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A Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard Medical Treatment
Rochester, MN
The primary purpose of this study is to see how GLPG1690 works together with current standard treatment on lung function and IPF disease in general. The study will also investigate how well GLPG1690 is tolerated (side effects).
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A Study to Assess the Feasibility of Folate Scan in Patients with Idiopathic Pulmonary Fibrosis
Rochester, MN
The purpose of this study is to assess the feasibility of Folate scan in patients with Idiopathic Pulmonary Fibrosis (IPF).
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A Study to Evaluate ORIN1001 in Idiopathic Pulmonary Fibrosis Subjects
Jacksonville, FL
The purpose of this study is to evaluate the safety profile and tolerability of ORIN1001 alone and/or in combination with the local standard of care (SOC) in adult subjects with idiopathic pulmonary fibrosis (IPF).
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Study of Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis
Jacksonville, FL; Rochester, MN
The primary objective of this study is to evaluate the safety and effectiveness of inhaled treprostinil in subjects with Idiopathic Pulmonary Fibrosis (IPF).
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Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial
Rochester, MN
The purpose of this study is to compare the effect of n-acetylcysteine (NAC) plus standard care with matched placebo plus standard of care in patients diagnosed with idiopathic pulmonary fibrosis (IPF) who have the TOLLIP rs3750920 TT genotype. The study will compare the time to a composite endpoint of relative decline in lung function [10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplantation, or all-cause mortality] The secondary objectives will be to examine the effect of NAC on the components of the primary composite endpoint, the rates of clinical events, change in physiology, change in ...
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A Study to Evaluate Safety and Effectiveness of PRM-151 to Treat Patients with Idiopathic Pulmonary Fibrosis
Rochester, MN
The purpose of this study is to confirm the long-term safety, effectiveness, and pharmacokinetics of PRM-151 in the treatment of eligible patients with IPF who have taken part in Study PRM-151-202 and received the open-label study drug or completed the Phase III Study WA42293 with PRM-151. Additionally, patients who have discontinued treatment from or have completed Study WA42293 and do not want to receive open-label PRM-151 in this study, will be invited to enroll in survival follow-up. Patients in Cohort C will not receive any treatment and will not undergo any safety or efficacy assessments during the study.
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A Study to Evaluate the Effectiveness and Safety of Pamrevlumab in Patients with Idiopathic Pulmonary Fibrosis
Jacksonville, FL
The purpose of this study is to evaluate the effectiveness and safety of 30 mg/kg intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in subjects with Idiopathic Pulmonary Fibrosis.
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A Phase 2 Study to See if Simtuzumab (GS-6624) is Safe and Works in Idiopathic Pulmonary Fibrosis (IPF)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if Simtuzumab (GS-6624) is safe and effective in treating Idiopathic Pulmonary Fibrosis.
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A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF
Jacksonville, FL
This phase 2 clinical study will be a randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, biological activity, and pharmacokinetics (PK) of ND-L02-s0201 for Injection in subjects with idiopathic pulmonary fibrosis (IPF).
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A Study of Pulmonary Rehabilitation in Patients with Idiopathic Pulmonary Fibrosis (IPF)
Rochester, MN
The main objectives of this study are to determine the difference in change from baseline in Six Minute Walk Distance (6MWD) when pulmonary rehabilitation (PR) is added to stable underlying nintedanib therapy in patients with idiopathic pulmonary fibrosis (IPF), to determine the difference in change in Quality of Life (QoL) when pulmonary rehabilitation (PR) is added to stable underlying nintedanib therapy in patients with idiopathic pulmonary fibrosis (IPF), and to determine if there is an enduring effect in 6MWD, QoL and lung function from pulmonary rehabilitation (PR) when pulmonary rehabilitation (PR) is added to stable underlying nintedanib therapy in patients with idiopathic pulmonary ...
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Advancing Prevention of Pulmonary Fibrosis
Rochester, MN
The purpose of this study is to learn more about pulmonary fibrosis and how it develops to determine if the disease can be detected early, before the lung is permanently scarred. This study will enroll participants who are not currently diagnosed with pulmonary fibrosis, but who have family members with pulmonary fibrosis. Because there is an increased risk within affected families, this cohort will allow us to learn how pulmonary fibrosis develops, and how the lungs change over time.
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Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis
Rochester, MN
The purpose of this study is to determine if study drug (BMS-986020) dose of 600 mg once daily or 600 mg twice daily for 26 weeks compared with placebo will reduce the decline in forced vital capacity (FVC) and will be well tolerated in subjects with idiopathic pulmonary fibrosis (IPF).
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A Study to Evaluate the Effectiveness and Safety of BG00011 in Participants with Idiopathic Pulmonary Fibrosis (SPIRIT)
Rochester, MN
The primary purpose of this study is to evaluate the effectiveness of BG00011 compared with placebo in participants with Idiopathic Pulmonary Fibrosis (IPF).
