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Home-based Pulmonary Rehabilitation and Health Coaching in Fibrotic Interstitial Lung Disease
Rochester, MN
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.
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Psychological Well-Being and Physical Activity in Patients with Fibrotic Interstitial Lung Disease: A Prospective Observational Cohort Study
Rochester, MN
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.
Closed for Enrollment
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A Double Blind, Randomized, Placebo-controlled Trial Evaluating The Efficacy And Safety Of BI 1015550 Over 52 Weeks In Patients With 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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An Open-label Extension Trial Of The Long-term Safety And Efficacy Of BI 1015550 Taken Orally In Patients With Idiopathic Pulmonary Fibrosis (IPF) And Progressive Pulmonary Fibrosis (PPF) (FIBRONEER™-ON)
Rochester, MN
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550.
The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die.
Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study.
Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.
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Development And Validation Of A Prognostic Transcriptomic Signature For Chronic Hypersensitivity Pneumonitis: PREDICT-HP
Rochester, MN
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.
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Home-based Pulmonary Rehabilitation and Health Coaching in Patients with Fibrotic Interstitial Lung Disease: A Prospective Pragmatic Randomized Waitlist-Controlled Trial
Rochester, MN
Jacksonville, FL
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.
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Prospective Assessment of Patient Reported Outcomes and Use of Self-Efficacy in the Management of Chronic Fibrotic Interstitial Lung Disease
Rochester, MN
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.
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Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy And Safety Study Of Pamrevlumab In Subjects 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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