ClinicalTrials.gov identifier NCT05037929
This study will test an investigational drug in addition to standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.
Long Covid is a syndrome where symptoms related to your initial COVID-19 infection persist for more than 3 months. There are currently no proven treatments for Long Haul COVID syndrome. We are doing this study to look at the effects of a 10-week, gentle and progressive exercise rehabilitation program on Long COVID symptoms, including physical fitness, mental health, and immune system.
This study aims to determine the effects on metabolism and immunity of single acute bout of exercise and of completing a pulmonary rehabilitation program in COPD patients compared with age-matched controls. Exercise capacity, muscle mass, muscle strength and power, resting metabolic rate and fatty acid oxidation will also be measured.
Supported by the NIH REACT Center for rehabilitation research.
And the Tobacco Related Disease Research Program: https://www.trdrp.org/
This study will measure muscle oxidative capacity and physical activity in COPD patients, 5-years after a previous assessment, and generate models to predict patients who decline rapidly.
Supported by the ATS Foundation: https://foundation.thoracic.org/
This study aims to identify why some COPD patients lose muscle mass, while others maintain it. In particular it will investigate the effects of iron metabolism on mitochondrial function in skeletal muscle in COPD patients with and without unintentional weight loss.
Supported by the NIH, National Heart Lung and Blood Institute: https://www.nhlbi.nih.gov/
This study, in collaboration with engineers at Caltech, aims to develop a wearable sensor to identify risk factors for acute COPD exacerbations by sampling sweat from the skin. Patients with stable COPD and hospital in-patients with acute exacerbation of COPD are being enrolled
Supported by the Tobacco Related Disease Research Program: https://www.trdrp.org/
COPD patients are at greater risk for developing cardiovascular disease than smokers without COPD. This study aims identify whether impaired mitochondrial function, a key consumer of blood-borne lipids, contributes to the link between COPD and cardiovascular disease in the form of coronary artery atherosclerosis.
Supported by the Tobacco Related Disease Research Program: https://www.trdrp.org/
ClinicalTrials.gov identifier NCT00608764
External Link: http://www.copdgene.org/
This nationwide multicenter study aims to identify the genetics behind why some smokers get COPD and other do not. The study is still open to enrollment, but only of participants who have never smoked.
External Link: hhtp://www.trinityhealthofne.nightingale
This is a randomized prospective observational study intended to show the clinical utility of the Percepta Nasal Swab in patients with a new lung nodule and a history of smoking. The test is designed to help to stratify the risk of primary lung cancer in both screening-identified and incidental nodules. The swab is a simple, office-based collection that involved a single, brief brushing of the nasal epithelium and employs RNA whole transcriptome sequencing. The test is run by a CLIA lab and is intended to help patients with benign nodules avoid unnecessary invasive procedures while optimizing the time to diagnosis and treatment for those with primary lung cancer.
This study will develop a reference values in healthy participants for a new diagnostic test of exercise capacity (called mCPET).
ClinicalTrials.gov Identifier NCT05568927
The project will validate a clinical decision tree designed to improve timely diagnosis and treatment of patients with pulmonary embolism.
The proposed project will validate a clinical decision tree to distinguish among the various discrete outcomes cost-effectively through a hierarchical series of tests with the acronym SEARCH (for symptom screen, exercise function, arterial perfusion, resting heart function, confirmatory imaging and hemodynamics). Each step of the algorithm sorts a subset of patients into a diagnostic category unequivocally in a cost-effective manner. The categories are mutually exclusive and collectively exhaustive, so that each case falls into one, and only one, category.
The study will evaluate the efficacy, safety, and pharmacokinetics of Vixarelimab in patients with IPF and in patients with SSc-ILD.
ClinicalTrials.gov Identifier NCT05321420
A trial will evaluate the antifibrotic and anti-inflammatory drug (Deupirafenidone) in patients with IPF.
This study is a randomized, double-blind, being conducted at centers globally to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in 240 treatment naïve adult patients with IPF ≥ 40 years in age. Patients will be randomized in a ratio of 1:1:1:1 to receive treatment of LYT-100, pirfenidone, or placebo to be taken daily for up to 183 days (26 week treatment period) with the primary outcome of Rate of decline in Forced Vital Capacity (FVC; in mL) over 26 weeks. Secondary endpoints, including spirometry, inflammatory biomarkers, and patient-reported outcomes will also be evaluated.
After completion of the double-blind period of the study, patients may participate in a long-term extension to evaluate tolerability and long-term safety. Patients receiving LYT-100 in the double-blind period will continue the dose throughout the long-term extension. Patients receiving pirfenidone or placebo in the double-blind period will be re-randomized in a 1:1 ratio to receive LYT-100 550mg or 825mg TID dose throughout the long-term extension.
ClinicalTrials.Gov Identifier NCT05326412
This study is an exploratory, two-part, 12-week, Phase 2a study to evaluate the mechanism of action of Itepekimab (anti-IL-33-mAb) and its impact on airway inflammation in former and current smokers with COPD, aged 40 to 70 years.
This study consists of participants who have been on a standard-of-care (SoC) mono (long-acting β2-agonist [LABA]) or long-acting muscarinic antagonist [LAMA]), double (inhaled corticosteroid [ICS] + LABA, LABA + LAMA or ICS + LAMA), or triple (ICS + LABA + LAMA) controller therapy for COPD for at least 3 months prior to Screening (Visit 1) with stable dose and regimen for controller therapy for ≥1 month prior to Screening (Visit 1) and during the screening period. Participants will stay on their established controller medications for COPD throughout the duration of the study, with the exception of systemic corticosteroids and/or antibiotics used for acute exacerbation of COPD (AECOPD).
ClinicalTrials.gov Identifier NCT05595369
This is study evaluates the effect of 15 and 25 days of a drug (Paxlovid) compared to placebo in Long COVID patients with fatigue, brain fog, and autonomic function. Participants will be randomized to study interventions or placebo/controls based on the arms that are actively enrolling at the time of randomization. Study interventions may be added or removed according to adaptive design and/or emerging evidence. When there are multiple study interventions available, randomization will occur based on appropriateness of each intervention for the participant as determined by the study protocol.
ClinicalTrials.gov Identifier NCT05965752
This study studies the effect of cognitive retraining, goal management, and transcranial stimulation on brain function in Long COVID. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating potential interventions for PASC-mediated cognitive dysfunction. The hypothesis is that PASC-mediated declines in cognitive domains, such as executive function and attention, may be improved by interventions that selectively focus on enhancing those domains.
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