Ignite Creation Date:
2025-12-17 @ 1:42 PM
Ignite Modification Date:
2025-12-23 @ 4:53 PM
Study NCT ID:
NCT00774761
Status:
COMPLETED
Last Update Posted:
2013-05-20
First Post:
2008-10-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Evaluating Systemic Exposure and Pharmacodynamics in Patients With Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}, {'id': 'D004194', 'term': 'Disease'}], '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'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068298', 'term': 'Fluticasone'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'dispFirstSubmitDate': '2013-05-10', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-10', 'studyFirstSubmitDate': '2008-10-16', 'dispFirstSubmitQcDate': '2013-05-10', 'studyFirstSubmitQcDate': '2008-10-16', 'dispFirstPostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma AUC(0-t) after 1 week of dosing', 'timeFrame': 'PK sampling over 24 hrs'}], 'secondaryOutcomes': [{'measure': 'FEV1', 'timeFrame': 'pre-dose and 2 hrs post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic', 'Obstructive', 'Pulmonary', 'Disease', 'COPD', 'Pharmacodynamic', 'Pharmacokinetic'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the systemic exposure and pharmacodynamics of two doses of nebulized fluticasone/formoterol combination as compared to the monocomponents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to understand the requirements of the study and provide consent\n* Medical diagnosis of COPD\n* A current or prior history of at least 10-pack years of cigarette smoking\n* Female of child-bearing potential to use adequate birth control\n\nExclusion Criteria:\n\n* Diagnosis of asthma\n* Other significant disease than COPD\n* Has donated a unit of blood within 30 days of study, or intends to donate\n* QTc greater than 0.460 seconds\n* Subjects who had radiation or chemotherapy in the previous 12 months\n* Subjects who had lung resection\n* History of illegal drug abuse or alcohol abuse within the past 5 years'}, 'identificationModule': {'nctId': 'NCT00774761', 'briefTitle': 'A Study Evaluating Systemic Exposure and Pharmacodynamics in Patients With Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dey'}, 'officialTitle': 'A Randomized, Multiple-Dose,Double-Blind,Crossover Trial to Assess the Systemic Exposure of Fluticasone Propionate (FP)/Formoterol Fumarate (FF) Fixed-Dose Combination in Subjects With Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': '191-087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: fluticasone propionate/formoterol fumarate']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: fluticasone propionate/formoterol fumarate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: fluticasone propionate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'interventionNames': ['Drug: fluticasone propionate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5', 'interventionNames': ['Drug: formoterol fumarate']}], 'interventions': [{'name': 'fluticasone propionate/formoterol fumarate', 'type': 'DRUG', 'description': 'inhalation suspension', 'armGroupLabels': ['1', '2']}, {'name': 'fluticasone propionate', 'type': 'DRUG', 'description': 'inhalation suspension', 'armGroupLabels': ['3', '4']}, {'name': 'formoterol fumarate', 'type': 'DRUG', 'description': 'inhalation solution', 'armGroupLabels': ['5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32405', 'city': 'Panama City', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 30.15946, 'lon': -85.65983}}, {'zip': '42431', 'city': 'Madisonville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 37.3281, 'lon': -87.49889}}, {'zip': '70584', 'city': 'Sunset', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 30.41131, 'lon': -92.06845}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '29379', 'city': 'Union', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 34.71541, 'lon': -81.62371}}, {'zip': '78205', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '99207', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dey', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}