Bacterial Gene Profiling to Predict Antibiotic Resistance During Cystic Fibrosis Pulmonary Exacerbations...
Cystic FibrosisPulmonary exacerbations (PEx) are key events that lead to a decline in health status among CF patients, with many never recovering to baseline health. With the advancement of new CFTR modulators and other therapies increasing the lifespan of those living with CF, it will become increasingly important to have better strategies to manage PEx in order to have better outcomes following treatment. PEx treatment decisions will need to take into consideration the increasing frequency of antimicrobial resistance bacteria and the need to treat multiple types of bacteria at once. The purpose of this study is to analyze sputum samples from CF subjects at the time of PEx in order to identify markers of antimicrobial resistant bacteria and see how those relate to treatment responses. CF patients will be recruited from patients followed by the Adult CF Program at National Jewish Health. Within 48 hours of admission to the hospital for treatment of a PEx, subjects will be enrolled and sputum will be collected. The sputum will be processed and analyzed for the presence of antimicrobial resistant bacteria. These results will be compared to clinical data, such as spirometry and frequency of hospitalizations.
68Ga-FAPI PET/CT to Detect Ongoing Fibroblast Activity in Post-acute COVID-19
Post-Acute COVID-19Post-Acute COVID-19 Infection2 moreThe goal of this observational study is to investigate the role fibroblasts play in the persistent respiratory complaints after a COVID-19 infection. Fibroblasts are involved in tissue remodeling and repair by creating scar-tissue (fibrosis) after tissue damage has occurred. The hypothesis is that this process of fibrosis is ongoing in patients with persistent complaints. To evaluate the roll of fibroblasts a new type of scan is used that is capable of imaging active fibroblasts, a 68Ga-FAPI PET/CT scan.
Heart Rate Variability and Nocturnal Blood Oxygen Saturation in Patients With Idiopathic Pulmonary...
Idiopathic Pulmonary FibrosisThe goal of this observational study is to compare the overnight heart rate variability (HRV) and nocturnal oxygen saturation (SpO2) in patients with idiopathic pulmonary fibrosis (IPF). The main questions it aims to answer are: (1). if there are correlations between pulmonary function test and HRV and overnight SpO2; (2). if HRV and SpO2 can predict the occurrence of acute exacerbation in patients with IPF. Participants will be asked to examine pulmonary function test (including lung volumes and six-minute walk test) and wear pulse oxygenation recorder and "LARGAN" ECG Holter" ("LARGAN HEALTH TECHNOLOGY" Sleep Apnea And Sleep Quality Examination System) during sleep.
Fibrosing ILD Biomarkers That Rule Acceleration
Pulmonary FibrosisSarcoidosisFIBRALUNG is a prospective cohort study with biobank of samples from patients with pulmonary fibrosis, aiming to explore the molecular determinants of different clinical outcomes, acute exacerbations and mortality. We expect to gain deeper insight into fibroproliferative common pathways, particularly between idiopathic pulmonary fibrosis and fibrotic hypersensitivity pneumonitis, paving the way for new biomarkers that reflect the progressive phenotype, that eventually will support new targeted therapies. Other idiopathic interstitial pneumonias, connective tissue disease-related interstitial lung diseases and sarcoidosis patients will be also recruited and their biological samples stored for further analyses.
Pulmonary Fibrosis Foundation Community Registry
Pulmonary FibrosisInterstitial Lung Disease2 morePulmonary fibrosis (PF) results from a diverse group of health conditions and affects the lives of patients (including those who are post lung transplant), caregivers and family members. The Pulmonary Fibrosis Foundation Community Registry will offer an online portal where participants can self-enroll and directly contribute information about their experience with PF to be compiled into a longitudinal data set for use by researchers.
