[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fraunhofer-Institute of Toxicology and Experimental Medicine\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100650793","induced-sputum-collection-in-copd-patients-with-and-without-a-vibroacoustic-device-100650793",false,"NCT07751705","Induced Sputum Collection in COPD Patients With and Without a Vibroacoustic Device","Randomized Crossover Study of Induced Sputum Collection in COPD Patients for Assay Development With and Without a Vibroacoustic Device","Inclusion Criteria:\n\n1. Able and willing to give written informed consent.\n2. Male and female participants, aged 40-70 years, inclusive. Women of childbearing potential (i.e. not post-menopausal, defined as amenorrhoeic for at least 12 months, and without documented surgical sterilization such as hysterectomy, bilateral oophorectomy, or tubal ligation) must not be pregnant, as confirmed by a negative urine pregnancy test prior to each sputum induction procedure, and must not be breastfeeding.\n3. Diagnosis of COPD based on post-bronchodilator spirometry, defined as FEV1\u002FFVC \\\u003C 0.70, consistent with GOLD criteria.\n4. FEV1 between 50% and 80% of predicted (post-bronchodilator).\n5. Body mass index between 18 and 38 kg\u002Fm2\n6. Subgroup \"Current Smokers\": current smoking with at least 15 cigarettes per day over the past 12 months and a cumulative smoking history of at least 10 pack-years, confirmed by a positive urine cotinine test at screening.\n7. Subgroup \"Ex-smokers\": no smoking for at least one year prior to screening and a cumulative smoking history of at least 10 pack-years, confirmed by a negative urine cotinine test at screening\n\nExclusion Criteria:\n\n1. Any clinically relevant disease or condition which, in the opinion of the investigator, may significantly compromise participant safety, affect study outcomes, or prevent adherence to the protocol. Explicitly excluded is cystic fibrosis or interstitial lung disease.\n2. Any condition that, as judged by the investigator, constitutes a contraindication or safety concern for the application of vibroacoustic chest therapy. This includes, but is not limited to:\n\n   * Any implanted or external electronic-mechanical device in the thoracic projection area (e.g. cardiac pacemaker, implantable cardioverter-defibrillator, cardiac assist devices, implantable drug delivery pumps, neurostimulators)\n   * Coronary heart disease with coronary stents or history of percutaneous coronary intervention or coronary artery bypass grafting\n   * Mechanical heart valve prosthesis\n   * Aortic stent graft or thoracic endovascular implant\n   * Unstable angina pectoris or acute coronary syndrome within the past 6 months\n   * Clinically significant cardiac arrhythmia requiring treatment (e.g. uncontrolled atrial fibrillation, ventricular tachycardia)\n   * Known large pulmonary bullae (\\>1 cm) or history of spontaneous pneumothorax\n   * Unstable rib fractures or thoracic vertebral fractures\n   * Active haemoptysis or known high risk of pulmonary haemorrhage\n   * Therapeutic anticoagulation or known coagulation disorder with increased bleeding risk\n   * Active thoracic malignancy\n   * Thoracic surgery within the past 6 month\n3. Initiation or discontinuation of mucolytic or expectorant agents (e.g., N-acetylcysteine, ambroxol) within 14 days prior to Visit 1 or between study visits. Participants on stable chronic mucolytic therapy (unchanged regimen for at least 4 weeks prior to Visit 1) may be enrolled provided they maintain the same regimen throughout the study.\n4. Treatment with systemic corticosteroids or biological therapies within 6 months prior to screening\n5. Treatment with antibiotics within 2 months prior to screening\n6. Lower respiratory tract infection within 4 weeks prior to screening\n7. Upper respiratory tract infection within 2 weeks prior to screening\n8. History of drug or alcohol abuse within 12 months prior to screening\n9. Participation in a clinical trial involving an investigational medicinal product within 6 months prior to screening\n10. Any condition associated with an increased risk of non-compliance with study procedures (e.g. inability to hold the vibroacoustic emitters against the chest because of severe arthritis, neuromuscular disease, or other condition significantly limiting upper extremity function).","ALL","40 Years","70 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","Induced sputum is a non-invasive method to collect samples from the airways. It involves inhaling a saline mist to loosen mucus, which is then coughed up. The samples are used to study markers of lung disease. In some people, this procedure yields only small amounts of sample.\n\nThis study looks at whether adding a vibroacoustic device during sputum induction can increase the amount of sputum collected in patients with chronic obstructive pulmonary disease (COPD). The device applies gentle sound-based vibrations to the chest to help move mucus in the airways.\n\nEach participant undergoes two sputum collection procedures on separate days:\n\none with and one without the device. The order is assigned at random. The main comparison is the amount of sputum obtained with versus without the device in the same person. The study also assesses how well the procedure is tolerated.",[27],"COPD (Chronic Obstructive Pulmonary Disease)",[29,30,31,32,33],"Chronic Obstructive Pulmonary Disease","Induced Sputum","Sputum Induction","Airway Sampling","COPD","RECRUITING","2026-08-18",{"date":37,"type":38},"2026-08-19","ACTUAL",{"date":35,"type":38},{"date":41,"type":21},"2026-12",{"name":43,"class":44},"Fraunhofer-Institute of Toxicology and Experimental Medicine","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":45},"100540520","development-of-a-novel-non-invasive-inflammometry-following-allergen-challenge-in-patients-with-mild-allergic-asthma-100540520","NCT06317909","Development of a Novel Non-invasive Inflammometry Following Allergen Challenge in Patients With Mild Allergic Asthma","Inclusion Criteria:\n\n1. Able and willing to give written informed consent.