Execise Intervention in Adult Severe Asthma
RecruitingPhysical activity has been shown to improve asthma control in individuals with asthma. Patients with severe asthma frequently experience exacerbations, which often result in a physically inactive lifestyle. The investigators therefore hypothesize that patients with severe asthma who initiate biological therapy may particularly benefit from increased physical activity, both in terms of exercise capacity and asthma control. The aim of this study is to determine whether an individually tailored exercise program improves exercise capacity and asthma control in patients with severe asthma. Additionally, the study evaluates the effects of the intervention on asthma symptoms, frequency of exacerbations, lung function, quality of life, and body composition. The primary outcome is the change in exercise tolerance, measured as peak oxygen uptake during cardiopulmonary exercise testing. Secondary outcomes include asthma symptoms (proportion of patients reporting improvement based on the Asthma Control Test), frequency of exacerbations, changes in lung function (FVC and FEV1), asthma-related quality of life (AQLQ), and changes in body composition (body mass index and waist circumference). At baseline, all participants undergo fitness assessments, including cardiopulmonary exercise testing and muscle strength tests. Participants are then randomized into two groups. The intervention group receives an individually tailored 6-month exercise program designed by a sports medicine physician and a physiotherapist based on baseline fitness level. The control group receives standard advice to increase physical activity. Asthma medication is managed according to standard clinical practice in both groups. Fitness assessments are repeated at 6 months for all participants, and asthma control is evaluated at 6 and 12 months
PhaseNA
TypeInterventional
Age18 Years
WhereHelsinki, Finland
SponsorHelsinki University Central Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Asthma Intervention With Residential Ventilation and Air Cleaner (AIRVAC) Study
NCT07196436 ·
Asthma Control, Pulmonary Function, Quality of Life
RecruitingThe primary goal of this study is to investigate the comparative long-term (i.e., 1-year) effectiveness of energy recovery ventilators (ERVs) and portable air cleaners (PACs) in reducing indoor air pollutants and mold levels and improving asthma-related health outcomes in inner-city children and adults with asthma in low-income households in the Dallas-Fort Worth (DFW) metropolitan area, TX. Secondary goals include: (1) examining associations among asthma outcomes, exposure to indoor air pollutants and mold, and housing-related factors, (2) conducting a cost-benefit analysis of ERV and PAC interventions for improving IAQ, mold control, and health outcomes, and (3) evaluating the utility of cost-effective methods and protocols for measuring IAQ and mold for indoor air pollution epidemiology studies and for providing practical information to patients and their physicians. Using a double-blind, placebo-controlled randomized controlled trial, 80 households will be assigned to receive active or placebo versions of ERVs or PACs. Environmental exposures and housing conditions will be monitored alongside comprehensive health assessments, including lung function tests and validated surveys on asthma control, quality of life, stress, and sleep quality.
PhaseNA
TypeInterventional
Age5 Years
WhereArlington, Texas, United States + 1 more
SponsorThe University of Texas at Arlington
▾Tap for detailsClick for full details — eligibility, all locations, contacts The objective of this study is to conduct a randomized controlled trial (RCT) to compare the adapted and refined ASTHMAXcel Voice platform to usual care (UC). It is hypothesized by the investigator team that ASTHMAXcel Voice will be associated with improved clinical and process outcomes, asthma quality of life (QOL), medication adherence, and self-efficacy as compared to UC.
PhaseNA
TypeInterventional
Age18 Years
WhereThe Bronx, New York, United States
SponsorMontefiore Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts This is a Non-interventional, Study to Assess Demographic Characteristics and Patient Reported Outcomes in China Patients With SEA Treated With Benralizumab
RecruitingThe objective of this study is to collect empirical data that elucidates the clinical profile and therapeutic efficacy of benralizumab among the patients aged 12 years and above, with severe eosinophilic asthma. The study will focus on the early treatment response, treatment outcomes and the change in asthma control of benralizumab therapy in a real-world setting in China. This study will also describe the physician-reported reasons for discontinuation and switching of benralizumab therapy.
