Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-01-01 @ 1:32 AM
Study NCT ID:
NCT01113593
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
2010-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Characterizing Pharmacodynamic Profiles in Subjects 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068759', 'term': 'Formoterol Fumarate'}], 'ancestors': [{'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'dispFirstSubmitDate': '2013-05-10', 'lastUpdateSubmitDate': '2013-05-17', 'studyFirstSubmitDate': '2010-04-27', 'dispFirstSubmitQcDate': '2013-05-17', 'studyFirstSubmitQcDate': '2010-04-28', 'dispFirstPostDateStruct': {'date': '2013-05-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced expiratory volume at one second (FEV1) measured (in liters) by serial spirometry to compare dosing effect and characterize pharmacodynamic profile of Formoterol Fumarate and Foradil', 'timeFrame': '12 hours on Day 1 and Day 7 of dosing during each treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterize the pharmacodynamic profile of Formoterol Fumarate and Foradil Aerolizer'}, '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 informed consent\n* A Clinical diagnosis of COPD\n* A current or prior history of at least 10-pack years of cigarette smoking\n* women of child-bearing potential (WOCBP) must have a negative pregnancy test at the Screening Visit and agree to avoid becoming pregnant for the duration of study\n\nExclusion Criteria:\n\n* A Clinical Diagnosis of Asthma\n* Other significant disease than COPD\n* Subjects who radiation or chemotherapy within the previous 12 months\n* Subjects who had any lung resection\n* QTcB greater than 0.460 seconds\n* History of illegal drug abuse or alcohol abuse within the past 5 years'}, 'identificationModule': {'nctId': 'NCT01113593', 'briefTitle': 'A Study Characterizing Pharmacodynamic Profiles in Subjects With Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dey'}, 'officialTitle': 'A Randomized, Multiple-Dose, Crossover Study Characterizing the Pharmacodynamic Profiles of Formoterol Fumarate Inhalation Solution and Formoterol Dry Powder Inhaler in Subjects With Stable Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': '191-089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Formoterol Fumarate']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: Formoterol Fumarate']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: Formoterol Fumarate']}, {'type': 'EXPERIMENTAL', 'label': '4', 'interventionNames': ['Drug: Foradil Aerolizer']}, {'type': 'EXPERIMENTAL', 'label': '5', 'interventionNames': ['Drug: Foradil Aerolizer']}], 'interventions': [{'name': 'Formoterol Fumarate', 'type': 'DRUG', 'description': 'Inhalation solution', 'armGroupLabels': ['1']}, {'name': 'Formoterol Fumarate', 'type': 'DRUG', 'description': 'Inhalation solution', 'armGroupLabels': ['2']}, {'name': 'Formoterol Fumarate', 'type': 'DRUG', 'description': 'Inhalation solution', 'armGroupLabels': ['3']}, {'name': 'Foradil Aerolizer', 'type': 'DRUG', 'description': 'Dry powder inhaler', 'armGroupLabels': ['4']}, {'name': 'Foradil Aerolizer', 'type': 'DRUG', 'description': 'Dry powder inhaler', 'armGroupLabels': ['5']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dey', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}