View clinical trials related to Asthma.
Filter by:This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 4 parts: Part 1 is a single ascending dose (SAD) study in healthy volunteers; Part 2 is a multiple ascending dose (MAD) study in subjects with stable, mild asthma; Part 3 is a repeat dose in patients with moderate to severe asthma and Part 4 is a repeat dose in patients with COPD.
Despite a strong evidence-base for the efficacy of multilevel programs in reducing asthma symptoms among low-income preschool minority children, gaps remain in our understanding of how to best translate and scale up these efficacious interventions into sustainable programs that reduce known asthma health disparities. Head Start (HS) serves over one million low income children in the US each year by focusing on early learning, physical health, and family engagement. HS is committed to implementing evidence based programs to promote overall child well-being, and is focused on addressing asthma symptoms due to the deleterious impact on school absences and child development. We have demonstrated the effectiveness of a multi-level staff and family education program (ABC Asthma) that significantly reduced asthma symptoms and courses of oral corticosteroids. However, these interventions are not successfully integrated within community organizations for long-term sustainability. It is unknown how to best scale up and implement these evidence based asthma interventions into low resource community organizations that serve children at risk. Implementation strategies are frequently developed atheoretically and may not be tailored to the setting. The overall purpose of this project is to inform best practices of implementation of an asthma education program by 1) systematically evaluating the use of intervention mapping to develop a tailored implementation strategy in partnership with Head Start stakeholders, 2) examining both staff and organizational level determinants associated with implementation of ABC Asthma, and 3) evaluating the success of tailored implementation strategies on implementation outcomes and school absences and other health outcomes. The YMCA of Central Maryland have enthusiastically agreed to implement the Maryland ABC HS Asthma within 40 sites in four communities: Baltimore City, Baltimore County, Anne Arundel County, and Prince George's County.
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.
Asthma is a heterogeneous disease, characterized by reversible airflow obstruction, airway hyperresponsiveness, and airway inflammation, in which 40% of patients exhibit eosinophil-driven pathobiology.The main treatment of asthma is the use of corticosteroid, whose use induces a reduction in eosinophils that is considered a strong predictor of response to treatment. Corticosteroids have remained the mainstay treatment of asthma and reduction in eosinophils has remained the unequivocal predictor of steroid response. The prevalence of asthma, which is expected to increase, it is about 300 million people worldwide. About 5-10% of asthma patients have severe disease, which is defined as asthma that requires high-dose inhaled corticosteroids (ICSs) plus a second controller to prevent it from becoming "uncontrolled" or which remains "uncontrolled" despite this therapy. Patients with severe disease have worse quality of life, and disproportionately high morbidity, mortality, and use of health care resources when compared with their peers with well-controlled disease.The pathophysiology of asthma is complex and heterogeneous between patients, as the disease itself; however, on the basis of immune system involvement, it is possible to define 2 subtypes - or endotypes- of asthma. These endotypes are named T2 (for type 2 cells) high or low, and are defined by the levels of expression of the T2 cytokines, IL-4, IL-5, and IL-13 produced by T helper 2 lymphocytes, and innate lymphoid cell-2.T2 high endotype patients display an increase in the number of blood and sputum eosinophils, and have a better response to the current available biological therapies , such as the administration of mepolizumab (anti IL-5 antibody). Eosinophilic asthma is associated to a more severe clinical phenotype,but patients with a T2 endotype respond better to biological therapies. The hypothesis of the present proposal is that the activation status of these cells, analyzed by the expression of activation markers, can be used to define a new, different, endotype, in which eosinophils, although quantitatively low or normal, are qualitatively more active and aggressive, and could therefore act as an indicator of the progression toward a T2 high endotype.Moreover, the investigators will verify whether a different expression of these molecules on eosinophil's surface might be associated with different clinical response to biologic medications.
