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NCT06154304
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.
NCT07054034
A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of MG-ZG122 Humanized Monoclonal Antibody Injection in Asthma Subjects, with Dosing Every 12 or 24 Weeks for 48 Weeks
NCT06962761
the study of the effect of vit d and probiotic as suprplementaion in the treatment of patient with bonchial asthma and its effect in decreasing number of excerbation
NCT06637748
Bronchial asthma is a common respiratory disorder among children, worldwide. Asthma is characterized by chronic inflammation and remodeling of the airways induced by recurrent exposure to hypoxemia that leads to repeated tissue injury and repair. The interaction between respiratory diseases and cardiovascular function is complex . Cardiac dysfunction can be attributed to pulmonary hypertension (PH) secondary to recurrent hypoxia in patients with bronchial asthma. PH affects the pulmonary vasculature by releasing various cytokines leading to pulmonary vasoconstriction and enhancing the remodeling process with muscularization and proliferation of the vascular media and intima . Other hypotheses concluded that the exaggerated respiratory efforts may raise the intrathoracic pressure and increase right ventricle (RV) afterload and consequently RV hypertrophy and/or dilatation . Children with severe bronchial asthma can experience cor pulmonale later in life, but little is known about the early cardiac changes that might be present during childhood especially for mild or moderate persistent asthma. Some studies have reported right ventricular dysfunction as the earliest hemodynamic change among those cases . Other studies did not report these results and reported impaired systolic function of the left ventricle (LV) even before diastolic dysfunction . Insufficient control of BA, in turn, can cause the formation of various pathological conditions. For example, there are studies showing the risk of cardiac arrhythmias and conduction disorders in patients with uncontrolled BA due to functional changes or pathological remodeling of the myocardium . Atrial remodeling, which is the pathomorphological basis of serious supraventricular cardiac arrhythmias, has a more rapid progression with poor BA control and is formed as a result of excessive stretching of the atrial wall, as well as other adverse factors . The connection between BA and supraventricular arrhythmias, including atrial fibrillation (AF), was noted in studies by Cepelis et al. Available data indicate that in the adult population, cardiac arrhythmias are significantly more common in patients with BA than in those without it (9). The results of a Norwegian population study HUNT study, demonstrate that the risks of supraventricular arrhythmias and AF are increased in patients with an uncontrolled BA . Electrocardiography (ECG) is the universal screening method for assessing the state of the atrial myocardium and the conducting system of the heart. According to German et al. ECG analysis can make a significant input to the assessment of the risk of formation of supraventricular rhythm and conduction disorders. Therefore, the analysis of the atrial component of the ECG, and atrioventricular conduction in patients with BA is an important component of the management of these patients, especially in pediatric practice. Consequently, the study of the characteristics of the ECG and its supraventricular component in children with BA is relevan
NCT06624735
Asthma is considered the most common chronic childhood disease and mainly affects children resident in urban areas. Asthma has been designated a serious public health problem due to the increase in its prevalence over the last two decades and the associated high health service costs in admissions and hospitalizations The cause of asthma is not yet completely understood, and there is no consensus about its etiology. A vast body of research emphasizes the role of genetic and environmental factors in the appearance of asthma, and a great deal of interest has recently emerged concerning the relationship between psychosocial factors and asthma morbidity Behavioural problems in children are generally described as "internalizing", which includes "anxiety, depressive, and somatic symptoms" or "externalizing", which includes "oppositional, hyperactive conduct". Both internalizing and externalizing problems can be experienced by healthy children with abnormal and "borderline" personality disorder, the latter referring to a mental illness marked by an ongoing pattern of varying moods, self-image, and behaviour
NCT06141161
Asthma is a significant public health threat, affecting more than 300 million individuals globally. Asthma is classified as a non-communicable disease and leads to reduced quality of life, poor physical functioning and reduced emotional well-being. The impact of this disease can be widespread and extends beyond the person living with the disease, affecting the lives of their family members, carers, communities and the health care system (1). Asthma is a variable chronic respiratory condition. It is characterized by symptoms of wheeze, cough, chest tightness, dyspnea and backed by variable airflow limitation, airway inflammation and airway hyper-responsiveness (AHR). The severity of asthma varies considerably, both between individuals and within individuals over time. Some people may have intermittent asthma and others may experience severe, potentially life-threatening disease (2, 3,4).
