Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-27 @ 10:02 PM
Study NCT ID:
NCT02479750
Status:
COMPLETED
Last Update Posted:
2019-02-07
First Post:
2015-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of ColdZyme® on Experimentally Induced Common Cold.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003139', 'term': 'Common Cold'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2016-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-05', 'studyFirstSubmitDate': '2015-06-22', 'studyFirstSubmitQcDate': '2015-06-23', 'lastUpdatePostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of virus load', 'timeFrame': '7 days', 'description': 'The primary objective is to investigate the protective effect of ColdZyme® mouth spray against infection in the oropharynx by common cold virus (rhinovirus 16) in vivo in relation to placebo'}], 'secondaryOutcomes': [{'measure': 'Reduce the number of days with common cold symptoms', 'timeFrame': '11 days'}, {'measure': 'Reduce the number of days with virus present in oropharynx', 'timeFrame': '11 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Common Cold']}, 'descriptionModule': {'briefSummary': 'This study evaluates the performance of ColdZyme® mouth spray on prevention of common cold symptoms on experimentally induced rhinovirus upper respiratory tract infection in healthy volunteers. Half of participants will receive ColdZyme® mouth spray while the other half will receive placebo.', 'detailedDescription': '88 subjects will be inoculated with rhinovirus 16 via the nasal route. The subjects will be randomized 1:1 to ColdZyme® or placebo. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. The subjects will visit the investigational clinic on 6 occasions. During these visits the subjects will leave nasal (lavage) and pharyngeal (swab) samples for quantification of virus replication. All subjects will have a diary for scoring of cold symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female subjects between 16-70 years. The investigator judges the definition of healthy by detailed medical history and physical examination.\n* Females of childbearing potential: shall use reliable method of birth control. Reliable methods are hormonal contraceptives (combination pills, injections or implants), intrauterine device, condom or declared absence of sexual contact. Post-menopausal woman is defined as absence of menstrual discharge for at least two years.\n* Signed informed consent form prior to any study-related procedures.\n* Willingness and ability to adhere to the prohibitions and restrictions specified in this protocol.\n* Perceived to have had at least one cold per year\n\nExclusion Criteria:\n\n* Smoker, during the last 12 months\n* Any cold symptom within the last month such as sore throat, sneezing, rhinorrhoea, malaise, nasal obstruction or cough.\n* Presence (at screening) of serum rhinovirus 16 neutralising antibody titers at greater than or equal to one in two dilution.\n* Active allergic rhinitis, asthma or chronic obstructive pulmonary disease during study period.\n* Nasal disease, e.g. nasal polyposis, significant septal deviation, chronic rhinosinusitis, etc.\n* Females: Pregnant, breast-feeding or intentions to become pregnant during the study.\n* Evidence or history of drug or alcohol abuse.\n* Use of any prescribed or non-prescribed medication (except for contraceptives, paracetamol and ibuprofen) within 2 weeks prior to the first administration of investigational product.\n* Use of any over the counter cold prophylaxis products such as ColdZyme®, C-vitamins, zinc or Echinacea within 1 month prior to the first administration of investigational product.\n* Participation in other clinical trial with medical investigational product within 60 days prior to the first administration of investigational product.\n* Hypersensitivity/allergy to any of the device ingredients\n* Individuals with close contact to at risk patient group:\n* infants (less than 6 months);\n* the extremely elderly or infirm;\n* pregnant women;\n* patients with severe lung disease (asthma/cystic fibrosis (CF)/COPD);\n* patients with immunosuppression.'}, 'identificationModule': {'nctId': 'NCT02479750', 'acronym': 'COLDPREVII', 'briefTitle': 'Evaluation of ColdZyme® on Experimentally Induced Common Cold.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Enzymatica AB'}, 'officialTitle': 'Evaluation of ColdZyme® on Experimentally Induced Common Cold. -A Double-blind, Randomized, Placebo-controlled Study in Healthy Volunteers.', 'orgStudyIdInfo': {'id': 'ENZY-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ColdZyme', 'description': 'ColdZyme® mouth spray liquid. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.', 'interventionNames': ['Device: ColdZyme® mouth spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Sugar based mouth spray liquid manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.', 'interventionNames': ['Device: Placebo']}], 'interventions': [{'name': 'ColdZyme® mouth spray', 'type': 'DEVICE', 'armGroupLabels': ['ColdZyme']}, {'name': 'Placebo', 'type': 'DEVICE', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W2 1PG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'National Heart and Lung Institute, Imperial College', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Patrick Mallia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHLI, Imperial College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Enzymatica AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}