Phase—
TypeObservational
AgeAny
WhereAnhui, China + 35 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline
NCT06432790 · Overweight, Childhood, Obesity, Childhood,
Asthma in Children RecruitingThe goal of this study is to evaluate the effectiveness of CHAMPION ("Comparative-effectiveness of a Healthy lifestyle and Asthma Management Program, In-person vs ONline"), a primary care-based intervention to address childhood obesity and asthma, and test the effectiveness of a telehealth-only version of the program. Intensive Health Behavior and Lifestyle Treatment (IHBLT), when delivered via telehealth vs. in-person among children with overweight or obesity and persistent asthma.
PhaseNA
TypeInterventional
Age4 Years – 17 Years
WhereBoston, Massachusetts, United States
SponsorMassachusetts General Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of CDX-622 in Participants With Mild to Moderate Asthma
RecruitingThis is a study to determine the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of CDX-622 in adults with mild to moderate asthma.
PhasePhase 1
TypeInterventional
Age18 Years
WhereSan Francisco, California, United States + 3 more
SponsorCelldex Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts Mechanistic Insights From Bronchoscopy Airway Samples
RecruitingThe purpose of this study is to examine the mechanisms of asthma. The investigators are comparing the cells of individuals with and without asthma and looking at the roles various parts of the cell play in the production and secretion of mucus.
Phase—
TypeObservational
Age18 Years – 70 Years
WhereSan Francisco, California, United States
SponsorUniversity of California, San Francisco
▾Tap for detailsClick for full details — eligibility, all locations, contacts Xenon-129 and Inert Fluorinated Gas Lung MRI: Study of Healthy Volunteers and Participants With Pulmonary Disease
NCT02740868 · Cystic Fibrosis,
Asthma RecruitingAim of this study is to evaluate image quality and reproducibility of Xenon-129 and Inert fluorinated (19F) gas Magnetic Resonance Imaging (MRI) and to evaluate changes in lung structure and function in participants with cystic fibrosis (CF) and asthma compared to healthy controls.
PhasePhase 2
TypeInterventional
Age8 Years
WhereToronto, Ontario, Canada
SponsorThe Hospital for Sick Children
▾Tap for detailsClick for full details — eligibility, all locations, contacts Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)
NCT05114096 · Preterm Birth, Premature Birth, Complication of Prematurity
RecruitingAntenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities in preterm infants, such as respiratory distress syndrome. The standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone (for a total of 24 mg in Canada, or 22.8 mg in Australia) to accelerate fetal lung maturity. The investigators plan to conduct a randomized controlled trial to determine whether half the usual dose (12 mg in Canada, or 11.4 mg in Australia) of Celestone is non-inferior to the standard double doses.
PhasePhase 4
TypeInterventional
Age18 Years – 55 Years
WhereCalgary, Alberta, Canada + 24 more
SponsorMcMaster University
▾Tap for detailsClick for full details — eligibility, all locations, contacts VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma
NCT06570889 ·
Asthma, Respiratory Tract Infections, Gastrointestinal Infection
RecruitingThe overall aim of the study is to develop a nutritional preventive vitamin D supplementation strategy in pregnancy for early childhood asthma/persistent wheeze during the first three years of life as we hypothesize that supplementation in higher doses than recommended could reduce the risk of disease development.
PhasePhase 3
TypeInterventional
Age18 Years – 45 Years
WhereGentofte Municipality, Denmark
SponsorProfessor Klaus Bønnelykke
▾Tap for detailsClick for full details — eligibility, all locations, contacts Taiwan Severe Asthma Biologic Registry
RecruitingThis is a prospective multi-centers cohort study for registration adult patients with severe asthma and were reimbursed biologics treatment in Taiwan. The goal of this observational study is to discover the real-world effectiveness, the impact of initiating, switching of biologics, and the possible prediction factors for selecting the best treatment option for patients. The main question\[s\] it aims to answer are: 1. Determine risk factors associated with poor asthma control. 2. Support the development of effectiveness and safety of therapeutic principles 3. To discover the real-world effectiveness of different biologics ( Clinical remission) 4. To discover the impact of initiating biologics for severe asthma patients. 5. To evaluate the prevalence of biologics switching and its benefits for patients. 6. To compare the achievement rate of clinical remission among different biologics. Participants who are treated either with omalizumab, mepolizumab, benralizumab dupilzumab or Tezepelumab after January 1, 2020 will be included in the study.