The secondary objectives of this study are: to evaluate the efficacy of BG00011 compared with placebo in participants with IPF as determined by change in percent predicted forced (expiratory) vital capacity (FVC); to assess progression-free survival in participants who receive BG00011 compared with placebo; to assess the occurrence of IPF exacerbation in participants who receive BG00011 compared with placebo; to assess the incidence of absolute decline in FVC ≥10% in participants who receive BG00011 compared with placebo; ...
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A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis
Rochester, MN
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab as monotherapy in the absence of background idiopathic pulmonary fibrosis (IPF) therapy or as combination therapy with pirfenidone background therapy in participants with idiopathic pulmonary fibrosis. Participants will be randomized to receive either lebrikizumab or placebo subcutaneously (SC) every 4 weeks.
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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability of single- and multiple-inhaled doses of TRK-250 in subjects with idiopathic pulmonary fibrosis (IPF).
TRK-250 is a nucleic acid medicine that inhibits the progression of pulmonary fibrosis by selectively suppressing the expression of transforming growth factor-beta 1 (TGF-β1) protein, at the gene expression level.
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CleanUP IPF for the Pulmonary Trials Cooperative
Rochester, MN
The purpose of this study is to compare the effect of standard care, versus standard of care plus antimicrobial therapy (co-trimoxazole or doxycycline), on clinical outcomes in patients diagnosed with idiopathic pulmonary fibrosis (IPF).
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Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis
Rochester, MN
Primary Objective: To evaluate, in comparison with placebo, the efficacy of 2 dose levels of SAR156597 administered subcutaneously during 52 weeks on lung function of patients with Idiopathic Pulmonary Fibrosis (IPF). Secondary Objectives: To evaluate the efficacy of 2 dose levels of SAR156597 compared to placebo on IPF disease progression. To evaluate the safety of 2 dose levels of SAR156597 compared to placebo in patients with IPF.
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A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults with Idiopathic Pulmonary Fibrosis
Rochester, MN
To study the safety and effectiveness of multiple-doses of tralokinumab on pulmonary function in adults with mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a chronic, progressive, irreversible, and usually fatal lung disease of unknown cause.
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A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
Rochester, MN
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of BI 1015550 compared to placebo in patients with Idiopathic Pulmonary Fibrosis (IPF) in addition to patient’s standard of care over the course of at least 52 weeks.
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A Study to Evaluate Lung Function in Subjects with Idiopathic Pulmonary Fibrosis (IPF) After Taking BI 1015550 for 12 Weeks
Rochester, MN
The purpose of this trial is to demonstrate proof of concept of clinical activity of BI 1015550 on the change of Forced Vital Capacity (FVC) between baseline and 12 weeks. New treatments are needed that further reduce the decline in FVC, positively affect symptoms and improve quality of life in patients with Idiopathic Pulmonary Fibrosis. This trial will investigate BI 1015550 to be used in this patient population either as stand-alone treatment or in addition to local standard of care (SoC), which may or may not include currently approved antifibrotic treatments (nintedanib or pirfenidone).
Mayo Clinic will not be participating in ...
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Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Rochester, MN
This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. The purpose of this study is to obtain additional safety data for pirfenidone 2403 mg/day in patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone.
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Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (TETON-OLE)
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with fibrotic interstitial lung disease
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A Registry for Patients by the Pulmonary Fibrosis Foundation
Rochester, MN
The purpose of the Pulmonary Fibrosis Foundation Patient Registry is to collect data on well-characterized patients with interstitial lung disease, especially idiopathic pulmonary fibrosis, for participation in retrospective and prospective research.
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Expanded Access Program (EAP): Allow Patients in the US with Idiopathic Pulmonary Fibrosis Access to Pirfenidone
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is an open label multi-center program to allow patients in the US with IPF access to treatment with pirfenidone.
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A Study to Evaluate PRM-151 in Patients with Idiopathic Pulmonary Fibrosis
Rochester, MN
The purpose of this study is to evaluate the effectiveness, safety, and pharmacokinetics of PRM-151 compared with placebo in patients with idiopathic pulmonary fibrosis (IPF). Specific objectives and corresponding endpoints for the study are outlined below.
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Zephyrus II: Effectiveness and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Rochester, MN
The purpose of this trial is to evaluate the effectiveness and safety of pamrevlumab in subjects with idiopathic pulmonary fibrosis (IPF). Subjects who were previously treated with approved IPF therapies (i.e., nintedanib or pirfenidone; unless neither treatment is available in the host country) may be eligible for screening, provided that the subject is not currently receiving treatment with an approved IPF therapy.
The overall objective of this trial is to evaluate the effectiveness and safety of pamrevlumab as compared to placebo in subjects with Idiopathic Pulmonary Fibrosis.
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A Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in Idiopathic Pulmonary Fibrosis (IPF)
Rochester, MN
The purpose of this study is to evaluate Inhaled RVT-1601 (formerly, PA101B), a new inhalation formulation of cromolyn sodium delivered via the eFlow® Closed System (CS) nebulizer, for the treatment of persistent cough in patients with idiopathic pulmonary fibrosis (IPF).
