Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-31 @ 6:57 PM
Study NCT ID:
NCT06338995
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2024-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double-blind, parallel group, placebo controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 510}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2024-03-25', 'studyFirstSubmitQcDate': '2024-03-25', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity', 'timeFrame': 'Baseline, Week 24', 'description': 'NCS severity is rated by study participants using a 4-point scale (range from 0 to 3), where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of nasal congestion for the previous 24 hours. This assessment will be collected in the participant eDiary.'}, {'measure': 'Mean CFBL in Endoscopic Nasal Polyp Score (NPS)', 'timeFrame': 'Baseline, Week 24', 'description': 'The endoscopic NPS is assessed by a centralized, blinded, independent review of nasal endoscopy video recordings. The total score is the sum of the right and left nasal cavity scores. For each nasal cavity, endoscopic NPS is graded based on polyp size from 0 to 4, where 0 = no polyps and 4 = large polyps.'}], 'secondaryOutcomes': [{'measure': 'Mean change in Opacification of Sinuses Measured by the Lund Mackay score (LMK)', 'timeFrame': 'Baseline, Week 24', 'description': 'Central read on sinus computed tomography (CT) scans for the Lund Mackay score (LMK) will be performed. Review of the CT scans of the right and left frontal sinuses will include the use of a scoring system. The LMK scoring system is a 3-point grading scale where 0 = normal, 1 = partial opacification, and 2 = total opacification. The total score is the sum of the scores from each side and ranges from 0 to 24, where 0 indicates no disease and 24 indicates the most severe disease.'}, {'measure': 'Mean change in Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Baseline, Week 24', 'description': 'FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.'}, {'measure': 'Mean CFBL in Severity of Loss of Smell', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants will be asked about the severity of loss of smell using a 4-point scale, where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of loss of smell, for the previous 24 hours. This assessment will be collected in the participant eDiary.'}, {'measure': 'Mean CFBL in Postnasal Drip', 'timeFrame': 'Baseline, Week 24', 'description': 'Postnasal drip is rated by study participants using a 4-point scale, where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of their postnasal drip, at its worst, for the previous 24 hours. This assessment will be collected in the participant eDiary.'}, {'measure': 'Mean Change from Baseline by Visit for the 22-item Sino-nasal Outcome Test (SNOT-22)', 'timeFrame': 'Baseline, Week 24', 'description': 'The 22-item Sino-nasal outcome test assessing sino-nasal and auricular function, psychological impact, productivity, and sleep quality. Participants will be asked to recall their experiences over the past 2 weeks and rate their symptoms on a scale ranging from 0, which corresponds to no problem, to 5, which corresponds to problem as bad as it can be.'}, {'measure': 'Mean Change from Baseline by Visit for the Nasal Peak Inspiratory Flow (NPIF)', 'timeFrame': 'Baseline, Week 24', 'description': 'NPIF measures the maximum inspiratory flow rate through both nostrils during inspiration with results expressed in liters per min (L/min). Participants with NPIF results \\>120 L/min represent no nasal obstruction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/472335', 'label': 'A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Physician-diagnosed chronic rhinosinusitis (CRS) with bilateral nasal polyps (NP).\n* Prior treatment with systemic corticosteroids (SCS) within the last 2 years (or a medical contraindication or intolerance to SCS), prior surgery for NP, or both.\n* Endoscopic bilateral NPS score of at least 5 out of 8, with a minimum score of 2 in each nasal cavity performed at screening and baseline.\n* Ongoing symptoms for at least 8 weeks prior to study entry (screening), including:\n\n 1. Nasal congestion with moderate or severe symptom severity (score 2 or 3) at screening and a weekly average severity score of at least 1 (range 0 to 3) at randomization, and\n 2. At least one other symptom, such as partial loss of smell (hyposmia), total loss of smell (anosmia), or anterior or posterior rhinorrhea.\n* Have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.\n\nExclusion Criteria:\n\n* Have received a dose of lebrikizumab.\n* Have received treatment with any rescue medication and/or have the need for surgery for NP during screening and/or run-in period.\n* Allergen immunotherapy (subcutaneous immunotherapy \\[SCIT\\]/sublingual immunotherapy \\[SLIT\\]) initiated within 6 months prior to screening, that is not on a stable dose (3 months prior to screening).\n* Has received a biologic treatment approved for use in CRSwNP, asthma, or AD, even if administered to treat a different condition, within 4 months or 5 half-lives, whichever is longer, prior to screening.\n* Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit:\n\n 1. B cell-depleting biologics, including rituximab, within 6 months.\n 2. other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.