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Asthma clinical trials

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NCT ID: NCT05709054 Recruiting - Asthma Clinical Trials

The Effect of Manual Therapy Techniques on the Mobility of the Diaphragm in People With Asthma

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The mechanical alterations related to the overload of respiratory muscles observed in people with persistent asthma can lead to the development of musculoskeletal dysfunctions. Moreover, the produced lung hyperinflation and high lung volumes in the asthma crisis put the diaphragm at a disadvantage in terms of its length-tension curve and lowered its excursion and capacity to generate force. According to a preliminary study, manual therapy (MT) techniques can be used as adjunctive therapy in asthma treatment. The proposed protocol is the first randomized controlled clinical trial to assess MT's efficacy on the diaphragm's ZOA in conjunction with BRE in individuals with well controlled mild moderate and severe asthma. Many musculoskeletal and respiratory outcomes will be used to investigate the under-study therapies' impact.

NCT ID: NCT05708300 Recruiting - Asthma Clinical Trials

Biomarkers of Response to Mepolizumab Treatment in Patients With Nasal Polyps With or Without Bronchial Asthma

CALIOPI
Start date: February 23, 2024
Phase:
Study type: Observational

Mepolizumab is a biologic agent already approved for severe asthma. Recently, there is increasing evidence concerning the benefit of anti-IL5 treatments upon patients with nasal polyposis with or without severe asthma. The novelty of this project is that no biologic agent has yet been fully investigated to identify any biomarkers of response for patients with nasal polyps with or without asthma including sinonasal tissue remodeling a key element in the resultant histopathological changes of the inflammation. The investigation of airway remodeling of various locations (nose and bronchus) under mepolizumab treatment will be our primary objective on the long-term basis of 156 weeks of treatment. Endobronchial and nasal biopsies will be performed as routine care for tissue evauation and disease investigation for every patient. Besides, the united airways will provide better guidance for medical treatment of chronic rhinosinusitis (CRS) patients with nasal polyps (CRSwNP) and asthma. The initial idea is based on investigating the characteristics that could predict the effectiveness of mepolizumab on patients with nasal polyposis with or without asthma. Patients will receive 39 doses of mepolizumab for 156 weeks. An additional aim of this study is to identify characteristics of non-responders and responders to mepolizumab. Responders will be identified based on airway remodeling status, biomarkers in tissue and secretion samples and on the reduction of the need of surgery through Lund-Kennedy endoscopic score, Lund-Mackay score and patient's clinical status in the 6th, 12th and 36th month after the initiation of treatment. Regarding the unified airway system, nose and pharyngeal microbiome will be evaluated before and after 52 weeks of mepolizumab treatment in patients with nasal polyps whereas in patients with nasal polyps and asthma bronchus microbiome will also be evaluated. Lung samples will help gain information about the inflammatory profile and local microbiome of CRSwNP patients with asthma through molecular and cellular assays. The human Pharyngeal Microbiome might play a protective role in Respiratory Tract Infections and it has been reported that the microbiome provides critical signals to promote maturation of immune cells and differentiation of the tissue. Thus, we will make an effort to correlate microbiome of various locations with clinical and laboratory characteristics of responders and non-responders to mepolizumab treatment.

NCT ID: NCT05706597 Recruiting - Asthma Clinical Trials

Clinical Relevance of Small Airways Disease in Severe Asthma Patients Treated With Anti-InterLeukin-5 Therapy

SAIL
Start date: December 2, 2022
Phase:
Study type: Observational

The aim of this research is to investigate the extent and clinical relevance of small airways disease in severe eosinophilic asthma patients treated with anti-IL5/5R therapy.

NCT ID: NCT05704101 Recruiting - Asthma Clinical Trials

NHFT Effects on Symptatheic Drive of Asthma Patients

MSNA in Asthma
Start date: July 1, 2023
Phase:
Study type: Observational

The project will be pursued in our respiratory, autonomic nervous system physiology laboratory (Respiratory, autonomic nervous system physiology laboratory, Department of Pneumology and Intensive Care Medicine, RWTH Aachen University Hospital). Overactivity of the sympathetic nerve activity (SNA) axis with "centrally" increased heart rate and peripheral vasoconstriction is a known phenomenon in patients with systolic heart failure (HF) and has recently been described in patients with primary lung diseases as in chronic obstructive pulmonary disease (COPD) and pulmonary hypertension (PH). Comprehensive studies investigating sympathetic drive in Asthma as one of the major pulmonary diseases are still lacking. Furthermore, the intention of this study is to determine the impact of Nasal High Flow Therapy (NHFT) on SNA and assess respiratory muscle function using state-of-the-art techniques.

NCT ID: NCT05703334 Completed - Clinical trials for Exercise Induced Asthma

Kt and Myofascial Release in Exc Asthma

Start date: January 20, 2023
Phase: N/A
Study type: Interventional

Purpose of this study was to compare between the effects of kinesio tap and myofascial release of respiratory muscles on exercise induced asthma

NCT ID: NCT05699941 Completed - Asthma Clinical Trials

Multicentre Post-market Study of Ectoin® Inhalation Solution in Treatment of Asthma.

