MILD-SEVERE ASTHMA
Asthma Feasibility Sub-Study & Volunteer Database
The purpose of this study is to develop and maintain a Research Volunteer Database for the purpose of collecting information about potential participants, communicating with participants regarding upcoming studies, and conducting pulmonary function testing to determine eligibility.
The CHRONICLE Study (PI: Que)
A Longitudinal Prospective Observational Study of the Characteristics, Treatment Patterns and Health Outcomes of Individuals with Severe Asthma in the United States.This is an asthma registry. Patients can participate in other studies while enrolled in the Chronicle Study. This study is sponsored by AstraZeneca.
PREPARE (PeRson EmPowered Asthma Relief Study)(PI:Riley)
This study will evaluate whether the additional use of an inhaled corticosteroid (ICS) whenever a person decides they need to use their short-acting beta agonists (SABA) for rescue therapy improves asthma outcomes. The outcomes we are looking at are reducing hospitalizations, emergency department visits, and asthma exacerbations. Compensation is provided.
AROA (Airway Remodeling in Obese Asthma)(PI:Ingram/Que)
The purpose of this study is to understand how hormones involved in obesity and insulin regulation interact with disease processes in allergic asthma. We are interested in evaluating cellular functions that contribute to airway fibrosis in early-onset allergic asthma. Non-diabetic, obese asthma patients with onset of disease before age 12 can enroll. Participation in the trial will include two visits to the clinic. The first visit will include lung function tests and blood tests and will take about 1-2 hours. The second visit will include a research bronchoscopy and will take about 4-5 hours. Compensation is provided. Compensation is provided.
SANDIA (Supplementing L-citrulline to overweight late Asthma oNset phenotypes to increase airway L-arginine/ADMA ratio and Improve Asthma control”) (PI:Que)
Amino acids are most commonly known as building blocks of proteins, the same as the proteins found in food. Asymmetric dimethyl arginine or ADMA is derived from the amino acid, L-arginine. The balance of L-arginine to ADMA may be important to the lung health of patients with asthma. The purpose of this 2-week study is to determine whether supplementation with L-citrulline, a naturally occurring amino acid which is a precursor of L-arginine, changes exhaled nitric oxide levels and ADMA in the blood of overweight patients with asthma. Compensation is provided.
MODERATE TO SEVERE ASTHMA
Sanofi_(PI:Scialla)
The purpose of this study is to evaluate the efficacy and safety of dupilumab in patients with persistent asthma over 52 weeks. Compensation is provided.
Meltemi_(PI:Scialla)
The purpose of this study is to evaluate the efficacy and safety of dupilumab in patients with persistent asthma over 52 weeks. Compensation is provided.
SEVERE ASTHMA
Tropos_(PI:Scialla)
The purpose of this study is to evaluate the effect of tralokinumab administered subcutaneously every 2 weeks in adults and adolescent subjects with OCS dependent asthma over a 40-week treatment period. Compensation is provided.
HEREDITARY ANGIOEDEMA (HAE)
The HELP Study TM (PI:Lugar)
The purpose of this study is to evaluate the efficacy of DX-2930 in preventing HAE attacks. The secondary objective is to evaluate the safety of repeated subcutaneous administrations of DX-2930 over 26 weeks. Compensation is provided.
BioCryst BCX7353-302 APeX-2 (PI:Lugar)
A Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two dose levels of BCX7353 as an oral treatment for the prevention of attacks in subjects with hereditary angioedema BCX7353-302. Compensation, including for travel provided.
Chronic Urticaria (CIU)
Chronic Idiopathic Urticaria (CIU) and gene expression profiling (PI: Lugar)
The purpose of this study is to investigate a population of immune cells monocytes in chronic idiopathic urticaria using gene expression profiling, and RNA and single cell sequencing to identify a molecular signature and its response to to specific therapies. No compensation is available for this study.
IMMUNE DEFICIENCIES
A genetic study of primary and secondary immune deficiencies (PI: Lugar)
Immune deficiencies are rare disorders affecting immune system function. Antibody deficiency is the most common immune disorder in kids and adults. This study aims to perform DNA sequencing focused on immune system genes and also develop models in the laboratory to better characterize immune system defects that results in antibody deficiency. We also hope to the discover the genetics and immune system defects that cause other health problems in our patients with antibody deficiency. There is no compensation for participation in this study.
IgPro20-4004 (PI: Dr. Lugar)
An Open-Label Multicenter Study to Evaluate the Safety and Tolerability of Higher Infusion Parameters of Immune Globulin Subcutaneous (Human), 20% Liquid (Hizentra®) in subjects with primary Immunodeficiency. The purpose of this study is to investigate the tolerability and safety with increased variability in infusing subcutaneous Ig therapy adapted to real world scenarios that our patients might prefer. There is compensation for participation.
Building a Registry of Patients with Primary Immunodeficiency (PI: Dr. Lugar)
Registry for immune deficiency in the United States has been poor. Understanding rare diseases is best when the patient experience and outcome can be followed to enhance the care, diagnostics and treatment for patients with rare disease. By participating in the USIDnet registry, a patient’s medical history and experience can be collected anonymously and used to inform disease in all with rare immune deficiencies.
COPD
LEEP (Losartan Effects on Emphysema Progression)(PI:Que)
The purpose of this study is to evaluate the efficacy of Losartan, an antihypertensive medication, in altering pathogenic mechanisms that promote COPD. This is a pragmatic, placebo-controlled, randomized clinical trial with a 48-week follow-up. Two hundred and twenty people with COPD and Computed Tomography evidence of emphysema will be assigned to losartan 100 mg daily or placebo. The primary outcomes will be an intermediate end-point reflecting anatomic lung remodeling, i.e. quantitative measures of emphysema by High Resolution Computed Tomography (HRCT). Compensation is provided.
INSIGHT (Intervention Study in Overweight Patients with COPD)(PI:Scialla)
Because symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap, the purpose of the INSIGHT COPD study is to try to find out if a lifestyle program that promotes modest weight loss and increased physical activity will improve COPD symptoms for those with a high BMI. We hope that the program will lead to weight loss and better exercise tolerance. Your participation in the study will last 18 months. Compensation is provided.
RETHINC (REdefining Therapy IN early COPD)(PI:Scialla)
The primary goal of this study is to determine whether inhaled bronchodilators improve clinical outcomes of adults with a history of tobacco smoking and who have significant respiratory symptoms (dyspnea and cough) but do not meet spirometric standards of airflow obstruction consistent with diagnosis of chronic obstructive pulmonary disease (COPD). Your participation is the study will last 12 weeks. Compensation is provided.
SAD CLD (Safety of Anti-Depressant in Chronic Lung Disease)(PI:Mathews/MacIntyre)
The purpose of this study is to determine if stress, anxiety or depression in people with COPD and/or ILD affects your ability to meet your pulmonary rehab goals. Additionally, this study is also being done to see if giving people with COPD and/or ILD an anti-depressant drug, sertraline, makes them feel less depressed or anxious and better able to perform pulmonary rehab. Participant enrollment in the maintenance program is provided.
Detecting ventilation and gas exchange abnormalities by 129Xe MRI in alpha-1 antitrypsin carriers (PI: Driehuys, Huang)
The study is to characterize ventilation and gas transfer distribution using 129Xe MRI in alpha-1 antitrypsin (AAT) heterozygotes (PiMZ) We will then identify the subjects with low ventilation and/or low gas transfer, the functional abnormalities that are consistent with small airway disease or early emphysema. These results will also generate a hypothesis that can be tested in future trials. If you have family history of alpha-1 antitrypsin deficiency and you don’t know your genetic type, we offer free genetic testing. Your participation include one MRI scan of about 4 hours. Compensation is provided.
Effects of glycopyrrolate/formoterol (Bevespi) on ventilation and gas exchange abnormalities in COPD assessed by 129Xe MRI (PI: Huang)
The study will determine how Glycopyrrolate/formoterol improves regional ventilation and gas transfer assessed by 129Xe MRI in GOLD II or III COPD patients. Your participation is 3 study visits and one phone call. The study is approximately 4 weeks in length. Compensation is provided.
Non-Invasive Diagnosis of Pulmonary Vascular Disease Using Inhaled 129Xe Magnetic Resonance Imaging (PI: Rajagopal /Driehuys)
To develop a novel, non invasive means of Comprehensively diagnosis of monitoring response to therapy in PVD using MRI Imaging. Your participation is one study visit with a 24hrs follow up contact. Compensation is provided.
Human Lung Regional Ventilation Defect Severity Measured by Fluorine-19 Gas MRI (PI: Charles)
The proposed study will determine regional qualitative and quantitative lung function information in the context of clinical trajectory of COPD subjects and subjects with normal gobal pulmonary fuction tests (ex-smokers and smokers). Your participation is one study visit with a 24hrs follow up contact. Compensation is provided.
AIRWAY and LUNG DISORDERS Including: ASTHMA, COPD, ILD, CF and PULMONARY HYPERTENISON
Hyperpolarized 129Xe MRI Imaging of Lung Function in Healthy Volunteers and Subjects with Pulmonary Disease (PIs: Mammarappallil/Driehuys)
The goal of this study is to develop and evaluate the usefulness of Hyperpolarized (HP) 129 Xe gas MRI for regional Assessment of Pulmonary Function. Your participation is one study visit with a 24hrs follow up contact. Compensation is provided.
COUGH
COCO (Chronic Refractory Cough Cohort) (PI:Que)
The purpose of this study is to test questionnaires that have been designed to measure cough and its impact on quality of life. It is also being done to establish if zinc deficiency is prevalent in people who have chronic cough. People with chronic cough may join the study. Compensation is provided.
ZICO (Zinc Acetate to Improve Chronic Cough)(PI:Que)
The purpose of this study is to see if zinc acetate will improve chronic cough, a cough that lasts 8 weeks or more. Many people find their chronic cough gets better when they take medicines for asthma, gastroesophageal reflux (GERD), or sinus problems. However, some people with chronic cough are not helped by these medicines. Zinc acetate has not been tested as a treatment for chronic cough. However, research suggests that zinc can help people with chronic cough. Zinc acetate has been approved by the Food and Drug Administration (FDA) for the treatment of Wilsons’s disease (a disease where the body absorbs too much copper). For this study, Zinc acetate is investigational, it is not approved by the FDA for use in chronic cough. You will be in this study for 9 weeks. There are 6 study visits. Compensation is provided.