A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
RecruitingThe purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.
PhasePhase 3
TypeInterventional
Age40 Years – 90 Years
WhereBirmingham, Alabama, United States + 485 more
SponsorHoffmann-La Roche
▾Tap for detailsClick for full details — eligibility, all locations, contacts Closed Loop Oxygen Control in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Nasal High Flow in the Hospital
RecruitingThe trial aims to evaluate whether the Airvo 3 device in OptiO2 mode can maintain patients' SpO2 levels within the target range better than manual oxygen titration in hospitalized COPD patients with hypoxemia/respiratory distress.
PhaseNA
TypeInterventional
Age22 Years
WhereBirmingham, Alabama, United States + 3 more
SponsorFisher and Paykel Healthcare
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease
RecruitingThis study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.
PhasePhase 3
TypeInterventional
Age40 Years – 80 Years
WhereAthens, Alabama, United States + 920 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Long-term Extension Study of PCI-32765 (Ibrutinib)
RecruitingThe purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.
PhasePhase 3
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 174 more
SponsorJanssen Research & Development, LLC
▾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 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 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 Temple Health Chest Initiative (THCI 2.0)
RecruitingChronic obstructive pulmonary disease is highly prevalent globally, with considerable morbidity and mortality associated. In the US, it is the 4th leading cause of death, as well as contributing to significant costs on healthcare utilization including hospitalization. Population-based screening for COPD has not been recommended by the US Preventative Services Task Force (USPSTF). However, LDCT screening for lung cancer in patients aged 50- 80 with ≥ 20 pack year smoking has been shown to improve survival. COPD is highly prevalent within LCS programs, with estimated rates of obstructive lung function of up to 59% and evidence of emphysema on CT scan in around 70%.
Phase—
TypeObservational
Age50 Years – 80 Years
WherePhiladelphia, Pennsylvania, United States
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 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 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 Non-Invasive Interventions for Respiratory Recovery in Chronic Spinal Cord Injury
NCT07135583 · Spinal Cord Injury, Chronic, Spinal Cord Injury Cervical, Spinal Cord Injury Thoracic
RecruitingSpinal cord injuries (SCI) can seriously affect a person's ability to breathe. This happens because the injury can damage the nerves that control the muscles used for breathing. As a result, people with SCI often face breathing problems, a higher risk of lung infections, and even early death. While breathing exercises can help strengthen these muscles, they often aren't intense enough to make a big difference, especially in people with long-term injuries. This research project is exploring a new way to improve breathing in people with chronic SCI. The goal is to "wake up" the remaining nerve pathways that still connect the brain and spinal cord to the breathing muscles. By doing this, the investigators hope to make breathing exercises more effective and improve overall respiratory health. The investigators are testing a combination of two non-invasive (non-surgical) techniques: Transcutaneous Spinal Cord Stimulation (tSCS): This uses small electrical pulses delivered through the skin to stimulate the spinal cord and help activate the muscles used for breathing. Hypercapnic-Hypoxia Protocol (HiCO₂-AIH): This involves breathing air with lower oxygen and higher carbon dioxide for short periods. This naturally increases the brain's drive to breathe and may help strengthen the breathing muscles. The investigators believe that using these two techniques together will "prime" the nervous system, making it more responsive to breathing exercises. This could lead to better outcomes for people with SCI. In addition to testing this treatment, the investigators are also collecting saliva and blood samples to look for biomarkers-biological clues that might help predict who will benefit most from this therapy. These include genetic markers and signs of nerve damage in the blood. Who Can Participate The investigators are looking for adults aged 18 to 70 who: Have had a spinal cord injury for at least one year. Have an injury between the neck and upper back (from C3 to T8). Have an incomplete injury (some nerve function remains). Are medically stable and cleared by a doctor. Have at least a 20% reduction in breathing strength. What Participants Will Do Each participant will complete four rounds of treatment. Each round includes four days in a row of therapy, followed by a three-week break before the next round. Each daily session lasts about two hours and includes: Breathing special air mixtures (low oxygen and high carbon dioxide) for short periods, followed by normal air. A short break. Then, spinal cord stimulation combined with breathing exercises that use resistance (like breathing through a straw). What the Investigators Will Measure The investigators will track: Breathing ability using lung function tests and pressure measurements. Nerve activity using brain and spinal cord stimulation to see how well the diaphragm (the main breathing muscle) responds. Safety by monitoring oxygen levels, heart rate, blood pressure, and breathing responses during each session. Biological Samples Participants will provide: A one-time saliva sample for genetic testing. A one-time blood sample to look for markers of nerve injury. Why This Matters This study could lead to new, non-invasive treatments that improve breathing and quality of life for people living with spinal cord injuries. By identifying who is most likely to benefit from this therapy, the investigators can also move toward more personalized and effective care in the future.
PhaseNA
TypeInterventional
Age18 Years – 70 Years
WherePhiladelphia, Pennsylvania, United States
SponsorThomas Jefferson University
▾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 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 2 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 + 367 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment
RecruitingThis is a Phase 2 study of the efficacy, safety, tolerability and pharmacokinetics of two doses of EXPD-101 in participants with COPD. Study participants will be randomized to receive either study drug or placebo administered once daily for 52 weeks.
PhasePhase 2
TypeInterventional
Age40 Years – 85 Years
WherePhoenix, Arizona, United States + 11 more
SponsorExpedition Therapeutics, Inc
▾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 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 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 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 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