[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mild-asthma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mild-asthma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,78,102,126],{"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":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100549430","phase-1-a-study-to-compare-the-relative-potency-of-salbutamol-administered-via-metered-dose-inhalers-mdi-containing-propellants-hfa-152a-to-hfa-134a-in-mild-asthmatics-aged-18-to-65-inclusive-100549430",false,"NCT06433921","A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive","A Phase 1, Randomized, 2-part, 7-way Cross-over (Part 1) and 7-way Cross-over (Part 2), Blinded, Single Dose Study in Mild Asthmatics Aged 18-65 to Assess the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152a (Test) and HFA-134a (Reference) Via Methacholine Bronchoprovocation and Systemic Pharmacodynamic Effects","Inclusion Criteria:\n\n1. Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.\n2. Participant must be 18 to 65 years of age inclusive, at the time of screening.\n3. ≥50 kg, at the time of screening.\n4. Body mass index (BMI) with 19.0-35.0 kg\u002Fm2 inclusive, at the time of screening.\n\n4\\. Documented history of asthma ≥ 6 months. 5. Receiving 1 of following asthma treatments, at a stable dose, for at least 12 weeks prior to the screening visit and is anticipated to remain stable for the duration of the study: i. Short-acting beta-agonist (SABA) only. ii. Daily maintenance low-dose inhaled corticosteroids (ICS) (defined as 100-250 μg\u002Fday fluticasone propionate or equivalent plus or minus SABA which is anticipated to remain stable for the duration of the study.\n\niii. Daily maintenance low-dose ICS + Long-acting beta-2 agonist (LABA) therapy (low-dose ICS defined as 100-250 μg\u002Fday fluticasone propionate or equivalent as defined by GINA \\[GINA, 2023\\]) plus or minus SABA, which is anticipated to remain stable for the duration of the study.\n\n6\\. No severe asthma exacerbations within 6 months prior to screening and ≤1 severe exacerbation during the 12 months prior to screening.\n\n7\\. Pre-bronchodilator FEV1 ≥80% of predicted, at screening. 8. PC20 to methacholine of ≤8 mg\u002FmL, at screening. 9. Participants should be able to withhold SABA for ≥12 hours and LABA-containing medications for ≥48 hours for the purposes of performing the spirometry and methacholine challenge at screening and during the study visits (treatment periods).\n\n10\\. A female participant is eligible to participate if she is not pregnant or breastfeeding, and Is a woman of woman of nonchildbearing potential (WONCBP) OR ii. Is a woman of child bearing potential (WOCBP) and using a contraceptive method that is highly effective.\n\n11\\. Provide signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.\n\n12\\. Non-smokers who have not used any tobacco containing-products within 12 months prior to study start, and with a total pack year history of ≤10 pack years.\n\nExclusion Criteria:\n\n1. Medical Conditions\n\n   1. A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.\n   2. A history of respiratory diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, cystic fibrosis, bronchiectasis, interstitial lung disease, emphysema, chronic obstructive pulmonary disease, tuberculosis, or other respiratory abnormalities other than asthma.\n   3. Asymptomatic gallstones.\n   4. History or current evidence of hematologic, neurologic, psychiatric, or other diseases that, in the opinion of the investigator, would put the participant at risk through study participation, or would affect the study analyses if the disease exacerbates during the study.\n   5. Recent eye surgery or any other condition in which raised intracranial pressure (caused by forceful exhalation) would be harmful.\n   6. Current use of cholinesterase inhibitor medication e.g., to treat myasthenia gravis.\n2. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day or participation in a clinical study within 30 days of study start, or 5 half-lives of study drug if that is longer.\n3. Participants who are currently or in the last 15 days have worked nightshifts.\n4. Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of \\>21 units for males or \\>14 units for females.\n5. A positive test result for drugs of abuse (including tetrahydrocannabinol) at screening or Day -1.