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22 recruiting in TN
Recruiting

A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD

Chronic Obstructive Pulmonary Disease

This study will assess the safety and efficacy of fixed dose combinations of ensifentrine with two different glycopyrrolate dose levels compared to placebo and to the individual components of the fixed dose combinations, each administered twice a day via standard jet nebulizer, in adult subjects with chronic obstructive pulmonary disease (COPD).

Chattanooga, Franklin +more, TN40โ€“80 yrsAll genders
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Recruiting

Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids

Asthma

This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.

Knoxville, TN18โ€“75 yrsAll genders
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Recruiting

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

COPD (Chronic Obstructive Pulmonary Disease)

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 ฮผg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 ฮผg in a population with COPD and elevated cardiopulmonary risk.

Chattanooga, Elizabethton +more, TN40โ€“80 yrsAll genders
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Recruiting

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

Chronic Obstructive Pulmonary Disease

This 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.

Chattanooga, TN40โ€“80 yrsAll genders
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Recruiting

An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema

Emphysema, Pulmonary ยท Emphysema or COPD

This 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.

Knoxville, TN40โ€“80 yrsAll genders
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Recruiting

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)

Chronic Obstructive Pulmonary Disease (COPD)

A 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)

Franklin, Johnson City, TN40โ€“80 yrsAll genders
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Recruiting

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)

Chronic Obstructive Pulmonary Disease (COPD)

A 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)

Knoxville, TN40โ€“80 yrsAll genders
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Recruiting

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Asthma

The purpose of this study is to assess the safety and efficacy of brenipatide at different dose levels compared with placebo in participants with moderate-to-severe asthma. Study participation will last approximately 65 weeks, including screening, treatment, and follow-up periods.

Nashville, TN18โ€“75 yrsAll genders
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Recruiting

A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma

Asthma

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) for the potential treatment of moderate-to-severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life and functioning of people who are affected. This study is seeking participants who: * Are 18 to 70 years old * Have had moderate-to-severe asthma for at least 12 months that is not well controlled * Have been taking their regular maintenance treatment(s) for asthma over the last 12 months All participants will receive PF-07275315 or a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. PF-07275315 or placebo will be given as multiple shots in the clinic over the course of 12 weeks. We will compare the experiences of people receiving PF-07275315 to those of the people who do not. This will help us determine if PF-07275315 is safe and effective. Participants will be involved in this study for about 7.5 months. During this time, they will have 9 visits at the study clinic.

Hendersonville, TN18โ€“70 yrsAll genders
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Recruiting

Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators

COPD (Chronic Obstructive Pulmonary Disease)

The purpose of this study is to compare the effectiveness of inhaled bronchodilators delivered via nebulizers vs. dry powder inhalers (DPIs) in symptomatic participants with Chronic Obstructive Pulmonary Disease (COPD) who have airflow obstruction (FEV1/FVC โ‰ค 70%) and show significant air trapping (RV โ‰ฅ 120% of predicted). The investigators hypothesize that, in patients with symptomatic COPD, therapy with a long-acting anti muscarinic agent/long-acting beta agonist (LAMA/LABA) combination administered by nebulizer will improve hyperinflation (increase in inspiratory capacity and reduction in residual volume) and reduce symptoms related to COPD to a greater extent than LAMA/LABA therapy given by a DPI. The study aims to demonstrate the following: 1. Compare the values of inspiratory capacity (IC) and residual volume (RV) in patients receiving LAMA/LABA by DPI with those receiving LAMA/LABA by nebulizer 2. Compare patient reported outcomes (COPD Assessment Test (CAT score), Baseline/Transition Dyspnea Index (BDI/TDI) and the St. George Respiratory Questionnaire (SGRQ) in symptomatic patients with COPD receiving LAMA/LABA by DPI with those receiving LAMA/LABA by nebulizer

Knoxville, TN40+ yrsAll genders
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Recruiting

Reducing Overuse of Antibiotics With Decision Support

Lower Respiratory Tract Infection ยท Pneumonia ยท Asthma

Eliminating inappropriate antibiotic use in pediatric lower respiratory tract infections (LRTI) is the central focus of this research. LRTIs (pneumonia, bronchiolitis, and infection-related exacerbations of asthma) account for nearly one-third of all emergency department (ED) visits and 40% of all infection-related hospitalizations in US children. LRTIs also account for more antibiotic use in children's hospitals than any other condition, despite most LRTIs being viral in nature. Inappropriate antibiotics are associated with substantial adverse effects. Accordingly, national guidelines strongly discourage routine antibiotic use for bronchiolitis and acute asthma and argue for significantly reducing antibiotic exposure (initiation, spectrum, and duration) in pneumonia. To address the problem of inappropriate antibiotic use, hospital-based antimicrobial stewardship programs (ASPs) are now common nationwide, and these programs have demonstrated effectiveness in some hospital settings. Unfortunately, traditional ASP approaches do not translate well to the fast-paced and unpredictable ED environment, and hospital-based ASP resources are finite and not always immediately available. Clinical decision support (CDS) embedded within the electronic health record (EHR) is a strategy that could address the ED antibiotic stewardship gap. Informed by a deep understanding of the key facilitators and barriers to using CDS to support appropriate antibiotic use in ED and hospital settings, the investigators have developed two stewardship-focused CDS interventions for pediatric LRTI. The overarching goal of this research is to rigorously evaluate the implementation and effectiveness of these CDS tools, alone and in combination, against usual care only in a pragmatic randomized clinical trial at 3 U.S. children's hospitals.

Nashville, TN0.5โ€“17 yrsAll genders
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Recruiting

A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease (COPD)

This 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.

Chattanooga, Franklin +more, TN40+ yrsAll genders
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Recruiting

Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)

Wheezing ยท Asthma

This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to \<6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to \<6 years old with uncontrolled asthma and/or recurrent severe asthmatic wheeze. At the end of Part A, all eligible participants will be offered participation in Part B, an optional open-label extension phase. Study details include: Part A: The study duration of part A will be up to 68 weeks consisting of a 4-week Screening, a 52week treatment period, and a 12-week post-treatment follow-up period. For participants who will chose to participate in Part B, the study duration will be up to 120 weeks (additional 52-week treatment period). Part B: For participants who will choose to participate in Part B, the study duration will be up to 120 weeks (Part A \[4-week Screening and a 52-week treatment period\] plus additional 52-week treatment period and a 12-week post-treatment follow-up period).

Nashville, TN2โ€“5 yrsAll genders
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Recruiting

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

Coronavirus Infection (COVID-19) ยท Pulmonary Arterial Hypertension ยท Urinary Tract Infections in Children

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

Nashville, TN0โ€“20 yrsAll genders
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Recruiting

Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma

Asthma

The purpose of this study is to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year.

Nashville, TN12โ€“17 yrsAll genders
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Recruiting

A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic Asthma

Eosinophilic Asthma

This Phase 2b study is designed to evaluate the safety and efficacy of KT-621 in participants with uncontrolled moderate to severe eosinophilic asthma. The main goals of this study are to investigate how effective KT-621 is at treating uncontrolled moderate to severe eosinophilic asthma, the safety and tolerability of KT-621, and how KT-621 behaves in the body.

Chattanooga, TN18โ€“75 yrsAll genders
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