The purpose of the study is to help doctors learn more about investigational dupilumab (the study drug) and to find out how safe it is and how well it works for patients with asthma. The study will investigate whether the study drug can help to improve the health of your lungs, reduce the inflammation in your airways and also improve your quality of life. If you join the study, your participation will last a minimum of 29 weeks and up to 41 weeks and is planned to include approximately 153 participants. The study will be conducted worldwide. If the study is suited for you, you will be randomized by chance (like drawing straws) to receive either the study drug (300 mg dupilumab) or placebo.
Youth with one or more chronic diseases are at increased risk of further complications, disease, or even early death as they enter their adult years. Recent increases in both asthma and obesity among youth have led to high health care utilization, increased health-related complications, and expanded risks of subsequent cardiovascular disease burden. The research team will develop educational content in core areas (e.g., fatigue, physical activity) for Managing AsThma AnD Obesity Related Symptoms (MATADORS), an mHealth technology-enhanced nurse-guided intervention. Youth with asthma and obesity and their primary caregivers will participate in interviews to explore their perspectives on barriers, facilitators, needs, and preferences toward adopting health behaviors, medication adherence, disease awareness, symptom self-management behaviors, and utilization of a mobile smartphone platform. Additional details on content availability, delivery approaches, system needs, and functionality will be explored through semi-structured interview questions. Health care providers (physicians, nurses, nurse practitioners, dietitians, and respiratory and exercise therapists) will be invited to participate in interviews to seek their input on patient-caregiver needs, priority clinical focal areas, recommendations for symptom self-management, and preferences for intervention delivery. Interview findings will be used to inform intervention and app design. Providing youth with strategies to enhance symptom self-management may result in decreased symptom prevalence, improved quality of life, and long-term reduction of cardiovascular morbidity and mortality as they move into adulthood.
Candidates for this study may or may not report disturbances in odor perception as their primary reason for seeking treatment at MUSC. This study is designed to collect long term, observational data from patients who are being treated with routine clinical care in health clinics at MUSC. Data from clinical questionnaires will be de-identified and stored in a database.
Asthma has high morbidity and mortality among adolescents and among youth from non-urban (i.e., rural and suburban) communities, both of whom are seldom included in asthma intervention research. This study will test the effectiveness and cost-effectiveness of high school-based intervention delivered by Community Health Workers (CHWs) to non-urban adolescents with uncontrolled asthma, and will examine factors associated with delivery of the intervention.
The TRANSFORM network is focused on improving child health outcomes in SC through research on conditions of highest priority for future generations. These include conditions like asthma, autism, diabetes, obesity and early childhood outcomes. To accelerate research study recruitment activities for future projects that TRANSFORM sites may participate in, the TRANSFORM network sites will create a research recruitment registry of families interested in volunteering for research. Participants will enter their own as well as their child(ren)'s information into the electronic registry which can be used to identify people to contact for future studies.