SPIROMICS Study of Early COPD Progression (SOURCE)
RecruitingThis is an observational study of 1000 participants to further define the nature of early chronic obstructive pulmonary disease (COPD) in younger, at-risk individuals. The study has three main goals: * To use CT scan imaging to identify which smokers will develop COPD. * To identify biomarkers predictive of smokers that will develop COPD. * To determine if sputum (phlegm) can be analyzed to predict which smokers will develop COPD. Procedures (methods): All participants will undergo study related questionnaires assessing medical history, smoke exposure and use, medication use, social and behavioral health, pulmonary symptoms, food frequency, and will provide nasal swab, blood, stool, and urine samples, pulmonary function testing to determine function, sputum induction to provide a sputum sample for airway biospecimen analysis, and CT imaging of the lungs.
Phase—
TypeObservational
Age30 Years – 55 Years
WhereBirmingham, Alabama, United States + 13 more
SponsorUniversity of Massachusetts, Worcester
▾Tap for detailsClick for full details — eligibility, all locations, contacts Leveraging Lung Cancer Screening to Optimize Screening Outcomes and COPD Management: COPD in LCS Registry
RecruitingThe COPD in LCS Registry will identify and characterize individuals who have functional or radiographic evidence of COPD and are receiving lung cancer screening. Clinical information will be obtained from study participants including symptom burden, lung cancer risk, spirometry, imaging characteristics, and peripheral blood eosinophils.
Phase—
TypeObservational
Age50 Years – 80 Years
WherePhiladelphia, Pennsylvania, United States
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
▾Tap for detailsClick for full details — eligibility, all locations, contacts myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home
RecruitingParallel-group, prospective, randomized, controlled phase III trial of home High flow Nasal Therapy (HFNT) via myAirvo 3 plus usual COPD medical care vs. usual COPD medical care, for at least 1 year and up to two years in 642 GOLD Grade D, Stages II-IV patients with moderate to very severe COPD at risk for moderate and severe exacerbations with a prior history of severe exacerbation requiring hospitalization within the past 6 weeks.
PhaseNA
TypeInterventional
Age30 Years
WhereBirmingham, Alabama, United States + 26 more
SponsorTemple University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE)
NCT06464926 · Nausea, Vomiting
RecruitingThe purpose of this research study is to determine if the Enterra® Therapy System can decrease nausea and vomiting symptoms and improve the quality of life for patients with chronic nausea, with or without vomiting, that have normal gastric emptying.
PhaseNA
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 21 more
SponsorEnterra Medical, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3
NCT06891755 ·
COPD, Emphysema
RecruitingThe objective of this study is to assess the safety and efficacy of Apreo BREATHE system when used to support native airways and release trapped air in the treatment of adult COPD patients with emphysema suffering from dyspnea due to hyperinflation despite optimal medical treatment. The Apreo BREATHE Airway Scaffold is a permanent implant designed to tent open native airways. The study will include up to 250 participants at up to 25 study centers located in the United States and Europe. Study subjects will be followed for 3 years. The main questions it aims to answer are: Is it safe? Does it work?
PhaseNA
TypeInterventional
Age40 Years – 84 Years
WhereBirmingham, Alabama, United States + 21 more
SponsorApreo Health, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)
RecruitingA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
PhasePhase 3
TypeInterventional
Age40 Years – 80 Years
WhereFoley, Alabama, United States + 300 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
RecruitingThis Phase IIb dose-ranging study will evaluate the efficacy and safety of 3 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive pulmonary disease.
PhasePhase 2
TypeInterventional
Age40 Years
WhereBirmingham, Alabama, United States + 362 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients
NCT06476132 · Lung Transplant
RecruitingThe purpose of this study is to see if taking the study drug, Belumosudil, for 52 weeks in addition to your usual care and medication, will prevent Chronic Lung Allograft Dysfunction (CLAD) in participants who have a lung biopsy that shows evidence of rejection or inflammation to the transplanted lung(s). For this study, biopsies that show evidence of Acute Rejection (AR), Lymphocytic Bronchiolitis (LB), Organizing Pneumonia (OP) or Acute Lung Injury (ALI) are referred to as "Qualifying Biopsies"; patients who had evidence of one or more of these conditions on a recent biopsy are eligible for enrollment in this study. Belumosudil is an investigational drug that blocks a molecule in the body that reduces inflammation and scarring and may play a role in the development and progression of CLAD. Belumosudil is a drug approved by the FDA to treat adults and children 12 years and older with chronic graft-versus-host disease (cGVHD), a condition with some similarities to CLAD. The primary objective it to determine the efficacy of treatment with Belumosudil + maintenance immunosuppression (IS) versus placebo + maintenance IS on preventing the subsequent development of probable or definite CLAD, lung retransplant, or death.