Primary Objective -To evaluate the efficacy of dupilumab compared to omalizumab in reducing the polyp size and improving sense of smell Secondary Objectives - To evaluate the efficacy of dupilumab in improving CRSwNP symptoms at Week 24 compared to omalizumab - To evaluate the efficacy of dupilumab in improving lung function at Week 24 compared to omalizumab - To evaluate the efficacy of dupilumab in improving CRSwNP total symptom score (TSS) at Week 24 compared to omalizumab - To evaluate the effect of dupilumab on health related quality of life (HRQoL) at week 24 compared to omalizumab - To evaluate the efficacy of dupilumab in improving nasal peak inspiratory flow at Week 24 compared to omalizumab - To evaluate the effect of dupilumab on CRSwNP overall disease severity at Week 24 compared to omalizumab - To evaluate the effect of dupilumab on asthma control at Week 24 compared to omalizumab - To evaluate the safety of dupilumab and omalizumab
This trial is being completed to determine baseline inhalation parameters and patterns of use in patients receiving treatment with TEVA digital inhalers, to develop predictive models for asthma exacerbations and response to biologics using data collected from these devices. Enrolled participants will complete questionnaires along with other study specific procedures. Additionally, in-person and phone visits will be performed.
The goal of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of a technology-enhanced educational intervention for caregivers and children who are hospitalized due to asthma. We will conduct a pilot RCT with 60 children (5-13 yrs) hospitalized with asthma at the Golisano Children's Hospital in Rochester, NY. After baseline assessment, subjects will be randomized to either: 1) the Telehealth Education for Asthma Connecting Hospital and Home (TEACHH) intervention, which includes inpatient child/caregiver education using pictorial materials, color/shape labels for home medications (green star=controller, yellow/red circles=rescue), and a pair of in-home, smartphone-based telehealth visits after discharge to reinforce effective home management; or, 2) the standard care (SC) condition, which features standard inpatient education and routine outpatient follow-up. Patients in TEACHH will also receive all SC measures. All caregivers will complete blinded telephone follow-up assessments at 2, 4, and 6 months after discharge; children will be asked medication questions at baseline and 6 months. We will describe the feasibility and acceptability of implementing the TEACHH intervention by reviewing process measure data collected throughout the study; assess the preliminary efficacy of TEACHH in improving key clinical outcomes, including asthma-related ACU at 7 days, 30 days, and 6 months (per electronic health record documentation) and symptom-free days at each follow-up (reported by caregivers); and assess secondary clinical and functional outcomes including asthma-related quality of life, missed school or work due to asthma, caregiver and child medication knowledge, and reported adherence. We will also invite all caregivers to complete a semi-structured qualitative interview (1 month after baseline for the TEACHH group, 6 months after baseline for the SC group). Findings from this work will establish a strong foundation for a full-scale trial, and guide future efforts to deliver guideline-based asthma care to underserved children and families at the greatest risk for preventable morbidity.
This is Phase I first-in-human trial evaluating the safety, tolerability, immunogenicity, and pharmacogenomics of LQ036 via inhalation and IV infusion. The study will be divided into 4 parts: Single Ascending Dose, Multiple Ascending Dose, and Intra Venous with a target of 88 healthy volunteers and 30 patients with mild Asthma.
This is a real-world, observational, prospective cohort study in patients with severe asthma recruited into the International Severe Asthma Registry (ISAR) and the US severe asthma registry (CHRONICLE) and followed-up for occurrence of new malignancies. The primary objective is to measure the incidence of malignancy in the overall severe asthma population as well as its relevant subgroups, including patients receiving benralizumab, patients receiving non-benralizumab biologics, and patients not receiving biologics. The secondary objective is to describe the clinical characteristics of new malignancy cases that develop in severe asthma patients and relevant subgroups.
This randomized controlled trial aims to examine the effectiveness of the Acceptance and Commitment Therapy-based Asthma Management Training Program on the health outcomes of asthmatic children with attention deficit hyperactivity disorder (ADHD) and their caregivers over a 12-month post-intervention.