NCT05088512
To research for a genetic marker of bronchial asthma, a single nucleotide polymorphism (SNP) analysis of DNA obtained from the peripheral blood of patients with bronchial asthma and normal control will be performed.
NCT03219736
Study Summary: Title: A Randomized Controlled Trial of Noninvasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations Principal Investigator: Thomas J. Abramo, MD Hypothesis: For acute moderate to severe pediatric asthma exacerbations the use of NIPPV/BiPAP, in conjunction with current standard of care therapies, will lead to a more rapid improvement in patient ventilation, faster resolution of respiratory distress and result in improved ventilatory parameters, secondary outcomes and pediatric asthma scores. Study Design: Prospective, randomized controlled trial Study Duration: This study will be conducted over a 36 month period. Sample Size: 240 subjects Population: Children ages 2-17 years of age presenting to the ED with Acute asthma exacerbation and a Pediatric Asthma Score (PAS) ≥ 8. Synopsis: Eligible subjects will be randomized to either a control group or study groups. The study groups will be either a NIPPV/BiPAP group. The subjects in the study groups will continue to receive all standard of care therapies per the asthma severity protocols. All nebulized therapies will be given through the NIPPV circuit. Patients will be assessed by the pediatric asthma score (PAS), measured respiratory parameters, volumetric end tidal carbon dioxide monitoring and measured cardiac parameters. Objectives: A. Evaluate if the use of NIPPV/BiPAP in conjunction with traditional inhaled beta-agonists improves the outcome in pediatric patients with acute moderate to severe asthma in the acute setting. B. Describe the physiology of NIPPV/BiPAP by measuring cardiac parameters in children randomized to a NIPPV group. C. Monitor safety of NIPPV/BiPAP use for acute asthma exacerbations in children. Safety A.: The study must be IRB approved. B.: Appropriate consent and assent documents will be obtained prior to enrolling the subject in the study. C.: A clear safety plan including DSMB will be established to monitor for adverse events. D.: Confidentiality will be ensured for all subjects enrolled in the study.
NCT03394989
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in adult patients with asthma.
NCT00505388
This patient follow-up programme was designed to describe the extent of Symbicort use in patients prescribed Symbicort as maintenance and reliever therapy in routine clinical practice in comparison with the already documented use of Symbicort as maintenance and reliever therapy in clinical therapies
NCT02624505
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.
NCT03816267
Asthma is a problem that affects many children and affects their physical health in addition to having a social and financial burden on individuals, families and healthcare systems. In our pediatric emergency department, nebulizers are still used for the management of asthma and, with the poor resources of families, they have no option of treatment at home. In this study, the investigators will compare the effectiveness of treatment through nebulizer versus metered dose inhaler and spacer in children with an acute asthmatic attack seeking medical care at the Pediatric Emergency Department of Suez Canal University Hospital.
NCT02918487
The aim of this trial is to study the effect of a polyherbal capsule containing four herbs: Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum in the treatment of bronchial asthma.
NCT03190759
Asthma is a heterogeneous disease, usually characterized by chronic airway inflammation. It is defined by the history of respiratory symptoms such as wheeze, shortness of breath, chest tightness and cough that vary over time and in intensity, together with variable expiatory airflow limitation. This definition was reached by consensus, based on consideration of the characteristics that are typical of asthma and that distinguish it from other respiratory conditions . Asthma is a problem worldwide, with an estimated 300 million affected individuals .It appears that the global prevalence of asthma ranges from 1% to 18% of the population in different countries .