\n6. Use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to \"vape\" within 12 months prior to the start of the study.","ALL","18 Years","65 Years",{"count":20,"type":21},84,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on efficacy (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1) \\[PC20\\]) of salbutamol administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma. Part 2: to compare the comparative dose response on efficacy (PC20) of salbutamol when administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma.",[27,28],"Asthma","Mild Asthma",[30,31,32,33,34],"Salbutamol","Propellant HFA-152a","Propellant HFA-134a","Metered dose inhalers","Mild asthma","RECRUITING","2026-06-19",{"date":38,"type":39},"2026-06-24","ACTUAL",{"date":41,"type":39},"2024-08-14",{"date":43,"type":21},"2027-02-26",{"name":45,"class":46},"GlaxoSmithKline","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":47},"100603994","paxt-pulmonary-imaging-of-mild-asthma-using-129xe-mri-and-tc-99-labeled-carbon-imaging-tc99cimaging-100603994","NCT07143747","PAXT: Pulmonary Imaging of Mild Asthma Using 129Xe MRI and Tc-99-Labeled-Carbon-Imaging (Tc99CImaging)","PAXT","Inclusion Criteria:\n\nParticipants eligible for inclusion in this study must meet all of the following criteria:\n\n1. Participant diagnosed with mild (GINA1) asthma by physician\n2. Participant understands study procedures and is willing to participate in the study as indicated by the participant's signature\n3. Provision of written, informed consent prior to any study specific procedures\n4. Males and females 17 to 35 years of age\n5. Women of childbearing potential (after menarche) must ensure that they are using an effective form of birth control for at least 2 months prior to each imaging visit. Examples of effective birth control include:\n\n   1. True sexual abstinence\n   2. A vasectomized sexual partner\n   3. Implanon®\n   4. Female sterilization by tubal occlusion\n   5. Effective intrauterine device (IUD)\u002Flevonogestrel intrauterine system (IUS)\n   6. Depo-Provera™ injections\n   7. Oral contraceptive\n   8. Evra Patch™\n   9. Nuvaring™\n\nExclusion Criteria:\n\nParticipants fulfilling any of the following criteria are not eligible for inclusion in this study:\n\n1. Participant has an implanted mechanically, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and\u002For ear implants) (at the discretion of the MRI Technologist)\n2. In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, CT, or Tc99CImaging, such as severe claustrophobia\n3. Participants who are pregnant, breastfeeding or have a positive pregnancy test at initial screening visit\n4. Participant is unable to perform spirometry or plethysmography maneuvers\n5. Participant is unable to perform MRI and CT breath-hold maneuvers","17 Years","35 Years",{"count":58,"type":21},40,"OBSERVATIONAL","The goal of this observational study is to better understand how asthma affects the lungs in young adults (ages 17-35) with mild asthma. The main questions it aims to answer are:\n\n* Can advanced imaging detect abnormal airway function in people with mild asthma?\n* Do changes in ventilation imaging correlate with asthma symptoms or quality of life? Researchers will compare hyperpolarized xenon-129 MRI and Technegas (Tc-99m) imaging to see if these techniques reveal more detailed lung abnormalities than standard lung function tests.\n\nParticipants will:\n\n* Complete a single 2-hour visit\n* Undergo two types of lung imaging: Hyperpolarized xenon-129 MRI (to visualize how air moves in the lungs), Technegas (Tc-99m) imaging (to assess airflow using nuclear medicine)\n* Perform spirometry and other breathing tests\n* Answer questionnaires about asthma symptoms and quality of life This study is designed to improve our understanding of subtle changes in lung function that may not be detected by standard tests in people with mild asthma. The findings may lead to better diagnostic tools and more personalized treatment strategies in the future.",[28],[63,64,65,28,66],"Hyperpolarized 129Xe MRI","Technegas Ventilation Imaging","Pulmonary Function Testing","Ventilation Defects","NOT_YET_RECRUITING","2025-08-19",{"date":70,"type":39},"2025-08-27",{"date":72,"type":21},"2025-09",{"date":74,"type":21},"2028-12",{"name":76,"class":77},"Dr. Grace Parraga","OTHER",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":18,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100432552","pharmacodynamic-equivalence-of-the-test-and-reference-metered-dose-inhalers-mdis-containing-albuterol-sulfate-in-adult-patients-with-stable-mild-asthma-100432552","NCT04912596","Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma","A Randomized, Single-dose, Double-blind, Double-dummy, Placebo and Active Controlled, Crossover Design Study Using Bronchoprovocation to Evaluate the Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma","Inclusion Criteria:\n\n1. Male, non-pregnant and non-lactating female subjects (20-65 years of age, inclusive).