Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-04 @ 2:24 AM
Study NCT ID:
NCT01907204
Status:
COMPLETED
Last Update Posted:
2014-01-27
First Post:
2013-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Inhaled Treatment in Sinusitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D019819', 'term': 'Budesonide'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-24', 'studyFirstSubmitDate': '2013-07-12', 'studyFirstSubmitQcDate': '2013-07-18', 'lastUpdatePostDateStruct': {'date': '2014-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Sniffin' Sticks Test", 'timeFrame': 'Baseline and day 15'}], 'secondaryOutcomes': [{'measure': 'Specific quality of life questionnaire (Snot 20)', 'timeFrame': 'Baseline and day 15'}, {'measure': 'Retro Olfaction Test', 'timeFrame': 'Baseline and day 15'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sinusitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether inhaled corticosteroid (specially nebulized) could be a good alternative to oral corticosteroid and whether they are effective in the treatment of sinusitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nasal/Sinus polyps\n\nExclusion Criteria:\n\n* Previous sinus surgery\n* Age under 18y\n* Use of antibiotics'}, 'identificationModule': {'nctId': 'NCT01907204', 'briefTitle': 'Evaluation of Inhaled Treatment in Sinusitis', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Evaluation of Inhaled Corticosteroid Treatment in Sinusitis', 'orgStudyIdInfo': {'id': 'Sinusitis001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oral', 'description': 'Oral drug (methylprednisolone) administration', 'interventionNames': ['Drug: methylprednisolone']}, {'type': 'EXPERIMENTAL', 'label': 'Metered dose inhaler', 'interventionNames': ['Drug: Budesonide']}, {'type': 'EXPERIMENTAL', 'label': 'Nebulized', 'interventionNames': ['Drug: Budesonide']}], 'interventions': [{'name': 'methylprednisolone', 'type': 'DRUG', 'description': 'Oral 32mg/8d-16mg/4d-8mg/4d', 'armGroupLabels': ['Oral']}, {'name': 'Budesonide', 'type': 'DRUG', 'description': 'Budesonide by metered dose inhaler', 'armGroupLabels': ['Metered dose inhaler']}, {'name': 'Budesonide', 'type': 'DRUG', 'description': 'Budesonide by nebulization', 'armGroupLabels': ['Nebulized']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gregory Reychler, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, {'name': 'Philippe Rombaux, Prof PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, {'name': 'Coralie Colbrant, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Docteur Gregory Reychler', 'investigatorFullName': 'G.Reychler', 'investigatorAffiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}}}}