Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-03-01 @ 9:46 AM
Study NCT ID:
NCT02367118
Status:
UNKNOWN
Last Update Posted:
2015-06-04
First Post:
2015-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prednisone in Chronic Rhinosinusitis Without Nasal Polyps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-06-06', 'releaseDate': '2024-01-02'}], 'estimatedResultsFirstSubmitDate': '2024-01-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012852', 'term': 'Sinusitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-02', 'studyFirstSubmitDate': '2015-02-08', 'studyFirstSubmitQcDate': '2015-02-12', 'lastUpdatePostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Symptoms as measured by SNOT 22 questionnaire and visual analogue scale at 6 months', 'timeFrame': 'Improvement in symptoms at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo'}, {'measure': 'Change in Olfactory function as measured by "Sniffin\'Sticks 12 tests" at 6 months', 'timeFrame': 'Improvement in Olfactory function at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo'}, {'measure': 'Change in Nasal patency as measured by Acoustic rhinometry and Rhinomanometry at 6 months', 'timeFrame': 'Improvement in nasal patency at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo'}, {'measure': 'Changes in Nasal endoscopy findings as measured by Lund-Kennedy score at 6 months', 'timeFrame': 'Changes in nasal endoscopy findings at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic rhinosinusitis without nasal polyps prednisone'], 'conditions': ['Sinusitis', 'Chronic Rhinosinusitis']}, 'referencesModule': {'references': [{'pmid': '21493210', 'type': 'BACKGROUND', 'citation': 'Bhattacharyya N, Orlandi RR, Grebner J, Martinson M. Cost burden of chronic rhinosinusitis: a claims-based study. Otolaryngol Head Neck Surg. 2011 Mar;144(3):440-5. doi: 10.1177/0194599810391852. Epub 2011 Feb 3.'}, {'pmid': '17882920', 'type': 'BACKGROUND', 'citation': 'Dubin MG, Liu C, Lin SY, Senior BA. American Rhinologic Society member survey on "maximal medical therapy" for chronic rhinosinusitis. Am J Rhinol. 2007 Jul-Aug;21(4):483-8. doi: 10.2500/ajr.2007.21.3047.'}, {'pmid': '19879441', 'type': 'BACKGROUND', 'citation': 'Mullol J, Obando A, Pujols L, Alobid I. Corticosteroid treatment in chronic rhinosinusitis: the possibilities and the limits. Immunol Allergy Clin North Am. 2009 Nov;29(4):657-68. doi: 10.1016/j.iac.2009.07.001.'}, {'pmid': '20488636', 'type': 'BACKGROUND', 'citation': 'Takeda K, Takeno S, Hirakawa K, Ishino T. Expression and distribution of glucocorticoid receptor isoforms in eosinophilic chronic rhinosinusitis. Auris Nasus Larynx. 2010 Dec;37(6):700-7. doi: 10.1016/j.anl.2010.03.005. Epub 2010 May 21.'}, {'pmid': '16652085', 'type': 'BACKGROUND', 'citation': 'Benitez P, Alobid I, de Haro J, Berenguer J, Bernal-Sprekelsen M, Pujols L, Picado C, Mullol J. A short course of oral prednisone followed by intranasal budesonide is an effective treatment of severe nasal polyps. Laryngoscope. 2006 May;116(5):770-5. doi: 10.1097/01.mlg.0000205218.37514.0f.'}, {'pmid': '7574265', 'type': 'BACKGROUND', 'citation': 'Lund VJ, Kennedy DW. Quantification for staging sinusitis. The Staging and Therapy Group. Ann Otol Rhinol Laryngol Suppl. 1995 Oct;167:17-21.'}, {'pmid': '10867835', 'type': 'BACKGROUND', 'citation': 'Kobal G, Klimek L, Wolfensberger M, Gudziol H, Temmel A, Owen CM, Seeber H, Pauli E, Hummel T. Multicenter investigation of 1,036 subjects using a standardized method for the assessment of olfactory function combining tests of odor identification, odor discrimination, and olfactory thresholds. Eur Arch Otorhinolaryngol. 2000;257(4):205-11. doi: 10.1007/s004050050223.'}, {'pmid': '20599080', 'type': 'BACKGROUND', 'citation': 'Poetker DM, Reh DD. A comprehensive review of the adverse effects of systemic corticosteroids. Otolaryngol Clin North Am. 2010 Aug;43(4):753-68. doi: 10.1016/j.otc.2010.04.003.'