Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-02 @ 6:34 AM
Study NCT ID:
NCT00465959
Status:
COMPLETED
Last Update Posted:
2013-12-27
First Post:
2007-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'dispFirstSubmitDate': '2013-12-03', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-03', 'studyFirstSubmitDate': '2007-04-24', 'dispFirstSubmitQcDate': '2013-12-03', 'studyFirstSubmitQcDate': '2007-04-25', 'dispFirstPostDateStruct': {'date': '2013-12-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-12-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and efficacy (measured by spirometry) of TrIP will be assessed in patients with chronic obstructive pulmonary disease.'}]}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'To assess the effect of a single dose of TrIP on pulmonary function in patients with COPD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female COPD patients between the ages of 40 and 80 years\n* Smoking history of at least 10 pack years\n* Not currently using (or able to wash out of) any long acting bronchodilators\n\nExclusion Criteria:\n\n* Candidate on a waiting list for surgery while on study\n* Using long-term oxygen therapy\n* Hospitalization for COPD exacerbation'}, 'identificationModule': {'nctId': 'NCT00465959', 'briefTitle': 'Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Endo Pharmaceuticals'}, 'officialTitle': 'Safety, Tolerability, Pharmacokinetics, and Efficacy of Single Inhaled Administrations of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'IP631-024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '400 mg TrIP', 'interventionNames': ['Drug: trospium chloride inhalation powder (TrIP)']}, {'type': 'EXPERIMENTAL', 'label': '800 mg TrIP', 'interventionNames': ['Drug: trospium chloride inhalation powder (TrIP)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'trospium chloride inhalation powder (TrIP)', 'type': 'DRUG', 'armGroupLabels': ['400 mg TrIP', '800 mg TrIP']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'United States Investigational Site', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endo Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Alkermes, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldOrganization': 'Endo Pharmaceuticals'}}}}