Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT05192720
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2021-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Andosan in Allergic and Asthma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C579023', 'term': 'AndoSan'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'the patients do not know if they get Andosan or placebo.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '25-30 patients in each arm receiving Andosan or placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2021-09-02', 'studyFirstSubmitQcDate': '2021-12-31', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV1', 'timeFrame': '20 days', 'description': 'Change in FEV1 within-day variation (%) from run-in-period of last five days of intervention.'}], 'secondaryOutcomes': [{'measure': 'Oscillometry', 'timeFrame': '20 days to four weeks', 'description': 'change in small airway obstruction as measured by the R5Hz and R5-20Hz level in oscillometry.'}, {'measure': 'Questionnaire ACT', 'timeFrame': 'four weeks', 'description': 'Change in asthma symptoms, as measured by the asthma control test'}, {'measure': 'Questionnaire RQLQ', 'timeFrame': 'four weeks', 'description': 'Change in burden of asthma symptoms measured by RQLQ (Respiratory questionnaire of life quality)'}, {'measure': 'Passive basophil cell activation in serum', 'timeFrame': 'four weeks', 'description': 'Difference in activation of basophil cells measured in serum before and after intervention'}, {'measure': 'Immunoglobulin E in serum', 'timeFrame': 'four weeks', 'description': 'difference in concentration before and after intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ASIT', 'SLIT', 'Andosan'], 'conditions': ['Allergic Asthma', 'Allergic Rhinoconjunctivitis', 'Immune Tolerance']}, 'descriptionModule': {'briefSummary': 'Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) in patients with asthma and allergy, undergoing allergen specific immunotherapy experience clinical and biochemical improvement in their disease.\n\nA prospective randomised study comparing the mushroom extract with placebo.', 'detailedDescription': 'Asthma and allergy are increasing in Norway and Western countries. Treatment is still mostly symptomatic. Extracts of the immunomodulatory and edible mushroom Agaricus blazei, such as Andosan™, have been shown to protect against asthma and allergy in murine models by changing the T helper cell 1(upregulation)-T helper cell 2 (downregulation) balance in the immune system. Positive effects on allergy were also shown in a RCT on blood donors with selfreported allergy. Andosan™ is produced in Japan and approved as food (mushroom juice) in Norway.\n\nThe aim of this study is to examine whether Andosan™ i) has similar clinical effects against allergy and asthma in patients as it has in mice, and as earlier shown in a study on blood donors with allergy ii) wether patients taking Andosan has any clinical impact on asthma while taken as supplementary treatment in addition to other medication compared to a placebo group while going through allergen specific immunotherapy (ASIT).\n\nIf the extract shows effect on these patients it support the hypotheses that Andosan helps against atopic diseases and facilitate the shift from Th-2 to Th-1 responses at a cellular level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asthma or allergy patients that are eligible for ASIT (Allergen specific immunotherapy).\n* Age above 18.\n* Able to understand written and oral Norwegian\n\nExclusion Criteria:\n\n\\- none other than not meeting the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT05192720', 'briefTitle': 'Andosan in Allergic and Asthma Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Akershus'}, 'officialTitle': 'Effect of Supplementary Treatment With Agaricus Blazei Based Mushroom Extract, Andosan, on Patients With Asthma and Allergy', 'orgStudyIdInfo': {'id': '20/01869'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Andosan', 'description': 'The Agaricus blazei Murill-based mushroom extract, Andosan™, is given as one dosage 100 ml/day orally for 1 month. The intervention solution is given in a neutral plastic container', 'interventionNames': ['Dietary Supplement: Andosan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The placebo is drinking water with brownish food coloring, given as one dosage 100 ml/day orally for 1 month. The placebo solution is given in a neutral plastic container (same as for intervention/experimental solution).', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Andosan', 'type': 'DIETARY_SUPPLEMENT', 'description': 'See also detailed study design, Mushroom juice based on Agaricus Blazei and two other types of mushroom.', 'armGroupLabels': ['Andosan']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'drinking water with food colour', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1478', 'city': 'Lørenskog', 'state': 'Akershus', 'country': 'Norway', 'facility': 'Akershus university hospital'}], 'overallOfficials': [{'name': 'Faiza Mahmood', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Akershus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Akershus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oslo University Hospital', 'class': 'OTHER'}, {'name': 'ImmunoPharma AS', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant, Department of Immunology and Transfusion Medicine', 'investigatorFullName': 'Faiza Mahmood', 'investigatorAffiliation': 'University Hospital, Akershus'}}}}