[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643871":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":43,"responsibleParty":58,"collaborators":60,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":24,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":24,"studyType":76,"phases":77,"briefSummary":80,"conditions":81,"keywords":24,"overallStatus":83,"whyStopped":24,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Kither Biotech Srl","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"KIT2014","EXPERIMENTAL","24 participants with Chronic Obstructive Pulmonary Disease to be enrolled in 3 cohorts, up to 3 dose levels",[13],"Drug: KIT2014",{"label":15,"type":10,"description":16,"interventionNames":17},"Placebo","12 participants with Chronic Obstructive Pulmonary Disease to be enrolled in 3 cohorts, up to 3 dose levels",[18],"Drug: Placebo",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","KIT2014 will be administered by inhalation with a nebuliser",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Placebo will be administered by inhalation with a nebuliser",[15],[29],{"name":30,"affiliation":31,"role":32},"Alexander Gordon, MBBS FRACP","Novatrials","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Katrina Asher","CONTACT","+61 2 4058 5477","katrina@novatrials.com.au",{"name":40,"role":36,"phone":41,"phoneExt":24,"email":42},"Kate Ramage","+61 2 4096 1176","Kate.Ramage@novatrials.com.au",[44],{"facility":31,"status":24,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Charlestown","New South Wales","2291","Australia","AU",{"type":51,"coordinates":52},"Point",[53,54],151.69318,-32.96828,{"lat":54,"lon":53},[57],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},{"type":59,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[61],{"name":62,"class":6},"Avance Clinical Pty Ltd.","100643871","phase-1-a-study-of-the-safety-tolerability-pharmacokinetics-and-efficacy-of-kit2014-in-patients-with-moderate-to-severe-copd-100643871",false,"NCT07668518","A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of KIT2014 in Patients With Moderate to Severe COPD","A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Dose Ranging, Phase 1b\u002F2a Study to Investigate the Safety, Tolerability, Pharmacokinetics and Early Efficacy of Inhaled KIT2014 Over 7 Days of Treatment in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n* Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects\n* Adult males and females, 40 to 80 years of age (inclusive) at screening.\n* Current or former cigarette smokers with a ≥10 pack-year smoking history\n* Established physician diagnosis of COPD with associated symptoms defined by the GOLD guidelines for ≥ 12 months of screening.\n* FEV1 post-bronchodilator of 40% to 80% of predicted normal at Screening\n* Current symptoms of COPD, including bronchitis and\u002For dyspnoea on moderate exertion at screening.\n\nExclusion Criteria:\n\n* History of life-threatening COPD\n* Chronic obstructive pulmonary disease exacerbation requiring oral or parenteral corticosteroids or hospitalisation within 3 months of Screening\n* Other clinically active, physician diagnosed moderate to severe respiratory disorders that could interfere with study assessments or confound results (e.g., asthma, bronchiectasis, pulmonary fibrosis, interstitial lung diseases, bronchiolitis obliterans, lung cancer, cor pulmonale, pulmonary hypertension, uncontrolled sleep apnoea, active tuberculosis).\n\nOther inclusion\u002Fexclusion eligibility criteria apply.","ALL","40 Years","80 Years",{"count":74,"type":75},36,"ESTIMATED","INTERVENTIONAL",[78,79],"PHASE1","PHASE2","Study investigating the safety, tolerability, pharmacokinetics and early efficacy with KIT2014 over 7 days of treatment in moderate to severe chronic obstructive pulmonary disease patients.",[82],"Chronic Obstructive Pulmonary Disease (COPD)","NOT_YET_RECRUITING","2026-06-19",{"date":86,"type":87},"2026-06-25","ACTUAL",{"date":89,"type":75},"2026-07-01",{"date":91,"type":75},"2027-07-31",{"name":5,"class":6},1]