\n 3. Systemic immunosuppressants within 4 weeks prior to baseline.\n* Have had any sinus intranasal surgery (including nasal polypectomy) within 6 months prior to screening\n* Have had prior sino-nasal surgery or sinus surgery changing lateral wall structure of the nose making it difficult to assess endoscopic NPS\n* Have a presence of any of the following conditions that may impact the assessment of endpoints at screening or baseline:\n\n 1. Nasal septal deviation occluding at least one nostril.\n 2. Antrochoanal polyps.\n 3. Acute sinusitis, acute nasal infection, or acute upper respiratory infection.\n 4. Ongoing rhinitis medicamentosa.\n 5. Presence of another diagnosis associated with NP (ie, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young's syndrome, primary ciliary dyskinesia, cystic fibrosis).\n 6. A nasal cavity tumor (malignant or benign).\n 7. Evidence of fungal rhinosinusitis.\n* Have anosmia from COVID or any reason other than CRSwNP.\n* Participants with forced expiratory volume in 1 second (FEV1) 50% or less (of predicted normal) at screening.\n* Female participant who is pregnant, breastfeeding, or is planning to become pregnant, or to breastfeed during the study."}, 'identificationModule': {'nctId': 'NCT06338995', 'briefTitle': 'A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 3 Efficacy and Safety Study of Lebrikizumab/ LY3650150 in Adults With Chronic Rhinosinusitis With Nasal Polyps on a Background Therapy With Intranasal Corticosteroids', 'orgStudyIdInfo': {'id': '18790'}, 'secondaryIdInfos': [{'id': 'J2T-MC-KGBU', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2023-508760-29-00', 'type': 'OTHER', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)', 'description': 'Lebrikizumab will be given as Subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS).', 'interventionNames': ['Drug: LY3650150', 'Drug: Standard therapy for INCS']}, {'type': 'EXPERIMENTAL', 'label': 'Lebrikizumab Q2W/every 8 weeks (Q8W)', 'description': 'Lebrikizumab will be given as SC injection. Participants will receive background therapy with INCS.', 'interventionNames': ['Drug: LY3650150', 'Drug: Standard therapy for INCS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Q2W/Q4W', 'description': 'Placebo will be given as SC injection. Participants will receive background therapy with INCS.', 'interventionNames': ['Drug: Placebo', 'Drug: Standard therapy for INCS']}], 'interventions': [{'name': 'LY3650150', 'type': 'DRUG', 'description': 'Administered SC.', 'armGroupLabels': ['Lebrikizumab Q2W/every 8 weeks (Q8W)', 'Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC.', 'armGroupLabels': ['Placebo Q2W/Q4W']}, {'name': 'Standard therapy for INCS', 'type': 'DRUG', 'description': 'Administered as intranasal spray.', 'armGroupLabels': ['Lebrikizumab Q2W/every 8 weeks (Q8W)', 'Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)', 'Placebo Q2W/Q4W']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Weily Soong', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AllerVie Clinical Research', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '205-934-7191'}, {'name': 'Do Yeon Cho', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '91007', 'city': 'Arcadia', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kevin Hur', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Keck Medicine of USC', 'geoPoint': {'lat': 34.13973, 'lon': -118.03534}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Naveen Bhandarkar', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '916-374-6730'}, {'name': 'Randall Ow', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'DaVinci Research LLC', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '90503', 'city': 'Torrance', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '310-372-0700'}, {'name': 'Steven Davis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Breathe Clear Institute', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80923', 'city': 'Colorado Springs', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '719-867-7804'}, {'name': 'Bryan Davis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Colorado ENT & Allergy', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '32825', 'city': 'Orlando', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cecelia Damask', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Orlando ENT & Allergy', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33060', 'city': 'Pompano Beach', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '954-280-7701'}, {'name': 'Jacqueline DeNobriga', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NuLine Clinical Trial Center', 'geoPoint': {'lat': 26.23786, 'lon': -80.12477}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '813-631-4024'}, {'name': 'Seong Cho', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '208-813-6505'}, {'name': 'Neetu Talreja', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Treasure Valley Medical Research', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60616', 'city': 'Chicago', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '312-399-9337'}, {'name': 'Pravin Muniyappa', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Entopy Research LLC', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '773-289-1823'}, {'name': 'Kirk