Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-01 @ 5:37 PM
Study NCT ID:
NCT02119234
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
2014-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of CHF 5993 pMDI With and Without Spacer in COPD Patients
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': 'D001507', 'term': 'Beclomethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013258', 'term': 'Steroids, Chlorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '2014-04-11', 'studyFirstSubmitQcDate': '2014-04-18', 'lastUpdatePostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve of B17MP, formoterol and glycopyrrolate', 'timeFrame': 'Over 24 and 48h after single administration', 'description': 'AUCt (up to the last quantifiable concentration) and Cmax (maximum concentration) from plasma concentrations vs time profiles.\n\nover 24h for formoterol and B17MP, over 48h for glycopyrrolate'}], 'secondaryOutcomes': [{'measure': 'Other pharmacokinetic parameters for formoterol, glycopyrrolate and B17MP in plasma', 'timeFrame': 'over 24 or 48h after single administration', 'description': 'B17MP AUC0-30min, AUC0-24h, AUCinf, tmax, half-life Formoterol AUC0-30min, AUC0-24h, AUCinf, tmax, half-life Glycopyrrolate AUC0-30min, AUC0-48h, AUCinf, tmax, half-life'}, {'measure': 'Adverse events', 'timeFrame': 'over a period of 6 to 11 weeks', 'description': 'from the signature of the informed consent until the follow-up phone call'}, {'measure': 'Lung function', 'timeFrame': '30 min after single administration', 'description': 'FEV1'}, {'measure': 'plasma cortisol', 'timeFrame': 'over 24 h after single administration', 'description': 'cortisol AUC0-24h, Cmin and tmin'}, {'measure': 'cortisol urinary excretion', 'timeFrame': 'over 24 h after single administration', 'description': 'cortisol excretion corrected and not corrected for creatinine'}, {'measure': 'potassium plasma profile', 'timeFrame': 'over 24 h after single administration', 'description': 'potassium AUC0-24h, tmin and Cmin'}, {'measure': 'Vital signs', 'timeFrame': 'over 24 h after single administration', 'description': 'systolic and diastolic blood pressure'}, {'measure': 'ECG parameters', 'timeFrame': 'over 24 h after single administration', 'description': 'extracted from holter recording HR, QTcF, PR and QRS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['COPD']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.chiesi.com/clinic/CSR_Synopsis_CCD-05993AA1-04.pdf', 'label': 'CSR Synopsis available in the Chiesi Clinical Study Register'}]}, 'descriptionModule': {'briefSummary': 'The study is performed to investigate the effect of the spacing device on the pharmacokinetics of CHF 5993 pMDI active ingredients administered with and without Aerochamber Plus Flow-vu antistatic VHC spacer as a single administration in COPD patients. Moreover, the general safety and tolerability of the treatments will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD patients\n* smokers or ex-smokers\n* post-bronchodilator FEV1 between 30 and 60% of predicted value\n\nExclusion Criteria:\n\n* Positive serology to HIV and hepatitis\n* Known respiratory disorder other than COPD\n* Recent COPD exacerbations or hospitalization for COPD\n* Treatment with non-permitted concomitant medication\n* clinically relevant concomitant disease\n* clinically relevant abnormal laboratory or ECG parameters'}, 'identificationModule': {'nctId': 'NCT02119234', 'acronym': 'TRIPLE 4', 'briefTitle': 'Pharmacokinetics of CHF 5993 pMDI With and Without Spacer in COPD Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi Farmaceutici S.p.A.'}, 'officialTitle': 'Open-label, Randomized, 3-way Cross-over, Placebo Controlled, Single Dose Clinical Pharmacology Study in COPD Patients After Inhalation of CHF 5993 pMDI Using the Standard Actuator With or Without AeroChamber Plus Flow-Vu VHC Spacer', 'orgStudyIdInfo': {'id': 'CCD-05993AA1-04'}, 'secondaryIdInfos': [{'id': '2013-003770-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CHF5993 pMDI + Spacer', 'description': 'CHF 5993 pMDI (Beclometasone/formoterol/glycopyrrolate 100/6/25 mcg per actuation) x 4 inhalations administered using Aerochamber Plus Flow-vu VHC spacer', 'interventionNames': ['Drug: Beclometasone/formoterol/glycopyrrolate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CHF5993 pMDI', 'description': 'CHF 5993 pMDI (Beclometasone/formoterol/glycopyrrolate 100/6/25 mcg per actuation) x 4 inhalations administered using standard actuator only', 'interventionNames': ['Drug: Beclometasone/formoterol/glycopyrrolate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo pMDI', 'description': 'Placebo pMDI x 4 inhalations', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Beclometasone/formoterol/glycopyrrolate', 'type': 'DRUG', 'otherNames': ['CHF5993 pMDI'], 'armGroupLabels': ['CHF5993 pMDI', 'CHF5993 pMDI + Spacer']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo pMDI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90-153', 'city': 'Lodz', 'state': 'Ul. Kopcińskiego 22', 'country': 'Poland', 'facility': 'Medical University in Lodz', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}], 'overallOfficials': [{'name': 'Piotr Kuna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University Lodz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi Farmaceutici S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}