}, {'pmid': '23369181', 'type': 'BACKGROUND', 'citation': 'Heinzerling L, Mari A, Bergmann KC, Bresciani M, Burbach G, Darsow U, Durham S, Fokkens W, Gjomarkaj M, Haahtela T, Bom AT, Wohrl S, Maibach H, Lockey R. The skin prick test - European standards. Clin Transl Allergy. 2013 Feb 1;3(1):3. doi: 10.1186/2045-7022-3-3.'}, {'pmid': '24932618', 'type': 'BACKGROUND', 'citation': 'Chaves C, de Andrade CR, Ibiapina C. Objective measures for functional diagnostic of the upper airways: practical aspects. Rhinology. 2014 Jun;52(2):99-103. doi: 10.4193/Rhino13.109.'}, {'pmid': '22764607', 'type': 'RESULT', 'citation': 'Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. European Position Paper on Rhinosinusitis and Nasal Polyps 2012. Rhinol Suppl. 2012 Mar;23:3 p preceding table of contents, 1-298.'}, {'pmid': '24889751', 'type': 'RESULT', 'citation': 'Orlandi RR, Smith TL, Marple BF, Harvey RJ, Hwang PH, Kern RC, Kingdom TT, Luong A, Rudmik L, Senior BA, Toskala E, Kennedy DW. Update on evidence-based reviews with recommendations in adult chronic rhinosinusitis. Int Forum Allergy Rhinol. 2014 Jul;4 Suppl 1:S1-S15. doi: 10.1002/alr.21344. Epub 2014 May 29.'}, {'pmid': '24610673', 'type': 'RESULT', 'citation': 'Baguley C, Brownlow A, Yeung K, Pratt E, Sacks R, Harvey R. The fate of chronic rhinosinusitis sufferers after maximal medical therapy. Int Forum Allergy Rhinol. 2014 Jul;4(7):525-32. doi: 10.1002/alr.21315. Epub 2014 Mar 7.'}, {'pmid': '24753507', 'type': 'RESULT', 'citation': 'Watanabe S, Pinto JM, Bashir ME, De Tineo M, Suzaki H, Baroody FM, Naclerio RM, Sharma S. Effect of prednisone on nasal symptoms and peripheral blood T-cell function in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2014 Aug;4(8):609-16. doi: 10.1002/alr.21336. Epub 2014 Apr 21.'}, {'pmid': '22887970', 'type': 'RESULT', 'citation': 'Poetker DM, Jakubowski LA, Lal D, Hwang PH, Wright ED, Smith TL. Oral corticosteroids in the management of adult chronic rhinosinusitis with and without nasal polyps: an evidence-based review with recommendations. Int Forum Allergy Rhinol. 2013 Feb;3(2):104-20. doi: 10.1002/alr.21072. Epub 2012 Aug 7.'}, {'pmid': '22287332', 'type': 'RESULT', 'citation': 'Lal D, Hwang PH. Oral corticosteroid therapy in chronic rhinosinusitis without polyposis: a systematic review. Int Forum Allergy Rhinol. 2011 Mar-Apr;1(2):136-43. doi: 10.1002/alr.20024.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether prednisone is effective in the treatment of chronic rhinosinusitis without nasal polyps in adult patients.', 'detailedDescription': 'General Objective:\n\n1\\. Compare clinical improvement in adult patients with chronic rhinosinusitis without nasal polyps (CRSsNP) through application of SNOT 22 questionnaire and visual analogue scale of symptoms, sniff test, acoustic rhinometry and rhinomanometry and nasal endoscopy using Lund-Kennedy score, after 6 months of follow-up after treatment prednisone or placebo plus standard medical treatment for 21 days.\n\nSpecific Objectives:\n\n1. Compare decreased in SNOT-22 questionnaire score and visual analog scale of symptoms after treatment with prednisone or placebo.\n2. Compare decreased in nasal endoscopy findings, through application of Lund-Kennedy score, after treatment with prednisone or placebo.\n3. Compare improvements in smell after treatment with prednisone or placebo.\n4. Determine whether there are differences in nasal permeability measured by rhinomanometry and acoustic rhinometry after treatment with prednisone or placebo.\n5. Determine whether there is a difference in the SNOT 22 questionnaire score, visual analogue scale of symptoms, score of smell and Lund-Kennedy score between CRSsNP patients and eosinophilia, and CRSsNP patients with normal eosinophils, receiving prednisone or placebo .