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398 active trials for Asthma

Phase 4 Study of Mepolizumab 100 Milligram (mg) Subcutaneous (SC) in Indian Subjects Aged >=18 Years With Severe Eosinophilic Asthma Requiring Maintenance Oral Corticosteroids

Mepolizumab is a humanized monoclonal antibody (IgG1, kappa) that blocks interleukin-5 (IL-5) thus inhibits production and survival of eosinophils. The aim of this phase 4, open-label, single-arm study is to evaluate the safety and efficacy of Mepolizumab 100 mg SC administered every 4 weeks in Indian subjects aged 18 years or above with severe eosinophilic asthma requiring oral corticosteroid (OCS) treatment to maintain asthma control. The study consists of four phases, OCS Optimization Phase (Week -8 to Week -3), an Induction Phase (Week 0 to Week 4), OCS Reduction Phase (Week 4 to Week 20) followed by Maintenance Phase (Week 20 to Week 24). In the Induction Phase subjects will be administered mepolizumab 100 mg subcutaneously every 4 weeks along with their Baseline asthma medications. This phase will allow sufficient time for subjects to achieve a decrease in the eosinophilic inflammation prior to the reduction in OCS. During the Optimization Phase, the investigator will adjust the OCS (prednisone/prednisolone) dose according to the Optimization titration schedule based on a review of Asthma Control Questionnaire (ACQ)-5 score and exacerbation. During the Reduction Phase, subjects will continue to receive 100 mg mepolizumab every 4 weeks and the OCS dose reduction will be done every 4 weeks using the reduction titration schedule based on a review of eDiary parameters recorded by the subject, the subjects' exacerbation history, and a review of the signs and symptoms of adrenal insufficiency. In the Maintenance Phase, subjects will be maintained during the last 4-weeks of the study without any further OCS dose adjustment.

PuneStart: June 2021
Microbiome and Exacerbations in Neutrophilic Asthma

Neutrophilic asthma (NA) is the least known severe asthma phenotype. It is associated with more exacerbations, worse control and impaired lung function. One of its possible etiologies is bronchial infections. The study of bronchial microbiology and its relationship with exacerbations is a new line of research. Objectives: 1) To analyze bronchial microbiome in patients with AN and non-neutrophilic (ANN), with frequent exacerbations and without exacerbations. 2) To relate the presence of bronchial infections with differences in the microbiome. 3) Correlate the characteristics of the microbiome with other evidence used in exacerbations. Methods: Prospective study involving 40 non-smoking asthmatics without bronchiectasis (20 with AN and 20 with ANN). Of these, 10 in each group will have frequent exacerbations (>2 rounds of systemic steroids in the last year, of >3 days each) and 10 non- frequent exacerbations. AN will be defined as >65% neutrophils in stable phase sputum. All patients will have two stable visits in which clinical variables, asthma control, lung function and induced sputum samples will be collected (for analysis of bronchial inflammatory cell count and for the study of the microbiome by 16 subunit rRNA). Specific Immunoglobulin A (IgA) for Chlamydia Pneumoniae will be determined. In exacerbations, sputum samples will be collected for culture and nasopharyngeal smears for the study of major respiratory viruses and bacteria by multiple polymerase chain reaction.

BarcelonaStart: January 2021
Effectiveness and Implementation of the Assessment of Burden of Chronic Conditions (ABCC)-Tool

This study is designed to evaluate the effectiveness and implementation of the Assessment of Burden of Chronic Conditions (ABCC)-tool for patients with COPD, asthma, diabetes mellitus type 2 or heart failure (and any combination of these conditions) in real-life routine practice. The ABCC-tool consists of a questionnaire, a visualisation using balloons that is based on cut-off points, and treatment advice. The ABCC-tool is intended to be used in daily healthcare practice, is designed to monitor a patient's integrated health status over time, to facilitate shared decision making, and to stimulate self-management. The study has a pragmatic clustered quasi-experimental design with two arms. The intervention group will use the ABCC-tool and the control group will receive usual care. The study will be implemented at a general practice-level, and has a follow-up period of 18 months. The primary outcome is change in perceived quality of care, as measured with the Patient Assessment of Chronic Illness Care (PACIC), as compared to usual care after 18 months. It is hypothesized that the change in perceived quality of care is significantly higher in the group using the ABCC-tool as compared to the group that receives usual care. Additionally the implementation of the ABCC-tool in general practices will be evaluated in 12 general practices. The implementation study will evaluate the context of caregivers with the Consolidated Framework for Implementation Research, the process of implementation with the RE-AIM framework, and fidelity to the intervention with the fidelity framework.

Maastricht, LimburgStart: October 2019