Active clinical trials for "Asthma"

Recognizing a decline in pediatric primary care visits and immunizations rates, an increase in utilization of the emergency room and stagnating academic achievement, leaders of MetroHealth Medical Center and the Cleveland Metropolitan School District understood that an innovative delivery option would be required to meet the needs of their pediatric urban population. In the fall of 2013, with support from local and regional funders, they collaborated to open the first School Based Health Center in Cleveland. During its first year, the MetroHealth School Health Program provided primary care services to children in 98 clinical care visits. Through an emphasis on population health and care coordination, the School Health Program has grew dramatically, completing over 2,400 visits in the 2017-2018 school year at clinical sites in over 13 schools. The School Health Program has been successful in developing a care management model to improve the percentage of students who complete recommended preventive services including immunization and preventive visits. The investigators intend to apply and expand upon lessons learned to develop an effective multi component asthma care management model that includes (1) registry utilization (2) evidence based clinical care protocols (3) implementation of an Environmental Screening Tool (4) effective utilization of a Medical Legal Partnership (5) effective partnership with an environmental health justice community organization, Environmental Health Watch, for home assessment and remediation (6) utilization of a unique data sharing partnership between a large health system and school district to document health and educational outcomes.

A trial to investigate if a single dose of the oral corticosteroid, Dexamethasone is as effective in treating exacerbations of asthma in children as 3 days of treatment with another oral corticosteroid, Prednisolone

Male and female subjects with mild to moderate asthma will be recruited to enroll in a 2-way crossover during which escalating doses of albuterol will be administered at 30 minute intervals on a single treatment day. Albuterol will be administered by the Halix albuterol unit dose disposable inhaler on one day and by Ventolin albuterol HFA MDI on the other day. Assignment to device for albuterol delivery will be by random allocation.

It has been observed that certain section of patients having severe to moderate Asthma, do not benefit from oral corticosteroids and IL-5 blocking biologics. There is increasing evidence that Airway auto immunity may be responsible for this poor response to treatment. It has been seen in earlier study done at Nair lab that these patients might benefit from Dupilumab, a biologic blocking IL-13/ IL-4. IL-13/IL-4 are the cytokines responsible for increased inflammation in these Asthmatics. The hypothesis is that blocking IL-13/IL-4 will also reduce the airway auto immunity which can be measured by comparing the auto immune markers in airway at baseline (before starting Dupilumab) and 16 weeks (after 4 months of Dupilumab treatment.

A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of ADX-629 in Subjects with Mild Asthma Induced by the Bronchial Allergen Challenge (BAC)

The primary objective of this study is to demonstrate the effectiveness of the Digital System (DS) in improving asthma control compared to the Standard of Care (SoC) group. The secondary objective is to describe the asthma management actions by investigational center health care providers (iHCPs) for all participants in both groups, to evaluate short-acting beta2 agonist (SABA) usage and the number of SABA-free days in the DS group, to evaluate adherence patterns to maintenance treatment (FS eMDPI) in the DS group, to assess behavioral correlates of responsiveness to digital health technology among participants for all participants in both groups, to evaluate work productivity and activity impairment in asthma participants in both groups, to assess the usability and acceptability of the DS by participants in the DS group and the investigational center personnel, and to evaluate the safety of FS eMDPI and Albuterol eMDPI.

Within the AGAVE project (2010-2014), funded by the 2008 AIFA (Italian Medicines Agency) Call (contract No. FARM8YRYZC), a severe/uncontrolled asthma online Registry (RItA) was implemented to assess the appropriateness of therapeutic strategies for severe/uncontrolled asthma patients, according to GINA (Global Initiative for Asthma) guidelines, in epidemiological and clinical samples. The online RItA Registry is a database containing information on patients' general characteristics, medical history, clinical data, risk factors, comorbidity, asthma exacerbations, current asthma treatment. Currently, it contains information on severe/uncontrolled asthma subjects, enrolled at national level, performing baseline (n tot=1018) and follow-up interviews (n tot=402). Aim of the RISER study is to increase knowledge about the risk factors, diagnosis, and management of severe/uncontrolled asthma in general population and clinical setting through the update and follow-up of the RItA registry. The RISER study is an observational longitudinal study involving a clinical setting and an epidemiological one. The field survey will comprise one or two follow-ups according to the sample. Observational longitudinal study in hospital specialist centres (clinical sample). Clinical cases of severe/uncontrolled asthma already included in the online RItA Registry and new clinical cases of severe/uncontrolled asthma attending the clinical centres and not yet included in the online RItA Registry, will be investigated at T0, T6 and T12 through a clinical form in order to collect information in accordance with the online RItA registry, and routine clinical/functional tests of asthma control. Observational longitudinal study in a general population sample (epidemiological sample). Epidemiological cases of severe/uncontrolled asthma from Pisa cohort already inserted in the online RItA Registry and new epidemiological cases of severe/uncontrolled asthma from pre-existing Pisa cohort not yet included in the online RItA Registry will be investigated at T0 and T12 through a questionnaire to collect information for feeding the online RItA registry. Subjects fitting the epidemiological definition of severe/uncontrolled asthma will be invited at the Pisa clinical centre to have routine clinical/functional tests. All data collected from clinical/epidemiological centres will be included in the RItA registry. Overall, it is expected to enroll 422 patients.

This is a pilot study in which the objective is to determine the feasibility of a randomized clinical trial investigating the safety and efficacy of OMT as an adjunctive treatment for patients with mild to moderate asthma compared to the same patient population without the use of OMT. OMT may be able to correct anatomical dysfunctions that contribute to increased symptoms in asthmatic patients. OMT's effect on asthma will be demonstrated by symptomatology reporting, frequency of medication use, and pulmonary function tests.

A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic Fluticasone Propionate 100 μg and Salmeterol Xinafoate 50 μg Inhalation Powder Compared with Advair Diskus® 100/50 in Subjects with Asthma

This is a Phase 3B, 12-week, multicenter, open-label study to evaluate the relationship between albuterol sulfate (ABS) eMDPI and clinical asthma exacerbation (CAE) in adult participants at least 18 years of age with exacerbation-prone asthma. The ABS eMDPI dose will be 90 micrograms (mcg), 1 to 2 inhalations every 4 hours as needed, but participant dosing will not be limited to this dosing regimen. The purpose of this study is to evaluate the relationship between albuterol dosing and CAE.