Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-04 @ 12:21 PM
Study NCT ID:
NCT03155204
Status:
COMPLETED
Last Update Posted:
2024-12-02
First Post:
2017-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With A Reference Product
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2017-05-15', 'studyFirstSubmitQcDate': '2017-05-15', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': '24 hr', 'description': 'noncompartmental analysis'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '24 hr', 'description': 'reported adverse events'}, {'measure': 'Area Under the Plasma Concentration vs Time Curve (AUC)', 'timeFrame': '24 hr', 'description': 'trapezoidal rule'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inhalation', 'LABA', 'corticosteroid'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the absorption of four different inhalation products with the reference product in healthy volunteers.', 'detailedDescription': 'Healthy subjects will be enrolled and will receive single doses of 4 test inhalation products and one reference inhalation product according to a five-period cross-over design. Plasma tiotropium levels will be measured pre-dose and over 8 hours post-dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Volunteer\n* Willing and able to give informed consent\n* Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic\n* Subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders\n* Any presence or history of a clinically significant allergy including any adverse reaction to study drug\n* History of drug or alcohol abuse within the past 2 years\n* Smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked)\n* Donation or loss of greater than 400 mL of blood within the previous 3 months\n* Have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted)\n* Have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days)\n* Upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months\n* If female, nursing, lactating or pregnant\n* Regular alcohol consumption in males \\>21 units per week and females \\>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)'}, 'identificationModule': {'nctId': 'NCT03155204', 'briefTitle': 'Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With A Reference Product', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solventum US LLC'}, 'officialTitle': 'Phase I Randomised, Five-period Cross-over Study in Healthy Male and Female Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Four Test pMDI Products With Spiriva Respimat', 'orgStudyIdInfo': {'id': 'CSP-07-000039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Product 1', 'description': 'tiotropium pMDI 2 inhalations', 'interventionNames': ['Drug: tiotropium pMDI']}, {'type': 'EXPERIMENTAL', 'label': 'Test Product 2', 'description': 'tiotropium pMDI 2 inhalations', 'interventionNames': ['Drug: tiotropium pMDI']}, {'type': 'EXPERIMENTAL', 'label': 'Test Product 3', 'description': 'tiotropium pMDI 2 inhalations', 'interventionNames': ['Drug: tiotropium pMDI']}, {'type': 'EXPERIMENTAL', 'label': 'Test Product 4', 'description': 'tiotropium pMDI 2 inhalations', 'interventionNames': ['Drug: tiotropium pMDI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Commercial Product', 'description': 'tiotropium Respimat 2 inhalations', 'interventionNames': ['Drug: tiotropium pMDI']}], 'interventions': [{'name': 'tiotropium pMDI', 'type': 'DRUG', 'otherNames': ['Spiriva Respimat'], 'description': 'inhalation', 'armGroupLabels': ['Commercial Product', 'Test Product 1', 'Test Product 2', 'Test Product 3', 'Test Product 4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Loughborough', 'country': 'United Kingdom', 'facility': '3M Health Care', 'geoPoint': {'lat': 52.76667, 'lon': -1.2}}], 'overallOfficials': [{'name': 'Victoria Sessions, PhD', 'role': 'STUDY_CHAIR', 'affiliation': '3M'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solventum US LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': '3M', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}