Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-15 @ 3:47 PM
Study NCT ID:
NCT01604018
Status:
COMPLETED
Last Update Posted:
2012-05-24
First Post:
2012-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Optional Two Year Follow Up Study to Study CP005A
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-23', 'studyFirstSubmitDate': '2012-05-21', 'studyFirstSubmitQcDate': '2012-05-22', 'lastUpdatePostDateStruct': {'date': '2012-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Rhinoconjunctivitis Symptom Score', 'timeFrame': '102-106 weeks after the start of treatment in CP005'}], 'secondaryOutcomes': [{'measure': 'Total Symptom scores for ocular and nasal symptoms', 'timeFrame': '102-106 weeks after the start of treatment in CP005'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cat Allergy', 'Rhinoconjunctivitis'], 'conditions': ['Cat Allergy', 'Rhinoconjunctivitis']}, 'descriptionModule': {'briefSummary': 'Cat allergy is an increasingly prevalent condition affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma.\n\nThe purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who completed all dosing visits in study CP005 and all visits in study CP005A approximately two years after the start of treatment.', 'detailedDescription': 'Subjects who completed all visits in studies CP005 and CP005A will be invited to attend the Screening Visit for CP005B. Subjects will attend for 4 visits to the EEC on successive days. Following the last EEC visit is a follow-up visit which will be performed 3-10 days later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects previously randomised in study CP005 and completed all dosing and PTC in CP005 and all visits in CP005A.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Previously randomised into study CP005 and completed all visits in the follow-on study CP005A\n\nExclusion Criteria:\n\n* "Partly controlled" and "uncontrolled" asthma\n* History of anaphylaxis to cat allergen\n* Subjects with an FEV1 \\< 70% of predicted\n* Subjects who cannot tolerate baseline challenge in the EEC\n* Treatment with beta-blockers, alpha-adrenoceptor blockers, tranquilizers, or psychoactive drugs\n* Symptoms of a clinically relevant illness, in the Investigator\'s opinion, within 6 weeks prior to Screening Visit'}, 'identificationModule': {'nctId': 'NCT01604018', 'briefTitle': 'An Optional Two Year Follow Up Study to Study CP005A', 'organization': {'class': 'INDUSTRY', 'fullName': 'Circassia Limited'}, 'officialTitle': 'An Optional Two Year Follow Up Study to Evaluate the Continued Efficacy of Cat-PAD ToleroMune Peptide Immunotherapy in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber', 'orgStudyIdInfo': {'id': 'CP005B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Placebo', 'description': 'Subjects previously randomized to receive placebo in study CP005 and completed CP005A.'}, {'label': 'Cat-PAD Group 1', 'description': 'Subjects previously randomized to receive Cat-PAD dose 1 in study CP005 and completed CP005A.'}, {'label': 'Cat-Pad Group 2', 'description': 'Subjects previously randomized to receive Cat-PAD dose 2 in study CP005 and completed CP005A.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cetero Research', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}], 'overallOfficials': [{'name': 'Peter Couroux, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cetero Research, San Antonio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Circassia Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Adiga Life Sciences, Inc.', 'class': 'INDUSTRY'}, {'name': 'Cetero Research, Toronto', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}