Phase—
TypeObservational
Age18 Years
WhereTaichung, Taiwan
SponsorTaichung Veterans General Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Quantitative Chest CT and Multi-Omics to Distinguish Asthma From COPD and Predict Treatment Response
RecruitingThis study aims to improve the diagnosis and treatment prediction of asthma and chronic obstructive pulmonary disease (COPD) by combining quantitative chest computed tomography (CT) imaging with multi-omics data. Adults with asthma or COPD will be enrolled and undergo routine clinical evaluations, pulmonary function tests, blood tests, and chest CT scans. Additional samples, such as sputum and microbiome specimens, may also be collected. No experimental drugs or devices will be administered as part of this study. Researchers will analyze CT imaging features together with clinical, laboratory, and biological data to better distinguish asthma from COPD and to identify factors that may predict treatment response. The findings are expected to contribute to more precise and personalized management of chronic airway diseases.
Phase—
TypeObservational
Age19 Years
WhereSeoul, Dongjak-gu, South Korea + 1 more
SponsorKorea University Guro Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Impact of the Implementation of a Telemedicine Program on Patients Diagnosed with Asthma
NCT06116292 ·
Asthma, Telemedicine, Adherence, Treatment
RecruitingIntroduction: Asthma is one of the most common chronic respiratory diseases worldwide. Despite the extensive knowledge of the condition and available therapeutic options, severe asthmatic patients have poor disease control in 50% of cases. Objective: To assess the impact of implementing a mobile application (ESTOI) in patients diagnosed with asthma on disease control, treatment adherence, and perceived quality of life. Methodology: A 52-week randomized clinical trial involving asthma patients receiving care at a highly specialized hospital in Spain. A total of 108 patients will be included and divided into two groups. The intervention group will receive more comprehensive monitoring than usual, including access to the ESTOI application. The Asthma Control Test (ACT) questionnaire will be used as the primary assessment variable. Other variables to be studied include the Inhaler Adherence Test (TAI), the number of exacerbations, peak expiratory flow, exhaled nitric oxide examination, hospital anxiety and depression scale, asthma quality of life questionnaire, forced spirometry parameters (FVC, FEV1, and reversibility), and analytical parameters (eosinophilia and IgE).
PhaseNA
TypeInterventional
Age18 Years
WhereBarcelona, Barcelona, Spain
SponsorHospital Universitari de Bellvitge
▾Tap for detailsClick for full details — eligibility, all locations, contacts The goal of this physiological pilot study with a randomized crossover design is to study the effect of Flow-controlled ventilation (FCV) on the minute volume compared to Volume-controlled ventilation (VCV) in intubated patients with an exacerbation of their asthma or COPD. Our hypothesis is that FCV will results in a lower minute volume compared to VCV in this patient category. Patients will be randomized between two ventilation sequences, namely 90 minutes of FCV followed by 90 minutes of VCV or vice versa.
PhaseNA
TypeInterventional
Age18 Years – 100 Years
WhereRotterdam, South Holland, Netherlands + 1 more
SponsorErasmus Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts The COCCOS Study: a Transition Program for Young Persons With Chronic Conditions
RecruitingA study is undertaken to examine the feasibility of the newly developed transition program in adolescents with type 1 diabetes, asthma and obesity in a multicentric setting. Specific objectives for this study are: (1) examining the impact of the program in terms of patient-reported health outcomes, (2) examining patients' and healthcare providers' experiences related to the program implementation process, and (3) examining the impact of the program in terms of cost-effectiveness.
PhaseNA
TypeInterventional
Age16 Years – 21 Years
WhereGhent, Belgium
SponsorUniversiteit Antwerpen
▾Tap for detailsClick for full details — eligibility, all locations, contacts Follow-up of Spanish Prospective Asthma and Nasal Polyposis Registry
NCT06163807 ·
Chronic Asthma RecruitingPrimary objective \- To study the stability of different phenotypes and endotypes of asthma at 3, 5, and 7 years of follow-up and - in MEGA COHORT and in patients on biologic treatment Secondary objective(s) * To study biomarkers variation post-treatment in patients with and without Nasal Polyposis * To demonstrate the existence of different subtypes of eosinophils that may be phenotypically and functionally heterogeneous * To increase the number of patients in the cohort on biologic treatment to reach at least 900 (400 over the current cohort).