\n2. A clinical diagnosis of mild asthma with historical documentation of the asthma diagnosis according to either: (1) the National Asthma Education and Prevention Program (NAEPP) guidelines (2007) or (2) the Global Initiative for Asthma (GINA) Global Strategy for Asthma Management and Prevention (2020).\n3. Stable mild asthma receiving the following required inhaled medications for at least 1 month prior to screening: Low doses of ICS alone, or in combination with SABA, used regularly with a stable regimen.\n4. Forced Expiratory Volume in 1 second (FEV1) ≥ 80% of the local predicted normal value after withholding SABA ≥ 8 hours.\n5. Airway responsiveness to methacholine demonstrated by a pre-albuterol-dose (baseline) PC20 ≤ 8 mg\u002FmL.\n6. Nonsmoker for at least 6 months prior to the study and a maximum smoking history of 5 pack-years (the equivalent of one pack per day for 5 years).\n7. Provision of written informed consent.\n8. Other than asthma, in general good health.\n9. Body mass index (BMI) between 17 and 35 kg\u002Fm2 (inclusive).\n10. Able to correctly use MDI inhalers.\n11. Able to perform valid and reproducible pulmonary function tests including no evidence of spirometry effort-induced bronchoconstriction.\n12. If the subject or subject's partner is of child-bearing potential, a medically acceptable form of contraception will be used for the duration of the study. Medically acceptable contraceptives include: (1) surgical sterilization, (2) Health Authority approved female hormonal contraceptives, (3) an intrauterine device (IUD), (4) condoms with spermicide, or (5) diaphragm with spermicide.\n\nExclusion Criteria:\n\n1. Evidence of conditions altering airway reactivity to methacholine, including upper or lower respiratory tract infections (e.g., pneumonia, viral bronchitis, allergic rhinitis, sinobronchitis, etc.) within 6 weeks before Screening.\n2. Evidence of a baseline FEV1 \\\u003C 60% of the local predicted normal value or FEV1 \\\u003C 1.5 L.\n3. History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season.\n4. History of cystic fibrosis, bronchiectasis, COPD, or other respiratory diseases including COPD, chronic bronchitis, emphysema, tuberculosis, pulmonary carcinoma, pulmonary fibrosis, pulmonary hypertension that, in the opinion of the Investigator, would compromise subject safety or interfere with the evaluations.\n5. History of cardiovascular, hematological, renal, neurologic, hepatic, psychiatric, endocrine dysfunction, including ECG with evidence of ischemic heart diseases and significant arrhythmias.\n6. Treatment in an emergency room or hospitalization for acute asthmatic symptoms within 3 months prior to screening.\n7. Known intolerance or hypersensitivity to any component of the albuterol MDI, beta2 receptor-agonist drug, HFA, any related compounds or methacholine.\n8. Need for daily oral corticosteroids within 3 months prior to screening.\n9. Cardiac arrhythmia or 12-lead electrocardiogram (ECG) abnormalities, that in the opinion of the Investigator would compromise subject safety or interfere with the evaluations, or a QTc \\> 440 ms for males and \\> 460 ms for females using Fredericia formula.\n10. Subjects receiving beta blocker via any route or who may require beta blockers during the study.\n11. History of narrow angle glaucoma, convulsive disorders, hyperthyroidism, uncontrolled diabetes, paradoxical bronchospasm.\n12. History of malignancies.\n13. History of alcohol or drug abuse.\n14. Eye, brain, thoracic, and abdominal surgeries within 3 months prior to screening.\n15. Use of cromyolyn, leukotriene receptor antagonists (LTRA), nedocromil, zileuton, theophylline, or long-acting beta-agonists (LABA) within 1 month prior to screening.\n16. History of receiving muscarinic beta2-agonists (MABAs), short-acting muscarinic antagonists (SAMAs), long-acting muscarinic antagonists (LAMAs), anti-IgE, anti-IL5\u002F5R, anti-IL4R, high dose ICS, or systemic corticosteroid for treatment of asthma within 6 months prior to screening.\n17. Known Human Immunodeficiency Virus (HIV)-positive status.\n18. Participated in any interventional clinical trials within 1 month prior to screening.