[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"moderate-asthma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:moderate-asthma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100617417","phase-3-study-of-formoterol-6-mcgfluticasone-125-mcg-by-eurofarma-laboratrios-sa-versus-alenia-6-mcg200-mcg-in-patients-with-asthma-forasma-100617417",false,"NCT07318350","Study of Formoterol 6 mcg\u002FFluticasone 125 mcg by Eurofarma Laboratórios S.A. Versus Alenia® 6 mcg\u002F200 mcg in Patients With Asthma (FORASMA)","Phase 3, Multicenter, Randomized, Parallel-group, Open-label, Non-inferiority Study of N0783 Versus Comparator (Formoterol 6 mcg \u002F Budesonide 200 mcg) in the Treatment of Moderate Asthma","FORASMA","Inclusion Criteria:\n\n* Age ≥ 12 and ≤ 65 years at Screening.\n* History of recurrent asthma symptoms (cough, wheezing, shortness of breath, chest tightness).\n* Previous medical diagnosis of asthma (confirmed by records, prescriptions, or participant report).\n* Documented reversible airway obstruction by spirometry: FEV₁ increase ≥ 200 mL and ≥ 12% post-bronchodilator (at screening or prior report).\n* Moderate asthma (GINA step 3) for ≥ 6 months, clinically stable and controlled with LABA + low-dose inhaled corticosteroid for ≥ 90 days.\n* ACQ-7 score ≤ 0.75 at Screening.\n* At Randomization: ACQ-7 score ≤ 0.75 and ≥ 70% adherence during run-in.\n\nExclusion Criteria:\n\n* Moderate\u002Fsevere asthma exacerbation within 90 days prior to screening.\n* Other pulmonary disease (including predominant COPD).\n* Symptomatic acute or chronic respiratory infection.\n* BMI ≥ 40 kg\u002Fm².\n* Use of LAMA within 6 months prior to screening.\n* Oral or depot corticosteroids within 30 days prior to screening.\n* Biologic therapy for asthma, allergic rhinitis, or urticaria within 12 months prior to screening.\n* Systemic vasoconstrictors within 7 days prior to screening.\n* Known hypersensitivity to formoterol, fluticasone, budesonide, or any component of study drugs.\n* Active pulmonary tuberculosis or fungal airway infection.\n* History or presence of ischemic heart disease, severe arrhythmias, cardiac decompensation, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm, pheochromocytoma, hypertrophic obstructive cardiomyopathy, thyrotoxicosis, QTc \\> 450 ms.\n* History of hyperthyroidism or uncontrolled diabetes mellitus.\n* Severe or uncontrolled disease at investigator's discretion.\n* Pregnancy or breastfeeding; women of childbearing potential not using effective contraception.\n* Participation in another clinical trial within 12 months unless direct benefit expected.\n* Any condition making participant unsuitable for study per investigator.\n* At Randomization: asthma exacerbation during run-in, prohibited medication use, HbA1c ≥ 10%, TSH below normal, ALT or AST \\> 2× ULN, serum potassium below normal, severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²), clinically significant ECG changes or QTc \\> 450 ms, or any abnormality making participant unsuitable.","ALL","12 Years","65 Years",{"count":21,"type":22},174,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a Phase 3, multicenter, randomized, parallel-group, open-label, non-inferiority clinical trial designed to evaluate the efficacy and safety of N0783 compared to Alenia® (Formoterol 6 mcg \u002F Budesonide 200 mcg) in the treatment of moderate asthma. Adult patients diagnosed with moderate asthma according to clinical and functional criteria will be enrolled. The primary objective is to demonstrate that N0783 is not inferior to Alenia® in improving asthma control. Participants will receive treatment according to the assigned intervention and will be monitored through scheduled visits for assessment of lung function, symptom control, and safety parameters throughout the study period.",[28],"Moderate Asthma",[30,28,31,32,33,34],"Asthma","Alenia®","Non-inferiority","Randomized Clinical Trial","Phase 3","NOT_YET_RECRUITING","2026-01-05",{"date":38,"type":39},"2026-01-07","ACTUAL",{"date":41,"type":22},"2026-10",{"date":43,"type":22},"2028-09",{"name":45,"class":46},"Eurofarma Laboratorios S.A.","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":59,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100423666","mani-real-life-perspective-observatory-100423666","NCT04796844","MANI Real-life Perspective Observatory","Mild\u002FModerate Asthma Network of Italy Observatory","MANI","Inclusion Criteria:\n\n* Adult patients\n* Asthma diagnosis according GINA 2020 algorithm (Annex 1)\n* Patients enrolled in other previous or ongoing observational studies\n\nExclusion Criteria:\n\n* Severe asthma patients according International ERS\u002FATS guidelines on definition, evaluation and treatment of severe asthma. \\[Chung KF et al. European Respiratory Journal Feb 2014, 43 (2) 343-373; DOI: 10.1183\u002F09031936.00202013 (Annex 2)\\]\n* Subjects are excluded from this cohort if they exhibit interstitial lung diseases, pulmonary neoplasms, current lung infections, immunological disorders leading to the use of immunosuppressants or continuous treatment with oral steroids.","18 Years","99 Years",{"count":58,"type":22},20000,"10 Years","OBSERVATIONAL","The purpose of this registry aims is to collect a large number of patients with mild and moderate asthma in a real-word conditions for a perspective observation of epidemiological evolution of the disease in relation to the therapeutic interventions available currently and in the near future.",[30,63,28],"Mild Asthma",[30,65,66,67,68,69],"Adult","Cluster","Cohort study","Italy","Prospective","RECRUITING","2023-11-22",{"date":73,"type":39},"2023-11-28",{"date":75,"type":39},"2021-05-01",{"date":77,"type":22},"2032-11",{"name":79,"class":80},"Societa Italiana di Pneumologia","OTHER",1]