Phase—
TypeObservational
Age18 Years – 80 Years
WhereSantiago de Compostela, Acoruña, Spain + 7 more
SponsorInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz
▾Tap for detailsClick for full details — eligibility, all locations, contacts Moving Towards Precision Medicine in United Airways Disease: Unraveling Inflammatory Patterns in Asthmatic Patients With or Without Nasal Polyps
NCT05009758 ·
Asthma, Chronic Rhinosinusitis With Nasal Polyps, Chronic Rhinosinusitis (Diagnosis)
RecruitingAsthma and chronic rhinosinusitis (CRS) are inflammatory diseases of the respiratory tract, asthma from the lower part, and CRS, from the upper part. In theory, these parts are correlated as if they are one single organ, namely "united airways", which means that if one is affected by any condition, the other might be impacted as well. However, this relationship has not yet been described down to the cellular and molecular levels. By investigating patients that have (1) asthma and CRS with nasal polyp, (2) asthma and CRS without nasal polyp, and (3) just CRS with nasal polyp, we aim to determine the correlation of the upper and lower part of the respiratory tract. At first, the characterization of disease will be determined by established clinical criteria, such as lung function, blood analysis for the presence of eosinophils (a type of white cells), and nasal polyp score. To continue, in-depth analysis of nose, oropharynx, and lung samples will help gain information about the inflammatory profile and local microbiome of the three different groups of patients through molecular and cellular assays. The results of this study will help to describe the hypothesis of the united airways which will provide better guidance for medical treatment of asthma and CRS with or without polyp, thus improving the life quality of patients.
PhaseNA
TypeInterventional
Age18 Years – 99 Years
WhereVienna, Austria
SponsorMedical University of Vienna
▾Tap for detailsClick for full details — eligibility, all locations, contacts Short Treatment with Omalizumab for Severe Asthma
RecruitingThe optimal duration of the treatment by OMA remains unclear when asthma is well controlled. Data suggest that a large part of patients with well controlled asthma can discontinue OMA therapy without any asthma control deterioration or with an acceptable decrease in asthma control, therefore French experts propose that omalizumab can be given for "3 to 5 yrs if asthma remains well controlled". The costs related to OMA are high and frequent injections represent severe constraints for patients. For all these reasons, evaluating whether shortening duration of OMA therapy is feasible while maintaining acceptable asthma control is a critical point. Therefore, the aim of this study is to evaluate asthma control after OMA discontinuation after at least 33 months of treatment when asthma is well controlled.
PhasePhase 4
TypeInterventional
Age18 Years
WhereParis, Île-de-France Region, France
SponsorAssistance Publique - Hôpitaux de Paris
▾Tap for detailsClick for full details — eligibility, all locations, contacts Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
RecruitingAsthma is a heterogeneous disorder in which multiple potential inflammatory pathways contribute to airway obstruction. The biological basis for airway inflammation is the subject of intensive investigation. This work is designed to identify airway factors that are responsible for recruiting cells and associate their airway presence with atopy and asthma.
PhasePhase 1
TypeInterventional
Age18 Years – 50 Years
WhereBoston, Massachusetts, United States
SponsorBenjamin Medoff
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase III Study of CM326 in Subjects With Moderate to Severe Asthma
RecruitingThis study is a multi-center, randomized, double-blind, placebo-controlled Phase Ⅲ clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM326 in subjects with moderate to severe asthma. The study consists of three periods, including an up to 4-week screening period, a 52-week double-blind randomized treatment period, and a 12-week safety follow-up period.
PhasePhase 3
TypeInterventional
Age18 Years – 80 Years
WhereShanghai, Shanghai Municipality, China
SponsorCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
▾Tap for detailsClick for full details — eligibility, all locations, contacts