PhasePhase 2
TypeInterventional
Age12 Years
WhereLos Angeles, California, United States + 11 more
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
▾Tap for detailsClick for full details — eligibility, all locations, contacts STRIVE Post-Market Registry Study
NCT04302272 · Emphysema
RecruitingThis is a single-arm, prospective, multi-center, Registry study to evaluate the long-term safety and effectiveness of the Spiration Valve System (SVS) for the treatment of severe emphysema in a post-market setting.
Phase—
TypeObservational
Age18 Years
WherePhoenix, Arizona, United States + 13 more
SponsorOlympus Corporation of the Americas
▾Tap for detailsClick for full details — eligibility, all locations, contacts Supporting Evidence-based Responses to Emotional Needs in Emphysema
RecruitingThe goal of this clinical trial is to understand how a Coping Skills Training program can reduce depression and anxiety in people with chronic obstructive pulmonary disease (COPD), particularly those who face health disparities, including those with low income, different racial backgrounds, or those living in rural areas. The main questions it aims to answer are: * How does the Coping Skills Training program help reduce stress and anxiety in patients? * What causes variations in the effectiveness of the Coping Skills Training program? * What are the barriers and facilitators to the uptake of the Coping Skills Training program? Researchers will compare a 12-week Coping Skills Training program with a COPD Education program to see if the training leads to better health outcomes for participants. Participants will: * Take part in weekly 30-minute sessions for 12 weeks if assigned to the Coping Skills Training group. * Take part in weekly 10-minute sessions for 12 weeks if assigned to the COPD Education group. * Complete surveys before, during, and after the intervention. * Patients and caregivers, including those who chose not to enroll, as well as clinicians, will be invited to participate in interviews to share their perspectives.
PhaseNA
TypeInterventional
Age18 Years
WhereDetroit, Michigan, United States + 1 more
SponsorUniversity of Pennsylvania
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)
NCT06615050 · Graft-versus-host Disease (GVHD)
RecruitingThe purpose of this study is to assess Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation
PhasePhase 3
TypeInterventional
Age18 Years
WherePalo Alto, California, United States + 29 more
SponsorIncyte Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies
NCT04959175 · Hematologic Neoplasms
RecruitingBackground: Certain blood cancers can be treated with blood or bone marrow transplants. Sometimes the donor cells attack the recipient's body, called graft-versus-host disease (GVHD). The chemotherapy drug cyclophosphamide helps reduce the risk and severity of GVHD. Researchers want to learn if using a lower dose of cyclophosphamide may reduce the drug's side effects while maintaining its effectiveness. Such an approach is being used in an ongoing clinical study at the NIH with promising results, but this approach has not been tested for transplants using lower doses of chemotherapy/radiation prior to the transplant. Objective: To learn if using a lower dose of cyclophosphamide will help people have a successful transplant and have fewer problems and side effects. Eligibility: Adults ages 18-85 who have a blood cancer that did not respond well to standard treatments or is at high risk for relapse without transplant, and their donors. Design: Participants may be screened with the following: Medical history Physical exam Blood and urine tests Heart and lung tests Body imaging scans (they may get a contrast agent) Spinal tap Bone marrow biopsy Participants will be hospitalized for 4-6 weeks. They will have a central venous catheter placed in a chest or neck vein. It will be used to give medicines, transfusions, and the donor cells, and to take blood. In the week before transplant, they will get 2 chemotherapy drugs and radiation. After the transplant, they will get the study drug for 2 days. They will take other drugs for up to 2 months. Participants must stay near NIH for 3 months after discharge for weekly study visits. Then they will have visits every 3-12 months until 5 years after transplant. Participants and donors will give blood, bone marrow, saliva, cheek swab, urine, and stool samples for research.
