Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-01-04 @ 9:15 PM
Study NCT ID:
NCT03825757
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2019-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aggravated Airway Inflammation: Research on Genomics and Optimal Medical Care (AirGOs-medical)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'The IMP producer (Galena Pharma Ltd., Kuopio, Finland) has packed the IMP according to study protocol and provides a code of each product. The IMP is used double-blinded in their numbered order. The key of the codes are stored in closed envelopes in Hospital´s locked closet. HYKS-institute performs regular study monitoring'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized double-blinded controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2019-01-26', 'studyFirstSubmitQcDate': '2019-01-30', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in endoscopic Nasal polyp score of both sides of the nasal cavity.', 'timeFrame': 'at -4 days vs. at 11 months post-randomization', 'description': 'Change means differences between at time -4 days versus (vs.) at time +11 months post-randomization. Minimum value is 0. Maximum value is 8. A higher score means worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Change in Sinonasal outcome test 22 (SNOT22). Validated nose-specific quality of life questionnaire, 0-110 points.', 'timeFrame': 'at -4 days vs. at 11 months post-randomization', 'description': 'Change means differences between at time -4 days vs. +11 months post-randomization. A higher score means worse outcome.'}, {'measure': 'Change in the Relative forced expiratory volume in 1 second (FEV1%) without bronchodilator.', 'timeFrame': 'at -1 month vs. at 11 months post-randomization', 'description': 'Change means differences between at time -1 month vs. +11 months post-randomization. A higher value means better outcome. FEV1% is measured by Spirometry.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic rhinosinusitis with nasal polyps', 'Acetyl salicylic acid exacerbated respiratory disease'], 'conditions': ['Chronic Rhinosinusitis (Diagnosis)']}, 'referencesModule': {'references': [{'pmid': '40463360', 'type': 'DERIVED', 'citation': 'Toppila-Salmi S, Lyly A, Salmi V, Nuutinen M, Kilpio M, Hanif T, Niemi M, Laulajainen-Hongisto A, Hafren L, Makela M, Kauppi P, Virkkula P, Heleva A. Study protocol for a randomized double-blinded placebo-controlled trial on ASA therapy for patients with chronic rhinosinusitis with nasal polyps, NSAID-exacerbated respiratory disease, and asthma. Front Allergy. 2025 May 20;6:1542481. doi: 10.3389/falgy.2025.1542481. eCollection 2025.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/30216468', 'label': 'Diagnosis and management of NSAID-Exacerbated Respiratory Disease (N-ERD)-a EAACI position paper.'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/30575459', 'label': 'Aspirin-Exacerbated Respiratory Disease. Publication.'}]}, 'descriptionModule': {'briefSummary': 'The study is performed as a randomized double-blinded prospective controlled trial. A total of 72 adult Acetyl salicylic acid (ASA) -exacerbated respiratory disease (AERD) -patients with uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP) will be recruited. Those negative to ASA-challenge test will not enter the Clinical Trial . All patients entering the Clinical Trial, have undergone earlier ethmoidal surgery (partial/total) and have not gained disease control. F-helicobacter antigen is tested and treatment is given if indicated. The patients are recruited at the Helsinki University Hospital (HUH). The study will be monitored by a professional monitor. Electronic CRF and paper/electronic patient questionnaires provided by HUS will be used (eCRF and patient questionnairea, Granitics).', 'detailedDescription': 'Randomization and the treatment arms I-II: The patients are randomized to two treatment arms I) ASA- desensitization po tablet daily for 11 months (n=36) II) Placebo po tablet daily for 11 months (n=18).\n\nASA challenge and desensitization (Primaspan) /Placebo: is conducted according to modified international protocol. FEV1 should be at least 1.5 L and \\> 60% of predicted before challenge or desensitization. On the first day every patient will receive 25 mg + 25 mg ASA at a hospital setting. On the second day every patient will receive 50 mg + 25 mg ASA at a hospital setting. On the third day every patient will receive 75 mg + 25 mg ASA at a hospital setting. On the fourth day every patient will receive 100 mg + 25 mg ASA at a hospital setting.\n\nDuring the ASA challenge, patient who is ASA-challenge positive is then randomized and starts the trial so that he/she uses blinded ½ tablet of 250 mg ASA or ½ tablet of placebo daily at home for the next 1 month. After this period of 1 month, the dosing is increased at hospital setting, so that the patient receives blindly 250 mg ASA 1/2 tablet + 1/2 tablet or placebo 1/2 tablet + 1/2 tablet. Thereafter he/she will continue using blindly 250 mg ASA 1 tablet or placebo 1 tablet daily at home for the next 10 months. If the patient does not tolerate the up-dosing of ASA/placebo, he/she will continue using blindly ½ tablet of 250 mg ASA/placebo daily at home for the next 10 months. The total duration of the ASA/placebo treatment is 11 months. We additionally take nasal, blood and urine samples during the trial.