Clinical Research Directory

Effects of Respiratory Muscle Strength Training in Children With Asthma

Asthma is a common long-term respiratory condition in children. In addition to affecting breathing, asthma may affect physical activity, exercise capacity, daily functioning, and quality of life. Respiratory muscles, particularly the muscles used for breathing in, play an important role in breathing and may also contribute to physical functioning. The purpose of this randomized controlled study is to investigate whether adding inspiratory muscle training to a respiratory exercise program provides additional benefits for children with asthma. The study will evaluate the effects of the training using the International Classification of Functioning, Disability and Health (ICF) framework, which provides a broad approach to understanding health by considering body functions, activities, participation, and related aspects of daily life. Participants will be randomly assigned to one of two groups. Both groups will perform thoracic mobility and thoracic expansion exercises. In addition, one group will receive inspiratory muscle training for 8 weeks. Before and after the 8-week program, participants will undergo assessments of breathing muscle function, lung function, exercise capacity, autonomic function, physical activity, and quality of life. The study aims to determine whether inspiratory muscle training can provide additional improvements in respiratory and physical functioning in children with asthma and to evaluate these effects from a broader perspective using the ICF framework.

A Study to Understand the Accuracy of a New Breathing Device Compared to Standard Testing for Asthma and COPD

The diagnosis of either asthma or chronic obstructive pulmonary disease (COPD) is currently based on a combination of symptoms, different lung tests and sometimes a 'trial by treatment'. Both COPD and Asthma tests currently include forced breathing using a test known as spirometry which can be difficult and uncomfortable for people to perform and needs expert interpretation. Asthma can require multiple tests in sequence which can make the process of diagnosis long and inconvenient for patients. In the UK, there have been challenges providing enough testing for COPD and asthma, in part because the tests are challenging to provide in the community to everyone who needs one. The STARDUST study aims to test and develop new ways of diagnosing asthma and COPD that are quick, accurate and easy for patient and healthcare professionals to perform. People who have been referred for routine lung testing will breathe normally in and out into a handheld device called the N-Tidal Handset for 75 seconds. This device measures how the level of carbon dioxide (CO2) changes in the breath as people breath through it. The information gathered on the N-Tidal Handsets, called breath records or capnograms, will not be used to alter the diagnosis of any participants in the study. After the capnograms have been collected, the research team will test 'algorithms' that have been developed using artificial intelligence, to see if they can accurately identify the correct diagnosis. Information collected in the study will also be used to make improvements in these algorithms. If confirmed to be accurate, these algorithms could be used in clinical practice to help healthcare professionals make faster, more accessible and accurate diagnoses, especially in settings like GP clinics in the community where access to specialist tests may be limited.

Changing Lifestyle to Improve Quality of Life in Spanish Adolescents With Asthma

The goal of this clinical trial is to evaluate if a multicomponent lifestyle intervention can improve health-related quality of life in adolescents with asthma. The main questions it aims to answer are: * Does the intervention improve health-related quality of life? * Does the intervention improve asthma control, movement behaviours adherence, and psychosocial outcomes? Researchers will compare a multicomponent intervention group to a usual care group to see if the intervention improves health-related quality of life and asthma control, movement behaviours adherence, and psychosocial outcomes. Participants will: * Complete assessments at baseline, after 3 months of intervention, and after 3 months of follow-up. * Answer questionnaires about health-related quality of life, asthma control, movement behaviours, and psychosocial factors. * Be assigned to either the intervention group or the usual care group. * Receive, if assigned to the intervention group, individualised goals program supported by a smartwatch, online group educational sessions, and motivational strategies to support participation and behaviour change.

A Long-term Study of KT-621 Administered Orally to Participants With Asthma Previously Enrolled in a KT-621 Asthma Study

This Phase 2b open-label, long-term extension study is designed to evaluate the long-term safety and efficacy of KT-621 in participants with asthma who were previously enrolled in the parent study (KT621-AS-202) of KT-621 for asthma. The main goals of this study are to investigate the long-term safety and tolerability of KT-621, the long-term efficacy of KT-621 at treating asthma, and how KT-621 behaves in the body long-term.

Sustained Asthma Remission and Reduced Relapse Using a Comprehensive Management Strategy (SARRE-COMS)

The goal of this pilot clinical trial is to learn whether it is feasible to conduct a future larger trial of a comprehensive management strategy for adults with severe asthma who are starting biologic therapy. The main questions this pilot study aims to answer are: Can eligible participants be recruited and retained in the study? Can the study visits, tests, and other study procedures be successfully completed? Is the comprehensive management strategy acceptable to participants and clinicians? What proportion of participants receiving usual asthma care achieve asthma remission at 12 months? Researchers will compare usual severe asthma care with a comprehensive management approach that uses specialized tests of airway inflammation and lung abnormalities to help doctors make treatment decisions. Participants will be followed for 12 months. They will complete questionnaires, lung function tests, blood tests, and sputum testing. Clinically available CT scans obtained as part of usual care may also be used for study assessments. Participants may also choose to undergo optional research MRI scans.

