Viewing Study NCT05219968

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Ignite Creation Date: 2025-12-24 @ 5:56 PM
Ignite Modification Date: 2026-01-28 @ 6:28 PM
Study NCT ID: NCT05219968
Status: COMPLETED
Last Update Posted: 2025-05-02
First Post: 2022-01-21
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lyraclinical@lyratx.com', 'phone': '617-393-4600', 'title': 'Senior Vice President, Clinical Affairs', 'organization': 'Lyra Therapeutics'}, 'certainAgreement': {'otherDetails': 'Except as approved by Sponsor, single center data will not be published before multicenter data, unless \\>1 year has elapsed since completion of the Study. PI may publish single center data provided that PI shall: i) provide a copy of the publication to Sponsor at least 60 days in advance of submission for publication; ii) delete Sponsor Confidential Information and make other reasonable changes; and iii) delay submission by up to 90 additional days to permit intellectual property filings.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52).', 'description': '190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included.\n\n131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.', 'eventGroups': [{'id': 'EG000', 'title': 'LYR-210 up to 24 Weeks', 'description': 'Single administration of LYR-210 drug matrix (7500 μg)\n\nLYR-210: LYR-210 drug matrix (mometasone furoate)\n\nBackground Therapy: Daily Saline Irrigation', 'otherNumAtRisk': 124, 'deathsNumAtRisk': 124, 'otherNumAffected': 78, 'seriousNumAtRisk': 124, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Sham Procedure Control up to 24 Weeks', 'description': 'Single mock administration procedure\n\nSham procedure control: Sham procedure control\n\nBackground Therapy: Daily Saline Irrigation', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 26, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'LYR-210-LYR-210 Extension', 'description': 'Repeat administration of LYR-210 at Week 24', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 21, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'LYR-210-Sham Extension', 'description': 'Crossover from LYR-210 to sham procedure control at Week 24', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 9, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Sham-LYR-210 Extension', 'description': 'Crossover from sham procedure control to LYR-210 at Week 24', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 19, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 29, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra (24.1)'}, {'term': 'Nasal Odour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 27, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Chronis Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Acute Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'seriousEvents': [{'term': 'Colonic Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra (24.1)'}, {'term': 'Medical Device Site Joint Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Rib Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cervical Vertebral Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pneumothorax traumatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra (24.1)'}, {'term': 'Tracheal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Loss of Consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Eosinophilic pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Renal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYR-210', 'description': 'Single administration of LYR-210 drug matrix (7500 μg)\n\nLYR-210: LYR-210 drug matrix (mometasone furoate)\n\nBackground Therapy: Daily Saline Irrigation'}, {'id': 'OG001', 'title': 'Sham Procedure Control', 'description': 'Single mock administration procedure\n\nSham procedure control: Sham procedure control\n\nBackground Therapy: Daily Saline Irrigation'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.13', 'spread': '2.172', 'groupId': 'OG000'}, {'value': '-2.06', 'spread': '2.136', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 Weeks', 'description': 'The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom/each question is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores.\n\nThe 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set Without Nasal Polyps'}, {'type': 'SECONDARY', 'title': 'CFBL in the 7-day Average Composite Score of 3CS in All Participants at Week 24.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYR-210', 'description': 'Single administration of LYR-210 drug matrix (7500 μg)\n\nLYR-210: LYR-210 drug matrix (mometasone furoate)\n\nBackground Therapy: Daily Saline Irrigation'}, {'id': 'OG001', 'title': 'Sham Procedure Control', 'description': 'Single mock administration procedure\n\nSham procedure control: Sham procedure control\n\nBackground Therapy: Daily Saline Irrigation'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.35', 'spread': '2.278', 'groupId': 'OG000'}, {'value': '-1.83', 'spread': '2.104', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom/each question is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores.\n\nThe 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set'}, {'type': 'SECONDARY', 'title': 'CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYR-210', 'description': 'Single administration of LYR-210 drug matrix (7500 μg)\n\nLYR-210: LYR-210 drug matrix (mometasone furoate)\n\nBackground Therapy: Daily Saline Irrigation'}, {'id': 'OG001', 'title': 'Sham Procedure Control', 'description': 'Single mock administration procedure\n\nSham procedure control: Sham procedure control\n\nBackground Therapy: Daily Saline Irrigation'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.7', 'spread': '21.67', 'groupId': 'OG000'}, {'value': '-15.7', 'spread': '18.