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36 recruiting in CO
Recruiting

Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English

Asthma in Children

The Nav-Team study reviews how well the asthma navigators/coordinator program can improve the lives of asthmatic children, and their caregivers, by providing additional assistance and education. Aim 1 of the study will partner with immigrant serving community organizations to hold meetings that will help tailor the programs. Aim 2 of the study looks at data to help see if the program is working to help children and their caregivers. Aim 2a looks at difference in emergency department use between families that did not use the Nav-Team program and those that did. Aim 2b reviews how well the Nav-Team program did with reaching and connecting with the asthma child and caregiver community. Aim 2b, also reviews the costs of the program, how well the program did will sticking to the program goals, and how well the staff was able to keep up with providing education and help.

Aurora, CO4โ€“89 yrsAll genders
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MoblO2 to Maintain Oxygenation

COPD (Chronic Obstructive Pulmonary Disease) ยท Intersitital Lung Disease

Many patients with chronic lung disease (e.g., chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD)) require supplemental oxygen (O2) at some point during their disease course. Practitioners prescribe O2 to patients with chronic lung disease in hopes of the following: 1) that it will limit desaturation events and combat breathlessness, thus preventing the frustratingly slow pace and numerous rest breaks patients are forced to adopt while doing even simple tasks; 2) that it will allow patients to be more active physically (perhaps increase their ability to exercise) and socially (perhaps leave the home more often); 3) that it will stave off putative complications of hypoxemia (e.g., cognitive dysfunction, pulmonary hypertension) and 4) that it will improve health-related quality of life (HRQL). However, despite the rationale for O2, and prescribers' good intentions, patients generally view O2 with frustration and fear - it threatens their HRQL, which is already impaired by having a condition that imposes itself on every aspect of their lives. Nasal cannulas and delivery devices call unwanted attention to patients when they are out in public. O2 users feel stigmatized and are often viewed as "smokers who get what they deserve, even if they never smoked a day in their lives" - or as disabled, sick or even infectious. O2 steals patients' independence, forcing them to plan their lives around it. The anxiety that patients and their caregivers experience around running out of oxygen, or not getting enough, immobilizes them and restricts participation in activities outside of the home. O2 disrupts the home environment, adding stress, and creating a burden for patients' caregiver-loved-ones who are often saddled with the responsibility of ensuring adequate equipment and supply of O2, and O2 is a constant reminder to patients they are living with a condition that could shorten their lives. O2 delivery equipment is typically heavy, unwieldy and intimidating. Different recommendations (e.g., insurance companies use 88% as a cut-off for SpO2, while many practitioners focus on 90%) make it confusing for patients, which almost certainly affects adherence. O2-requiringpatients are starving for things that can make their lives easier. An auto-adjusting O2 delivery device - one that automatically delivers the correct amount of O2 to maintain blood oxygen at desired, pre-set levels - would alleviate the need for patients to constantly (incessantly for many) monitor their peripheral oxygen saturation (SpO2) and adjust O2flow to meet the demands as exertion levels vary . The MoblO2 device is a battery-operated, light-weight, closed-loop O2 delivery device that houses a regulator (which attaches to compressed gas O2 tanks) and adjusts O2 flow to meet a pre-set blood oxygen level. A pulse oximeter is worn on the ear and transmits via Bluetooth to the device, which adjusts an internal valve to control flow on a second-to-second basis. The user sets the dial to the highest flow of O2 needed to meet the demands of activities they might perform (up to 15 liters per minute), and the device adjusts flow, up to the pre-set level to maintain SpO2 at a preset level (e.g., \> 90%). To conserve O2 supply in the tank - and to avoid over-oxygenation (which could be problematic for a small percentage of patients with the most severe COPD) - the MoblO2 begins to limit O2 flow at a SpO2 of 93%. The device can be manually over-ridden by the user, and should the battery run out - or the device fail for some unforeseen reason - the default position is valve open, so the users receive whatever flow of oxygen has been set on the dial. Given the substantial burdens of O2 on patients and their families, the hassles patients describe with having to monitor their SpO2 and repeatedly adjust the flow of O2 to meet their needs, patients and experts around the world have called for improvements in O2 delivery equipment. The MoblO2 is just such a remarkable improvement and a giant step forward in helping to ease the burdens of O2 on patients who require it. The purpose of this study is to investigate the effects of the MoblO2 O2 delivery device on a range of outcomes, including physical activity, amount (liters) O2 use; maintenance of adequate SpO2 levels; patient reported outcomes including symptoms, HRQL and satisfaction with the MoblO2 O2 device.

