Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT01627158
Status:
COMPLETED
Last Update Posted:
2012-10-15
First Post:
2012-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D000069502', 'term': 'Budesonide, Formoterol Fumarate Drug Combination'}, {'id': 'D002606', 'term': 'Charcoal'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002244', 'term': 'Carbon'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-12', 'studyFirstSubmitDate': '2012-06-21', 'studyFirstSubmitQcDate': '2012-06-22', 'lastUpdatePostDateStruct': {'date': '2012-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic parameter Cmax of plasma budesonide concentration', 'timeFrame': 'within 12 h'}, {'measure': 'Pharmacokinetic parameter AUCt of plasma budesonide concentration', 'timeFrame': '12 h'}, {'measure': 'Pharmacokinetic parameter Cmax of plasma formoterol concentration', 'timeFrame': '24 h'}, {'measure': 'Pharmacokinetic parameter AUCt of plasma formoterol concentration', 'timeFrame': '24 h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent (IC) obtained.\n2. Males and females, 18-60 (inclusive) years of age.\n\nExclusion Criteria:\n\n1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.\n2. Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.\n3. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.\n4. Known hypersensitivity to the active substance(s) or the excipient of the drug.\n5. Pregnant or lactating females.'}, 'identificationModule': {'nctId': 'NCT01627158', 'acronym': 'ADECO', 'briefTitle': 'Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orion Corporation, Orion Pharma'}, 'officialTitle': 'Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte; a Randomised, Double-blind, Double-dummy, Single Centre, Single Dose, Crossover Study in Healthy Subjects', 'orgStudyIdInfo': {'id': '3103011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Budesonide/formoterol Easyhaler', 'description': 'Budesonide/formoterol Easyhaler', 'interventionNames': ['Drug: Budesonide/formoterol Easyhaler']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Symbicort Turbuhaler', 'description': 'Symbicort Turbuhaler', 'interventionNames': ['Drug: Symbicort Turbuhaler']}, {'type': 'EXPERIMENTAL', 'label': 'Charcoal and Budesonide/formoterol Easyhaler', 'interventionNames': ['Drug: Charcoal and Budesonide/formoterol Easyhaler']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Charcoal and Symbicort Turbuhaler', 'interventionNames': ['Drug: Charcoal and Symbicort Turbuhaler']}], 'interventions': [{'name': 'Budesonide/formoterol Easyhaler', 'type': 'DRUG', 'description': 'Budesonide/formoterol Easyhaler', 'armGroupLabels': ['Budesonide/formoterol Easyhaler']}, {'name': 'Symbicort Turbuhaler', 'type': 'DRUG', 'description': 'Symbicort Turbuhaler', 'armGroupLabels': ['Symbicort Turbuhaler']}, {'name': 'Charcoal and Budesonide/formoterol Easyhaler', 'type': 'DRUG', 'description': 'Charcoal and Budesonide/formoterol Easyhaler', 'armGroupLabels': ['Charcoal and Budesonide/formoterol Easyhaler']}, {'name': 'Charcoal and Symbicort Turbuhaler', 'type': 'DRUG', 'description': 'Charcoal and Symbicort Turbuhaler', 'armGroupLabels': ['Charcoal and Symbicort Turbuhaler']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14050', 'city': 'Berlin', 'country': 'Germany', 'facility': 'PAREXEL International GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Irja Korpela, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Orion Corporation, Orion Pharma'}, {'name': 'Rainard Fuhr, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parexel Berlin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orion Corporation, Orion Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}