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'The SNOT-22 questionnaire is a 22-item disease-specific quality of life instrument. Each symptom is scored on a 6-point scale where 0 = no problem and 5 = problem as bad as it can be. The total SNOT-22 score is the sum of the 22 items and can range from 0 to 110 with higher scores indicating worse symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set'}, {'type': 'SECONDARY', 'title': 'CFBL in the 3-D Volumetric CT Score at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYR-210', 'description': 'Single administration of LYR-210 drug matrix (7500 μg)\n\nLYR-210: LYR-210 drug matrix (mometasone furoate)\n\nBackground Therapy: Daily Saline Irrigation'}, {'id': 'OG001', 'title': 'Sham Procedure Control', 'description': 'Single mock administration procedure\n\nSham procedure control: Sham procedure control\n\nBackground Therapy: Daily Saline Irrigation'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.705', 'spread': '10.9320', 'groupId': 'OG000'}, {'value': '-0.279', 'spread': '9.9706', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 20', 'description': 'The percent opacification of the bilateral anterior and posterior ethmoids will be assessed by 3-D volumetric CT analysis at baseline and Week 20.\n\nA negative change from Baseline indicates improvement from Baseline.', 'unitOfMeasure': 'Percent ethmoid opacification', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set'}, {'type': 'SECONDARY', 'title': 'Participants With Rescue Treatments for CRS Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYR-210', 'description': 'Single administration of LYR-210 drug matrix (7500 μg)\n\nLYR-210: LYR-210 drug matrix (mometasone furoate)\n\nBackground Therapy: Daily Saline Irrigation'}, {'id': 'OG001', 'title': 'Sham Procedure Control', 'description': 'Single mock administration procedure\n\nSham procedure control: Sham procedure control\n\nBackground Therapy: Daily Saline Irrigation'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'This endpoint is descriptively summarized per the prespecified plan. This includes participants that used systemic corticosteroid for any reason as well as participants that were recommended/underwent sinonasal surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LYR-210', 'description': 'Single administration of LYR-210 drug matrix (7500 μg)\n\nLYR-210: LYR-210 drug matrix (mometasone furoate)\n\nBackground Therapy: Daily Saline Irrigation'}, {'id': 'FG001', 'title': 'Sham Procedure Control', 'description': 'Single mock administration procedure\n\nSham procedure control: Sham procedure control\n\nBackground Therapy: Daily Saline Irrigation'}, {'id': 'FG002', 'title': 'LYR-210 - LYR-210', 'description': 'Repeat administration of LYR-210 at Week 24.\n\nParticipants randomized to LYR-210 during the Week 24 Treatment Period received LYR-210 in the Safety Extension.\n\nBackground therapy: Saline rinse'}, {'id': 'FG003', 'title': 'LYR-210 - Sham', 'description': 'Crossover from LYR-210 to sham procedure control at Week 24.\n\nParticipants randomized to LYR-210 during the Week 24 Treatment Period received sham procedure contol in the Safety Extension.\n\nBackground therapy: Saline rinse'}, {'id': 'FG004', 'title': 'Sham - LYR-210', 'description': 'Crossover from sham procedure control to LYR-210 at Week 24.\n\nParticipants randomized to sham procedure contril during the Week 24 Treatment Period received LYR-210 in the Safety Extension.\n\nBackground therapy: Saline rinse'}], 'periods': [{'title': 'Week 24 Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Entered Extension', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Did Not Enter Extension', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Completed Week 24 Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Treatment administration failure/procedure not attempted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Bilateral dislodgement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other, not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Safety Extension Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '42'}, {'groupId': 'FG004', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '39'}, {'groupId': 'FG004', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Treatment administration failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Bilateral dislodgement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Week 24 Treatment Period: 2:1 (LYR-210 to Sham) Randomization;\n\nSafety Extension Period: Sham participants received LYR-210; LYR-210 participants received LYR-210 or Sham (1:1)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LYR-210', 'description': 'Single administration of LYR-210 drug matrix (7500 μg)\n\nLYR-210: LYR-210 drug matrix (mometasone furoate)\n\nBackground Therapy: Daily Saline Irrigation'}, {'id': 'BG001', 'title': 'Sham Procedure Control', 'description': 'Single mock administration procedure\n\nSham procedure control: Sham procedure control\n\nBackground Therapy: Daily Saline Irrigation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '13.65', 'groupId': 'BG000'}, {'value': '45', 'spread': '14.42', 'groupId': 'BG001'}, {'value': '48', 'spread': '14.06', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '27.9', 'spread': '5.63', 'groupId': 'BG000'}, {'value': '27.4', 'spread': '4.96', 'groupId': 'BG001'}, {'value': '27.7', 'spread': '5.