Denver, CO25โ€“95 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.

Boulder, Lakewood, CO40โ€“80 yrsAll genders
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Recruiting

Phenotyping Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease

COPD ยท Pulmonary Hypertension ยท Right Ventricular Dysfunction

This study plans to learn about heart function among individuals with chronic obstructive pulmonary disease (COPD). In particular, the investigators want to understand the different patterns of right ventricular response during rest and moderate- vs high-intensity exercise. By identifying patterns of right ventricular dysfunction, this study will help identify better treatments for patients with COPD in the future.

Aurora, CO40+ yrsAll genders
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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.

Aurora, CO0โ€“20 yrsAll genders
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Recruiting

Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study

Asthma

Reslizumab is a type of medicine called a monoclonal antibody that is made in the research clinic; it works by blocking a specific protein in the body called interleukin-5. The study medicine, reslizumab, is not yet approved for doctors to treat patients with EGPA. It is considered an experimental drug in this study.

Denver, CO18+ yrsAll genders
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Recruiting

eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation

Pulmonary Disease, Chronic Obstructive

Depemokimab is being developed as a treatment for individuals with moderate to severe Chronic Obstructive Pulmonary Disorder (COPD). The aim of this study is to assess the efficacy and safety of early initiation of depemokimab as an add-on medicine in participants with moderate to severe COPD with type 2 inflammation.

Lakewood, CO40โ€“75 yrsAll genders
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Recruiting

Protocol CAUSE-03 / CHEETAH

Asthma

This is a one-year longitudinal, observational study of 250 urban children and adolescents with asthma and 60 without asthma, ages 6-17 years old. Participants with asthma will require daily controller therapy with inhaled corticosteroids ICS (at least Step 2 therapy). Those without asthma cannot have used asthma medications in the year prior to enrollment and cannot demonstrate bronchodilator reversibility at baseline. Phenotypic characteristics will be established at baseline, and the participants will be seen at scheduled visits over 12 months. Each participant will be asked to monitor and self-report cold symptoms and will be asked to complete up to three cold visits

Aurora, CO6โ€“17 yrsAll genders
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Recruiting

Anti Inflammatory Lipid Mediators in Asthma Lipid Anti-Inflammtory Mediators in Asthma

Asthma ยท Obesity

The main purpose of this Phase 2 double blind, placebo controlled crossover clinical study is to demonstrate the efficacy and safety of CXA-10 in obese adult asthmatics. Obesity induces a chronic systemic inflammatory state characterized by impaired adipokine signaling, pro-inflammatory cytokine responses, inflammatory cell activation and enhanced generation of oxidative inflammatory mediators. This impacts the lung, increasing the severity of asthma and its exacerbations. This research will evaluate how a synthetic nitro-fatty acid (CXA-10, 10-nitro-octadec-9-enoic acid) suppresses the systemic and airway inflammation that contributes to the obese asthmatic phenotype. Current data support the pleiotropic signaling actions of CXA-10 to induce adaptive signaling actions that beneficially modulate adipokine and cytokine expression and inhibit systemic and pulmonary inflammation. The investigators hypothesize that CXA-10 induced signaling responses will alleviate obesity-related airway hyperreactivity in obese adult asthmatics.