Shepard', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chicago ENT', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70471', 'city': 'Mandeville', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Connolly', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS', 'geoPoint': {'lat': 30.35825, 'lon': -90.06563}}, {'zip': '21162', 'city': 'White Marsh', 'state': 'Maryland', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '410-931-1966 extension 103'}, {'name': 'Sudhir Sekhsaria', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chesapeake Clinical Research, Inc.', 'geoPoint': {'lat': 39.38372, 'lon': -76.43218}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '617-732-6410'}, {'name': 'Stella Lee', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '573-882-7150'}, {'name': 'Christine Franzese', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '314-996-0186'}, {'name': 'H James Wedner', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08619', 'city': 'Hamilton', 'state': 'New Jersey', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '201-725-9407'}, {'name': 'Peter Ricketti', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Circuit Clinical/Mercer Allergy and Pulmonary Associates', 'geoPoint': {'lat': 40.20706, 'lon': -74.08125}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '551-655-4979'}, {'name': 'Stacey Silvers', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Madison ENT & Facial Plastic Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '212-686-6321'}, {'name': 'Robert Lin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New York Allergy and Sinus Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10455', 'city': 'The Bronx', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '332-264-0155'}, {'name': 'Alissa McInerney', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Equity Medical', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ahmad Sedaghat', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCMC', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43235', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '614-430-3030'}, {'name': 'Donald McNeil', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Optimed Research, LTD', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '18017', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '610-866-5555'}, {'name': 'David Yen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Specialty Physician Associates', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '843-792-1356'}, {'name': 'Rodney Schlosser', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of South Carolina- Department of Otolaryngology and Head and Neck Surgery', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75209', 'city': 'Dallas', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '214-363-1411'}, {'name': 'Barbara Baxter', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alina Clinical Trials', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390-9035', 'city': 'Dallas', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '214-633-4608'}, {'name': 'Sei Chung', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '713-704-4137'}, {'name': 'Amber Luong', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas Physicians Department of Otorhinolaryngology Clinc', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75070-5735', 'city': 'McKinney', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dale Ehmer, Jr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ear Nose and Throat Associates of Texas PA', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}, {'zip': '78258-3227', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '210-545-0404'}, {'name': 'Jeffrey Rosenbloom', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alamo ENT Associates', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '757-388-6238'}, {'name': 'Kent Lam', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Eastern Virginia Medical School', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23235', 'city': 'Richmond', 'state': 'Virginia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '804-622-3768'}, {'name': 'Michael Armstrong', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Richmond Ear Nose and Throat', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '53226-3548', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '414-805-3145,414-314-0430'}, {'name': 'David Poetker', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'B7240KJB', 'city': 'Beunos Aires', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 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{'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'role': 'CONTACT', 'phone': '82 2 2072 1688'}, {'name': 'Dong-Young Kim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SNUH - Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'role': 'CONTACT', 'phone': '82-2-2258-2540'}, {'name': 'Soo-Whan Kim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Catholic University of Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08308', 'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'role': 'CONTACT', 'phone': '82-2-2626-1624'}, {'name': 'Heung-Man Lee', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '7061', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South 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