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'ITT Analysis Set'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-31', 'size': 6157527, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-28T15:01', 'hasProtocol': True}, {'date': '2024-03-26', 'size': 3515944, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-28T15:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2022-01-21', 'resultsFirstSubmitDate': '2025-03-28', 'studyFirstSubmitQcDate': '2022-01-21', 'lastUpdatePostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-16', 'studyFirstPostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps.', 'timeFrame': '24 Weeks', 'description': 'The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom/each question is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores.\n\nThe 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.'}], 'secondaryOutcomes': [{'measure': 'CFBL in the 7-day Average Composite Score of 3CS in All Participants at Week 24.', 'timeFrame': 'Week 24', 'description': 'The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom/each question is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores.\n\nThe 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.'}, {'measure': 'CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24', 'timeFrame': 'Week 24', 'description': 'The SNOT-22 questionnaire is a 22-item disease-specific quality of life instrument. Each symptom is scored on a 6-point scale where 0 = no problem and 5 = problem as bad as it can be. The total SNOT-22 score is the sum of the 22 items and can range from 0 to 110 with higher scores indicating worse symptoms.'}, {'measure': 'CFBL in the 3-D Volumetric CT Score at Week 20', 'timeFrame': 'Week 20', 'description': 'The percent opacification of the bilateral anterior and posterior ethmoids will be assessed by 3-D volumetric CT analysis at baseline and Week 20.\n\nA negative change from Baseline indicates improvement from Baseline.'}, {'measure': 'Participants With Rescue Treatments for CRS Through Week 24', 'timeFrame': 'Week 24', 'description': 'This endpoint is descriptively summarized per the prespecified plan. This includes participants that used systemic corticosteroid for any reason as well as participants that were recommended/underwent sinonasal surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Sinusitis', 'Chronic Rhinosinusitis (Diagnosis)']}, 'descriptionModule': {'briefSummary': 'Multicenter, phase III, randomized, blinded, controlled, parallel group with safety extension phase with crossover or continued treatment.', 'detailedDescription': 'This is a 52-week, multicenter, phase III, randomized, blinded, controlled, parallel group with a 24-week treatment period followed by a safety extension phase with crossover or continued treatment to evaluate the efficacy and safety of LYR-210 compared with sham control for treatment in adults with CRS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18\n* Diagnosed as having CRS\n* Undergone at least 2 trials of medical treatments in the past\n* Mean 3 cardinal symptom (3CS) score\n* Bilateral ethmoid disease confirmed on CT\n* Has been informed of the nature of the study and provided written informed consent\n* Agrees to comply with all study requirements\n* If on a waiting list for sinonasal surgery, willing to be removed from list or have surgery date cancelled for the duration of the study.\n\nExclusion Criteria:\n\n* Inability to tolerate topical anesthesia or endoscopic procedure\n* Previous nasal surgery\n* Presence of nasal polyp grade 2 or higher\n* Seasonal allergic rhinitis\n* Perennial rhinitis with symptoms that are well controlled by regular use of intranasal corticosteroids\n* Severe asthma\n* History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, atrophic rhinitis, or odontogenic sinusitis\n* Obstruction preventing proper placement and retention of LYR-210 as seen on endoscopy\n* Anatomic variation that, in the opinion of the investigator, would adversely impact placement of LYR-210 as seen on CT\n* Known history of hypersensitivity or intolerance to corticosteroids\n* Known history of hypothalamic pituitary adrenal axial dysfunction\n* Previous pituitary or adrenal surgery\n* Dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.\n* Past or present acute or chronic intracranial or orbital complications of CRS\n* History or diagnosis (in either eye) of glaucoma or ocular hypertension\n* Past or present functional vision in only 1 eye\n* Past, present, or planned organ transplant or chemotherapy with immunosuppression\n* Currently positive for COVID-19 or residual sinonasal symptoms from a previous COVID-19 infection\n* Pregnant or breast feeding. Females of child-bearing potential must test negative for pregnancy at the time of screening\n* Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments\n* Currently participating in an investigational drug or device study\n* Determined by the investigator as not suitable to be enrolled'}, 'identificationModule': {'nctId': 'NCT05219968', 'acronym': 'ENLIGHTEN 1', 'briefTitle': 'Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lyra Therapeutics'}, 'officialTitle': 'ENLIGHTEN 1: A Phase III, Randomized, Blinded, Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis (CRS) in Adults', 'orgStudyIdInfo': {'id': 'LYR-210-2021-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LYR-210', 'description': 'Single administration of LYR-210 drug matrix (7500 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