Clinical Research Directory

Somatic Health Screening for Adults in Outpatient Psychiatric Care in Denmark (SomaScreen)

People with severe mental illness have a substantially increased risk of undiagnosed and insufficiently treated somatic disease. Somatic Screening in the Capital Region Mental Health Service in Denmark (SomaScreen) is a service-level intervention implemented in psychiatric outpatient clinics in the Capital Region of Denmark to improve the detection and follow-up of somatic disease among patients with psychotic and affective disorders. This study evaluates whether integrating structured somatic screening into mental health services leads to improved identification and management of somatic disease compared with care as usual. Using a quasi-experimental controlled design with a matched cohort, outcomes among patients exposed to the SomaScreen intervention are compared with those of patients receiving usual care in comparable psychiatric outpatient clinics outside the Capital Region.

Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma

This study is trying to identify the right dose of a long-acting medicine called WIN378 for people with moderate or severe asthma. WIN378 blocks the action of a protein called TSLP which causes inflammation in the lung and may contribute to your asthma control and symptoms. The study will test how doses of WIN378 are handled by your body (pharmacokinetics) and assess the safety of the medicine and will assess markers of asthma inflammation in your breath and in your blood, lung function and asthma control (pharmacodynamics).

Can Astaxanthin Help Manage Asthma in POlluted Areas?

This study will test whether astaxanthin, a naturally occurring antioxidant supplement, can improve lung function, reduce airway inflammation, and improve asthma control in adults with mild-to-moderate asthma. Participants will receive astaxanthin and placebo in random order in a double-blind crossover design. Each treatment period lasts 4 weeks and is separated by a 3-week washout period. The study also measures indoor and personal air pollution exposure to examine whether pollution influences asthma symptoms, airway responsiveness, and response to treatment. Exploratory thoracic bioelectrical impedance spectroscopy will be assessed alongside standard respiratory tests.

Immune Status and Disease Control of Inflammatory Airway Diseases

The goal of this study is to learn how the body's immune system affects disease control in people with different airway inflammatory diseases.We want to understand: 1.Whether specific immune cell patterns in the blood are linked to how severe the disease is or how well it is controlled. Participants will: 1. Answer questions about their health and symptoms. 2. Give blood samples 3. Have lung function tests and other standard check-ups. 4. share sleep study results. We will compare people with airway diseases to healthy volunteers to see how their immune systems differ.

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

Efficacy of Indonesian Asthmatic Gymnastic as Combine Pulmonary Rehabilitation Based on Asthma Classification

This study aims to evaluate the efficacy of Indonesian Asthma Gymnastic for stable asthmatic patients in all asthma classification. The outcome measurements includes 6 minutes walk test, Asthma Control Test, peak flow rate value, and lung function. All participants have been in routine standard treatment of asthma (medication, education of healthy life style and smoking cessation).

Investigation and Classification of Treatable Traits in Patients With Chronic Airway Diseases

This research study focuses on chronic airway diseases, such as Chronic Obstructive Pulmonary Disease (COPD) and asthma. These conditions make it difficult for patients to breathe, but breathing difficulty (dyspnea) is often perceived very differently. Some patients may feel severe distress with mild breathing problems, while others might not notice significant breathing issues even when lung function is poor. This difference in perception is termed "dyspnea perception." The main goal of this study is to understand how dyspnea perception varies among patients with chronic airway diseases. The investigators aim to determine if patients can be grouped into different subtypes based on the perception of breathing difficulties. The study will also investigate how these subtypes relate to other treatable characteristics, such as blood cell counts, allergy test results, and findings from lung function tests and brain scans. Approximately 800 patients with COPD or asthma and 150 healthy volunteers will participate. Participants will answer questionnaires, undergo lung function tests, provide blood samples, and a subset will undergo a special brain scan (functional MRI). No new treatments will be assigned; instead, these characteristics will be observed and measured over time. It is hoped that this study will help doctors better understand chronic airway diseases and lead to more personalized management strategies for patients in the future.

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.