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Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis
Rochester, MN
ORV-PF-01 is a two way, placebo controlled, cross-over study, to evaluate the effect of two doses of orvepitant on cough in patients with Idiopathic Pulmonary Fibrosis (IPF).
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A Study of AF-219 in Subjects with Idiopathic Pulmonary Fibrosis with Persistent Cough
Rochester, MN
The purpose of this study is to assess the safety and effectiveness of AF-219 in patients with idiopathic pulmonary fibrosis with persistent cough.
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A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and efffectiveness of pulsed inhaled nitric oxide (iNO) in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy.
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A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard Medical Treatment
Scottsdale/Phoenix, AZ
The main purpose of this study is to see how GLPG1690 works together with current standard treatment on lung function and IPF disease in general. The study will also investigate how well GLPG1690 is tolerated; i.e., side effects while on study drug).
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Safety and Efficacy of Inhaled Treprostinil in Adult PH With ILD Including CPFE
Jacksonville, FL; Rochester, MN
This is a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded, placebo-controlled trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 314 patients at approximately 120 clinical trial centers. The treatment phase of the study will last approximately 16 weeks. Patients who complete all required assessments will also be eligible to enter an open-label, extension study (RIN-PH-202).
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A Study of Interstitial Lung Disease Relating to the Development of Fibrosis in the Lungs
Rochester, MN
The purpose of this study is to investigate the possibility that B lymphocytes (a kind of white blood cell ) may be contributing to the development of fibrosis in the lungs. This study will examine if B lymphocytes, isolated from blood, can induce the stimulation of fibroblasts. Fibroblasts are cells that are responsible for the formation of scarring in the lungs. Specific markers found in the surface of B lymphocytes will also be investigated to see if it can be identified why these cells may induce the development of fibrosis.
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Creation of a Longitudinal Biospecimen Repository From Patients With Interstitial Lung Diseases (ILD)
Rochester, MN
To develop a repository of blood, urine and tissue samples from patients with ILD to support future studies into the development of such biomarkers.
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A Study to Evaluate the Long-Term Safety of Nintedanib in Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Rochester, MN
The purpose of this study is to assess the long-term tolerability and safety of oral nintedanib treatment in patients with Progressive Fibrosing Interstitial Lung Disease who have completed (and did not prematurely discontinue trial medication in) the phase III parent trial, 1199.247 (INBUILD®).
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A Study of a Computer-Aided Analysis Tool for the Assessment of Pulmonary Fibrosis Treatment
Rochester, MN
The purpose of this study is to determine the effectiveness of a new computer-aided analysis tool in identifying treatment response in idiopathic pulmonary fibrosis. Computer-Aided Lung Informatics for Pathology Evaluation and Ratings (CALIPER) is an image analysis tool for characterizing and measuring mixed parenchymal diseases such as emphysema and interstitial lung diseases and has been shown to correlate with idiopathic pulmonary fibrosis mortality.
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Immune Cell Activation of Healthy Human Subjects
Rochester, MN
The purpose of this research study is to establish a pool of healthy donors who will regularly participate in our research studies of human immunity. The studies in our laboratory investigate the role of human blood cells in immunity to fungal disease and lung fibrosis. Most of our studies require blood that is freshly drawn. Thus, we propose to draw blood on an as needed, ongoing basis.
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A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis
Rochester, MN
The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).
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An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE
Jacksonville, FL; Rochester, MN
This is a multicenter, open-label trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 266 patients who completed all required assessments in the RIN-PH-201 study at approximately 100 clinical trial centers. The study will continue Your participation in this study is voluntary and will last until you discontinue from the study or the study ends. The study will continue until each subject reaches the Week 108 visit or until inhaled treprostinil become commercially available ...
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A Study of Inhaled Molgramostim in Cystic Fibrosis Subjects with Nontuberculous Mycobacterial (NTM) Infection
Rochester, MN
The purpose of this study is to evaluate the effectiveness of inhaled molgramostim, administered open-label, to adult cystic fibrosis subjects with chronic pulmonary nontuberculous mycobacterial (NTM) infection, with or without ongoing antimycobacterial guideline based combination therapy.
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A Study of the Effectiveness of Palliative Care Consultation for Patients with Advanced Lung Disease
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the usefulness of palliative care consultations by a specialty physician and a pulmonologist for patients who have advanced lung disease.
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A Study to Evaluate the Effectiveness and Safety of Remdesivir to Treat Coronavirus Disease 2019 in an Outpatient Setting
Rochester, MN
The purpose of this study is to evaluate the effietiveness of remdesivir (RDV) in reducing the rate of of all-cause medically attended visits (MAVs; medical visits attended in person by the participant and a health care professional) or death in non-hospitalized participants with early stage coronavirus disease 2019 (COVID-19) and to evaluate the safety of RDV administered in an outpatient setting.