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Pulmonary Eosinophilia clinical trials

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NCT ID: NCT06288516 Recruiting - Clinical trials for Asthma; Eosinophilic

BenRalizumab Effect on Airway Remodeling in Severe asTHma

BREATH
Start date: March 1, 2024
Phase: Phase 4
Study type: Interventional

Response to biologic therapies in severe asthma is variable, with patients being either non-responders, responders or super-responders. There is currently no explanation for this broad variation in response. It is important to examine whether these patients have distinct characteristics that could help the treating physician in making the correct diagnosis in clinical practice. Aim of this clinical study is to evaluate the efficacy of benralizumab, a humanized an anti-interleukin 5 receptor α monoclonal antibody in patients with severe eosinophilic asthma and to evaluate airway remodeling before and after benralizumab treatment. Hypothesis Identification of pathological and clinical characteristics in patients with severe eosinophilic asthma after benralizumab treatment regarding the airway remodeling, inflammatory cells, and other biomarkers on a long-term basis. Research questions Is there any improvement in airway remodeling? Are there any biomarkers to predict response to benralizumab treatment in severe eosinophilic asthmatic patients?

NCT ID: NCT06069310 Recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

Mepolizumab Effectiveness in Patients With Chronic Rhinosinusitis, Nasal Polyps and Comorbid Severe Eosinophilic Asthma

MepoRiNaPAs
Start date: September 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about clinical and functional outcomes in patients with Chronic rhinosinusitis with nasal polyps and comorbid Severe Eosinophilic Asthma and patients with Chronic rhinosinusitis with nasal polyps only treated with mepolizumab compared to healthy controls. Participants will be asked to give nasal, blood and sputum samples before mepolizumab administration (T0) and at 3 (T3), 6 (T6) and 12 (T12) months after mepolizumab initiation The main aims are to identify airways microbiota modifications and differential gene expression after mepolizumab initiation. Researchers will compare: - Patients with Chronic rhinosinusitis with nasal polyps and comorbid Severe Eosinophilic Asthma - Patients with Chronic rhinosinusitis with nasal polyps only - Healthy subjects The research will address the following questions: 1. What are the prospective clinical and functional outcomes of mepolizumab treatment 2. What is the impact of mepolizumab therapy on the airways microbiota and how this may relate to a potentially reduced need for steroids 3. What are the host differential gene expression patterns and the immune/inflammatory (cytokines/chemokines) profile alterations in airways microenvironment and in systemic circulation in response to therapy 4. What are the associations between host and microbiome variables for building up diagnostic and predictive biomarker classifiers of responsive disease endotypes

NCT ID: NCT05985694 Recruiting - Eosinophilic Asthma Clinical Trials

AD17002 Treating Poorly Controlled, Moderate to Severe Eosinophilic Asthma

Start date: November 27, 2023
Phase: Phase 2
Study type: Interventional

This clinical trial aims to investigate patients with poorly controlled, moderate to severe eosinophilic asthma. The main questions it aims to answer are 1. Could the LTh(αK) intranasal treatment improve the clinical condition of these patients? 2. Could patients self-administrate LTh(αK) via the intranasal route? 3. Is the LTh(αK) at multiple doses safe for asthmatic patients? 4. Participants will be asked to self-administrate two doses per week for a total of 6 weeks (11 doses). A diary on LTh(αK) usage, adverse events, and reliever medication will be recorded.

NCT ID: NCT05942222 Recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

A Randomized, Real-world Head-to-head Study of Dupilumab Versus Mepolizumab in Danish CRSwNP Patients

TORNADO
Start date: April 27, 2023
Phase: Phase 4
Study type: Interventional

The goal of this randomized clinical trial is to compare the effects of two newly available biological drugs for the treatment of severe chronic rhinosinusitis with nasal polyps in Danish patients. The main questions it aims to answer are whether the two drugs are comparable in effect after 24 weeks in terms of: - A subjective score (the SNOT-22) - An objective score, i.e.the physician-assessed score of nasal polyp size (the Nasal Polyp Score (0-8)) Methods: Participants will be randomized into two groups and receive either drug in the standard dose. After 24 weeks the effect is assessed. If the clinical effect is sufficient in terms of the criteria set by the Danish Medicinal Council (see elsewhere), treatment continues with the same drug for an additional 24 weeks. If the effect criteria are not met, the subject crosses-over to the opposite drug for an additional 24 weeks. After 48 weeks the effect is assessed once more.