\n\nFollow-ups. The symptom questionnaire and interview of side-effects are performed during each visit. Lung function (eNO, nNO, PEF, spirometry) is monitored and the patient will visit doctor and/or nurse at 1, 5, 11, and 12 months post-starting with the treatment. Samples are taken during recruitment visit, before and after ASA-challenge and at 5, 11 and 12 months post-starting with the treatment. We also monitor side-effects, exacerbations, need of medication (po. cortisocteroids; antibiotics) and satisfaction to treatment.\n\nPrimary end point is change in nasal endoscopic nasal polyp score at -4 days vs. +11 months post-randomization. Secondary end point is change in Sinonasal Outcome Test -22 (SNOT-22) score at -4 days vs. +11 months post-randomization, and change in relative Forced expiratory volume in 1 second (FEV1 %) without bronchodilator at -1 month vs. +11 months post-randomization.\n\nSafety (complications, adverse effects), costs and loss of productivity between study arms will be compared.\n\nTrial medication will be discontinued, if surgery is needed before the end of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: ALL these need to be positive:\n\n* Endoscopic nasal polyp score ≥4\n* SNOT-22 ≥30\n* Sinus Computed tomography Lund-Mackay score ≥14. The new sinus CT scans are needed if the previous sinus CT scans have been performed over 36 months before recruitment visit or if there is a suspicion of complication of CRS (f.ex. mucocele, invasive fungal rhinosinusitis)\n* ≥1 previous partial/total ethmoidectomy surgery.\n\nIn addition, patient should have a history of at least one of the following:\n\n\\>1 oral corticosteroids during the past two years \\>3 antibiotic courses during the past two years. In patients with contraindication/adverse effects in using oral steroids additional criteria are not required.\n\nExclusion Criteria:\n\n* complication of CRS (f.e. mucocele, invasive fungal rhinosinusitis)\n* bleeding diathesis\n* pregnancy/ breastfeeding\n* cystic fibrosis\n* primary ciliary dyskinesia (PCD)\n* sarcoidosis\n* granulomatosis with polyangitis (GPA)\n* eosinophilic granulomatosis with polyangitis (EGPA)\n* immunosuppression (diagnosed Spesific antibody deficiency (SAD), CVI, HIV\n* use of biologicals/immunosuppressive medication\n* immunotherapy\n* Daily use of systemic corticosteroids (Prednisolon 10mg or equivalent) -communication problems (f.e. neurological/psychiatric disease, language skills) -unlikely to comply\n* other severe disease\n* uncontrolled asthma\n* ASA-challenge negative\n* gastric ulcer\n* anticoagulant treatment\n* SSRI-depression medication\n* beta-blocker\n* severe chronic urticaria\n* ASA anaphylaxis'}, 'identificationModule': {'nctId': 'NCT03825757', 'acronym': 'AirGOs-med', 'briefTitle': 'Aggravated Airway Inflammation: Research on Genomics and Optimal Medical Care (AirGOs-medical)', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Aggravated Airway Inflammation: Research on Genomics and Optimal Medical Care (AirGOs-medical)', 'orgStudyIdInfo': {'id': 'TYH2018203'}, 'secondaryIdInfos': [{'id': '2017-001570-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Primaspan tablet 250 mg', 'description': 'Primaspan tablet 250 mg (Acetyl salicylic acid): 1/2 tablet once daily during 1 month. 1 tablet once daily during 10 months. If not tolerated the dose 1 tablet x1/day, the patient is allowed to continue with the dose of 1/2 tablet x1/day.', 'interventionNames': ['Drug: Acetyl Salicylic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo tablet', 'description': 'Placebo Oral Tablet: 1/2 tablet once daily during 1 month. 1 tablet once daily during 10 months. If not tolerated the dose 1 tablet x1/day, the patient is allowed to continue with the dose of 1/2 tablet x1/day.', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Placebo Oral Tablet', 'armGroupLabels': ['Placebo tablet']}, {'name': 'Acetyl Salicylic Acid', 'type': 'DRUG', 'otherNames': ['Primaspan 250 mg tablet'], 'description': 'Primaspan 250 mg tablet Acetyl Salicylic Acid', 'armGroupLabels': ['Primaspan tablet 250 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Sanna Toppila-Salmi, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data is owned by Helsinki University Hospital and University of Helsinki.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanna Salmi', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Helsinki', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant Otorhinolaryngologist, PI', 'investigatorFullName': 'Sanna Salmi', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}