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Asthma; Eosinophilic 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: 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: NCT05404763 Recruiting - Asthma Clinical Trials

Mepolizumab and Physical Activity in Severe Asthma

TEXAS
Start date: February 2, 2023
Phase:
Study type: Observational

Severe asthma is a debilitating condition associated with frequent symptoms, life-threatening exacerbations and corticosteroid side-effects. Exercise limitation due to exercise-induced bronchoconstriction, dynamic lung hyperinflation and comorbidity may be a strong determinant of the disease burden. Mepolizumab is a monoclonal anti-interleukin-5 (IL-5) antibody that reduces the rate of severe exacerbations, asthma symptoms and oral glucocorticoid requirement, and improves quality of life and work productivity in severe eosinophilic asthma. However, its impact on physical activity and exercise tolerance is unknown. We hypothesize that a 6-month treatment with mepolizumab is associated with an improvement in daily life physical activity and exercise tolerance in relation with enhanced ventilatory mechanics.

NCT ID: NCT05078281 Recruiting - Clinical trials for Asthma; Eosinophilic

Patients With Severe Eosinophilic Asthma Treated With Benralizumab

Asthma
Start date: November 1, 2020
Phase:
Study type: Observational

Retrospective, multicenter, routine clinical practice study with consecutive inclusion of adult patients with severe eosinophilic asthma receiving benralizumab treatment.

NCT ID: NCT04565483 Recruiting - Severe Asthma Clinical Trials

Predictive Signature of Benralizumab Response

BENRAPRED
Start date: October 11, 2021
Phase: Phase 4
Study type: Interventional

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)

NCT ID: NCT04512521 Recruiting - Clinical trials for Asthma; Eosinophilic

Functional Lung MRI for Early Treatment Response Assessment for Patients With Eosinophilic Asthma

FUNLUM
Start date: May 4, 2020
Phase:
Study type: Observational

Patients with severe eosinophilic asthma will be placed on biologics if they continue to be uncontrolled despite maximized inhalation therapy or if they are only controlled under oral corticosteroids. Among biologics, 80% of patients respond to treatment and improve clinically, but approximately 20% are non-responders and up to date no established predictive factors for treatment response exist. Among the responders, about 30% respond very well (so-called super responders), the rest shows moderate improvements. As the lung function, one main criterion to evaluate treatment response improves in most patients with delay, the response (or non-response) to treatment can only be reliably estimated after 4 to 12 months. This can lead to prolonged use of medication in non-responders (overtreatment) on one hand and to unjustified and premature termination of therapy (undertreatment) on the other hand (GINA report 2019). Functional lung MRI has the potential to show early changes in lung microstructure, regional ventilation and perfusion and thus has the potential for early detection of therapy response. Very promising results of dynamic regional ventilation and perfusion mapping using phase resolved functional lung (PREFUL) MRI have been shown recently. However, if functional lung MRI can reliably detect treatment effects under Mepolizumab therapy and can help to predict a long-term patient outcome is still unknown. As these findings could directly influence clinical decision making this question is of high clinical relevance.