Validation of 1 Minute Sit-to Stand Test for Assessment of Breathlessness at Exertion in Individuals With Chronic Lung Disease

Breathlessness is a common symptom in people with chronic lung and heart diseases. It can affect daily activities, quality of life, and overall health. Current questionnaires used to assess breathlessness depend on a person's memory of symptoms and may not accurately capture breathlessness during physical activity. This study aims to evaluate whether the one-minute sit-to-stand test (1MSTS), a simple test that involves repeatedly standing up from and sitting down on a chair for one minute, can measure breathlessness during exercise. Adults with chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease (ILD) or heart failure (HF) will participate. Participants will attend three study visits and complete exercise tests, including the 1MSTS, a six-minute walk test (6MWT), and cardiopulmonary exercise testing (CPET). The study will assess how well breathlessness measured during the 1MSTS test reflects breathlessness during other established exercise tests, and whether the test provides reliable and responsive measurements over time. The results may help establish the 1MSTS as a practical and easy-to-use tool for assessing exertional breathlessness in both clinical practice and research.

Resources and Education for Addressing Chronic Health (REACH)

This study pilots REACH, Resources and Education for Addressing Chronic Health, a service model to facilitate care coordination and communication across medical, school, and home settings. REACH seeks to address barriers to school-based asthma management, improving health and educational outcomes and reducing negative impacts for children with asthma.

Development and Validation of the Indian Asthma Care Bundle for Reducing Readmission and Improving Post-hospitalisation Care After Discharge From Hospital Due to an Acute Asthma Exacerbation

The goal of this study is to assess the effectiveness of the Indian Asthma Care Bundle (I-ACB) in improving post-discharge asthma management among patients with asthma in India, specifically targeting adults and children experiencing severe asthma exacerbations. The main questions it aims to answer are: 1. Does the I-ACB reduce the rate of hospital readmissions within 30, 60, and 90 days post-discharge? 2. How does the I-ACB impact treatment adherence, lung function, symptom control, and overall quality of life, compared to usual care? Researchers will compare outcomes among participants receiving the I-ACB with those receiving standard asthma care (usual care) to determine whether the I-ACB improves health outcomes and reduces the need for emergency department visits. Participants will be asked to: * Engage in a structured asthma management program that includes education on inhaler techniques and adherence to treatment plans. * Report their symptoms and treatment adherence regularly. * Participate in follow-up assessments that monitor lung function and quality of life over a specified period. The importance of this study lies in its potential to address significant gaps in asthma management in India, which currently lead to high hospitalisation rates and substantial healthcare costs. By developing a tailored care strategy, the I-ACB aims to improve health outcomes for millions of asthma patients, reducing the burden on families and healthcare systems alike, and ultimately transforming the approach to asthma care in the region.

A Randomized, Phase Ib, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SKB575 (HBM7575) in Participants With Asthma

This study is a multicenter, randomized, double-blind, placebo-controlled phase Ib study to evaluate the safety, tolerability, efficacy, PK/PD characteristics, and immunogenicity of SKB575 (HBM7575) injection in subjects with asthma.

Using a Digital Spacer for Inhaler Technique Education in Pediatric Asthma

This pilot study evaluates the feasibility, usability, and potential effect of the aflo™ Smart Spacer platform in children aged 6-18 with uncontrolled asthma using pMDIs and spacers. The study investigates changes in inhaler technique, asthma control, and lung function following 3 months of daily use of the CE-marked aflo™ device.

First-Line Diagnostic Investigations for Suspected Adult Asthma

Asthma is a common long-term condition that can be difficult to diagnose accurately. Symptoms such as breathlessness, wheeze and cough can vary over time and may be caused by other conditions. Some people with asthma have normal breathing test results when they are assessed, which can make diagnosis challenging and lead to delays in treatment. This study aims to determine which commonly used tests, either alone or in combination, are most accurate for diagnosing asthma in adults with suspected disease. Participants referred to George Eliot Hospital for investigation of possible asthma will be invited to take part. Following informed consent, participants will undergo a range of routine diagnostic tests during their first visit. These include spirometry with bronchodilator response testing in patient with both normal airway function and airflow obstruction, fractional exhaled nitric oxide (FeNO), which measures airway inflammation, and oscillometry, which assesses how air moves through the lungs. Participants will then attend a second visit for a bronchial provocation challange test, which helps determine whether the airways are unusually sensitive, a key feature of asthma. The study will compare the results of these tests with the final diagnosis to assess how accurately each test identifies or excludes asthma. It will also investigate whether combining different tests improves diagnostic accuracy and whether factors such as obesity affect diagnostic measurements of increased asthma prevalence. The findings will help improve understanding of the most effective ways to diagnose asthma in routine clinical practice. This may lead to faster and more accurate diagnoses, reduce the need for unnecessary investigations, and support better care for people with suspected asthma.