NCT ID: NCT05813288 Recruiting - Asthma Clinical Trials

A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma (EXHALE-3)

EXHALE-3
Start date: March 27, 2023
Phase: Phase 3
Study type: Interventional

The objective of this clinical study is to investigate the safety, tolerability, and efficacy of dexpramipexole in participants with inadequately controlled severe eosinophilic asthma.

NCT ID: NCT05787678 Recruiting - Clinical trials for Asthma; Eosinophilic

Dupilumab Efficacy on Bronchial Inflammation, Small Airways Disfunction and Mucous Secretion

DEBORA
Start date: October 1, 2023
Phase:
Study type: Observational

Unicentric prospective real life study designed to analyse the efficacy of Dupilumab to reduce bronchial inflammation of asthma measured by inflammatory cell counts obtained in induced sputum and other related characteristics (small airway dysfunction and mucin production) in uncontrolled severe asthma patients in the real life setting without control group

NCT ID: NCT05763121 Recruiting - Asthma Clinical Trials

A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma.

EXHALE-2
Start date: January 30, 2023
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of dexpramipexole as an adjunctive oral therapy in participants with inadequately controlled asthma with an eosinophilic phenotype and a history of asthma exacerbations.

NCT ID: NCT05748600 Recruiting - Clinical trials for Asthma; Eosinophilic

A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma

EXHALE-4
Start date: January 30, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate dexpramipexole as an add-on oral therapy in participants with inadequately controlled eosinophilic asthma to evaluate improvements in lung function, asthma control, and quality of life. In addition, the study will further evaluate the safety and tolerability of dexpramipexole in participants with eosinophilic asthma.

NCT ID: NCT05692180 Recruiting - Asthma Clinical Trials

A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)

DOMINICA
Start date: April 5, 2023
Phase: Phase 3
Study type: Interventional

A study to evaluate the efficacy and safety of benralizumab administered subcutaneously in patients ≥ 6 to < 18 years of age with severe eosinophilic asthma, including a well-documented history of asthma exacerbations and uncontrolled asthma receiving high-dose inhaled corticosteroid (ICS) plus at least one additional controller medication.

NCT ID: NCT05440656 Recruiting - Clinical trials for Severe Eosinophilic Asthma

A Real World Study to Capture Clinical and Patient Centered Outcomes in Adults With Severe Eosinophilic Asthma Treated With Benralizumab.

EMPOWAIR
Start date: June 29, 2022
Phase:
Study type: Observational

Severe eosinophilic asthma (SEA) is associated with poor disease control and compromised health-related quality of life (HRQoL), leading to a substantial psychosocial and economic disease burden. Benralizumab (Fasenra®), an interleukin (IL)-5-alpha receptor monoclonal antibody, is approved as an add-on maintenance treatment for SEA. This study aims at collecting real-world data that extend beyond the clinical effectiveness of benralizumab to the participant-reported impact of treatment on their HRQoL, sleep quality, depression, anxiety, work productivity and activity impairment, but also on treatment effectiveness. Recent technological advances in portable spirometers and wearable activity trackers (WAT) to increase physical activity for participants with asthma, even for older participants, allow this study to collect data on lung function parameters and physical activity from such devices for the first time at a country level in Greece. Using a multi-aspect approach, this study will generate real-world evidence on a broad range of both well-established clinical and novel patient-centered outcomes which are critical to the assessment of the therapeutic benefit both from the physician's and the participant's perspective. All main study outcomes will be examined at various timepoints throughout the course of the 48-week observation period, starting as early as 4 weeks after treatment initiation, thus enabling the identification of 'early' treatment responders with a closer focus on patients' physical and psychological well-being and HRQoL in addition to asthma control and lung function metrics