMD- ILD) based on a history of at least 5 years' work in surface or underground coal mining and presence of Progressive Massive Fibrosis (PMF) within 24 months of screening visit; or small opacity pneumoconiosis plus decline in percent predicted FVC of > 5% relative to high quality spirometry performed 12-24 months prior to screening visit, as assessed by the investigator.
Pneumoconiotic changes documented on screening chest HRCT. Must include large opacities consistent with PMF or small opacities consistent with pneumoconiosis (as described previously).
Carbon Monoxide Diffusion Capacity (DLCO) corrected for Hemoglobin (Hb) ≥ 30% and <80% predicted of normal at screening visit.

Key exclusion criteria (42 listed)

For those with PMF and past spirometry data, stable lung function based on a fall in percent predicted FVC of < 5% relative to most recent high quality spirometry obtained at least 12 months but no more than 5 years prior to screening
Continued employment in a job such as active mining associated with ongoing coal mine dust or respirable crystalline silica dust exposure.
Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit of Normal (ULN) at screening visit.
Bilirubin > 1.5 x ULN at screening visit.
Creatinine clearance <30 mL/min calculated by Cockcroft-Gault formula at screening visit.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NintedanibAlso: OFEVRandomized in a 1:1 ratio to either oral nintedanib 150 mg (n=80) or matching placebo (n=80) twice daily.	Drug	Nintedanib
PlaceboRandomized in a 1:1 ratio to either oral nintedanib 150 mg (n=80) or matching placebo (n=80) twice daily.	Drug	Placebo

Primary outcome

Annual rate of decline in FVC in mL (absolute)
Time frame: Baseline after first drug intake (planned post visits with Spirometry test)
Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Annual rate of decline in FVC in mL (absolute)
Time frame: 12 weeks after first drug intake (planned post visits with Spirometry test)
Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Annual rate of decline in FVC in mL (absolute)
Time frame: 24 weeks after first drug intake (planned post visits with Spirometry test)
Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Annual rate of decline in FVC in mL (absolute)
Time frame: 36 weeks after first drug intake (planned post visits with Spirometry test)
Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Annual rate of decline in FVC in mL (absolute)
Time frame: 52 weeks after first drug intake (planned post visits with Spirometry test)
Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible.

33 secondary outcomes

FVC change from baseline
Time frame: 52 weeks after first drug intake (planned post visits with Spirometry test)
FVC Change from baseline, relative decline % predicted
Time frame: 52 weeks after first drug intake (planned post visits with Spirometry test)
Absolute FEV1 annual rate of decline in mL
Time frame: 52 weeks after first drug intake (planned post visits with Spirometry test)
Relative decline in FEV1 % predicted
Time frame: 52 weeks after first drug intake (planned post visits with Spirometry test)
Change from baseline in FEV1 change % predicted
Time frame: 52 weeks after first drug intake (planned post visits with Spirometry test)
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms cough domain score
Time frame: Baseline
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms cough domain score
Time frame: Week 2
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms cough domain score
Time frame: Week 18
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms cough domain score
Time frame: Week 30
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms cough domain score
Time frame: Week 44
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms cough domain score
Time frame: Week 51
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms dyspnea domain score
Time frame: Baseline
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms dyspnea domain score
Time frame: Week 2
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms dyspnea domain score
Time frame: Week 18
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms dyspnea domain score
Time frame: Week 30
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms dyspnea domain score
Time frame: Week 44
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms dyspnea domain score
Time frame: Week 51
Absolute change from baseline in King's Brief Interstitial Lung Disease Questionnaire (K- BILD) total score
Time frame: Baseline
Absolute change from baseline in King's Brief Interstitial Lung Disease Questionnaire (K- BILD) total score
Time frame: Week 2
Absolute change from baseline in King's Brief Interstitial Lung Disease Questionnaire (K- BILD) total score
Time frame: Week 18
Absolute change from baseline in King's Brief Interstitial Lung Disease Questionnaire (K- BILD) total score
Time frame: Week 30
Absolute change from baseline in King's Brief Interstitial Lung Disease Questionnaire (K- BILD) total score
Time frame: Week 44
Absolute change from baseline in King's Brief Interstitial Lung Disease Questionnaire (K- BILD) total score
Time frame: Week 51
Progression of chest HRCT findings graded according to the International Classification of High-Resolution Computed Tomography for Occupational and Environmental Respiratory Diseases (ICOERD) system
Time frame: Week 52
6 Minute Walk Test
Time frame: Week 52
Time to all-cause mortality
Time frame: 52 weeks after first drug intake
Time to respiratory mortality over 52 weeks
Time frame: 52 weeks after first drug intake
Time to progression (defined a ≥10 %absolute decline in Forced Vital Capacity (FVC) % predicted) or death
Time frame: Over 52 weeks
Proportion of patients with a relative decline from baseline in FEV1 and/or FVC % predicted of more than 10 percent at week 52
Time frame: Up to 52 weeks after first drug intake
Proportion of patients with a relative decline from baseline in FEV1 and/or FVC % predicted of more than 5 percent at week 52
Time frame: Up to 52 weeks after first drug intake
Proportion of patients with an absolute decline from baseline in FVC % predicted of >10% at week 52
Time frame: Week 52
Proportion of patients with an absolute decline from baseline in FVC % predicted of >5% at week 52
Time frame: Week 52
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Total score at week 52
Time frame: Week 52

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.

Related trials for Progressive Fibrosing Interstitial Lung Disease

Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingPhase 2
Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Fibrosis
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A Study to Explore the Therapeutic Effect of HEC585 on Delaying Forced Vital Capacity (FVC) Decline and Tolerance in Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Patients
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A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rahul Sangani, MD principal investigator

West Virginia University

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nintedanib in people with Progressive Fibrosing Interstitial Lung Disease, run by West Virginia University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annual rate of decline in FVC in mL (absolute) (time frame: Baseline after first drug intake (planned post visits with Spirometry test)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05067517.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.