\n19. Pregnancy or breast feeding.","20 Years",{"count":87,"type":21},148,[89],"NA","The objective of this study is to evaluate the pharmacodynamic (PD) bioequivalence (BE) of albuterol inhalers, test formulation: Albuterol Sulfate HFA inhalation aerosol 108 mcg (equal to albuterol base 90 mcg) per actuation and reference formulation: ProAir HFA (albuterol sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg (equal to albuterol base 90 mcg) per actuation manufactured by two different manufacturers using methacholine bronchoprovocation challenge test in patients with stable mild asthma.",[28],"2025-02-13",{"date":94,"type":39},"2025-02-17",{"date":96,"type":39},"2022-08-15",{"date":98,"type":21},"2025-06",{"name":100,"class":46},"Intech Biopharm Ltd.",12,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":47},"100563587","phase-3-bronchoprovocation-study-to-demonstrate-the-pharmacodynamic-bioequivalence-of-albuterol-sulfate-hfa-inhalation-aerosol-eq-90-mcg-of-albuterol-baseinh-of-macleods-pharmaceuticals-ltd-100563587","NCT06618105","Bronchoprovocation Study to Demonstrate the Pharmacodynamic Bioequivalence of Albuterol Sulfate HFA Inhalation Aerosol (E.Q. 90 mcg of Albuterol Base\u002FInh) of Macleods Pharmaceuticals Ltd","A Prospective, Randomized, Single-dose, Double-blind, Double-dummy, Four-period, Four-treatment Crossover Pivotal Bronchoprovocation Study to Demonstrate the Pharmacodynamic Bioequivalence of Albuterol Sulfate HFA Inhalation Aerosol (E.Q. 90 mcg of Albuterol Base\u002FInh) (of Macleods Pharmaceuticals Ltd.) to Albuterol Sulfate HFA Inhalation Aerosol (E.Q. 90 mcg of Albuterol Base\u002FInh) (Distributed by Teva Pharmaceuticals USA, Inc.) in Adult Patients With Stable Mild Asthma","Inclusion Criteria:\n\n1. Male and non-pregnant, non-lactating female subjects aged between 18 to 65 years (both ages inclusive)\n2. Stable mild asthmatics based on National Asthma Education and Prevention Programme (NAEPP) guidelines\n3. Subjects who were diagnosed by physician with mild asthma at least 6 months prior to screening visit date\n4. Pre-bronchodilator forced expiratory volume in one second (FEV1) ≥ 80% of predicted\n5. Airway responsiveness to methacholine demonstrated by pre-albuterol-dose (baseline) PC20 less than or equal to 1.56 mg\u002FmL using AeroEclipse II BAN and 1-minute tidal breathing method at Screening MCT A\n6. The ≥20% reduction in FEV1 at Screening MCT A relative to post-saline FEV1 should be obtained above the lowest methacholine concentration\n7. At Screening MCT-B, subjects should have at least four-fold increase in PC20 over Screening MCT-A\n8. At Screening MCT -B, the ≥ 20% reduction in FEV1 relative to post saline FEV1 must be obtained up to methacholine concentration 24.96 mg\u002FmL\n9. Non-smokers for at least six months prior to screening visit and a maximum smoking history of five-pack years (the equivalent of one pack per day for five years)\n10. Women of child-bearing potential or women who are less than or equal to 1 year postmenopausal prior to screening visit must have negative result for urine pregnancy test\n11. Women of child-bearing potential or women who are less than or equal to 1 year postmenopausal prior to screening visit must agree to the use of a reliable and medically acceptable method of contraception throughout the duration of the study\n12. Women of child-bearing potential or women who are less than or equal to 1 year postmenopausal prior to screening visit using hormonal contraception must be on the same hormonal contraceptive for at least thirty days before the screening period and must be continued same throughout the study.\n13. Able to provide signed written informed consent and willing to comply with all aspects of the clinical study protocol\n\nExclusion Criteria:\n\n* 1.Subjects with FEV1 \\< 1.5L during methacholine challenge test 2.Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study.\n\n  3.History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season 4.History of cystic fibrosis, bronchiectasis or other respiratory diseases other than asthma (e.g., COPD, interstitial lung disease) 5.Treatment in an emergency room or hospitalization for acute asthmatic symptoms within past three months prior to screening visit 6.Need for daily oral corticosteroids within past three months prior to screening visit 7.History of life-threatening asthma leading to hospitalization within the past 1 year prior to screening visit 8.Known intolerance or hypersensitivity to any component of the albuterol metered dose inhaler (MDI) 9.Uncontrolled hypertension (systolic BP \\>200 mmHg, or diastolic BP \\>100 mmHg) 10.History or evidence of myocardial infarction or stroke 11.History of known aortic aneurysm 12.Current use of cholinesterase inhibitor medication (for myasthenia gravis) 13.Clinically significant ECG recording at screening such as flattening of T wave, prolongation of QTc interval (\\>450 milliseconds), and ST segment depression, which in the opinion of the Investigator, would compromise subject's safety or interfere with the study results 14.History of recent eye surgery or intracranial pressure elevation risk 15.Uncontrolled diabetes (HbA1c ≥9%) at screening 16.Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled artery disease, cardiac dysrhythmia, or ECG with evidence of ischemic heart disease. In addition, historical or current evidence of significant hematologic, hepatic neurologic, psychiatric, renal, or other disease or that, in the opinion of the Investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbates in the study 17.Presence of any abnormal clinically significant laboratory investigation at screening visit 18.History of paradoxical bronchospasm 19.Has participated in another investigational study or device research study within 30 days before screening visit date 20.Women are pregnant, breast-feeding, or planning pregnancy during study\n\nPeriod continuation criteria If subject does not meet any one Period continuation criteria at any visit of Period; retest visit will be conducted and study treatment dosing should not be administered. Period continuation criteria will be checked for maximum three visits.\n\nIf subject does not meet all Period continuation criteria at any one visit and within three consecutive visits:\n\nAt Period 1: subject should not be randomized and will be considered a 'randomization failure' At Period 2 to Period 4: subject should not administer study treatment dosing and must be discontinued from the study\n\n1. Baseline FEV1 should not be less than 70% of predicted normal value and should be within 88 -112% of qualifying day FEV1 value.\n\n   Baseline FEV1: highest pre-saline FEV1 obtained prior to saline control test at Period MCT and which has met the acceptability criteria and have repeatable quality grade A, B, C mentioned in ATS 2019 standards Qualifying day FEV1 value: highest pre-saline FEV1 obtained prior to saline control test on qualifying day and which has met the acceptability criteria and have repeatable quality grade A, B, C mentioned in ATS 2019 standards and which has not met the retest criteria for Scr-MCT A on qualifying day\n\n   -Qualifying day: Scr-MCT A PC20 is obtained and the results of the Scr-MCT A on this day confirms that subject has met inclusion criteria 4, 5, and 6\n2. Baseline FEV1 should be ≥ 1.5 L\n3. Baseline FEV1 should meet FEV1 acceptability criteria as mentioned in ATS 2019 standards\n4. Baseline FEV1 should meet repeatability quality grade A, B, or C as mentioned in ATS 2019 standards\n5. Fall in FEV1 due to the saline control (i.e. post-saline FEV1) should not be more than 10% from the baseline FEV1 Post-saline FEV1: is the highest post-saline FEV1 value from at least one acceptable FEV1 maneuver obtained after nebulization with normal saline is completed (i.e. after saline control test is completed)\n6. At least one FEV1 obtained after saline control test (post-saline FEV1) should meet acceptability criteria mentioned in ATS 2019 standards",{"count":110,"type":21},144,[112],"PHASE3","This is a pharmacodynamic bioequivalence bronchoprovocation study using single-dose, double-blind, double-dummy, randomized, study consisting of four study treatments (zero dose \\[Placebo\\], E.Q. 90 mcg Base dose of R inhalation aerosol, E.Q. 180 mcg Base dose of R inhalation aerosol, E.Q. 90 mcg Base dose of T inhalation aerosol) and four Periods (Period 1 to Period 4). Randomization procedure at Period 1 will assign any one study treatment to be administered in each Period in a cross-over manner. By the end of Period 4, a subject who completes dosing in all four Periods would have administered all four treatments in the study.\n\nThe efficacy variable, post-dose PC20 obtained during each Period is the provocative concentration of the methacholine challenge agent required to reduce the FEV1 by 20% following administration of differing doses of albuterol (or placebo) by inhalation. The 20% reduction in FEV1 is determined as compared to post-saline FEV1 measured before the Placebo or Albuterol administration.\n\nThe pharmacodynamic equivalence will be based on the dose-scale method of analysis of the post-dose PC20 If the 90% confidence interval for the relative bioavailability (F) falls within 67.00% -150.00% then it will be considered that pharmacodynamic equivalence is established.",[28],[116],"Bronchoprovocation Study","2024-10-01",{"date":119,"type":39},"2024-10-03",{"date":121,"type":21},"2024-10-15",{"date":123,"type":21},"2025-05-31",{"name":125,"class":46},"Macleods Pharmaceuticals Ltd",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":134,"enrollmentInfo":135,"targetDuration":137,"studyType":59,"phases":4,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":47},"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.","99 Years",{"count":136,"type":21},20000,"10 Years","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.",[27,28,140],"Moderate Asthma",[27,142,143,144,145,146],"Adult","Cluster","Cohort study","Italy","Prospective","2023-11-22",{"date":149,"type":39},"2023-11-28",{"date":151,"type":39},"2021-05-01",{"date":153,"type":21},"2032-11",{"name":155,"class":77},"Societa Italiana di Pneumologia"]