Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-27 @ 9:13 PM
Study NCT ID:
NCT06267261
Status:
COMPLETED
Last Update Posted:
2024-07-30
First Post:
2024-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Face Mask in Reducing Respiratory Allergic Symptoms in Birch-allergic Subjects in ALYATEC Exposure Chamber
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2024-02-12', 'studyFirstSubmitQcDate': '2024-02-19', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to early asthma response (EAR)', 'timeFrame': '0 to 6 hours', 'description': 'The efficacy of face mask is evaluated by the time necessary to observe an EAR during birch pollen allergen exposure in EEC'}], 'secondaryOutcomes': [{'measure': 'Frequency of EAR and late asthma response (LAR)', 'timeFrame': '0 to 6 hours (EAR) - 3 to 24 hours after exposure (LAR)', 'description': 'The efficacy of face mask is evaluaed by the frequency of EAR and LAR during and after birch pollen allergen exposure in EEC'}, {'measure': 'Severity of EAR and LAR', 'timeFrame': '0 to 6 hours (EAR) - 3 to 24 hours after exposure (LAR)', 'description': 'The efficacy of face mask is evaluated by the maximum percentage of drop of FEV1during and after EEC exposure'}, {'measure': 'Nasal Symptoms', 'timeFrame': '0 to 6 hours. (Total Nasal Symptoms Score from 0 to 12, 0 being the worse and 12 the better score)', 'description': 'The efficacy of face mask is evaluated with specific questionnaire (Total Nasal Symptoms Score - TNSS)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergic Asthma', 'Allergic Rhinitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.em-consulte.com/article/1557183/evaluation-clinique-de-l-efficacite-d-un-masque-ch', 'label': 'Study results'}]}, 'descriptionModule': {'briefSummary': 'There is no clinical evidence that face masks are efficient in birch pollen-induced asthma. As the use of face masks has become widespread worldwide to limit the spread of SARS-CoV-2, this study aims to demonstrate the clinical efficacy of medical masks in patients allergic to birch in the same way that clinical trial with drugs.', 'detailedDescription': 'All patients should have positive skin prick tests and specific IgE to birch at screening visit. 24 patients with asthma response during 1-hour baseline exposure to airborne Bet v 1 in ALYATEC environmental exposure chamber.will be randomized into 2 groups: with (n=12) and without (n=12) a KOLMI® surgical face mask (OP-Air), for a 6-hour exposure to birch allergen.\n\nAllergic symptoms will be observed during the 6-hour exposure and compared between the 2 different groups (with and without face mask) to evaluate the efficacy of the face mask.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Subjects who signed the written informed consent,\n* Subjects covered by health social identification number,\n* Subjects able to understand and complete study-related procedures,\n* Subjects reported history of symptomatic birch pollen allergen-triggered asthma (GINA1) with associated allergic rhinitis,\n* Positive skin prick test (SPT) with cat hair extract with mean wheal diameter ≥ 5 mm compared to negative control (NaCl reaction \\< 2 mm),\n* Positive sIgE tests for birch tree pollen and Bet v 1 (≥0.7 kUa/L),\n* Subjects with FEV1 ≥ 70% predicted at screening and before allergen exposure,\n* Subjects with at least one drop in FEV1 ≥20% during the 1-hour baseline exposure\n* ACT≥ 20,\n* Women of childbearing potential with a negative pregnancy test throughout the study period and a highly effective contraception: oral contraceptives, condom with spermicide, intrauterine device, bilateral tubal ligation, vasectomized partner.\n\nMain Exclusion Criteria:\n\n* Allergen immunotherapy to birch pollen allergen for more than 1 month in the 3 years prior to the screening visit,\n* Ongoing allergen immunotherapy to another allergen,\n* History of anaphylactic reactions to birch allergen exposure or birch allergen immunotherapy,\n* History of anaphylactic reactions to another allergen in the last 6 weeks before inclusion,\n* Nasal polyposis, deviation of nasal septum or diagnosis of uncontrolled non-allergic rhinitis,\n* Subjects allergic to indoor environmental allergens (molds, house dust mite allergens) with obvious exposure to these allergens causing allergic symptoms,'}, 'identificationModule': {'nctId': 'NCT06267261', 'briefTitle': 'Efficacy of Face Mask in Reducing Respiratory Allergic Symptoms in Birch-allergic Subjects in ALYATEC Exposure Chamber', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alyatec'}, 'officialTitle': 'Clinical Evaluation of Surgical Face Mask Efficacy in Reducing Asthma and Rhinitis Symptoms in Birch-allergic Subjects in ALYATEC Environmental Exposure Chamber', 'orgStudyIdInfo': {'id': 'KOL-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with face mask', 'description': 'Birch pollen allergen exposure in ALYATEC chamber with face mask', 'interventionNames': ['Device: KOLMI® surgical face mask (OP-Air)']}, {'type': 'NO_INTERVENTION', 'label': 'Patients without face mask', 'description': 'Birch pollen allergen exposure in ALYATEC chamber without face mask'}], 'interventions': [{'name': 'KOLMI® surgical face mask (OP-Air)', 'type': 'DEVICE', 'description': '12 subjects are exposed to birch pollen allergen in ALYATEC EEC while wearing a KOLMI® surgical face mask (OP-Air)', 'armGroupLabels': ['Patients with face mask']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Strasbourg', 'country': 'France', 'facility': 'ALYATEC', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Frédéric de Blay, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chest Diseases Department, Strasbourg University Hospital, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alyatec', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medicom', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}