Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2025-06-20
Completion: 2026-05-20
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This study is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3002 multiple doses in participants with asthma. The study plans to enroll participants with asthma on stable inhaled treatment, FeNO≥25ppb at screening and randomization, elevated peripheral blood eosinophils and Pre-BD FEV1 ≤ 80% of the prediction. The safety, tolerability, PK, immunogenicity and changes in PD and clinical characteristics of multiple doses of IBI3002 in asthma subjects will be evaluated. The entire study includes the screening period (4 weeks before dosing), the treatment period (12 weeks), and the safety follow-up period (8 weeks). The study plans to enroll 9 to 27 participants with asthma, who will be randomly assigned in a 1:1:1 ratio to the following 3 cohorts to receive subcutaneous injection of the corresponding dose of IBI3002 or a matching volume of placebo. Investigators and participants will remain blind within the cohort. Cohort 1: 150mg SC(IBI3002: placebo =2 :1); Cohort 2: 300mg SC(IBI3002: placebo =2 :1); Cohort 3: 600mg SC(IBI3002: placebo =2 :1); The participants need to be observed at the study site for 3 hours after each dose and are allowed to leave after investigators determine no safety risk.
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.
Despite its common occurrence, still little is known about pathomechanisms determining different wheeze and asthma trajectories and phenotypes in children, and those beginning in adulthood. Therefore, deciphering underlying determinants for different childhood and adult asthma phenotypes is urgently needed to develop personalized treatment approaches targeting distinct underlying mechanisms. Thereby, secondary prevention early in the disease process can also be achieved. The decoding of such mechanisms and their translation to the individual patient is the aim of the Disease Area Asthma Allergy of the 'German Centre for Lung Research' (DZL).
Women with polysyctic ovarian syndrome (PCOS) usually develop many complications including asthma. Nowdays, diet restriction combimed with phsyical exercises may improve both problems
Introduction: The etiology and therapy of eosinophilic lung diseases are still poorly understood. For individual forms of disease, such as eosinophilic asthma or eosinophilic granulomatosis with polyangiitis (EGPA), new therapeutic approaches exist that block the interleukin IL-5 or the IL-5 receptor. Eosinophilic manifestations of the respiratory tract can exclusively affect the lungs or occur as part of a systemic disease. The manifestations partially overlap and are clinically difficult to differentiate (e.g. eosinophilic asthma, Samter Triad, EGPA or hypereosinophilic syndrome (HES)). It is now known that blood eosinophil counts correlate with the level of eosinophils recruited to the airways. However, it is still unclear whether there is a blood eosinophilia without clinical relevance or whether there is a risk of organ damage (e.g. in HES). Hence, different subtypes of eosinophils with different polarization are discussed. Aim of the study: A registry of patients with eosinophilia and respiratory manifestation will be established at the University Hospital of Innsbruck. The course of disease will be evaluated prospectively in a non-interventional study. This study stands on three main clinical pillars with focus on further characterization of eosinophilic cells: 1. Patients will be included who switch from a previous application of the anti-IL5 antibody mepolizumab (production and administration of the injection from lyophysate through the doctor) to the pre-mixed pen (self-injection at home). 2. Furthermore, special focus is set on patients suffering from the so-called Samter Triad. In these patients, the control of asthma, nasal polyps and NSAID intolerance will be examined in an interdisciplinary fashion during the course of treatment. 3. Previous clinical studies at our Department indicate that some patients with severe eosinophilic asthma or Samter Triad could represent a mono-organic or limited manifestation of lymphoid HES. This hypothesis is tested by measuring additional chemokines, somatic mutations and FACS parameters in this subgroup to verify a clonal disease. In addition, translational research will differentiate resident and inflammatory eosinophilic granulocytes by FACS analysis and further characterize them by fluorescence microscopy, electron microscopy, gene chip analysis and lipidomics, in the above-mentioned diseases and in healthy controls, respectively. Patients and methods: All patients suffering from eosinophilia with pulmonary involvement who are diagnosed with eosinophilic asthma, EGPA, Samter Triad, HES, and eosinophilic pneumonia with signed consent are included in the prospective registry. Provided, that they are registered at the outpatient department of pneumology, ENT, haematology or allergology at the University Hospital Innsbruck. The investigators will collect laboratory analyses, lung function, imaging, bone marrow biopsies, ENT findings and allergological findings over the course of the study…
The overall goal of this research study is to evaluate a multi-level program called PRAGMATIC-S to improve the delivery of guideline-based asthma care through a unique partnership between clinical practices and schools. PRAGMATIC-S represents a novel approach that addresses multiple barriers to adherence by bridging primary care and schools, ensuring delivery of guideline-based asthma care to urban children across these settings thereby improving adherence to therapy and clinical outcomes.