\n2. Male and female subjects aged 18-65 years. Women will be considered for inclusion if they are:\n\n   * Not pregnant, as confirmed by pregnancy test (see assessment schedule), and not nursing.\n   * Of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarcheal or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the Screening Visit).\n   * Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence, implants, injectables, combined oral contraceptives, hormonal Intrauterine Devices (IUDs) or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).\n3. History of mild asthma for at least 12 months prior to the Screening Visit that is well controlled with Short Acting Beta-Adrenergic Stimulator (SABA) only.\n4. Body mass index between 18 and 32 kg\u002Fm2\n5. Normal pulmonary function with forced Expiratory Volume in the first second (FEV1) ≥80% of predicted normal and FEV1\u002FForced Vital Capacity(FVC) ≥70% at Screening Visit. Calculations will be based on Global Lung Function Initiative (GLI) formula. If the participant fails to meet this criterion on the first measurement, spirometry may be repeated twice.\n6. Positive skin prick test (wheal diameter reaction ≥3 mm) for the respective challenge aeroallergen (i.e. tree, weed, grass or house dust mite) at or within 12 months prior to the Screening Visit (if performed and documented at Fraunhofer ITEM).\n7. Positive early and late asthmatic response upon incremental inhaled allergen challenge at or prior to the Screening Visit (if performed and documented at Fraunhofer ITEM).\n8. Production of adequate sputum with ≥1 x 106 total non-squamous cells at or within 12 month prior to the Screening Visit 1 (if not performed and documented at Fraunhofer ITEM).\n9. Nonsmokers with a history of less than 1 pack year having been nonsmokers for at least one year.\n\nExclusion Criteria:\n\n1. Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, lung function or ECG at Screening Visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study.\n2. Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, metabolic disease (asymptomatic Gilbert's syndrome is allowed), endocrine disease (stable and asymptomatic hypothyroidism with or without hormone replacement therapy (HRT) is allowed), or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).\n3. Regular intake of any prescribed or over the counter medication. Exceptions include paracetamol for pain relief, contraceptive medication, hormonal replacement therapy, dietary and vitamin supplements.\n4. Specific Immunotherapy (SIT) within three years prior to the study.\n5. Intake of systemic or inhaled steroids within 4 weeks before Screening Visit 1a.\n6. Respiratory tract infection (RTI) within 4 weeks before Screening Visit 1a.\n7. Mild to moderate asthma exacerbation within 3 months before Screening Visit 1a.\n8. Any history of life-threatening asthma, defined as an asthma episode that required intubation and\u002For was associated with hypercapnea, respiratory arrest or hypoxic seizures.\n9. Suspected hypersensitivity to any ingredients of the medication in line with bronchoscopy (bronchodilators, sedatives and local anesthetics).\n10. Conditions or factors, which would make the subject unlikely to be able to undergo bronchoscopy or allergen challenge.\n11. Conditions or factors, which would make the subject unlikely to undergo MRI (e.g. due to claustrophobia, cardiac pacemaker, hypersensitivity to MR i.v. contrast imaging agents).\n12. Participation in another clinical trial with Investigational Medicinal Product (IMP) 30 days or 5 half-lives, whichever is longer, prior to enrollment.\n13. Participation in the observation period of a competing study within 30 days prior to Screening.\n14. Segmental allergen challenge three months prior to bronchoscopy.\n15. Donation of more than 400 ml of blood the preceding 60 days before screening.\n16. History of regular drug or alcohol abuse\n17. Risk of non-compliance with study procedures.\n18. Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.","18 Years","65 Years",{"count":55,"type":21},15,[24],"The goal of this exploratory method-development study is to to establish and evaluate novel non-invasive methods to monitor airway inflammation induced by allergen challenge (both by instillation during bronchoscopy and by inhalation) in patients with mild allergic asthma.\n\nThe investigator wants to further profile and develop the allergen challenge model by investigating the utility of various non-invasive monitoring methods. The hypothesis of the project is that local inflammatory changes in the lung induced by allergen can be captured by gas-enhanced magnetic resonance imaging (MRI) and analysis of exhaled breath.\n\nThe validation of cellular outcome measures and non-invasive inflammometry can be used in future clinical trials for proof of concept of novel anti-inflammatory medications.\n\nParticipants will undergo\n\n* methacholine challenge\n* 2 inhaled allergen challenges\n* 2 MRI with hyperpolarized xenon and gadolinium based contrast agent\n* 2 bronchoscopies with bronchoalveolar lavage (BAL)\n* segmental allergen challenge during the first bronchoscopy\n* spirometry\n* skin prick test and skin prick dilution tests\n* measurement of particles in exhaled air\n* nasal filter\n* nasal lavage\n* sputum induction\n* peak flow meter tests\n* exhaled NO (nictric oxide)\n* blood sampling (in total approx. 190 ml)",[59],"Mild Allergic Asthma","2026-07-23",{"date":62,"type":38},"2026-07-24",{"date":64,"type":38},"2024-08-09",{"date":66,"type":21},"2027-03",{"name":43,"class":44},""]