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Eosinophilic Asthma clinical trials

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NCT ID: NCT06388889 Enrolling by invitation - Eosinophilic Asthma Clinical Trials

Phase III Long-Term Extension Study With Dexpramipexole

EXHALE-5
Start date: May 8, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial] is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma, aged ≥12 years, on Global Initiative for Asthma (GINA) 2021 [GINA, 2021] Step 4 or 5 therapy and who completed either of the Phase III studies EXHALE-2 or EXHALE-3.

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: 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: 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: NCT05398133 Recruiting - Eosinophilic Asthma Clinical Trials

Phenotype Assessment of Blood and Airway Eosinophils in Patients With COPD and Asthma

Start date: September 1, 2020
Phase:
Study type: Observational

Around 1/3 of patients with COPD have elevated eosinophil levels. However, the role of eosinophils in COPD has not been yet understood and is probably different in COPD and in asthma. The aim of this study was to assess the expression of selected surface markers on eosinophils and to assess the gene expression in eosinophils in COPD and asthma patients. We are planning to enrol 12 COPD, 12 asthma and 12 control subjects. Patients will undergo routine clinical assessment, spirometry, blood sampling and sputum induction. Eosinophils will be isolated from blood and sputum. Surface markers on eosinophils will be assessed in flow cytometry, gene expression will be assessed by RNAseq.

NCT ID: NCT05002621 Completed - Eosinophilic Asthma Clinical Trials

Changes in Gene Transcription and Immunophenotypes Following Mepolizumab Treatment for Asthma

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

The purpose of this study is to identify gene transcripts after initiation of mepolizumab in individuals with severe eosinophilic asthma (SEA), and to determine the composition of immune cells present in the microenvironment of individuals with SEA after initiation of mepolizumab.

NCT ID: NCT04674137 Completed - Bronchial Asthma Clinical Trials

XC8 in the Treatment of Patients With the Eosinophilic Phenotype of Bronchial Asthma

Start date: December 16, 2020
Phase: Phase 2
Study type: Interventional

A multicenter, double-blind, randomized, pilot study in parallel groups to assess the efficacy and safety of XC8 at a dose of 100 mg versus placebo over a 12-week treatment period in non-smoking patients with a confirmed bronchial asthma (BA) and the eosinophil blood level 2 times within 1 week interval of ≥ 300 cells/μl. Study design was developed by Chemlmmune Therapeutics LLC, Russia in cooperation with Eurrus Biotech GmbH, Austria.

NCT ID: NCT04671446 Recruiting - Clinical trials for Eosinophilic Esophagitis

Identification of Autoantigens in EGPA and Severe Eosinophilic Asthma

IDEA
Start date: December 10, 2020
Phase:
Study type: Observational

In this project the investigators will look for auto-antibodies to relevant proteins both in native form and importantly in post-translationally modified forms. Potential modified auto-antigens are eosinophil proteins (analogous to the cytoplasmic neutrophil proteins identified in vasculitides such as Granulomatosis with Polyangiitis (formerly known as Wegener's granulomatosis) and alternatively structural proteins such as collagen V. As well as advancing the understanding of asthma pathology, identifying a serum auto-antibody that could then be used as a clinical blood test, analogous to anti-cyclic citrullinated peptide (CCP) antibodies in rheumatoid arthritis, may revolutionise diagnosis of severe eosinophilic asthma and Eosinophilic Granulomatosis with Polyangiitis (EGPA). There is a considerable burden of undiagnosed severe eosinophilic asthma in part due to difficulties in definitive diagnosis and a diagnostic blood test would help diagnose these patients, allowing them to receive necessary treatment.

NCT ID: NCT04641741 Recruiting - Asthma Clinical Trials

Effect of Mepolizumab on Severe Eosinophilic Asthma

EMESEA
Start date: April 1, 2021
Phase:
Study type: Observational [Patient Registry]

Two parts: A:Case-control study including 15 healthy adult donors and 15 severe adult eosinophilic asthmatics selected for treatment with mepolizumab. B: A longitudinal cohort study,where the same patients once on mepolizumab treatment are followed over time (0, 4, 16 and 32 weeks). SCOPE: response to mepolizumab in severe adult eosinophilic asthma. INCLUSION CRITERIA: Male or female, 18-75 years-old, with severe eosinophilic asthma. EXCLUSION CRITERIA: Smoking history, recent exacerbations, other pulmonary or systemic disease with eosinophilia, malignancy, pregnancy, obesity (BMI >35). OBJECTIVES: General objective: Discovery of predictive/prognostic biomarkers of response to mepolizumab using flow cytometry, transcriptomic, and proteomic technologies. OTHER OBJECTIVES: 1.-To identify changes in surface markers of eosinophils and eosinophil subpopulations in response to treatment with mepolizumab using flow cytometry techniques. 2.-Transcriptomic analysis to identify mRNAs within the eosinophil transcriptome displaying enhanced or reduced levels in response to treatment with mepolizumab.3.-Proteomic profiling to identify proteins with differential abundance within the eosinophils in response to treatment with mepolizumab.4.-Check whether late-onset severe eosinophilic asthmatics display elevated levels of IGF-1, IGF-BP3, IGF-ALS in serum samples, if the response of mepolizumab depends on the levels of this markers, and if treatment with this biological reduces the concentration in serum of these IGF-family members. 5.-Identify proteins with differential abundance within the deep serum proteome of patients with SEA in response to treatment with mepolizumab by means of non-targeted proteomic analysis. MEASUREMENTS: Flow cytometry assays with multimarker panels 1 (regulatory), 2 (activation), and 3 eosinophil subsets. Clinical, hematological, biochemical and flow cytometry data generated at times T4, T16 and T32. Total RNA extraction from eosinophil lysates, assay of quality and quantity of RNA, and storage at -80ºC. Evaluation of the levels of 770 human protein-coding mRNAs linked to the recruitment, activation, and effector functions of myeloid cells by means of a direct multiplexed molecular measurement platform named nCounter® NanoString) in combination with a pre-made "nCounter® Human Myeloid Innate Immunity Panel (v2)". Perform retrotranscription and qPCR analyses of those mRNAs in eosinophils displaying the greatest abundance changes in response to mepolizumab treatment according to the nCounter® study. In addition, some additional mRNAs not included in the "nanoString Myeloid Innate Immunity" panel, such as FOXP3 (regulatory function), CRLF2, ST2, or IL-7R (cytokine receptors; activation), will be analysed. HPRT1 gene will be used as a house-keeping gene in this set of RTqPCR experiments. Perform SWATH-MS analysis in samples from 15 healthy donors and 15 patients (T0, T4, T16, T32) ("information-dependent acquisition" method or IDA; "Targeted label-free proteomics") in eosinophil homogenates. High abundant serum protein depletion using two protocols (P1: affinity chromatography, and P2: DTT precipitation) and SWATH-MS analysis of medium-low abundant serum proteome in samples from 15 healthy donors and 15 patients (T0, T4, T16, T32) ("information-dependent acquisition" method or IDA; "Targeted label-free proteomics").