PhasePhase 1 / Phase 2
TypeInterventional
Age12 Years – 85 Years
WhereBethesda, Maryland, United States + 1 more
SponsorNational Cancer Institute (NCI)
▾Tap for detailsClick for full details — eligibility, all locations, contacts Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype
RecruitingThis is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participation to the study consists of 3 periods: * Screening period of up to 4 weeks * Randomized intervention period of approximately 48 weeks * Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.
PhasePhase 3
TypeInterventional
Age40 Years – 80 Years
WhereChandler, Arizona, United States + 195 more
SponsorSanofi
▾Tap for detailsClick for full details — eligibility, all locations, contacts An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema
NCT06035120 · Emphysema, Pulmonary,
Emphysema or COPD RecruitingThis is a prospective, open-label, multi-center, single-arm study planned to enroll 200 subjects with heterogeneous emphysema and collateral ventilation (CV) in the target lobe. Subjects will undergo instillation of AeriSeal Foam in the target lobe and subsequent assessment of CV status using Chartis Pulmonary Assessment System. Subjects with CV- status will then undergo placement of Zephyr Valve in the target lobe for bronchoscopic lung volume reduction (BLVR) and be followed for 24 months.
PhaseNA
TypeInterventional
Age40 Years – 80 Years
WherePhoenix, Arizona, United States + 35 more
SponsorPulmonx Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD
RecruitingThis research is being done to test if a drug called omalizumab can help people with Chronic Obstructive Pulmonary Disease (COPD) and allergies. Each participant will be in the study for about 16 months, including 1-3 months of screening, 12 months of receiving the study drug at a clinic, and a follow-up call one month after your final clinic visit.
PhasePhase 2
TypeInterventional
Age40 Years
WhereBirmingham, Alabama, United States + 22 more
SponsorJohns Hopkins University
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection
NCT06016088 · Cystic Fibrosis Lung, Respiratory Infections, Recurrent, Chronic, Pseudomonas Aeruginosa
RecruitingA double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.
PhasePhase 1 / Phase 2
TypeInterventional
Age12 Years
WhereTucson, Arizona, United States + 21 more
SponsorRespirion Pharmaceuticals Pty Ltd
▾Tap for detailsClick for full details — eligibility, all locations, contacts Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening
RecruitingThe PROACT LUNG study is a prospective multi-center observational study to validate a blood-based test for the early detection of lung cancer by collecting blood samples from high-risk participants who will undergo a routine, standard-of-care screening Low-Dose Computed Tomography (LDCT).
Phase—
TypeObservational
Age50 Years
WhereLos Angeles, California, United States + 35 more
SponsorFreenome Holdings Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts The goal of this clinical trial is to learn whether semaglutide, an FDA-approved treatment for diabetes and obesity, is feasible and tolerable in patients with advanced lung disease. The main question\[s\] it aims to answer are: 1. Are patients with advanced lung disease able to tolerate semaglutide therapy? 2. Are we able to titrate semaglutide therapy to a target weight? Participants will be asked to perform pulmonary function, physical function and body composition testing, as well as a blood draw before and after 12-weeks of semaglutide therapy. While on therapy, subjects will be surveyed regarding any adverse events or side effects.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years – 80 Years
WherePhiladelphia, Pennsylvania, United States
SponsorUniversity of Pennsylvania
▾Tap for detailsClick for full details — eligibility, all locations, contacts Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD
RecruitingThe dNerva Lung Denervation System is one-time treatment intended to improve breathing in Chronic Obstructive Pulmonary Disease (COPD) patients on standard medical care. The purpose of this study is to confirm the safety and efficacy of the Nuvaira Lung Denervation System in the treatment of COPD.
PhaseNA
TypeInterventional
Age40 Years – 80 Years
WhereBirmingham, Alabama, United States + 9 more
SponsorNuvaira, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
NCT06585774 · Chronic Graft-versus-host-disease
RecruitingThis study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).
PhasePhase 3
TypeInterventional
Age12 Years
WhereBirmingham, Alabama, United States + 121 more
SponsorIncyte Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts