Asthma Clinical Trials - Mayo Clinic Research (2023)

  • Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients with Uncontrolled Asthma Rochester, MN

    The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.

  • Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics (CHINOOK) Rochester, MN

    The purposes of this study areto evaluate the effect of benralizumab on submucosal eosinophils in endobronchial biopsies as measured by major basic protein (MBP) staining, and to evaluate the effect of treatment with benralizumab on airway wall dimensions as measured by QCT imaging.

  • A Study to Evaluate Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants with Moderate-to-Severe Allergic Asthma Rochester, MN

    The purpose of this study is to test the effects of omalizumabon exercise capacity, physical activity, and sleep quality after 24 weeks of treatment in participants with moderate to severe allergic asthma. Exercise capacity will be assessed using cardiopulmonary exercise testing (CPET). Physical activity and sleep quality will be assessed with a wearable physical activity and sleep monitor.

  • Efficacy and Safety Study of Benralizumab to Reduce OCS Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus LABA and Chronic OCS Therapy Rochester, MN

    The purpose of this trial is to confirm if benralizumab can reduce OCS dependence (after dose optimisation) in patients who are uncontrolled on high-dose ICS-LABA, and chronically dependent on OCS as part of their regular asthma controller regimen.

  • Eosinophil/Asthma Study Rochester, MN

    The objectives of this study are to correlate concentrations of EDN in serum with peripheral blood eosinophil counts, to compare sensitivity and specificity of serum EDN and peripheral blood eosinophil counts for diagnosis of asthma, and to compare correlation of serum EDN and eosinophil counts with asthma disease severity. Data collected during this study will submittted to the FDAU and used to support the end goal of FDAapproval for this device.

  • Study of Safety of Foradil in Patients with Persistent Asthma Rochester, MN

    The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, asthma related intubations, and asthma related deaths) in adolescents and adults (12 years of age and older) taking inhaled formoterol fumarate/fluticasone propionate combination is the same as those taking inhaled fluticasone propionate alone.

  • A Study to Analyze Gut Microbiota Dysbiosis and Asthma Severity Rochester, MN

    The purpose of this study is to compare the gut bacterial and fungal microbiota profiles of patients with poorly-controlled asthma and patients with well-controlled asthma.

  • A Study for Predicting Asthma Stability After Decreasing Chronic Medications Using a Home Test Measuring Airway Inflammation Scottsdale/Phoenix, AZ

    The purpose of this study isfor patients who have decreased their chronic asthma medications to collect periodic homenasal swabs that measure levels of airway inflammation and may predict their asthma stability.

  • A Study of the Effectiveness and Safety of Mepolizumab as Adjunctive Therapy in Participants with Severe Eosinophilic Asthma Rochester, MN

    The purpose of this study is to evaluate the effectiveness and safety of mepolizumab adjunctive therapy in participants with severe eosinophilic asthma by measuring it on markers of asthma control. The overall intent of the current study is to more fully explore the impact of mepolizumab on health-related quality of life and other measures of asthma control, including lung function.

  • Minimally Invasive Biomarker for Asthma Disease Severity Scottsdale/Phoenix, AZ

    Can a clinical test be developed that could help manage asthma symptoms?

  • A Study of Cells in the Blood that may be Contributing to Allergic Inflammation in Asthmatics Rochester, MN

    The purpose of this study is to identify a new population of cells in the blood that may be contributing to allergic inflammation in atopic asthmatics.

  • A Safety Extension Study With Benralizumab for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist Rochester, MN

    The purpose of this study is to continue to characterize the safety profile of benralizumab administration and monitor the pharmacodynamic activity of the drug in those asthma patients who remain on treatment for at least 16 weeks and not more than 40 weeks in the predecessor study D3250C00021 (BORA).

  • Asthma Ascertainment and Characterization through Electronic Health Records Rochester, MN

    The purpose of this study is to look to see if automated chart review by computer predicts asthma status and asthma status characterization.

  • Olmsted County, Minnesota Air Quality (OMAQ) Study Rochester, MN

    The purpose of this study is to develop an Olmsted County nitrogen dioxide (NO2) model by assessing residential levels of indoor (eg, from gas stove or oven) and outdoor NO2 (eg, from motor fuels and power plants) using passive monitors placed for a 4-week period.

  • A Study to Implement Asthma Control Tests and Asthma Action Plans in the Retail Clinic Setting to Improve Minnesota Community Quality Measures in the Employee and Community Health Patient Population of a Large Medical Center Rochester, MN

    The purpose of this study is to provide asthma management in the retail clinic setting in order to increase standardized asthma quality metrics in the Mayo Clinic Rochester Employee and Community Health asthma patient population.

  • Registry of Asthma Patients Initiating DUPIXENT® Rochester, MN

    The purpose of this study is to characterize the patients who initiate treatment for asthma with DUPIXENT® in a real-world setting to understand the attributes of treated patients in real life. This includes characterization of patient demographics, and patient baseline characteristics (eg, prior medications and procedures, medical history, asthma history, weight, height). T

    Additionally to characterize real-world use patterns, safety, and long-term effectivenessof DUPIXENT® for asthmam and to assess effectiveness on comorbid type 2 inflammatory conditions in asthma patients treated with DUPIXENT® .

  • A Study to Develop and Implement the Asthma-Guidance and Prediction System to Improve Management of Asthma Symptoms in Children Rochester, MN

    Asthma is the most common chronic condition in children and one of the five most burdensome diseases in the United States.However, research and care for childhood asthmais limited by an inefficientuse of electronic medical records toassist withlarge-scale studies and care. The purpose of this studyis to test the use and effectiveness of the asthma-Guidance and Prediction System (a-GPS)within the Asthma Management Program, a current care coordination program for the asthma care of children aged 5-17 years at Mayo Clinic.

  • A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma Rochester, MN

    A randomized, multicenter, double-blind, placebo- controlled parallel-group study to determine the efficacy and safety of QAW039, compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1 second (FEV1) at the end of 12 weeks of treatment.

  • Pneumococcal Vaccines in Patients With Asthma Rochester, MN

    Investigators are assessing if patients with asthma respond better to the Pneumovax vaccine if they are given Prevnar initially.

  • A Study to Explore Changes in Gene Transcription and Immunophenotypes Following Mepolizumab Treatment for Asthma Rochester, MN

    The purpose of this study is to identify gene transcripts after initiation of mepolizumab in individuals with severe eosinophilic asthma (SEA), and to determine the composition of immune cells present in the microenvironment of individuals with SEA after initiation of mepolizumab.

  • Stopping Versus Continuation of Long-term Mepolizumab in Severe Eosinophilic Asthma Patients Rochester, MN

    Primary objective of the study is to evaluate whether patients with severe eosinophilic asthma who have received long-term treatment with mepolizumab (at least 3 years) need to maintain treatment with mepolizumab to continue to receive benefit.

  • PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study Scottsdale/Phoenix, AZ

    The purpose of this study isto evaluate several interventions given to participants with severe asthma. Interventions are administered in a crossover manner with 16-week treatment periods followed by 8 to 16 week washout.

  • A Study to Evaluate the Onset of Effect and Time Course of Change in Lung Function With Benralizumab in Severe, Uncontrolled Asthma Patients With Eosinophilic Inflammation Rochester, MN

    The purpose of this study is to investigate the onset and maintenance of effect of benralizumab on lung function, blood eosinophils, asthma control metrics and quality of life during 12-week treatment in patients with uncontrolled, severe asthma with eosinophilic inflammation. A subset of patients will take part in body plethysmography substudy to further investigate the effect on lung function.

  • Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma Rochester, MN

    The primary objective of the study is to evaluate the effect of 3 dose levels of MEDI9929 (AMG 157) on asthma exacerbations in adult subjects with inadequately controlled, severe asthma.

  • Immune Response to Pneumococcal Polysaccharide Vaccine (23-valent) Predicts Asthma Status and Outcomes in Late Adolescents With Asthma Rochester, MN

    Advisory Committee for Immunization Practices (ACIP) from the Centers for Disease Control (CDC) recommends that children (6-18 years) and adults (≥19 years old) with chronic lung condition such as asthma or cigarette smoking be vaccinated with Pneumococcal vaccine (PPSV23). The purpose of this study is to increase awareness of vaccination to late adolescents with asthma and smokers (social aspect of study), and to recommend vaccination (which is the clinical aspect). Individuals who agree to receiving vaccine will be enrolled in research to determine whether late adolescents with and without asthma (smokers) have distinctive pneumococcal vaccine response patterns and whether such ...

  • Study of Fluticasone Propionate MDPI Compared With Fluticasone/Salmeterol MDPI in Adolescent and Adult Patients With Persistent Asthma Rochester, MN

    Study drug and placebo will be supplied in Teva multidose dry powder inhaler (MDPI) devices and provided for participants to use at home. Participants will perform spirometry at every visit. Each participant will be given a diary at each visit for use until the next visit. Rescue medication (albuterol/salbutamol) will be dispensed at each visit, if needed, as determined by the investigational center personnel.

  • Study of Reslizumab in Patients With Uncontrolled Asthma and Elevated Blood Eosinophils Rochester, MN

    The primary objective of this study is to determine the effect of reslizumab (110 mg) administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and adolescents with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care asthma therapy.

  • A Study of the Effects of Preterm Birth on Lung Disease and Innate Immunity Later in Life Rochester, MN

    The primary purpose of this study is to investigate the cytokine responses of blood ILC2s from preterm children by collecting peripheral blood at age 5-10 years from children born either preterm or at term, and to analyze the functions of their circulating ILC2s in vitro.

  • IL-33 Production by Nasal Epithelial Cells Rochester, MN

    This research study is being done for people who haveasthma and chronic rhinosinusitis, hay fever, or you do not have any sinus disease, asthma or hay fever (control). The aim of the study is to investigate the functions of nasal epithelial cells.

  • Recording Breath Acoustics and Lung Mechanics in Patients with COPD, Asthma, and Cystic Fibrosis Scottsdale/Phoenix, AZ

    The purpose of this study is to obtain breath acoustic recordings and measures of lung mechanics in patients with COPD, asthma, and cystic fibrosis breathing at rest and during light submaximal exercise.The plan is to examine these respiratory acoustics and mechanics in relation to determinants of disease and/or disease states (classic respiratory pathophysiology) and quality of life measures in these patient populations to determine if any relationship or patterns exist when comparing across respiratory diseases and within a condition based on disease severity.

  • A Study of the Safety and Effectiveness of Benralizumab to Treat Patients With Severe Uncontrolled Asthma Rochester, MN

    The purpose of this study is to investigate the effect of benralizumab on the rate of asthma exacerbations, patient reported quality of life and lung function during 24-week treatment in patients with uncontrolled, severe asthma with eosinophilic inflammation. A subset of patients will be assessed for their ongoing chronic rhinosinusitis with nasal polyps.

  • Excretion of Mast Cell Mediators in Children with Allergic Disorders Rochester, MN

    The aim of this study is to examine the role of mast cell mediators in children with allergic disorders in a two part study. Part 1 of the study will prospectively obtain the values of mast cell mediators, including 2,3 dinor 11β-PGF2α, n-MH, and LTE4 in the urine of a healthy pediatric reference population. Part 2 of the study will prospectively evaluate the urine concentrations of mast cell mediators in a cohort of pediatric allergic disorder patients including asthma, allergic rhinoconjunctivitis, eczema, urticaria, systemic anaphylaxis, and mast cell disorders, as well as POTS (postural orthostatic tachycardia syndrome). Comparisons of these ...

  • A Study of Whole Blood-based Blood Biomarker (i.e., cytokine) that May Predict Status and Severity of Diseases Rochester, MN

    The purpose of this study is to see if whole blood-based blood biomarker (i.e., cytokine) predicts status and severity of diseases such as asthma, Juvenile Idiopathic Arthritis (JIA), Rheumatoid Arthritis (RA), or Inflammatory Bowel Disease (IBD).

  • A Study of the Effectiveness of Palliative Care Consultation for Patients with Advanced Lung Disease Scottsdale/Phoenix, AZ

    The purpose of this study is todetermine theusefulness of palliative care consultationsby a specialtyphysician and a pulmonologist for patients who haveadvanced lung disease.

  • A Study to Evaluate the Effectiveness and Safety of Remdesivir to Treat Coronavirus Disease 2019 in an Outpatient Setting Rochester, MN

    The purpose of this study is toevaluate the effietivenessof remdesivir (RDV) in reducing the rate of of all-cause medically attended visits (MAVs; medical visits attended in person by the participant and a health care professional) or death in non-hospitalized participants with early stage coronavirus disease 2019 (COVID-19) and to evaluate the safety of RDV administered in an outpatient setting.

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