Active clinical trials for "Asthma"

Asthma currently affects 358 million individuals worldwide, posing a substantial burden on health care systems. In particular patients with severe asthma have higher morbidity, mortality and asthma-related costs than non-severe patients. The management of severe asthma is still an unmet need and improving the disease-related knowledge is important to optimize care pathways. Registries provide an opportunity to phenotypically describe a cohort of patients in real-world settings. We hypothesize whether patient profiling based on data in the Portuguese Severe Asthma Registry (RAG - Registo de Asma Grave) may contribute to identify predictors of disease control and therapeutic response. This study aims to (Coprimary Objectives): 1) Identify multidimensional phenotypes associated with health outcomes and therapeutic responses, based on demographic characteristics, clinical features and biomarkers; 2) Explore novel composite endpoint measures of disease control and evaluate its association with the different severe asthma profiles. This is a cross-sectional, observational, multicenter, real-world study. The study population are the patients of all ages with severe asthma included in the RAG, until Dec 2021. It is estimated that 150 patients will be enrolled, in approximately 12 sites throughout Portugal, which is expected to be a representative sample of Portuguese patients with severe asthma. Eligible patients will be invited to integrate RAG by clinicians at scheduled clinic appointments. The criteria for patients' inclusion in the RAG is based on the definition of Severe Asthma by GINA guidelines, based on step of treatment, adherence and comorbidities management. An additional inclusion criterion is the patient's signed consent to have his/her data included in the registry. The main data source of this project is the data collected by RAG, an electronic Case Report Form. Descriptive and inferential statistics will be used to characterize and compare the characteristics across different sub-groups. Advanced data-driven statistical methods, such clustering analysis and latent class analysis, will be used for phenotype classification. Multivariate logistic regression modelling and Classification and Regression Tree analysis will be considered. To address the potential limitations, the RAG has database specifications concerning data definitions and parameters and data validation rules enabling collection of data in the same manner for every patient, with specific and consistent data definitions. To minimize errors related to data completeness and consistency, several validation rules have been implemented and periodic data audits are planned. To avoid unnecessary burden within the clinical workflow, data will be collected at the time of routine medical appointments by the clinician and data entry personnel will assist on this task.

The purpose of this study is to assess the evolution of disease control, health-related quality of life, and the risk of severe asthma exacerbations in children and adolescents with persistent asthma in Spain at short, mid and long-term follow-up. Patient-reported information in this project is collected by computer assisted telephone interviews (CATI) and a mobile application (ARCA App).

The objective of the study is to establish the predictive value of early blood gene expression signature of Benralizumab response associated with a significant reduction of the number of exacerbations in treated severe asthmatic patients. This trial is a French, multicenter and no-randomized trial. Patients enrolled will be clinically followed for 16 months (the treatment period: 12 months and 1 month follow-up; 6 clinical visit on site and in phone call at 13 months)

The French Society for Respiratory diseases (SPLF), through its Asthma and Allergy working group (G2A), wishes to set up a national cohort of severe asthma patients to describe this population and the use of step 4 and 5 treatment. This study also meets the demand for post - registration studies required by the Health Authorities for biotherapies and bronchial thermoplasty. Other European or international cohorts of asthmatic patients exist and RAMSES could contribute to data sharing initiatives.

The primary purpose of this study is to provide preliminary data to determine if an acute increase in airway inflammation, provoked by an inhaled allergen challenge, is associated with an increase in microglial activation and may inform whether individuals with asthma, in the long-term, are at increased risk for neurodegeneration, cognitive decline, and forms of dementia. Though in the long-term airway inflammation may be associated with neurodegenerative processes, these changes reflect the accumulation over a lifetime of allergen exposures and disease-related changes. This relationship between peripheral inflammation and microglial activation is analogous to the impact of sleep loss. No single night of poor sleep will lead to long-term change in brain structure, function, or cognitive function, but the accumulation of frequent and repeated sleep loss over a lifetime has been shown to have a major impact. These data will be used for a larger scale study to determine if asthma is a risk factor for neurodegeneration, and will inform brain health issues in asthma more broadly.

Study is conducted to assess the prevalence and structure of comorbidity among patients undergoing abdominal surgery and produce the stratification of the risk of postoperative complications by identifying independent predictors for its development.

Our study aiming to look in improvement of Pediatric Respiratory Assessment Measure (PRAM) score as a primary outcome. The secondary outcomes involving the need for second step management, need for admission and possible side effects. It's double blinded randomized control study comparing Nebulized Epinephrine with standard treatment (salbutamol + Ipratropium) versus the standard treatment only in pediatric patient. A pilot study will be conducted before to detect the sample size required and data will be collected at deferent interval post treatment targeting intension to treat for analysis.

SIMAP is a triple-masked randomised trial aimed at assessing whether an automated system of pictograms associated to medical indications results in better comprehension and adherence of said indications. Adult patients with a recent diagnosis of asthma will be randomised to receive a pictographic depiction of their treatments and recommended interventions or standard communication without assistance from their attending physician. Patients will be followed-up for 60 days using the Asthma Control Questionnaire (ACT). The primary endpoint of this study is the degree of asthma control as assessed by the aforementioned questionnaire. Secondary outcomes include the number of hospitalisations, emergency care unit visits and the need to increase bronchodilator therapy as per current Global Initiative for Asthma guidelines. Outcomes will be analysed under the intention-to-treat principle by a statistician unaware of treatment allocation.

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.

Asthma is a syndrome compromising many phenotypes including N-ERD (caused by increased 4-series leukotriene (LT) production). n-3 PUFA supplementation modulates 4-series LT and has anti-inflammatory effects. However, other than in a pilot study with dietary manipulation, the effects of N-ERD are unknown. The primary objective is to determine whether n-3 PUFA supplementation in people with N-ERD can improve asthma control using the asthma control questionnaire (ACQ-7). This is a placebo controlled randomised controlled parallel multicentre study with of 6g per day of PUFA for 6 months in people with N-ERD and poor asthma control