\n6. Determine if there is a difference in the SNOT 22 questionnaire score, visual analogue scale of symptoms, score of smell and Lund-Kennedy score between CRSsNP patients with elevated total immunoglobulin E and CRSsNP patients with normal total immunoglobulin E, receiving treatment with prednisone or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of CRSsNP as recommended European Position Paper on Rhinosinusitis and Nasal Polyps 2012\n\nExclusion Criteria:\n\n* Treatment with oral corticosteroids or topical corticosteroids the last 4 weeks.\n* Previous surgical treatment for CRSsNP\n* History of diabetes mellitus and / or glaucoma and / or decompensated hypertension and / or gastric ulcer.\n* Pregnancy.\n* History of cystic fibrosis, primary ciliary dyskinesia, immunodeficiency, allergic fungal sinusitis, nasal polyps, nasal tumors, hepatic or renal dysfunction.\n* Hypersensitivity to prednisone'}, 'identificationModule': {'nctId': 'NCT02367118', 'briefTitle': 'Prednisone in Chronic Rhinosinusitis Without Nasal Polyps', 'organization': {'class': 'OTHER', 'fullName': 'University of Chile'}, 'officialTitle': 'Prednisone in Chronic Rhinosinusitis Without Nasal Polyps. A Double-blind, Randomized, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'PRD- CRSsNP-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prednisone', 'description': 'Intervention: prednisone 5 mg tablets taken orally, in decreasing doses. Beginning with 6 tablets (30 mg) daily for 7 days, then 3 tablets (15 mg) daily for 7 days, then 1 tablet (5 mg) daily for 7 days. Total days of treatment: 21 days.', 'interventionNames': ['Drug: Prednisone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Intervention: placebo tablets taken orally (similar to prednisone), in decreasing doses. Beginning with 6 tablets daily for 7 days, then 3 tablets daily for 7 days, then 1 tablet daily for 7 days. Total days of treatment: 21 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Prednisone', 'type': 'DRUG', 'armGroupLabels': ['Prednisone']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7600490', 'city': 'Santiago', 'state': 'Santiago Metropolitan', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Constanza J Valdes, MD', 'role': 'CONTACT', 'email': 'cjvaldes@gmail.com', 'phone': '56-02-2575-3968'}, {'name': 'Marcela A Veloz, MD', 'role': 'CONTACT', 'email': 'marceveloz@gmail.com', 'phone': '56-02-2575-3968'}, {'name': 'Nicole S Jimenez', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Felipe Cardemil, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital del Salvador', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'centralContacts': [{'name': 'Constanza J Valdes, MD', 'role': 'CONTACT', 'email': 'cjvaldes@gmail.com', 'phone': '56-02-2575-3968'}, {'name': 'Marcela A Veloz, MD', 'role': 'CONTACT', 'email': 'marceveloz@gmail.com', 'phone': '56-02-2575-3968'}], 'overallOfficials': [{'name': 'Constanza J Valdes, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Chile'}, {'name': 'Marcela A Veloz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chile'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chile', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sociedad Chilena de Otorrinolaringología, Medicina y Cirugía de Cabeza y Cuello', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Professor Assistant University of Chile. Department of Otorhinolaryngology-Head and Neck Surgery.', 'investigatorFullName': 'Constanza J. Valdes', 'investigatorAffiliation': 'University of Chile'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-01-02', 'type': 'RELEASE'}, {'date': '2024-06-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Constanza J. Valdes, MD, Professor Assistant University of Chile. Department of Otorhinolaryngology-Head and Neck Surgery., University of Chile'}}}}