Multicomponent Breathlessness and Physical Activity Intervention in People With Asthma Using a Digital Platform

Treating breathlessness could help people with asthma have fewer symptoms and be more physically active. People with asthma report that it is important to deal with breathlessness during physical activity programs, but past research hasn't focused on this need. The investigators have developed a multicomponent digitally supported intervention targeting breathlessness and physical inactivity. This study will test whether the multicomponent digital supported intervention will help people with asthma. The main question the study aims to answer is: Does the multicomponent digitally supported intervention improve quality of life? Participants will: * Be allocated to the intervention or usual care. Allocation to either group will be random (like tossing a coin). * Attend study visits to complete an assessment involving questionnaires and measurements * Receive telephone calls to ask questions about health * Be invited to take part in an interview to have a conversation about thoughts on participating in the study * Be asked to provide consent to collect information from Services Australia regarding use of health care services and medications

Research on Disease Control and Mental Health Status of Adolescent Asthma Patients

Background: Currently in China, adolescent asthma care is characterized by both undertreatment and overtreatment. Patients in this age group may exhibit negative emotions toward disease treatment and long-term control. Insufficient disease knowledge, irregular lifestyle habits, and negative attitudes toward the disease can all reduce medication adherence, affect disease control outcomes, and thereby increase the risk of severe chronic respiratory conditions and disease burden in adulthood. Objectives: To assess disease control status in adolescent asthma patients, evaluate the psychological well-being of patients and their family members, and understand patients' self-management skills and readiness for transition to adulthood. Procedures: Eligible participants will complete a series of assessment questionnaires through the Youran Huxi mobile application, including questionnaires on asthma control, physical activity, psychological health, self-management behaviors, and transition readiness. The study period is 12 months; the baseline assessment involves one-time completion of written questionnaires with no interim follow-up visits. The study does not intervene in clinical diagnosis or treatment decisions.

Pressurized Meter Dose Inhaler V/S Dry Powder Inhaler

This study compares two commonly used inhalation devices in asthma management. It focuses on evaluating how effectively PMDIs and DPIs deliver the same combination of inhaled corticosteroids and long-acting beta agonists in patients whose asthma remains poorly controlled despite treatment. The study is conducted in a tertiary care hospital setting, emphasizing real-world clinical practice and aiming to determine whether device choice influences asthma control outcomes.

ADO-5030 in Bronchoconstriction Challenge, Phase 1b

This is a Phase 1 study to learn about the safety and pharmacokinetics of the study drug in patients with asthma and whether the study drug has effect during a respiratory challenge.

Body Composition Related Evaluation of Airway Tone and Hyper-rEactivity Using Oscillometry

This study will determine if airway resistance to airflow and pressure, measured by Oscillometry, is associated with abnormal findings on methacholine challenge testing and whether these findings are associated with body habitus,

Optimizing a Sensor-Enabled mHealth Intervention for Adolescents With Suboptimal Asthma Control

Asthma affects nearly 1 in 10 teenagers in the United States and can seriously impact their health and daily life. Teens are expected to manage their asthma by taking medications correctly and paying attention to symptoms, but this can be hard. Adolescents are still developing the skills needed to manage their thoughts, feelings, and behaviors, and they often receive less help from parents during this time. Because each teen struggles in different ways and at different times, they need support that is personalized and responds to what is happening in the moment. Smartphones offer a promising way to help teens manage asthma well. However, most existing asthma apps do not use the full range of proven behavior-change strategies or adapt to what the teen is actually doing day to day. To address this gap, our team created Responsive Asthma Care for Teens (ReACT)-a system that collects data about each time an adolescent takes or misses a dose of medication and monitors symptoms. ReACT helps teens set goals, get feedback, notice barriers, and practice problem-solving skills. Early testing showed that teens liked ReACT and that it improved the skills needed for better asthma management. In this study, the investigators will pilot test ReACT in a study with 160 teens ages 13-17 who have poorly controlled asthma. Teens will be randomly assigned to use ReACT or a comparison intervention for six months. The comparison intervention provides basic asthma education and a place to log symptoms and medication use-similar to what they might normally receive in standard care. Investigators will look at how well the study procedures work across multiple sites and whether ReACT improves the skills that help teens manage their asthma. The investigators will also explore whether ReACT leads to better asthma control and quality of life. Teens will complete assessments at the start of the study, at three months, and at six months. The investigators will gather information through surveys and objective data such as medication use. By the end of this project, the investigators will know whether the ReACT system and study protocol are feasible and ready for a larger clinical trial, and will have early estimates of how much ReACT may improve asthma outcomes for teens.

Retrospective Cohort Study of Low-Flow Extracorporeal Carbon Dioxide Removal (ECCO2R) System: Evaluating ECCO2R's Efficacy and Safety in Participants With Respiratory Failure

This is an observational study performed by retrospective review of data routinely collected for patients receiving low-flow extracorporeal carbon dioxide removal (ECCO2R) therapy in intensive care units (ICUs). Our aim is to firstly, describe the local practice in terms of patient selection and technical details of clinical management related to the use of low-flow ECCO2R system, and secondly, the clinical results in terms of patient outcomes and adverse events. These findings may allow clinicians to improve the quality and safety of ECCO2R therapy provision in the ICU.