Aurora, CO18โ€“65 yrsAll genders
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Recruiting

Reducing Asthma Attacks in Disadvantaged School Children With Asthma

Asthma in Children

Our UH3 clinical trial, "Reducing Asthma Attacks in Disadvantaged School Children with Asthma," seeks broad-scale implementation of our effective school-based approach to improve asthma disparities for children, ages 5-12 years, in low-income communities. The investigators will contextualize dissemination and implementation (D\&I) of our Colorado school-based asthma program (Col-SBAP) that reduces asthma exacerbations and missed school days, while also addressing social determinants of health. Our Better Asthma Control for Kids (BACK) Program will evaluate key metrics identified by diverse stakeholders during this dissemination trial in rural and small metropolitan areas of Colorado. Our clinical trial includes two implementation strategies: our standard Col-SBAP, titled BACK-Standard (BACK-S) and an enhanced community-centered approach, titled Back-Enhanced (BACK-E). These two strategies are designed for sustainable delivery by school asthma navigators and school nurses who coordinate with primary care and community resources. The Exploration, Preparation, Implementation, Sustainment (EPIS) D\&I framework was applied with community partners during the UG3 planning phase to tailor implementation plans that meet local community needs, resources and priorities (EPIS Phases 1 \& 2). BACK-S and BACK-E will be delivered from years 1-3 with data collection for implementation and effectiveness outcomes in 4 Colorado regions. In year 4, the investigators will collect data for sustainment outcomes (EPIS phase 3). The investigators will apply the work from EPIS phases 1-3 to refine our "dissemination playbook" that guides adoption by other school systems (EPIS Phase 4). Our primary implementation hypothesis is: Reach will be greater among students when delivered using the BACK-E arm as compared to BACK-S. Our effectiveness hypothesis is: BACK will be more effective than usual care at reducing asthma exacerbations. The BACK playbook includes training materials and a calculation of return on investment. The investigators are targeting schools with high levels of uncontrolled asthma and asthma associated burden. Our UH3 trial includes partner engagement to ensure BACK is disseminated to diverse geopolitical areas of Colorado with attention to sustainability. Collectively, our approach will accelerate dissemination of BACK nationally to communities experiencing health inequities in pediatric asthma care.

Ault, Colorado Springs +more, CO5โ€“12 yrsAll genders
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Recruiting

Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment

Asthma ยท Eosinophilic Granulomatosis With Polyangiitis (EGPA) ยท Hypereosinophilic Syndrome (HES)

The rationale of the roll-over study (ROSY) is to provide continuous access to study treatment for participants who have completed or exited a parent study and are deemed appropriate for continued benralizumab treatment, as judged by the Investigator, while monitoring long-term safety and tolerability of benralizumab.

Aurora, CO6+ yrsAll genders
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Recruiting

Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment

Eosinophilic Asthma

This study evaluates the efficacy and safety of benralizumab as an add-on therapy in uncontrolled eosinophilic asthma participants treated with medium-dose ICS-LABA compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA.

Denver, CO12โ€“75 yrsAll genders
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Recruiting

Individualizing Treatment for Asthma in Primary Care (Full Study)

Asthma ยท Asthma Attack ยท Asthma Exacerbations

While asthma therapy is becoming more individualized based on asthma phenotypes, more research is needed to tailor newer therapies to individuals. Inhaled corticosteroid (ICS) medications are the foundation of care for all individuals with persistent asthma. But ICS use is not without possible long term side effects. This study will compare two currently available approaches to reduce AEX in primary care patients: (1) use of inhaled corticosteroids (ICS) as part of rescue therapy, also known as MART (Maintenance And Reliever Therapy) or PARTICS (Patient Activated Reliever Trigger Inhaled Corticosteriods) therapy - either of these therapies will be called Rescue-Inhaled Corticosteroids or R-ICS pronounced "Ricks," and (2) use of azithromycin (AZ) as a preventive therapy. These treatments will be studied both individually and in combination.

Aurora, CO13โ€“75 yrsAll genders
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Recruiting

A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)

Severe Asthma

The objective of this study is to assess the potential for GB-0895 treatment to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers. The study details include: Study treatment: randomized to receive either GB-0895 or placebo administered every 6 months over 52 weeks. Visit frequency: every 1-2 months after the first month.

Colorado Springs, CO12โ€“80 yrsAll genders
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