[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bronchial-obstruction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bronchial-obstruction":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100656681","phase-4-preterm-infants-with-bronchial-obstruction---prospective-study-of-efficacy-and-safety-of-inhaled-tiotropium-100656681",false,"NCT07827859","PREterm Infants With Bronchial Obstruction - Prospective Study of Efficacy and Safety of Inhaled Tiotropium","A Prospective, Randomized, Controlled, Crossover Phase IV Study to Evaluate the Efficacy and Safety of Inhaled Tiotropium in Preterm Infants With Bronchial Obstruction Compared to Standard Treatment","PRETIO","Inclusion Criteria:\n\n* Age between 6 and 18 years.\n* History of preterm birth (defined as delivery at \\\u003C 37 gestational weeks).\n* Spirometrically proven bronchial obstruction, defined as a z-score of FEV1 and\u002For \\>= 2 other parameters - Forced Vital Capacity (FVC; liters \\[L\\]), Peak Expiratory Flow (PEF; liters per second \\[L\u002Fs\\]), and Forced Expiratory Flow between 25% and 75% of Forced Vital Capacity (FEF25-75; liters per second \\[L\u002Fs\\]).) below -1.65 SD.\n* Positive bronchodilatation test, defined as an increase in FEV₁ or FVC of more than 10% of the corresponding GLI-predicted value following administration of ipratropium bromide. Bronchodilator responsiveness will be calculated separately for FEV₁ and FVC as:\n\n\\[(post-bronchodilator value - pre-bronchodilator value) \u002F predicted value\\] × 100.\n\nFEV₁ and FVC will be measured in litres (L) after ipratropium administration.\n\n* Acceptable spirometry performance in accordance with American Thoracic Society\u002FEuropean Respiratory Society (ATS\u002FERS) 2019 standards.\n* No long-term inhalation therapy (such as a long-acting beta₂-agonist (LABA) or a combination of an inhaled corticosteroid and a long-acting beta₂-agonist (ICS\u002FLABA)) within the last month prior to study enrollment.\n\nExclusion Criteria:\n\n* Other chronic respiratory diseases (e.g., asthma, cystic fibrosis).\n* Anatomical abnormalities of the respiratory tract or presence of glaucoma.\n* Congenital malformations of the uropoetic tract or cardiac arrhythmias\u002Fcongenital heart defects.\n* Concomitant use of anticholinergic medications for enuresis nocturna.\n* Pregnancy (mandatory urine screening required for all female participants aged 13 years and older).\n* Insufficient cooperation or inability to properly perform spirometry maneuvers.","ALL","6 Years","18 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","The purpose of this clinical trial is to evaluate the efficacy and safety of inhaled tiotropium bromide (Spiriva Respimat) in preterm-born children and adolescents suffering from chronic bronchial obstruction.\n\nPreterm infants often experience persistent narrowing of the airways, which leads to shortness of breath, chronic respiratory symptoms, and reduced exercise tolerance.\n\nTiotropium is a long-acting muscarinic antagonist (LAMA) that helps dilate the airways and facilitate breathing. While this medication is already approved for pediatric patients aged 6 years and older with severe asthma, its efficacy and safety have not yet been validated in the specific population of preterm infants with bronchial obstruction. This study aims to fill this clinical knowledge gap.\n\nThis is a non-commercial, monocentric, prospective, randomized, open-label, phase IV study utilizing a 2x2 crossover design. The trial will enroll 50 participants aged 6 to 18 years. Each participant will undergo two distinct 3-month phases: a treatment period with daily inhaled tiotropium (5 µg once daily) and a control observation period without long-term anticholinergic therapy. The sequence of these periods will be randomly assigned to each participant. The primary objective is to demonstrate lung function improvement by evaluating the change in forced expiratory volume in 1 second (FEV1) expressed in liters and Forced Vital Capacity (FVC) expressed in liters between the treatment and control periods. No blood samples or invasive procedures are required for this study.",[28,29],"Bronchial Obstruction","Premature Birth",[31,32,33,34],"Tiotropium","LAMA","Preterm Infants","Spirometry","NOT_YET_RECRUITING","2026-09-15",{"date":38,"type":39},"2026-09-18","ACTUAL",{"date":41,"type":22},"2026-11-01",{"date":43,"type":22},"2029-08-01",{"name":45,"class":46},"General University Hospital, Prague","OTHER"]