Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-22 @ 10:14 AM
Study NCT ID:
NCT00274534
Status:
COMPLETED
Last Update Posted:
2013-11-05
First Post:
2006-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of the Effects of Tiotropium Inhalation qd and Salmeterol Inhalation Bid on Arterial Blood Gases.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069447', 'term': 'Tiotropium Bromide'}, {'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}], 'ancestors': [{'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-12'}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2003-07'}, 'lastUpdateSubmitDate': '2013-11-04', 'studyFirstSubmitDate': '2006-01-09', 'studyFirstSubmitQcDate': '2006-01-09', 'lastUpdatePostDateStruct': {'date': '2013-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change from baseline (Visit 2) in the PaO2 area under the curve (AUC) for the time period 0 to 105 minutes obtained through arterial blood gases (ABGs) at the end of each treatment period.', 'timeFrame': 'up to day 90'}], 'secondaryOutcomes': [{'measure': 'Maximum decline in PaO2 from baseline', 'timeFrame': 'up to day 90'}, {'measure': 'Maximum increase in alveolar-arterial oxygen gradient from baseline', 'timeFrame': 'up to day 90'}, {'measure': 'Change from baseline (Visit 2) in FEV1 prior to insertion of catheter and 15 minutes post removal of catheter', 'timeFrame': 'up to day 90'}, {'measure': 'Change from baseline (Visit 2) in FVC prior to insertion of catheter and 15 minutes post removal of catheter', 'timeFrame': 'up to day 90'}, {'measure': 'Rescue medication use', 'timeFrame': 'up to day 90'}, {'measure': 'COPD symptom score', 'timeFrame': 'up to day 90'}, {'measure': 'Occurrence of adverse events', 'timeFrame': 'up to day 90'}, {'measure': 'Pulse rate and sitting blood pressure in conjunction with spirometry', 'timeFrame': 'up to day 90'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'To evaluate changes in PaO2 following inhalation of Tiotropium by HandiHaler compared to Salmeterol MDI in patients with moderate to severe COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False}, 'identificationModule': {'nctId': 'NCT00274534', 'briefTitle': 'A Comparison of the Effects of Tiotropium Inhalation qd and Salmeterol Inhalation Bid on Arterial Blood Gases.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Comparison of the Effects of Tiotropium (18 Mcg) Inhalation Capsule q.d. and Salmeterol (50 Mcg) Inhalation Aerosol b.i.d. on Arterial Blood Gases in a Double-blind, Double-dummy, 4-week Crossover Study in Patients With Chronic Obstructive Pulmonary Disease (COPD).', 'orgStudyIdInfo': {'id': '205.234'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tiotropium', 'type': 'DRUG'}, {'name': 'Salmeterol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hines', 'state': 'Illinois', 'country': 'United States', 'facility': 'Hines Veterans Administration Hospital', 'geoPoint': {'lat': 41.85364, 'lon': -87.8395}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hunter Holmes McGuire Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim Study Coordinator', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}}}}