[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100193865":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":37,"centralContacts":42,"locations":51,"responsibleParty":66,"collaborators":27,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":27,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":27,"studyType":81,"phases":82,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":54,"whyStopped":27,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"1","EXPERIMENTAL","Nebullizer",[13,14],"Drug: albuterol nebulizer","Procedure: PFT",{"label":16,"type":17,"description":18,"interventionNames":19},"2","ACTIVE_COMPARATOR","Inhaler",[20,14],"Drug: albuterol inhaler",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","albuterol inhaler","2 puffs of Metered Dose inhaler for Bronchodilation",[16],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"albuterol nebulizer","Albuterol administered by nebulization will produce a greater increase in FEV1",[9],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"PROCEDURE","PFT","Breathing Test",[9,16],[38],{"name":39,"affiliation":40,"role":41},"Joel Moss, M.D.","National Heart, Lung, and Blood Institute (NHLBI)","PRINCIPAL_INVESTIGATOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":27,"email":47},"Tatyana A Worthy, R.N.","CONTACT","(301) 827-1376","worthyt@mail.nih.gov",{"name":39,"role":45,"phone":49,"phoneExt":27,"email":50},"(301) 496-1597","mossj@nhlbi.nih.gov",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":27},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-77.10026,38.98067,{"lat":64,"lon":63},{"type":67,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100193865","phase-1-nebulized-or-inhaled-albuterol-for-lymphangioleiomyomatosis-100193865",false,"NCT01799538","Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis","Bronchodilator Effects of Nebulized Versus Inhaled Albuterol in Subjects With Lymphangioleiomyomatosis","* INCLUSION CRITERIA:\n* Diagnosis of LAM either by tissue biopsy, evidence of lung and other organ involvement (renal angiomyolipomas, chylous effusions, lymphangioleiomyomas), high serum levels of vascular endothelial growth factor D (VGEF-D)(1) or a diagnosis of TSC associated with cystic lung lesions.\n* Age 18 years or over\n* Evidence of airflow obstruction: FEV1\u002FVC ratio \\\u003C fifth percentile of predicted normal and an FEV(1) \\\u003C80% predicted of the normal values.\n\nEXCLUSION CRITERIA:\n\nSubjects will be excluded from the study if they meet one or more of the following criteria:\n\n* History of hypersensitivity to albuterol or any of its components.\n* Moderate or large pleural effusions (chest x-ray and or CT scan procedure completed under Protocol 95-H-0186)\n* History of seizures other than during infancy\n* Inability to withhold bronchodilators for 24 hours\n* Cognitive Impairment\n* Age less than 18 years\n* Male sex\n* Status-post lung or kidney transplantation\n* Pregnant or breast feeding (women of childbearing potential will undergo a blood or urine pregnancy test under Protocol 95-H-0186).\n* Treatment with monoaminoxidase inhibitors, tricyclic antidepressants or Beta-adrenergic receptor antagonists or long acting anticholinergic bronchodilators who are unable to be discontinued for at least seven days before enrollment.\n* Patients with URI, uncontrolled hyperthyroidism or severe gastro-esophageal reflux. Major systemic diseases (i.e., malignancy; myocardial infarction or unstable angina; type 1 diabetes, severe hypertension; liver cirrhosis).","FEMALE","18 Years","100 Years",{"count":79,"type":80},100,"ESTIMATED","INTERVENTIONAL",[83,84],"PHASE1","PHASE2","Background:\n\n\\- Lymphangioleiomyomatosis (LAM) is a rare type of lung disease that occurs almost exclusively in women. In LAM, muscle tissue grows in the lungs and starts to block the flow of air. It is a progressive disease, and in severe cases may require a lung transplant. One possible treatment to improve breathing in people with LAM is inhaled albuterol. Albuterol can be given in a metered dose inhaler (MDI) or with a nebulizer. Researchers want to compare these methods to see which method best improves lung function in women with LAM.\n\nObjectives:\n\n\\- To see whether a nebulizer or MDI can better improve lung function in women with LAM.\n\nEligibility:\n\n\\- Women at least 18 years of age who have impaired lung function because of LAM.\n\nDesign:\n\n* Participants will be screened with a physical exam and medical history. No lab tests will be needed for this study.\n* Participants will have a 3-day overnight stay at the National Institutes of Health. Those who are using long-acting inhalers will have to stop taking these drugs 1 week before the study.\n* Participants will receive either the nebulizer or two or four puffs of the inhaler. Four puffs of albuterol is a higher dose than is normally prescribed, and is being tested on this study.\n* Participants will have each treatment around the same time of day on each of the 3 days. Before and after taking the albuterol, participants will have lung function tests.",[87],"Lymphangioleiomyomatosis",[89,90,91,92],"Albuterol","Bronchodilator","Nebulizer","Metered Dose Inhaler","2026-06-13",{"date":95,"type":96},"2026-06-16","ACTUAL",{"date":98,"type":96},"2013-06-10",{"date":100,"type":80},"2027-11-01",{"name":40,"class":6},1]