The overarching goal of this study is to optimize pediatric asthma care and to continuously evaluate variations/innovations of the care (including transformation to remote eHealth care). Primary Objectives within cmRCT cohort: * Provide a framework for multiple randomized (eHealth) interventions for asthmatic children * Generate short- and long-term data on Quality of life (QoL), asthma outcomes (asthma control, lung function), quality of care, self-management capacity, healthcare use, and therapy compliance in a representative secondary care pediatric asthma cohort. Secondary Objectives within cmRCT cohort: * Evaluate current pediatric asthma care at the Pediatric department of Medisch Spectrum Twente, in order to explore possible improvements for the pediatric asthma care. * Compare the short and long-term asthma outcomes between the eHealth care path and the outpatient care path. * Compose patient risk profiles that include both personal, clinical and exposome markers and clinical asthma endpoints (for example clinical admission/exacerbations).
Postpartum (child age 0-5 years) mental health problems are common, with prevalence rates ranging from 15-20% for depression, 3-43% for anxiety, and approximately 30% for anger. Depression, anxiety, and anger often occur comorbidly. If left untreated, these disorders can be long-lasting and lead to child behaviour problems, brain changes, and risk for later mental illness. We developed an app-based treatment for parental mental illness: Building Emotional Awareness and Mental Health in Parenting (BEAM). The BEAM program includes mental health and parenting videos, peer coaching, as well as a forum and drop-in Zoom sessions where parents can connect with each other to receive and provide social support. The program is supported by peer coaches (parents with lived experience of recovery from mental illness and who may have received emotion-focused parenting support) and supervised by clinically-trained staff. Peer coaches check-in with parents weekly to support their progress. Our study will see the BEAM app's effect on parent mental health, parenting stress, child behaviour, and child brain structure and function. 240 parents with high depression, anxiety, and/or anger symptoms will be recruited, with half forming the treatment-as-usual group.
This study evaluates the effectiveness of additional content on loneliness offered alongside the Wellbeing Course - an internet-delivered cognitive behavioral therapy (ICBT) intervention for symptoms of depression and anxiety- in improving treatment outcomes for individuals with elevated scores on loneliness seeking treatment for depression and anxiety at a routine care online therapy clinic (the Online Therapy Unit). In this partially randomized control trial, the investigators aim to contribute to the literature by examining whether providing additional content on loneliness alongside the Wellbeing Course enhances engagement, satisfaction, and treatment outcomes among clients experiencing frequent loneliness compared to those completing only the Wellbeing Course. Over 8 weeks, participants will review course materials (with the addition of the loneliness content for those assigned to the loneliness content condition) online and complete questionnaires assessing changes in various outcomes over time.
The purpose of the study is to compare a text message-based mental health and substance use screening and referral to a treatment program, called Listening to Women and Pregnant and Postpartum People (LTWP), to standard of care in-person mental health and substance use screening to look at rates of treatment attendance and retention in treatment. Participation would involve completing online questionnaires. You may be eligible to participate if you are age 18-45 years, are pregnant and entering prenatal care in one of MUSC's OB clinics, and attended a prenatal appointment at an MUSC clinic.
Objective: This study aims to evaluate the effectiveness of Clostridium butyricum in improving anxiety and depression in patients diagnosed with functional dyspepsia according to the Rome IV criteria. Methods: This trial plans to enroll 180 patients (90 per group). The study will employ a double-blind design. For patients diagnosed with FD according to the Rome IV criteria, in addition to conventional treatment (treated with Mosapride Citrate Tablets (Guangdong Anno Guocai) for Postmeal Discomfort Syndrome (PDS) and Esomeprazole Enteric Coated Tablets (Shijiazhuang Longze Pharmaceutical Guocai) for Upper Abdominal Pain Syndrome (EPS)), the experimental group was treated with Clostridium butyricum, while the control group received a placebo with the same appearance and odor. The treatment intervention will last for 4 weeks. The main indicator of this experiment is the improvement of the Hospital Anxiety and Depression Scale (HADS score) after 4 weeks of treatment. The secondary indicators are the improvement rate of the overall treatment effectiveness evaluation questionnaire (OTE questionnaire), the improvement of the global overall symptom score (GOS score), the improvement of the simplified Nipin scale (SF-NDI), and the improvement of the Pittsburgh Sleep Index (PSQI) after 4 weeks of treatment. Upon completion of the trial, the patients' conditions will be re-evaluated, and treatment plans will be adjusted accordingly.
