Clinical Trials

Chronic fibrosing interstitial lung disease has significant negative impact on functional status and quality of life through often progressive and debilitating symptom burden. Prior studies have used various surveillance tools for assessing patient reported parameters and attested to the utility of these measurements for directing therapy and predicting outcome. We hypothesize that directed prospective measurements of such physiologic, emotional, and psychologic domains may correlate with baseline or presenting functional parameter and be incorporated into disease progression or staging models, perhaps capable of predicting outcomes as well as be targets of directed medical and non-medical therapies.  

The purpose of this study is to assess the effect-size of a novel combined home-based telemonitored pulmonary rehabilitation and telephonic health coaching program on two co-primary endpoints: 1) patient-reported quality of life as assessed by the Chronic Respiratory Questionnaire (CRQ) and 2) physical activity (PA) as measured by steps per day.

The purpose of the study is to describe the frequency with which pathogens will be detected using nasopharyngeal (NP) FilmArray respiratory pathogen panel (FARP) in Interstitial lung disease (ILD) patients with acute exacerbations.

Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as ...

The purpose of this research study is testing a new technique for measuring stiffness of the lung. This new technique is called Magnetic Resonance Elastography (MRE). In this study we will look at the stiffness measurements in humans.

The aim of the current study is to investigate the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) defined as patients who present with features of diffuse fibrosing lung disease of >10% extent on high-resolution computed tomography (HRCT) and whose lung function and respiratory symptoms or chest imaging have worsened despite treatment with unapproved medications used in clinical practice to treat ILD. There is currently no efficacious treatment available for PF-ILD. Based on its efficacy and safety in Idiopatic Pulmonary Fibrosis (IPF), it is anticipated that Nintedanib will be a new ...

The purpose of this study is to evaluate the effectiveness of two escalating doses of Duloxetine & Amitriptyline in reducing awake objective cough frequency (at 4 & 8 weeks).

The purpose of this study is to assess the safety, tolerability, and effectiveness of PRA023 in subjects with Systemic Sclerosis (SSc) with diffuse cutaneous disease and Interstitial Lung Disease (ILD). 

The purpose of this study is to to assess the safety and tolerability of pirfenidone 2403 mg/day for the treatment of RA-associated interstitial lung disease.

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).

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®).

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.

To develop a repository of blood, urine and tissue samples from patients with ILD to support future studies into the development of such biomarkers.

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.

The purpose of this study is to determine the efficacy of abatacept compared to placebo for treatment of subjects with GLILD in the context of CVID.

There is no standard of care therapy for patients with granulomatous-lymphocytic interstitial lung disease (GLILD) seen in common variable immunodeficiency (CVID). Abatacept has recently looked promising for the treatment of patients with complex CVID.

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).

The purpose of this study is to assess the safety of mesenchymal stem cells in patients with Interstitial Lung Disease (ILD) associated with Connective Tissue Disorders (CTD).

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).

The purpose of this study is to establish the immunometabolic profile of T cells isolated from patients with Rheumatoid Arthritis/Interstitial Lung Disease (RA/ILD), to identify distinguishing features in the metabolic status of T cells from RA patients with and without ILD, and to explore the use of immunometabolic determinants as a biomarker in RA patients with and without ILD.

PSSc-001 (LOTUSS) This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in patients with systemic sclerosis−related interstitial lung disease (SSc-ILD).

The purpose of this study is to evaluate the safety and tolerability of ixazomib in patients with scleroderma.

The purpose of this study is to determine the effectiveness of Fisetin compared to placebo for treatment of subjects with granulomatous-lymphocytic interstitial lung disease (GLILD) in the context of Common Variable Immunodeficiency (CVID), as assessed quantitatively on radiologic imaging.

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 ...

The primary objective of this proposal is to develop a Thoracic Specimen Registry at Mayo Clinic. The purpose of the registry will be to support ongoing research in the etiology, early diagnosis, clinical management, and prognosis of lung cancer and other cancers and diseases of the thorax by developing a complete repository of specimens from patients with thoracic disease including but not limited to suspected lung cancer, mediastinal and pleural tumors and from patients at a very high risk of developing other thoracic cancers or other thoracic diseases. 

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.