Clinical Research Directory

Reducing Exposure With Air Cleaners and Technology

Fine particulate matter (PM2.5) is a type of air pollution made up of extremely tiny particles that can harm our health. Because PM2.5 particles are so small, they can travel deep into the lungs when we breathe. Exposure to PM2.5 can worsen asthma, cause breathing problems, increase the risk of heart attacks, and lead to early death, especially for people with existing heart or lung conditions. In California's Bayview Hunters Point (BVHP), a San Francisco community already facing high levels of air pollution and health impacts, sources of PM2.5 include industrial activity, commuter traffic, heavy-duty diesel trucks, freight trains, and port and maritime activities. The Reducing Exposure with Air Cleaners and Technology (REACT) Study is a partnership between UC Berkeley, UC San Francisco, and Brightline Defense. The goal is to see if air cleaners (also called air purifiers) can help reduce indoor PM2.5 levels and improve respiratory health. For this study, we'll be recruiting 100 households in BVHP to participate. In each home, we'll monitor indoor PM2.5 levels and the health status of household members who are 13 years old or older and have asthma or chronic obstructive pulmonary disease (COPD). Each home will be part of the study for 90 to 120 days, depending on scheduling. Households must reside in BVHP for the duration of the study and not have used an air cleaner in their home within the last 6 months. On Day 1, each household will receive a PurpleAir indoor air quality monitor to measure PM2.5 levels in their home. * For the first 30 days, we'll measure the home's normal air quality (baseline). * After 30 days, each household will receive an air cleaner (Figure 2) with information about how to best use it. * At that point, we'll also turn on a PM2.5 indicator light on half of the PurpleAir monitors. For the other half, we'll keep that indicator light turned off. This helps us study whether seeing the air quality in real time changes how people use the air cleaner. * For the next 30 days, we'll continue monitoring indoor PM2.5 levels. We'll also track how often the air cleaner is used with smart plug data loggers. * After 60 days, if a household isn't using the air cleaner much or it doesn't seem to be working well, we'll offer more training and support. * We'll continue monitoring over the final 30 days of the study.

Agricultural Health Study Follow-up

Background: \- The Agricultural Health Study (AHS) is looking at the long-term health effects of farming exposures including pesticides, crops, and animals. The chronic health effects of exposure to pesticides are easier to study in farmers and their spouses. They know what chemicals they use and tend to live in the same place for most of their adult lives. AHS participants are expected to report any changes in their health. This includes any new medical conditions. Researchers want to follow up on these reports to confirm their accuracy. Objectives: \- To follow up AHS participants who have self-reported that they have a new disease and confirm their diagnosis. Eligibility: \- Current AHS participants. Design: * Researchers will confirm self-reported changes in medical conditions by contacting the AHS participant to ask for more information. * The AHS participant will give permission for researchers to contact their doctor to look at their medical records. They will also be asked to provide a cheek swab or saliva sample. * Diseases of interest are rheumatoid arthritis, lupus, and Sjogren s Syndrome. Other diseases will be followed up in the future. Other diseases will be followed up in the future....

A Study to Learn How Different Amounts of the Study Medicine Called PF-08103402 Are Tolerated and Act in the Body in Healthy Adults or Adults With Mild To-moderate Asthma

The purpose of this study is to learn about the safety of a new study medicine called PF-08103402 in healthy adults (do not have disease) and or in adults with mild-to-moderate asthma. This is the first time the study medicine is being given to people. For Parts A, B, C, D and F, the study is seeking participants who: * Are healthy (do not have disease) males or females who can no longer have children, * Are 18 to 65 years old, * Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a body weight of more than 50 kilograms (110 pounds). Body mass index is a way to measure body fat by using a person's height and weight For Part A (optional group or cohort 3: Japanese participants only): * A body weight of more than 45 kilograms (100 pounds). * Have 4 biological Japanese grandparents who were born in Japan. For Part E only: * Adults with a documented history of asthma (confirmed by a doctor) for at least 12 months before entering the study. * Have a body mass index (BMI) of 16 to 35 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds). The study has six parts: Part A, Part B, Part C, Part D, Part E and Part F. The study medicine will be taken as a suspension or tablet by mouth 1 time a day (except in Parts B and E where it will be taken 1 time a day for 14 days) at the study clinic. The study will help understand: * how the body processes the study medicine in healthy participants (Parts A and B), * how much of the study medicine gets into the bloodstream and if food affects the amount of study medicine in the blood in healthy participants (Part C), * how the study medicine is broken down and leaves the body in healthy participants (Optional Part D), * how the study medicine is processed in adults with mild-to-moderate asthma (Optional Part E), * if taking the study medicine together with another medicine affects how each medicine is processed by the body in healthy participants (Optional Part F). Participants will take part in the study for about 10 weeks (Parts A and F), 12 weeks (Part B), 9 weeks (Parts C and D), and 16 weeks (Part E). During this time, they will have 2 study visits at the study clinic and up to 28 overnight stays (Part A), 18 overnight stays (Parts B and E), 10 overnight stays (Part C), 11 overnight stays (Part D), and 16 overnight stays (Part F). The study team will also call participants 1 time over the phone at the end of the study to assess how they are doing. Study measurements will be taken by body examination, monitoring side effects, blood and urine tests, heart tests (ECG), vital signs (blood pressure, pulse and respiratory rate), questionnaires (Parts C and E), stool samples (Part D only), and breathing tests (Part E only).

Nasal Immune Challenge Study

Respiratory viral infections cause significant illness, especially in vulnerable individuals and is a topic of immense significance during the current COVID-19 global pandemic. Respiratory diseases such as asthma involve inflammation of the airways and viruses are a major cause of asthma attacks. The nose is easier to access than the lungs but has similar cells and is therefore useful to study immune responses throughout the respiratory tract. Rather than study the effects of a live virus on the immune system, it is possible to give a component or mimic of a virus to simulate an infection in a similar but more straightforward manner, without causing disease. In this study we will use a nasal spray containing a sterile substance called Resiquimod (also called R848) to mimic a viral infection. Resiquimod does not contain any living organisms and therefore there is no possibility of developing a real infection. Resiquimod works by binding to receptors in cells that line the inside of the nose (epithelial cells) as well as cells that can fight infection (immune cells). These cells respond to Resiquimod and cause mild inflammation in the nose, similar to a mild cold. We can then take samples to measure this response and investigate how it differs between individuals. This will help us better understand how the human immune system responds to viruses, and which cells and molecules the body uses to defend itself against infection.

Lung Immune Challenge Study: Controlled Exposure to Inhaled Resiquimod (R848)

Respiratory viral infections can be a cause of significant illness, particularly in vulnerable individuals as seen in the COVID-19 pandemic. An underactive or overactive immune response can lead to ineffective resolution of inflammation after an infection, especially in people with airway diseases such as asthma. A better understanding of immune responses to infection that does not rely on cell or animal models is crucial to help develop better treatments for lung inflammation. An established method of studying inflammation in humans is through careful and controlled exposure (or "challenge") with a mimic of a virus to simulate an infection in a similar manner to that of a virus, but with the advantage of not causing an infection. The investigators have already developed a well-tolerated mimic of human viral infection using a sterile substance called Resiquimod (or R848). Since it does not contain living organisms there is no possibility of being infected. This has been used previously as a nasal spray to cause a mild short-lived inflammation that mimics a mild cold. This has been used safely in a range of people of different ages including those who have asthma. There are differences however in how the nose and lungs respond to viral infections. This is particularly true in those with airway diseases such as asthma, who have cells in the airways of their lungs that respond in a different way to inflammatory triggers (such as viruses). The current study aims to build on previous research by developing a new approach of studying inflammation in the lungs using a small volume of Resiquimod. This will be done by gently inhaling a fine mist through a mouthpiece into the lungs. Blood and phlegm samples would then be collected to assess inflammation and how well people tolerate the procedure.

A Study of JNJ-95597528 in Participants With Inadequately Controlled Moderate to Severe Asthma

The purpose of this study is to assess how well JNJ-95597528 works when compared to placebo in adult participants with moderate to severe asthma (long-term condition that affects the airways in your lungs).

Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)

Background: Exposure to smoke increases the risk of many diseases. People can be exposed to dangerous levels of smoke during wildfires. Also, smoke from fires that burn manmade materials may contain toxic chemicals. Researchers want to know more about how breathing smoke affects a person s airways (nose, sinuses, lungs) and immune system. Objective: To learn how exposure to smoke over time affects the health of people who work as firefighters. Eligibility: Healthy, nonsmoking people aged 18 to 65 years who work as firefighters. Some people older than 65 may also be included. Design: Participants will have study visits about every 6 months for up to 10 years. They will also have visits after a smoke exposure event. Some visits may be by telehealth. Each visit will include some or all of the following: Imaging scans of the sinuses or chest. Sample collection. These will include blood, nasal fluids, a skin swab, urine, and fluid coughed up from the lungs. Lung function test. Participants will blow air into a machine that measures the volume moving in and out of their lungs. Particles in exhaled air (PExA). Participants will breathe into a device that collects particles. Heart function test. Smell test. Participants will identify odors on scratch-and-sniff cards. Wearable air monitors. Participants may be asked to wear a device that measures particles and chemicals in the air around them for 1 to 20 days. International Public Safety Data Institute (IPSDI) reports. Participants will provide copies of these fire suppression event reports, if they are available. Participants who have exams of the airways as part of their routine health care may have extra tissue samples collected for research.

Perception of the Benefits and Effectiveness of Inhalation Therapy in Patients With Obstructive Dyspnea

Obstructive ventilatory disorders, including chronic obstructive pulmonary disease (COPD), asthma, and pulmonary emphysema, are chronic conditions characterized by progressive airflow limitation and worsening dyspnea, leading to increasing restrictions in daily activities and quality of life. Although these diseases are not curable, early diagnosis and appropriate treatment can slow disease progression, reduce exacerbations, and preserve functional capacity and well-being. Adherence to prescribed inhaled therapies is therefore essential from the earliest stages of the disease. However, both clinical experience and published evidence suggest that many patients with COPD and asthma experience poor disease control, relapses, and exacerbations due to inadequate inhaler use and suboptimal treatment adherence. Previous research has explored treatment satisfaction among patients with COPD and examined perceptions and beliefs regarding pharmacological therapies in other chronic conditions, such as diabetes, depression, and autoimmune diseases. Studies have also highlighted the importance of adopting a patient-centered approach when selecting inhaler devices based on individual patient characteristics. Nevertheless, little is known about how patients with obstructive ventilatory disorders perceive inhaled therapies and their role in disease management. The aim of this study is to investigate patients' perceptions of inhalation therapy, focusing on factors that influence its use, the value attributed to inhaled medications, preferences regarding the route of administration, awareness of the underlying disease, perceived barriers to treatment, and beliefs about medications in general. Understanding how patients perceive both the treatment and its route of administration is a key component of patient engagement, which emphasizes patients' active involvement in managing their health and healthcare pathway. Currently, no validated tools, either internationally or in Italian, are specifically designed to assess perceptions of the usefulness and effectiveness of inhalation therapy in patients with obstructive ventilatory disorders. This study therefore aims to address an important gap in the literature and support the development of more patient-centered therapeutic strategies.

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

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.

A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma

The main objective of this study is to assess the safety and tolerability of AMG 691 as single doses (healthy participants only) and multiple doses in healthy participants and participants with mild-to-moderate asthma.

A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma

The purpose of this clinical study is to learn about the safety and effects of the study medicine (called tilrekimig) for the potential treatment of severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life of people who are affected. The study is seeking participants who: * Have a history of severe asthma for at least 12 months * Have had at least 2 asthma attacks (also known as exacerbations) within the last 12 months All participants will be given shots of study medicine or a placebo at the study clinic. The study will compare the experiences of people receiving tilrekimig to those people who receive the placebo. This will help determine if tilrekimig is safe and effective.