Creation of a Biological Collection of BRonchiaI and Pulmonary Tissues From Surgical wastE

The biological samples and associated data will facilitate the successful implementation of the research collaboration between Bordeaux University Hospital and the University of Bordeaux on the pathophysiology of bronchopulmonary diseases. In the longer term, this research could lead to the discovery of new therapeutic targets for asthma, chronic obstructive pulmonary disease (COPD), pulmonary hypertension, and acute respiratory distress syndrome.

Respiratory Admittance by Oscillometry in Children

Oscillometry is a pulmonary function testing technique suited for children because it does not require specific respiratory maneuvers like spirometry. Oscillometry provides a measure of respiratory impedance (Zrs) that is underestimated when the oscillatory signal is applied at the subject's mouth particularly during bronchoconstriction induced by an exercise challenge test (ECT). This limitation may be overcome by calculating respiratory admittance (Ars), the inverse of respiratory impedance during an ECT.

Beclometasone Dipropionate and Formoterol Inhalation Aerosol for Asthma

A multicenter, randomized, double-blind, active-controlled, parallel-group Phase III clinical study comparing the efficacy and safety of Beclometasone Dipropionate and Formoterol Inhalation Aerosol versus FOSTER® in patients with asthma. The purpose of this study is to compare the efficacy and safety of the Beclomethasone Dipropionate and Formoterol Fumarate inhalation aerosol (manufactured by Lunan Better Pharmaceutical Co., Ltd.) with FOSTER® in the treatment of patients with asthma.

Predictive Factors for a Positive Exercise Bronchial Hyperresponsiveness Test

Exertional dyspnea has a significant impact on a child's daily life. Current guidelines recommend performing an exercise challenge test to confirm or rule out exercise-induced bronchoconstriction (EIB). But the test is not widely available. The objective of this research is to identify the clinical and respiratory functional factors predictive of a positive exercise challenge test in children.

Effects of Wet Cupping Therapy in Patients With Asthma

This study evaluated the effects of wet cupping therapy on immune modulation, pulmonary function, and quality of life in adults with asthma. A total of 52 participants aged 30 to 55 years were allocated to either a control group or a wet cupping therapy group. Participants in the wet cupping therapy group received two sessions of wet cupping therapy, at baseline and one month later. Participants in both groups underwent clinical assessments at baseline and at two months. Pulmonary function, asthma-related quality of life, asthma control, dyspnea, fatigue, anxiety, and depression were assessed in both groups. Selected inflammatory markers were assessed only in the wet cupping therapy group.

Effect of AI(Artificial Intelligence)-Based Storytelling Video on Anxiety and Fear During Skin Prick Test in Children

This study evaluates the effectiveness of an AI-generated therapeutic storytelling video on pre-procedural anxiety and fear levels in children aged 4 to 10 years undergoing their first Skin Prick Test (SPT). The study aims to determine if watching a cognitive preparation video at home prior to the appointment reduces anxiety compared to standard care. Participants will be randomized into two groups: an intervention group watching the AI-generated video and a control group receiving standard clinic care

Pediatric Asthma Trial of Corticosteroid Heterogeneity (PATCH): Trial of Dexamethasone Versus Methylprednisolone for Pediatric Critical Asthma

Acute asthma exacerbation is caused by dysregulated pulmonary inflammatory pathways such that standard treatment includes prompt administration of exogenous systemic corticosteroids (SCs), but there remains an ongoing dialogue among the expert medical community regarding the superiority of specific SCs including dose, frequency of administration, route, and delivery. Regimens are often chosen based on provider preference, and different strategies include once-daily dosing (ODD) dexamethasone (DM) 0.6 mg/kg/dose for 2 days, every 6 hours (q6h) DM 0.25 mg/kg/dose for 2 days, and methylprednisolone (MP) 1 mg/kg/dose every 6 hours for 5-days. To address this knowledge gap, the investigators plan to perform a single-center, phase 2, randomized clinical trial of children 3-17 years of age hospitalized for critical asthma (CA) randomized to one of three regimens above. The study would be powered to evaluate rates of additional prescriptions of SC and also secondarily evaluate quality of life metrics.

