Teng Moua, M.D.

The purpose of this study is to evaluate the safety and effectiveness of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period.

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.

The purpose of this study is to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with fibrotic interstitial lung disease

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.

This is a prospective observational cohort study assessing baseline and short-term changes in patient-reported outcomes and physical activity in patients with fibrotic interstitial lung disease (f-ILD). Primary endpoints will be the prevalence and extent of anxiety and depression at baseline and over time (6 months) with focused exploration of predictive and modifying covariables, and extent of physical activity at baseline and over time (6 months) and its impact on self-reported quality of life. All patients with f-ILD seen at Mayo Clinic Rochester will be enrolled by telephonic or in-person screening, and formally consented before enrollment. Measurements of symptom burden, psychologic and emotional health, and respiratory-related quality of life will be assessed with 9 standardized questionnaires, provided to participants electronically through an crypted REDCap link. Physical activity will be measured using the Actigraph GT3X-BT, a standardized research activity monitor worn on the wrist continuously for seven days. Mean steps per day and mean minutes of sedentary and moderate activity time will be serve as quantifiable physical activity endpoints. Baseline demographics, f-ILD disease subtype and duration, pulmonary function testing, radiologic findings, medical comorbidities, and social determinants of health will be obtained and followed over the 6 month period, in conjunction with repeated questionnaire and physical activity measures at enrollment, 3, and 6 months. Statistical analysis will involve descriptors of symptom burden, emotional and psychological wellbeing, and health-related quality at baseline and over time, as stratified by a prior subgroups or covariables. Particular focus will be on the extent and severity of anxiety and depression and any correlating or modifying variables, as assessed by multivariable logistic regression or predictive modeling with elastic net. Similar descriptors of physical activity extent and change over time correlating with baseline or changes in clinical, demographic, or patient-reported outcomes will also be pursued. For modeling and covariable adjustment, 250-300 participants will be enrolled to allow adjustment for up 10 variables for each outcome.    

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 a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.

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.

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 treatment option for patients with PF-ILD.

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).

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 the optional Digital lung Auscultation Test substudy.

The primary objective of this study is to evaluate the safety and effectiveness of inhaled treprostinil in subjects with Idiopathic Pulmonary Fibrosis (IPF).

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 follow-up study is to assess the tolerability, long-term safety, and effectiveness of BI 1015550 in patients with IPF and PPF over a longer duration of treatment.  

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 establish and validate testing for disease progression in peripheral mononuclear cells (PMBC) from patients with Chronic Hypersensitivity Pneumonitis (CHP) at initial presentation, and to validate blood tests over time to predict disease progression.

The purpose of this study is to conduct a trial in patients with f-ILD to determine the effect size of a home-based PR intervention with telemonitoring and telephonic health coaching on patient-reported respiratory-related quality of life (King’s Brief Interstitial Lung Disease (K-BILD) questionnaire) compared to usual care. 

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 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).

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 fibrosis (IPF).

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.