New Approaches for Empowering Studies of Asthma in Populations of African Descent

Background: Some groups of people have a high prevalence of asthma and allergic disease. Also, asthma and allergic disease are often found in several members of the same family. Researchers want to learn more about what factors might cause asthma, both genetic and environmental. Objective: To build a collection of information to try to find genes that cause conditions and disorders such as asthma and allergic disease. Eligibility: People ages 18 99 of self-identified African, African American, or African Caribbean descent who either have no history of asthma or wheeze or have a physician s diagnosis of asthma Design: Participants will be screened with an interview by phone or in person. Participants will fill out a questionnaire about their general health and exposure to allergens and smoke. Participants will have a physical exam. Participants will have blood tests. Participants will provide a skin cell sample. Up to two samples will be taken from the inside of the nose. A brush will be used to take the samples. Participants will have a breathing test. They will be asked to blow forcefully 3 or more times into a lung function machine. Participants may have their blood and skin samples sent to a lab. DNA will be extracted from the samples and tested. Participants blood and skin samples will be stored. Samples may be used in future research studies.

Using the Blood Eosinophil Count to Guide Systemic Corticosteroid Treatment in Asthma Exacerbations

Asthma attacks which are moderate-to-severe are typically treated with corticosteroids, but the optimal treatment duration is unknown and treatment responses can be variable. Inadequate treatment may compromise recovery, but increased exposure to corticosteroids is, in turn, associated with drug-related adverse effects. There is a need for a biomarker to guide duration of corticosteroid treatment in asthma attacks. One such candidate biomarker is the blood eosinophil count, which may predict steroid-responsiveness. We hypothesize that the blood eosinophil count can potentially be used as a biomarker to guide the duration of corticosteroids in moderate-to-severe asthma attacks. This study will recruit individuals hospitalized for asthma attack. Participants will be randomized to standard care or blood-eosinophil guided systemic corticosteroid therapy. Subjects in the standard arm will receive oral corticosteroids for a total of 5 days. Subjects in the blood-eosinophil guided arm will receive oral corticosteroids for a total of 5 days if admission eosinophil count is ≥ 0.300 x 10\^3/µL, and receive 3 days of oral corticosteroids if the admission blood eosinophil is \< 0.300 x 10\^3/µL. The rate of treatment failure will be compared between these two groups.

A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma

A study to evaluate the efficacy and safety of benralizumab administered subcutaneously in patients ≥ 6 to \< 18 years of age with severe eosinophilic asthma, including a well-documented history of asthma exacerbations and uncontrolled asthma receiving high-dose inhaled corticosteroid (ICS) plus at least one additional controller medication.

Study of HXN-1013 in Healthy Participants and Participants With Mild-to-Moderate Asthma

This is a Phase I, randomized, double-blind, placebo-controlled, single ascending dose study evaluating HXN-1013 in healthy participants and participants with mild-to-moderate asthma.

A Study to Evaluate Solriktug in Adult Participants With Asthma

Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solriktug with adult participants with asthma.

A Study of HB0056 in Adult Participants With Moderate to Severe Asthma

The goal of this clinical trial is to learn if drug HB0056 works to treat severe asthma in adults. It will also learn about the safety of drugHB0056. The main questions it aims to answer are: Does drug HB0056 lower the number of times participants need to use a rescue inhaler? What medical problems do participants have when taking drug HB0056? Researchers will compare drug HB0056 to a placebo to see if drug HB0056 works to treat severe asthma. Participants will: Take drug HB0056 or a placebo Q2W. Keep a diary of their symptoms and the number of times they use a rescue inhaler

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

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.