The goal of this clinical trial is to learn if a fast-acting brain stimulation treatment called transcranial magnetic stimulation (TMS) can help people with depression and suicidal thoughts. The treatment is non-invasive (does not involve surgery or medications), is given over 5 days, and uses brain imaging (MRI) to guide which part of the brain to target. This study tests whether this treatment is a helpful and practical option for adolescents and young adults who are depressed and have suicidal thoughts. We want to see if: 1. This treatment is feasible and acceptable to patients 2. It can reduce depression and suicidal thoughts 3. It can lower the chance of going to the hospital 4. It affects daily functioning (school, work, relationships) All participants will undergo 5-days of TMS treatment and complete MRI brain scans before and after treatment. They will return for check-ups after 1 week and 4 weeks.
Improving maternal mental health is a worldwide health priority. Nevertheless, several scientific sources highlighted lack of empirical data which could drive clinical practice. The present project addresses psychobiological mechanisms leading to peripartum mental disorders. It focuses on one key risk factor for psychopathology, which is poor sleep continuity. The project aims to describe the link between maternal poor sleep quality and the cascade of events which may enhance vulnerability to stress and risk for mental disorders and to evaluate the efficacy of an online automated psychological prenatal intervention directed to sleep problems in preventing these negative outcomes.
This study aims to evaluate the effectiveness of metacognitive therapy (MCT) in reducing fear of cancer recurrence (FCR) among cancer survivors. With advances in cancer treatment, more patients are surviving cancer. However, many survivors continue to experience fear of cancer recurrence, which can affect their emotional well-being, quality of life, and ability to return to normal daily activities. In this study, participants will receive a structured psychological intervention adapted from the ConquerFear program. This program has been modified to better fit local cultural needs. Participants will be randomly assigned to receive either metacognitive therapy or relaxation therapy. The study will compare the effects of these interventions on reducing fear of cancer recurrence, as well as their impact on emotional distress and quality of life. The results of this study may help develop effective psychological treatments to support cancer survivors in managing fear of recurrence and improving overall well-being.
For patients with treatment-resistant depression (TRD), a single low dose of intravenous (IV) ketamine can help relieve symptoms as quickly as 24 hours later. The main problem with IV ketamine for TRD is that the effect is short-lived, lasting only days to 1 or 2 weeks. Furthermore, IV ketamine is a resource-intensive treatment, and the safety of long-term, repeated use for depression is unknown. To provide this treatment in a safe and cost-effective way, Investigators must allocate it efficiently to those patients who have the greatest need and probability of benefit. Therefore, this project aims to find clinical features (signs, symptoms, and parts of a patient's history) that will help predict which patients are most likely to respond to a single dose of IV ketamine for TRD. This will help guide patient selection and triaging. Investigators will recruit 40 participants with TRD, and randomize them to one of two conditions (ketamine followed by an active placebo 3-weeks later, or vice versa). With clinical data collected through detailed interviews, questionnaires, actigraphy, speech sampling, electroencephalography (EEG), and computerized tasks, this study design will let us evaluate how well such factors predict (A) rapid response at 24-hours, and (B) sustained response at 7 and 14 days.
The aim of this randomized multicentre phase 2 clinical trial is to compare the effects of rTMS and SSRI medication as early treatment of depression. In this two-stage, therapy response-adapted trial, 106 patients suffering from non-treatment resistant major depression (non-TR MD) will be randomized in Stage I to either 4 weeks bilateral theta burst stimulation (TBS) or 4 weeks antidepressant SSRI medication. The allocation to Stage II occurs therapy response-adapted. Patients receive either a maintenance treatment or a switch to the respective other treatment arm. The primary outcome is the comparison of the two study arms with regard to therapy response measured with the Montgomery-Asberg Depression Rating Scale (MADRS) after 4 weeks at the end of Stage I.