EIL-AST
Start date: January 13, 2023
Phase: N/A
Study type: Interventional

The goal of this multi-centre, prospective, open-label, single-arm, post-market clinical follow-up study is to further strengthen the already existing clinical evidence for supportive treatment and symptoms alleviation in asthma by evaluating the clinical efficacy of Ectoin® Inhalation Solution in paediatric and adults patients with mild to moderate 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: NCT05691218 Recruiting - Clinical trials for Severe Asthma Exacerbation

Early High-flow Oxygen Therapy With nebuLized Beta-2-agonist Using a Vibrating Mesh for the Management of Moderate to Severe Asthma Exacerbation in the Emergency Department

EOLE
Start date: February 19, 2024
Phase: N/A
Study type: Interventional

Acute exacerbation of asthma represents an acute or sub-acute worsening in symptoms and lung function in patients with asthma. It is characterized by a progressive increase in symptoms of shortness of breath, cough, wheezing, or chest tightness. It is a common diagnosis in patients admitted in an Emergency Department for dyspnoea. Near 10 to 15% of respiratory symptoms in an ED are related to acute exacerbation of asthma. Treatment of acute exacerbation of asthma associates nebulized beta-2 agonist adrenergic with or without ipratropium bromide, oral corticosteroids and controlled oxygen therapy to maintain SpO2 between 93 and 95%. Treatment in the ED did not vary during last years, including for patients with a lack of efficacy after first line treatment, and exacerbation are always associated with a hospitalisation in 40% of adult patients and with mortality in 1% of hospitalized patients. Vibrating mesh nebulizers are devices using vibration to push drug through the mesh, resulting in the drug nebulization. Vibrating mesh nebulizers have been associated with better pulmonary drug delivery than jet-nebulizers, provide faster improvement in peak expiratory flow and have been associated in retrospective studies with patient prognosis, particularly in terms of throughput time and need for hospitalisation. However, no studies have prospectively compared nebulisation with a vibrating membrane device with standard nebulisation in patients with asthma exacerbation on clinically relevant criteria. Nebulisation with a vibrating membrane device may potentiate the clinical efficacy of short-acting bronchodilators, result in faster and more effective clinical improvement, and be associated with improved short- and medium-term patient outcomes. High-flow nasal cannula heated, and humidified oxygen (HNFO) is a ventilatory support which is commonly used for the management of acute respiratory failure for acute respiratory failure in intensive care units and in emergency departments. HFNO delivers high fraction of inspired oxygen (FiO2), generates a low level of positive pressure and provides washout of dead space in the upper airways, thereby improving mechanical pulmonary properties and unloading inspiratory muscles during ARF. Consequently, HFNO is associated with a decrease in the work of breathing. During asthma exacerbation, HFNO was associated with an improvement in the dyspnea level and in the respiratory rate compared with conventional oxygen therapy. However, HFNO has never been assessed in association with nebulized beta-2 adrenergic agonist. To resume, beta-2 adrenergic agonist nebulization with a vibrating mesh nebulizer seems effective, especially compared to standard jet nebulization. In addition, HFNO is a technique that appears to be suitable for the pathophysiological conditions of chronic reversible respiratory failure, and can be used during exacerbations of asthmatic disease. The high flow rate of gas makes it possible to control the FiO2 in order to avoid hyperoxia, to generate a PEEP effect, to reduce the patient's work of breathing and the respiratory resistance, and to avoid the re-inhalation of CO2 by a dead space wash-out. In the EOLE study, the investigators propose to compare three therapeutic management strategies. One standard strategy (nebulisation with a jet-nebulizer), and two experimental strategies (nebulisation with a vibrating mesh device, and nebulisation with a vibrating mesh device in association with HFNO). The investigators hypothesise that bronchodilator nebulization with a vibrating mesh nebulizer is more effective than jet-nebulizers for the management of patients admitted for asthma exacerbation and non-responders or with lack to efficacy to initial treatment. Furthermore, the investigators also hypothesise that the addition of the physiological effects of HFNO may enhance the efficacy of the treatment. The therapeutic effects of nebulisation with a vibrating membrane device alone or with the addition of the physiological effects of HFNO could constitute a new approach to the management of asthma patients, particularly in patients who are insufficiently responsive or non-respondent to initial treatment.

NCT ID: NCT05689983 Recruiting - Asthma in Children Clinical Trials

Symptom-driven ICS/LABA Therapy for Adolescent Patients With Asthma Non-adherent to Daily Maintenance Inhalers

Start date: April 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Inhaler nonadherence is a common problem that has been estimated to account for approximately 60% of all asthma-related hospitalizations. Unfortunately, prior interventions to improve inhaler nonadherence have shown a lack of long-term success. This study proposes to assess the problem of non-adherence using a D&I research lens while testing a new inhaler approach to potentially ameliorate the detrimental consequences of maintenance inhaler nonadherence.

NCT ID: NCT05689931 Recruiting - Asthma Clinical Trials

Blood Leukocyte Profiling in Eosinophilic Type 2 Asthma: Influence of Systemic IL-5 Targeting

Start date: February 1, 2023
Phase:
Study type: Observational

The goal of this exploratory and observational prospective study is to study the composition and phenotypes of blood leukocytes collected from asthmatic patients before and after instantiated treatment with the interleukin-5 neutralizing antibody mepolizumab. Comparisons will be made to leukocyte profiles in patients already on mepolizumab treatment, asthma patients without any biological treatment, and non-diseased control subjects.