Allergy, Asthma, and Atopic Eczema in Finland

The summary is available at --\> https://www.finnatopy.fi/summary

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Background: \- Asthma is a serious clinical and public health problem. Researchers want to collect data to better understand how bacteria and other things in the environment can affect people's asthma. Eligibility: \- Nonsmoking adults age 18 - 60 who have moderate to severe asthma. Design: * Participants will complete a medical history form before the first visit. * Study visits will include collecting medical history, and conducting physical exam, lung and smoking tests. Participants will give blood, urine, stool, dust, saliva, and sputum samples. * Participants will take tests that measure their breathing abilities. They will give saliva samples for DNA study. They will get kits to collect stool and dust samples at home. They will fill out surveys. * Participants will have visits every 6 months for 5 years. They can schedule sick visits, if needed, at no cost to the participant. For all visits, they will have asthma check-ups and get treatment, at no cost to the participant. * Some participants may take part in a sub-study that includes one 4-hour visit. They will have medical history, physical exam, and lung tests. They will have urine tests to check for pregnancy and tobacco exposure. Then they will have bronchoscopy. For this, an intravenous line will be placed in an arm vein. The nose and throat will be numbed. A flexible fiber-optic tube will be inserted into their airways through the nose. Their airways will be examined and areas of their lung will be washed. A small sample of cells will be taken.

Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada

Wildfire smoke (WFS) is the leading climate-related risk in Canada and the main source of harmful air pollution. While short-term breathing problems caused by smoke are well known, there is limited knowledge on how repeated exposure contributes to long-term lung disease. This study is a controlled human exposure to varying concentrations of WFS in a safe setting. By comparing the effects of different concentrations, this research will improve understanding of health impacts, identify who may be most vulnerable to exposures, and explore biological changes that could lead to chronic illness.

R34 Asthma Depression

Depressive disorders are highly prevalent among older adults with asthma and are associated with poor asthma outcomes. The overall objective of this study is to integrate an asthma self-management support program that the research team previously developed with cognitive behavioral therapy (CBT) for adherence and depression for older adults with uncontrolled asthma and a comorbid depressive disorder. The research team will conduct a pilot randomized controlled trial to assess the feasibility and preliminary impact of the intervention on asthma and depression outcomes.

Longitudinal Observational Study of Severe Asthma

Background: \- Asthma is a lung condition that causes difficulty breathing and decreased lung function. Some people with asthma have more severe disease symptoms. They may be less responsive to standard treatments such as steroids. Researchers want to compare severe asthmatics with mild or moderate asthmatics or people without asthma over a long period. This information may help identify new treatments for people whose asthma is not well controlled by standard medications. Objectives: \- To compare severe asthmatics with mild or moderate asthmatics, and healthy volunteers, to study the progression and outcomes of the disease. Eligibility: * Individuals at least 18 years of age who have been diagnosed with asthma for at least 1 year. * Healthy volunteers at least 18 years of age. Design: * This study will involve an initial visit to the NIH Clinical Center for all participants. Selected participants may be asked to return for repeat visits over a number of years. The test results from participants with asthma will be compared with those from the healthy volunteers. * All participants will be screened with a physical exam and medical history. * Participants may (but will not necessarily) have the following tests at each visit: * Complete medical history and physical exam * Blood, urine, sputum, and nasal cell samples * Breath tests and heart and lung function tests * Six-minute walk test to measure ability to exercise * Imaging studies such as chest x-rays, bone density scans, and sinus scans * Allergy skin testing * Vocal cord exam * Overnight sleep study * Participants may remain on the study for as long as they are willing to participate and do not develop health problems that will interfere with the study.

Role of Genetic Factors in the Development of Lung Disease

This study is designed to evaluate the genetics involved in the development of lung disease by surveying genes involved in the process of breathing and examining the genes in lung cells of patients with lung disease. The study will focus on defining the distribution of abnormal genes responsible for processes directly involved in different diseases affecting the lungs of patients and healthy volunteers. Optional CT Sub-study The standard CT scan will be compared to the low dose radiation CT scan for the 150 subjects enrolled in the sub-study to assess the variation between the two techniques. Specifically, the quantitative computer aided detection of lung CT abnormalities from LAM can be compared to assess whether low radiation dose CT exams is an alternative to conventional CT to monitor disease status. This optional sub-study will be offered to up to 100 adult subjects with lung disease and up to 50 children age 9 and older with CF. Children will not be enrolled in the optional CT sub-study unless they have had a standard CT scan for medical purposes to use in comparison. One additional low dose radiation CT scan of the chest may be done as part of this sub-study when these subjects have their next annual CT scan.