C-mo System 1.0's Validation - Cough Monitoring
CoughAsthma3 moreCough is one of the most reported symptoms, especially associated with respiratory diseases. Additionally, cough contains extremely insightful information regarding the patient's health. It is a symptom full of physiopathological information, which can be extremely helpful in clinical practice. However, cough is not currently used as a clinical biomarker given that: Cough is an extremely subjective symptom for patients (patients can't accurately describe and understand their cough's traits). There is currently no tool available to evaluate cough objectively and thoroughly. As such, there is an unmet medical need: solutions for objective cough monitoring and management. C-mo System is a novel non-invasive medical device, which performs an objective monitoring of the patient's cough for long periods of time. The C-mo System consists of a wearable device (C-mo wearable) and a desktop software (C-mo Medical Platform). C-mo System characterises cough automatically through data collection and processing techniques (automatic classification), and its base outputs include: Cough frequency (how many times the patient coughs) Cough intensity (how strong cough's expiratory effort is) Cough type (if the cough is dry, wet, or laryngeal) Identification of patterns (associations between cough characteristics and specific events, namely the time of day, body position, physical exercising, and meals). It is extremely important to validate C-mo System in a wide and diverse population, given the use of signal processing algorithms and artificial intelligence. C-mo System's base outputs will allow healthcare professionals to improve significantly the medical care associated with this symptom, namely: Speed-up and improve the accuracy of the diagnosis of several medical conditions, especially respiratory diseases. C-mo System's ability to objectively monitor cough will allow healthcare professionals to make associations between specific cough patterns and specific medical conditions. Optimize treatment prescription and monitor their effectiveness. C-mo System's objective assessment of cough will allow healthcare professionals to understand if a given therapy is working as intended. Objectively monitor chronic disease progression. C-mo System's monitoring of cough will allow healthcare professionals to objectively assess the progression of the patient's cough.
Skeletal Muscle Function in Interstitial Lung Disease
Interstitial Lung DiseaseIdiopathic Pulmonary Fibrosis3 moreDyspnea (i.e. breathlessness) and exercise intolerance are common symptoms for patients with interstitial lung disease (ILD), yet it is not known why. It has been suggested that muscle dysfunction may contribute to dyspnea and exercise intolerance in ILD. Our study aims to: i) examine differences in the structure and function of the leg muscles in ILD patients, ii) determine if leg muscle fatigue contributes to dyspnea and exercise limitation in patients with ILD, and iii) determine the effects of breathing extra oxygen on leg muscle fatigue, as well as ability to exercise in ILD patients.
Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With...
Idiopathic Pulmonary FibrosisThe purpose of this study was to investigate the safety, tolerability and efficacy of VAY736 as potential therapy for the treatment of idiopathic pulmonary fibrosis (IPF).
A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis...
Idiopathic Pulmonary FibrosisFibrosis6 moreThis is a Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, pharmacokinetics (PK), quality of life and exploratory pharmacodynamics (PD) of two treatment doses of CC-90001, 200 mg and 400 mg, compared with placebo, when delivered once daily per os (PO) in subjects with idiopathic pulmonary fibrosis (IPF). This study is designed to assess response to treatment by using measures of lung function, disease progression, fibrosis on radiography, and patient-reported outcomes. It will also assess dose response.
Single Doses of GSK3008348 in Idiopathic Pulmonary Fibrosis (IPF) Participants Using Positron Emission...
Idiopathic Pulmonary FibrosisGSK3008348 is being developed as a treatment for IPF. A first-time-in-human study showed that single nebulized doses of 1-3000 micrograms (mcg) GSK3008348 in healthy volunteers were well tolerated, with pharmacokinetic (PK) exposures within the defined limits set in the protocol. The proposed study is a 2-cohort study of single doses, intended to evaluate the safety, tolerability and PK of the drug in participants with IPF not currently treated with pirfenidone or nintedanib, and to obtain preliminary information on target engagement. Cohort 1 will be a 2-period, randomized, double-blind, placebo-controlled group with at least 7 days washout between doses, and follow-up period of up to 7-14 days. Cohort 2 is optional. It will be designed to further explore safety and to provide additional information on the target engagement profile of GSK3008348. The total duration of the study will be up to 62 days.