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.

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.

Longitudinal Phenotyping and Endotyping Study in Adult Patients With Mild, Moderate, or Severe Asthma

Background and study aims: The purpose of this research registry is to understand how asthma varies from person to person and monitor changes that may occur over time. The effects that asthma has on the body will be assessed, by looking at different causes/triggers of flare-ups/exacerbations, asthma symptoms, and how inflammation of the airways may affect respiratory health over time. The information obtained from this study will allow hVIVO to better understand respiratory disease progression and outcomes in asthma patients. Who can participate: Male or Female patients aged ≥ 18 years who are attending the hVIVO respiratory site clinics and have a clinical diagnosis of asthma. What does the study involve: The study will consist of a baseline clinic visit to confirm suitability and assess participants' asthma followed by approximately 5 annual clinic visits and follow-up phone calls, as necessary. Intermediate home self-assessments will also be scheduled for halfway between each annual clinic visit. Upon experiencing cold-like symptoms, participants will be asked to complete a at home self-nasal and throat swab as well as symptom, medication, and lung function home diary cards. What are the possible benefits and risks of participating: Taking part will not improve participants' health, although participants might benefit from a general health check at Screening as well as additional health checks and assessments of participants' inhaler technique during the conduct of the study. There may be unexpected and unforeseen risks related to the study procedures. When attending for clinic visits, assessment will be performed by appropriately trained and qualified staff. Participants will be monitored for any procedure related symptoms such as, pain or bruising at the site where blood is drawn. Discomfort, sneezing, watery eyes, irritated nose, or nose bleeding during nasal sample collection. Light-headedness, dizziness, fatigue, coughing, shortness of breath, headaches, chest discomfort, throat irritation and itching during lung function testing. Skin irritation and allergic reactions from skin prick testing. Should participants experience any of these symptoms, trained staff will be on hand to provide the appropriate medical treatment. The Methacholine bronchial challenge test is also likely to cause asthma symptoms such as wheezing, shortness of breath, and chest tightness. In rare cases, the test can cause severe bronchospasm. After the test or if the bronchospasm is severe, the technician will give the participant medication to inhale that will open the airways. If the participant experiences any asthma exacerbation as a result of the methacholine test, the exacerbation management guidelines will be used to assess the participant and guide treatment. Only participants that are not contraindicated for a methacholine test will have this performed. For the at home assessments, participants will receive proper training on how to perform these during screening visit and as needed during each clinic follow-up visit. Any abnormalities identified during the study will be communicated to the participant, as well as to the participant's GP or a specialist if necessary. Where is the study run from: hVIVO Services Limited - UK. Please see Participating Centres listed above for address. When is the study starting and how long is it expected to run for: The study began enrolling participants from 08th August 2025 and is unending, with an initial cohort of 235 expected to last approximately 5 years for each participant. Who is funding the study: hVIVO Services Limited Who is the main contact: Alex Mann - projectadmin@hvivo.com

Obstructive Sleep Apnoea and Difficult Asthma (OSADA)

The OSADA (Obstructive Sleep Apnoea in Difficult Asthma) trial is an open-label, randomized control trial investigating the impact of diagnosing and treating obstructive sleep apnoea (OSA) on a asthma control in patients with difficult-to-control asthma. Participants will undergo home-based sleep studies to assess for OSA and are then allocated to one of three arms: 1) Patients with OSA treated with CPAP (intervention group), 2) Patients with OSA not treated for OSA (control group) and 3) Patients without OSA (reference group). The primary objective is to evaluate whether treating OSA improves asthma control, symptom burden, and quality of life compared to untreated OSA and to patients without OSA. Secondary outcomes include exacerbation rates, sleep quality, and healthcare utilization. This trial aims to clarify the contribution of OSA to poor asthma control and the potential benefits of integrated sleep and respiratory care in this complex population.

Phase IIa Trial in Participants With Asthma to Evaluate Impact of Intranasal ETH47 on Development of Asthma-related Symptoms Following Rhinovirus Challenge

A Phase IIa trial in participants with asthma to evaluate the impact of intranasal ETH47 on the development of asthma-related symptoms following rhinovirus challenge