Dietary Nitrate and Nitrite Intake and Phosphate Biomarkers and Risk of Chronic Diseases

Nitrate, nitrite, and phosphate (NO3, NO2, P) are at all age stages ubiquitous in our everyday foods, including naturally occurring and as food additives, and in our drinking water. These compounds are essential in maintaining human well-being and health, but they have also been linked to detrimental health effects including contribution to cancer initiation and artery calcification, making it difficult to evaluate their overall health impact. Therefore, the overarching aim of this project is to shed light on the potential dual effect of these compounds on a variety of chronic diseases (cardiovascular and respiratory diseases, gastrointestinal cancers) at different life stages and to further elucidate on the molecular mechanisms suggested to underly the pathogenesis of these disease outcomes. This will be achieved by using prospective, longitudinal population-based cohorts linked to comprehensive databases of NO3 and NO2 and using a biomarker of P while also integrating omics data on inflammatory and cardiometabolic biomarkers as well as the microbiome and urine bacterial metabolites. The project will be led by the PI and conducted by a team of PhD students and postdoc in close collaboration with relevant experts. It will be initiated early on and continued throughout a 4-year study period. With this research, the investigators attempt to provide the strongest scientific evidence with etiologically more relevant exposure-disease associations and to shape future health risk assessments.

IV DEXAMETHASONE VS. METHYLPREDNISOLONE IN CHILDREN WITH SEVERE ASTHMA EXACERBATION

The study aims to determine whether a two-day intravenous course of dexamethasone is non-inferior to a conventional five-day intravenous course of methylprednisolone in children presenting with severe asthma exacerbations. To answer this question, researchers randomly assign eligible children to receive either IV dexamethasone or IV methylprednisolone. The clinical response to the treatments is objectively evaluated and compared using the Pediatric Respiratory Assessment Measure (PRAM) score at the 4th hour of treatment and on the 2nd day following hospital discharge.

Comparison of Box Breathing and Rhythmic Breathing Techniques in Patients With Asthma

Asthma is a chronic respiratory disease that can cause breathing difficulties, reduced lung function, and poor sleep quality. Breathing exercises are increasingly used as non-pharmacological interventions to improve respiratory symptoms and overall well-being in individuals with asthma. This study aims to compare the effects of two breathing techniques, Box Breathing and Rhythmic Breathing, on dyspnea (breathlessness), pulmonary function, and quality of sleep in patients with asthma. Participants with asthma will be randomly assigned to receive either Box Breathing or Rhythmic Breathing exercises in addition to standard care. Both interventions will be performed three times per week for eight weeks. The primary outcomes of this study include changes in dyspnea severity, pulmonary function measured by spirometry, and sleep quality assessed using validated questionnaires. The findings of this study may help determine which breathing technique is more effective and provide evidence for incorporating structured breathing exercises into asthma management programs.

VR vs Treadmill Exercise in Children With Asthma

This study aims to compare the effects of virtual reality-based aerobic exercise and treadmill-based aerobic exercise on functional capacity, pulmonary function, and clinical outcomes in children with asthma. Participants aged 10-17 years with physician-diagnosed asthma will be randomly assigned to either a virtual reality-based exercise group or a treadmill exercise group. Both groups will undergo supervised exercise training sessions twice a week for 8 weeks. Primary outcome will be the 6-Minute Walk Test. Secondary outcomes include pulmonary function, respiratory muscle strength, asthma control, quality of life, and exercise adherence.

Effect of Linvemastat in Patients With Partially Controlled Asthma (syMMPonia)

This study explores a potential new treatment for adults with moderate-to-severe asthma using a drug called linvemastat, which targets an enzyme linked to lung inflammation. Despite using standard asthma medications, many patients still struggle with symptoms, so researchers are testing whether linvemastat can improve lung function and reduce flare-ups. In a carefully controlled trial, participants receive either one of two doses of the drug or a placebo, while continuing their usual treatments. Over 16 weeks, scientists monitor breathing capacity, symptom control, and safety to determine if linvemastat could offer a meaningful new option for asthma management.

Anakinra Rescue Treatment for Moderate Asthma Attacks (ARTMA)

In this single center, interventional pilot study, 40 participants at high risk for future exacerbation will be randomized to anakinra (v. placebo control) treatment for home administration as part of an asthma action plan (AAP) and monitored through their first moderate asthma exacerbation, triggering treatment dosing over a 26 week period. Key feasibility questions will be assessed in this pilot study to inform trial design and sample size selection for a future multi-site phase II clinical trial testing anakinra as a rescue treatment for moderate asthma exacerbations.