NCT03176745
The investigators aim to determine the optimal number of measurements required for multiple-breath-washout derived lung function parameters in adults with pulmonary disease as well as in healthy controls
NCT02934945
Bronchial asthma is a common respiratory disease characterized by chronic airway inflammation, which have been affecting about 1-18% of the population in the world, causing tremendous economic burden for the patients and countries. Generally, asthma is a heterogeneous disease, and it could be classified into many types on the basis of symptoms, that is, typical asthma, cough variant asthma, and chest tightness variant asthma etc. Typical asthma (TA) is defined according to the history of repeated respiratory symptoms such as wheeze, shortness of breath, chest tightness, and cough, usually with reversible airflow limitation, airway hyper-responsiveness, and airway remodeling. Cough variant asthma (CVA) is characterized by the single manifestation, recurrent cough, which could be improved after the use of bronchodilators. However, according to different guidelines, it is still controversial on the treatment of CVA and TA. The guidelines of Global Initiative for Asthma(GINA) in 2014 put forward the treatment of TA patients, but did not list the treatment specific to CVA. The guideline of ACCP（American College of Chest Physicians） and cough guidelines of China are proposed to treat the CVA effectively with bronchial diastolic drug. Inhaled corticosteroids (ICS) and leukotriene receptor antagonists are effective for the treatment of CVA. Currently, more and more studies supported that application of ICS combined with bronchial dilation agents is more beneficial to CVA patients. Budesonide/formoterol is a compound of ICS and long-acting beta2-agonist(LABA), which can not only be used as a maintenance medication, but also be used as a relief medication, namely, budesonide/formoterol treatment regimen for SMART (Symbicort as both maintenance and reliever therapy). Most studies show that SMART treatment can be used in the treatment of TA patients. But the study on whether budesonide/formoterol can be used to treat CVA is still little. To provide basis for clinical medication guidance for patients with CVA and TA, this study will enroll 30 patients with TA or CVA , who will be required to adopt the SMART regimen in the following 6 months.The symptom score, airway inflammation, pulmonary function and airway reactivity changes, will be measured every mouth. After the study finished, the investigators will compare the difference between the two groups.
NCT01386151
This study will look at the permeability, or 'leakiness' of the airway epithelium (the inner lining of the lung) in asthmatic patients. Increased leakiness of this lining has been shown in asthmatic patients by other studies, not only in the lung but also possibly in the gut, perhaps reflecting a widespread defect. This leakiness may underline the interaction between the environment and a person's genetic make up, and may contribute to why some people get asthma, and how severe it is. Increased leakiness may allow increased exposure to inhaled allergic substances, helping to perpetuate the inflammation in the lungs that is a hallmark of asthma. Specifically, this study will attempt to modify and reduce this permeability through the use of a substance called 'keratinocyte growth factor', or 'kgf'. KGF is a naturally occuring human protein, which is involved in stimulating the growth of cells lining the layers of the skin and gut, helping to repair damage and maintain their structure. It has been manufactured in a laboratory as the commercial compound 'Palifermin', which has already been used in humans to reduce damage to the lining of the mouth after chemotherapy. The study will see if Palifermin can similarly improve the lining of the lung in asthma patients and improve their symptoms. To date no treatments have been used in this area in asthma, and if successful the study will open up a whole new area of therapy
NCT01762917
Non-invasive inert gas rebreathing (IGR) based on the Fick Principle showed promising results in the determination of pulmonary blood flow (PBF). The volume of the rebreathing bag (Vbag) is proposed by the system, however, elderly patients or those suffering from high grade pulmonary diseases might be unable to entirely rebreathe this volume and therefore fail to completely mix the test gases. The aim of our study is to evaluate the effect of adapting Vbag on the reproducibility of IGR measurements in patients with obstruction (group A), restriction (group B) and pulmonary healthy controls (group C).
NCT00536731
The purpose of the this study is to evaluate the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.
NCT01543516
The aim of this case-control study is the comparison of the cell distribution in induced sputum in young adults with asthma and in healthy controls. The study consists of two visits. At both visits subjects are asked to perform a lung function test (body plethysmography) and levels of exhaled nitric oxide (eNO) are measured. At the first visit a blood sample is drawn to determine the inflammatory and allergic status of the subjects and the sputum is induced by an ultrasonic nebulizer. At the second visit another sputum sample is induced by a nozzle nebulizer. The cell distribution will be evaluated in both sputum samples.