Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:10 AM
Study NCT ID:
NCT01644734
Status:
COMPLETED
Last Update Posted:
2014-05-26
First Post:
2012-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Assessment of Health-status of Patients With Chronic Obstructive Pulmonary Disease (COPD) on Maintenance Therapy With Spiriva HH Measured by COPD Assessment Test (CAT) Test
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Average of 92.4 days', 'eventGroups': [{'id': 'EG000', 'title': 'Patients Treated With Spiriva HandiHaler', 'description': 'Inhalator is administered once daily in the dosage of 18µg.', 'otherNumAtRisk': 1282, 'otherNumAffected': 0, 'seriousNumAtRisk': 1282, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Maintaining or Improving Their Health Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1016', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With Spiriva HandiHaler', 'description': 'Inhalator is administered once daily in the dosage of 18µg.'}], 'classes': [{'categories': [{'measurements': [{'value': '972', 'groupId': 'OG000', 'lowerLimit': '94.2', 'upperLimit': '96.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 3 months', 'description': 'The health status was measured by the total COPD Assessment Test (CAT) score at baseline and at the end of the observation period after app. 3 months (visit 3). Therefore, the total CAT score at baseline and at Visit 3 was calculated by adding up the scores of the single questions of the CAT questionnaire. In the case of one or more missing items the total score was not determined for the specific visit. The health status is considered to be maintained or improved if the change in the total CAT score from baseline at Visit 3 is ≥0.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from the Full Analysis Set (FAS) which includes all patients in the treated set and who have valid CAT questionnaire results both at baseline and at visit 3.'}, {'type': 'SECONDARY', 'title': 'Change in the Total CAT Score (Value Baseline Minus 3 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1016', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With Spiriva HandiHaler', 'description': 'Inhalator is administered once daily in the dosage of 18µg.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'spread': '5.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Null hypothesis: no change in the total CAT score between baseline and after 3 months.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months', 'description': 'The change represents the value at baseline minus the value after 3 months. The total CAT score ranges from 0 to 40 where 0 represents no symptoms and 40 very bad symptoms. Therefore, a positive value for the change in the total CAT score means an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients Treated With Spiriva HandiHaler', 'description': 'Inhalator is administered once daily in the dosage of 18µg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Patients with documentation of treatment.', 'groupId': 'FG000', 'numSubjects': '1282'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1016'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '266'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Reasons other than stated above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Missing documentation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '238'}]}]}], 'preAssignmentDetails': '46 patients were not documented to be treated with the study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1282', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients Treated With Spiriva HandiHaler', 'description': 'Inhalator is administered once daily in the dosage of 18µg.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.2', 'spread': '10.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '494', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '788', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Patients from the Treated Set (TS) which are dispensed study medication and were documented to have taken at least one dose of investigational treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1328}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-30', 'studyFirstSubmitDate': '2012-07-17', 'resultsFirstSubmitDate': '2014-03-28', 'studyFirstSubmitQcDate': '2012-07-18', 'lastUpdatePostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-30', 'studyFirstPostDateStruct': {'date': '2012-07-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Maintaining or Improving Their Health Status', 'timeFrame': 'Baseline, 3 months', 'description': 'The health status was measured by the total COPD Assessment Test (CAT) score at baseline and at the end of the observation period after app. 3 months (visit 3). Therefore, the total CAT score at baseline and at Visit 3 was calculated by adding up the scores of the single questions of the CAT questionnaire. In the case of one or more missing items the total score was not determined for the specific visit. The health status is considered to be maintained or improved if the change in the total CAT score from baseline at Visit 3 is ≥0.'}], 'secondaryOutcomes': [{'measure': 'Change in the Total CAT Score (Value Baseline Minus 3 Months)', 'timeFrame': 'Baseline, 3 months', 'description': 'The change represents the value at baseline minus the value after 3 months. The total CAT score ranges from 0 to 40 where 0 represents no symptoms and 40 very bad symptoms. Therefore, a positive value for the change in the total CAT score means an improvement.'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'To evaluate the early (3-month) impact of the long-acting anticholinergic Spiriva HH maintenance treatment on the COPD symptoms using the novel COPD Assessment test (CAT) in the real life setting of COPD patients, previously treated with short-acting bronchodilator on regular or as-needed basis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Male and female ambulatory outpatients being seen in a participating physicians office for routine care,\n* Patients with a clinical diagnosis of COPD (all stages according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2010) being treated with long-acting anticholinergic (Tiotropium, Spiriva® HandiHaler® ) as maintenance therapy within the product label and a maximum of the last 4 weeks (0.-28. days before Visit 1),\n* Patients previously treated with short-acting bronchodilators on regular or as-needed basis for at least 3 months before change to long-acting anticholinergic treatment,\n* Patient fluent in language of questionnaire and having the cognitive and functional abilities required to fill in the questionnaire alone.\n\nExclusion criteria:\n\n* Uncooperative patients as judged by the physician,\n* Patients with any conditions excluded as per Country specific package insert,\n* Patients currently enrolled in any clinical trial,\n* Patients with COPD exacerbation or any acute disease in the last 3 months before Visit 1.'}, 'identificationModule': {'nctId': 'NCT01644734', 'briefTitle': 'Assessment of Health-status of Patients With Chronic Obstructive Pulmonary Disease (COPD) on Maintenance Therapy With Spiriva HH Measured by COPD Assessment Test (CAT) Test', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'MATHS: Assessment of Health-status of Patients With COPD on MAintenance THerapy With Spiriva® HH Measured by CAT Test', 'orgStudyIdInfo': {'id': '205.502'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Spiriva HandiHaler', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Andrychów', 'country': 'Poland', 'facility': 'Boehringer Ingelheim Investigational Site 236', 'geoPoint': {'lat': 49.85497, 'lon': 19.33834}}, {'city': 'Bialystok', 'country': 'Poland', 'facility': 'Boehringer Ingelheim Investigational Site 170', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Bialystok', 'country': 'Poland', 'facility': 'Boehringer Ingelheim Investigational Site 184', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Bialystok', 'country': 'Poland', 'facility': 'Boehringer Ingelheim Investigational Site 240', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, 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