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Severe Asthma clinical trials

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NCT ID: NCT06455462 Recruiting - Severe Asthma Clinical Trials

Patient Characteristics, Treatment Patterns and Outcomes of Patients Enrolled in the Tezepelumab Patient Access Programme; a Retrospective, Observational Medical Chart Review Conducted in UK Severe Asthma Centres

TPAP
Start date: April 22, 2024
Phase:
Study type: Observational

This is a retrospective, observational chart review that will include patients with severe asthma (SA) who have participated in the tezepelumab patient access programme (TPAP). Electronic case report forms (eCRFs) will be used for data abstraction of clinical information from the health records of patients enrolled in the TPAP from eight NHS acute trusts. Approximately 200 patients with SA who took part in the TPAP with an index date (defined as the date of administration of the first dose of tezepelumab) between 1st January 2023 and 19th July 2023, and who meet the study eligibility criteria will be recruited to the study. Participation in the study does not affect the patients' treatment decisions since all data will be collected retrospectively from medical records. Key study definitions include: - Index date - the date of tezepelumab initiation (i.e., the date of first dose). - Pre-index period - defined as any time prior to tezepelumab initiation - Baseline period - defined as the 52 weeks prior to the index date - Outcomes period - defined as the 52 weeks post-index date. Patients will be followed up from their index date until the first of the following events (whichever is first): reach 52 weeks post-index, they switch to a different biologic treatment, die, or are otherwise lost to follow-up.

NCT ID: NCT06421402 Enrolling by invitation - COPD Clinical Trials

K-HEALTH in AIR - Barcelona Pilot - Cohort

Start date: October 13, 2023
Phase:
Study type: Observational [Patient Registry]

The study protocol is part of the European (EU) project "Knowledge for improving indoor AIR quality and HEALTH" (K-HEALTHinAIR, 2022-2026 - registry 101057693), which focuses on enhancing our understanding of how poor indoor air quality (IAQ) affects human health. Specifically, the project aims to identify IAQ determinants of adverse health events and to explore the development of cost-effective strategies for the precise monitoring and improvement, of IAQ across Europe. With the current study protocol, the Barcelona Pilot, at the Integrated Health District of Barcelona-Esquerra (AISBE, 520 k citizens), is conducting a cohort study over a two-year period (January 2024 to December 2025) to explore the relationships between IAQ (assessment of chemical pollutants in patients' homes) and health status (acute episodes) in multimorbid patients with chronic respiratory diseases (asthma and Chronic Obstructive Pulmonary Disease - COPD) over a two-year period. The protocol investigates the effectiveness of customized interventions across four critical areas: i) Advanced lung function testing, ii) Continuous IAQ monitoring, iii) Advanced digital support to innovative clinical processes, and iv) Predictive modeling for early identification and management of exacerbations. The ultimate objective is to design and evaluate an innovative integrated care service aiming at enhancing both IAQ and the management of multimorbid patients with chronic obstructive respiratory diseases, with focus on COPD and severe asthma.

NCT ID: NCT06389058 Active, not recruiting - Severe Asthma Clinical Trials

Using NLP and Neural Networks to Autonomously Identify Severe Asthma and Determine Study Eligibility in a Large Healthcare System

Start date: May 1, 2023
Phase:
Study type: Observational [Patient Registry]

The study aims to to use new technologies (ML, AI, NLP), to autonomously identify moderate to severe asthma populations within an EHR system, describe differences in treatment patterns across different populations, and determine trial eligibility. Primary Objectives Please ensure you detail primary objectives Aim 1. Determine and validate a diagnosis of severe asthma (SA) using predictive features obtained from the Scripps Health EHR. - Aim 1a: Use ML applied to structured EHR data to predict SA. Use the opinion of 2 specialty-trained physicians and ATS guidelines to determine model accuracy. - Aim 1b: Use NLP applied to unstructured text to predict SA. Determine model accuracy as above in Aim 1a. - Aim 1c: Use a combination of ML applied to structured data to predict SA. Determine model accuracy as above in Aim 1a.

