Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-27 @ 4:10 PM
Study NCT ID:
NCT00822861
Status:
COMPLETED
Last Update Posted:
2013-11-15
First Post:
2009-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Four Escalating Dose Regimens of TPI ASM8 in Patients With Allergic Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C559988', 'term': 'TPI ASM8'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-14', 'studyFirstSubmitDate': '2009-01-13', 'studyFirstSubmitQcDate': '2009-01-14', 'lastUpdatePostDateStruct': {'date': '2013-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sputum eosinophils (%) on Day 4 versus Screening for each dose level.', 'timeFrame': '7 and 24 hrs post-allergen challenge'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability.', 'timeFrame': 'Throughout the study'}, {'measure': 'Plasma and sputum pharmacokinetic profile at the two highest dose levels.', 'timeFrame': 'Dose level 3 and 4'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'During this proposed clinical trial, the investigators intend to evaluate the pharmacodynamic anti-inflammatory properties and safety of TPI ASM8, by investigating the effect on sputum eosinophils and the airway responses during an allergen challenge at different dose levels.', 'detailedDescription': 'The early and late asthmatic response were both significantly attenuated by the highest dose of ASM8. The methacholine challenge and other parameters (ECP, mRNA knockdown on CCR3 and B-Chain of IL-3-Il-5 and GMCSF were attenuated by ASM8.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women 18 to 65 years of age\n* Generally good health; steroid naïve (or who have not taken inhaled/oral corticosteroid within last month) mild to moderate, stable, allergic asthma as defined by ATS criteria\n* History of episodic wheeze and shortness of breath\n* Forced expiratory volume in one second (FEV1) at baseline ≥ 70% of the predicted value\n* Able to comprehend and follow all required study procedures; willing and able to sign an informed consent form.\n\nExclusion Criteria:\n\n* Significant acute or chronic medical or psychiatric illness\n* Known coagulopathy, worsening of asthma or respiratory infection in the preceding 6 weeks\n* Use of inhaled or oral corticosteroids within the last 30 days, or need for antihistamines within 72 hours of each allergen or methacholine challenge, immunosuppressives, nonsteroidal anti-inflammatory drugs, or anticoagulants (intermittent doses of short-acting β2-agonist are allowed).'}, 'identificationModule': {'nctId': 'NCT00822861', 'briefTitle': 'Efficacy and Safety of Four Escalating Dose Regimens of TPI ASM8 in Patients With Allergic Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Syntara'}, 'officialTitle': 'A Single Center, Open Label, Stepwise, Dose Profiling Study to Evaluate the Efficacy and Safety of Four Dose Regimens of Inhaled TPI ASM8 in Patients With Allergic Asthma', 'orgStudyIdInfo': {'id': 'TPI ASM8-206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose level No.1', 'description': 'TPI ASM8 1 mg BID', 'interventionNames': ['Drug: TPI ASM8']}, {'type': 'EXPERIMENTAL', 'label': 'Dose level No.2', 'description': 'TPI ASM8 2 mg BID', 'interventionNames': ['Drug: TPI ASM8']}, {'type': 'EXPERIMENTAL', 'label': 'Dose level No.3', 'description': 'TPI ASM8 4mg BID', 'interventionNames': ['Drug: TPI ASM8']}, {'type': 'EXPERIMENTAL', 'label': 'Dose level No.4', 'description': 'TPI ASM8 8 mg Die', 'interventionNames': ['Drug: TPI ASM8']}], 'interventions': [{'name': 'TPI ASM8', 'type': 'DRUG', 'otherNames': ['ASM8'], 'description': '4 mg/mL, 1 mg BID for 4 days', 'armGroupLabels': ['Dose level No.1']}, {'name': 'TPI ASM8', 'type': 'DRUG', 'otherNames': ['ASM8'], 'description': '4 mg/mL, 2 mg BID for 4 days', 'armGroupLabels': ['Dose level No.2']}, {'name': 'TPI ASM8', 'type': 'DRUG', 'otherNames': ['ASM8'], 'description': '4 mg/mL, 4 mg BID for 4 days', 'armGroupLabels': ['Dose level No.3']}, {'name': 'TPI ASM8', 'type': 'DRUG', 'otherNames': ['ASM8'], 'description': '4 mg/mL, 8 mg OD for 4 days', 'armGroupLabels': ['Dose level No.4']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Rene Pageau, B.Pharm M.Sc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Topigen Pharmaceuticals Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Syntara', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}