Major depressive disorder (MDD) is the most common mental disorder. It can be a huge burden not only for the person affected by it, but also for his/her whole family. The goal of this clinical trial is to test the efficacy of a family supportive intervention called psychoeducational family intervention (PFI) compared to a brief informative intervention in families with a member affected by MDD. Families will participate in one of the two interventions for a period of 6 months more or less, and they will be asked to answer some questionnaires about how much MDD impacts on their everyday life and the patient's symptoms, in order to understand whether a more structured intervention such as PFI can be useful for families in order to better deal with this complicated illness.
The pilot study on the impact of a Psychiatric Consultation-Liaison Intervention in Primary Care Medical Consultations in French-speaking Switzerland (PLIMeC-P), is a mixed method randomized controlled trial. The investigated health-related intervention is a brief Consultation-Liaison (CL) psychiatry intervention in primary care. Primary Care Physicians (PCPs) have a key role in preventing, detecting, and managing mental disorders. Therefore, the optimization of both the quality of their interventions and their cooperation with psychiatric and psychological care networks are important challenges. It is well demonstrated that multidisciplinary interventions improve the efficacy of mental health care, CL psychiatry being one such type of intervention. Therefore, community CL-psychiatry, for example in private primary care group practices, are rare. The impact of such community, primary care CL-psychiatry interventions, should be investigated. The mixed methods randomized controlled trial PLIMeC study will examine the impact of a CL-psychiatric intervention in primary care settings, for newly reported mental illness, versus a Treatment As Usual (TAU) control arm. The intervention consists of a CL-psychiatric intervention into private medical practices, provided to patients suffering from mental health problems, a group of patients generally under-treated. The CL-psychiatrist will receive and discuss PCPs' referrals for patients with mental distress, who don't have a psychiatric follow-up. After a brief intervention (1-4 sessions), feedback conjoint (PCP-psychiatrist) session will be organized, to complete the intervention and provide proposals. The pilot study (PLIMeC-P) will determine whether the main planned study (PLIMeC) is feasible and practicable. It will be conducted on two sites, the Neuchâtel Psychiatry Centre (CNP) and the North-west Adult Psychiatry Service (SPANO), Department of Psychiatry of CHUV, Yverdon. For the pilot study (PLIMeC-P), 15 eligible participants are expected for each group, 30 participants in total. They will be recruited in three private primary care group practices. After eligibility and randomization 15 participants will be included for the intervention arm (brief CL-psychiatric intervention) and 15 for the control arm (TAU). The expected number of participants for the main trial (PLIMeC) will be estimated through analysis of the initial results of the PLIMeC-P.
Anxiety, depression and stress are common during pregnancy. These have been found to negatively impact mother and child outcomes. When anxiety, depression, and stress are present in pregnant women, it is therefore important to manage them to improve the outcome of the mother and her child. Although pregnancy itself has been shown to increase anxiety, depression and stress, these issues are further elevated in high-risk pregnancy groups. Mothers at risk of preterm delivery (less than 37 weeks gestational age), have been found to have higher rates of depression, anxiety and stress compared to uncomplicated term pregnancies. In addition, anxiety, depression and stress symptoms themselves increase the risk for preterm delivery, creating a vicious cycle for this high-risk group. Mindfulness is a tool that has been during pregnancy to reduce depression, anxiety, and stress. Many studies have found mindfulness to be an appropriate management option in normal term pregnancies. To date, there have been no studies that have looked at Mindfulness as a tool for mothers admitted due to risk of preterm delivery. This study will explore the impact of teaching mindfulness skills to inpatient mothers at risk of preterm delivery and studying its effects on maternal depression, anxiety, and stress. This study involves providing Mindfulness strategies during the mother's inpatient admission for the risk of preterm delivery for four consecutive weeks. Participants will be enrolled through informed consent. All participants will be given pre and post participation questionnaires to examine the impact of mindfulness on anxiety, depression and stress. The participants will also be encouraged to maintain a weekly mindfulness log. The results of this research may lead to future studies looking at the impact of mindfulness practice for high-risk pregnancies. This will also help open up the possibility of offering such courses for inpatient and outpatient high-risk pregnancies in the future.
The overall purpose of this study is to help determine how best to incorporate small amounts of human and digital support into a meditation app. The meditation app used is the Healthy Minds Program (HMP) which provides training in four pillars of well-being (Awareness, Connection, Insight, Purpose) through a combination of podcast-style didactic material and guided meditation practices.