NCT ID: NCT06283290 Recruiting - Severe Asthma Clinical Trials

PROPE Severe Asthma Study in Egypt

Start date: March 12, 2024
Phase:
Study type: Observational

Asthma is a syndrome characterized by airway inflammation, reversible airway obstruction, and airway hyper-responsiveness. Patients present clinically with recurrent wheezing, shortness of breath, cough, and chest tightness. Asthma is a leading cause of morbidity with a global prevalence of approximately 300 million; it is estimated that the number of people with asthma may increase to 400 to 450 million people worldwide by 2025. Severe asthma is not considered a single disease; instead, it is divided into several phenotypes, owing to the variety of inflammatory, clinical, and functional characteristics that it can present with. One of the proposed and most studied phenotypes is severe eosinophilic asthma. Patients with severe asthma that is accompanied by a high concentration of eosinophils require greater healthcare resource use, greater disease management costs, and a much more impaired QoL than those who do not present with raised eosinophilia. While the number of targeted treatments for asthma management has been growing in recent years, the heterogeneity of clinical presentations, treatment responses, and inflammatory processes involved represent an added challenge for health care professionals. Thus, severe asthma management is a complex endeavor, and a thorough and up-to-date understanding of the pathophysiologic characteristics of the patient population promotes effective therapeutic decision-making. This cross-sectional, multicenter study aims to determine the prevalence of oral corticosteroid (OCS) use among severe asthma patients who attend to different sites specialized in the management of severe asthma across Egypt. In addition, the prevalence of eosinophilic phenotype of blood eosinophil count ≥ 150 cells/mm3, prevalence of atopic phenotype, and asthma control will also be studied.

NCT ID: NCT06239441 Completed - Severe Asthma Clinical Trials

Effectiveness of Anti-IL-5/IL5R Inhibitors

Start date: February 16, 2021
Phase:
Study type: Observational

The goal of this observational study is to assess the response to treatment, in patients 18 years and older diagnosed with severe asthma in whom an IL5/IL5R antagonists was initiated between 2012 and 2020. The main question[s] it aims to answer are: - What is the response rate after one year of treatment with IL5/IL5R antagonists. - What is the response and remission rate after one year of treatment with IL5/IL5R antagonists in subjects who fullfilled the original randomized control trials (RCTs) inclusion criteria compared with those who did not.

NCT ID: NCT06196879 Recruiting - Severe Asthma Clinical Trials

A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)

Start date: February 27, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of verekitug (UPB-101) in participants with severe asthma. The study will evaluate the incidence of asthma exacerbations, other pharmacodynamic (PD) parameters such as lung function and asthma control, and the safety and tolerability of verekitug (UPB-101) compared to placebo.

NCT ID: NCT06126692 Recruiting - Severe Asthma Clinical Trials

3TR Asthma Biologics Cohort (ABC) Study

3TR-ABC
Start date: January 10, 2022
Phase:
Study type: Observational

The 3TR-ABC study is a multicentre observational prospective cohort study platform that follows patients with severe asthma from the start of biological therapy and three years onwards. In the 3TR-ABC platform, individual studies are conducted on specific biologics, using aligned study designs. The aim of the study is to assess response to treatment and examine clinical characteristics, biomarkers, and immunological mechanisms related to response, including remission and non-response, that might be new targets or explanations for insufficient treatment. Patients will be extensively characterized at baseline and then followed throughout the years with formal clinical and biological assessment at 4, 16, 52 weeks, and 2, 3 years. Based on the response to treatment, patients will be stratified into remission, clinical responders, and non-responders, and pre-treatment biomarker profiles obtained at the baseline visit will be compared, as well as the immunological response to treatment. Healthy individuals and patients with mild/moderate controlled asthma are included as reference groups and will undergo the same baseline visit as patients with severe asthma. Several bio-samples, to perform multi-omic analysis, will be taken to examine biological pathways associated with response and non-response to biologics.

NCT ID: NCT06035289 Recruiting - Severe Asthma Clinical Trials

Register Schweres Asthma - German Asthma Net e.V.

Start date: November 1, 2011
Phase:
Study type: Observational [Patient Registry]

The German Asthma Net e.V. focusses on science and research in patients with severe asthma. This includes, in particular, the optimization of medical care and treatment for patients with severe asthma as well as the elucidation and information. An unavoidable basis for a better understanding of severe asthma is the registration and comprehensive characterization of a large patient population. To date, there are only few reliable data on incidence, prevalence, phenotypes and treatment of patients with severe asthma. For this reason, the German Asthma Net e.V. was established in December 2011 as a clinical registry for patients with severe asthma, initially set up on a national basis.

NCT ID: NCT06024902 Completed - Severe Asthma Clinical Trials

Clinical Characteristics of Severe Childhood Asthma

Start date: January 1, 2021
Phase:
Study type: Observational

Asthma remains a serious health problem with increasing prevalence and incidence. There is limited information about severe asthma among Chinese pediatric patients. In this context, we decided to explore the clinical characteristics and risk factors of severe asthma in children. This is a descriptive, observational, retrospective cohort study in children with asthma. The purpose of this retrospective study is: to determine the clinical characteristics of severe asthma of children; to identify the factors associated with severe childhood asthma.

NCT ID: NCT05946421 Recruiting - Severe Asthma Clinical Trials

The BASA Study: Breath Analysis for Severe Asthma Patients

Start date: July 4, 2023
Phase:
Study type: Observational

This study will evaluate the fluctuations of exhaled breath markers in patients with severe asthma on biologics. In the study, severe asthma patients will be followed up to 16 weeks monitoring lung function and inflammation through non-invasive technologies such as exhaled breath analysis (FeNO, GC-MS and EBC). A control group will be followed up to two weeks with the overall objective to indentify and evaluate the modifcations of markers of inflammation in patient under biologic treatment.