Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-29 @ 4:44 AM
Study NCT ID:
NCT01176903
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
2010-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration
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': 'D006024', 'term': 'Glycopyrrolate'}, {'id': 'D000069447', 'term': 'Tiotropium Bromide'}], 'ancestors': [{'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '2010-08-05', 'studyFirstSubmitQcDate': '2010-08-05', 'lastUpdatePostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'Up to 24 hours after single administration', 'description': 'Adverse events, vital signs, ECG parameters, 24-hours ECG holter recording, clinical laboratory abnormalities.\n\nThis primary outcome is for the Part 1 of the study.'}, {'measure': 'Lung function (trough FEV1)', 'timeFrame': '12 hours post dose after repeated administration', 'description': 'This primary variable is for the Part 2 of the study.'}], 'secondaryOutcomes': [{'measure': 'Lung function', 'timeFrame': 'up to 24 hours post dose', 'description': 'for Part 1 of the study'}, {'measure': 'Lung function (other parameters)', 'timeFrame': 'up to 12 hours after repated administration', 'description': 'for Part 2 of the study'}, {'measure': 'Body plethysmography', 'timeFrame': 'up tp 12 hours after repeated administration', 'description': 'for Part 2 of the study'}, {'measure': 'Pharmacokinetics', 'timeFrame': 'up to 12 hours after single and repeated administration', 'description': 'Pharmacokinetics in plasma and urine. For Part 2 of the study.'}, {'measure': 'Safety', 'timeFrame': 'up to 12 hours after single and repeated administration', 'description': 'Adverse events, Vital signs, ECG parameters, 24-hour ECG holter recording. For Part 2 of the study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '28744115', 'type': 'RESULT', 'citation': 'Singh D, Scuri M, Collarini S, Vezzoli S, Mariotti F, Muraro A, Acerbi D. Bronchodilator efficacy of extrafine glycopyrronium bromide: the Glyco 2 study. Int J Chron Obstruct Pulmon Dis. 2017 Jul 7;12:2001-2014. doi: 10.2147/COPD.S137659. eCollection 2017.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/search?query=2010-018668-18', 'label': 'Study Record on EU Clinical Trials Register including results'}, {'url': 'https://www.chiesi.com/clinic/CSR_Synopsis_CCD-0916-PR-0032.pdf', 'label': 'CSR Synopsis available in the CHIESI Clinical Study Register'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and the efficacy of Glycopyrrolate as pMDI after single and repeated administration.', 'detailedDescription': 'The study is divided into two parts:\n\n\\- Part 1 will be conducted according to a single-centre, randomized, double-blind, placebo-controlled, single-dose escalation, alternating crossover design in two groups of COPD patients.\n\nTreatments to be administered on Part 1 (SD1, SD2, SD3, SD4, SD5, SP). The primary objective of Part 1 is the evaluation of the safety and tolerability of Glyco after single administration.\n\n\\- Part 2 will be conducted according to a single-centre, randomized, double-blind, placebo-controlled, 4-period, 4-treatment, repeated dose cross-over design followed by an open-label extension period with tiotropium.\n\nTreatments administered on Part 2 (MD1, MD2, MD3, MP, Tiotropium). On the last treatment day in the morning, Formoterol 12 µg will be administered to all patients on top of placebo or Glyco or Tiotropium.\n\nThe primary objective of Part 2 is the evaluation of the efficacy of Glyco after repeated administration.\n\nPart 2 will start after a safety review of the results obtained from Part 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females patients aged 40-75 years;\n* Written informed consent obtained;\n* Diagnosis of moderate-severe COPD, according to the GOLD guidelines;\n* Current or ex-smokers with a smoking history of ≥ 10 pack-years\n* Post bronchodilator FEV1 between 40% and 80% predicted values (40% ≤ FEV1 \\< 80%), documented at screening visit ;\n* Post bronchodilator FEV1/Forced Vital Capacity (FEV1/FVC) ≤ 0.70 (absolute value) documented at screening visit;\n* Airway reversibility of at least 100 mL within 30 to 45 minutes after inhalation of ipratropium 80µg.\n\nExclusion Criteria:\n\n* History of chronic or seasonal allergy\n* Blood eosinophil count above 600 per µl\n* Clinically relevant findings on physical examination laboratory and ECG parameters at screening\n* Occurrence of clinically relevant abnormalities in the 24-h Holter ECG recording at screening;\n* Significant disease not related to COPD (eg. Myocardial infarction, stroke within the preceding 6 months);\n* Respiratory tract infection (including upper tract) 4 weeks prior to study entry requiring changing treatment;\n* Patients requiring oxygen therapy on a daily basis for chronic hypoxemia;\n* History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which is considered to be clinically significant by the investigator.\n* Intolerance/hypersensitivity or any contra-indication to treatment with M3 Antagonist or any of the excipients contained in the formulations used in the study.\n* History of alcohol or substance abuse that in the opinion of the Investigator may be of clinical significance.\n* Patients treated with slow-release oral or parental corticosteroids 8 weeks prior to Screening Visit.\n* Patients treated with tiotropium in the 10 days prior to the Screening Visit;\n* Pregnant or lactating women and female or male subjects not willing to use an acceptable method of contraception.'}, 'identificationModule': {'nctId': 'NCT01176903', 'acronym': 'GLY2', 'briefTitle': 'Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi Farmaceutici S.p.A.'}, 'officialTitle': 'Randomized, Double-blind, Placebo-controlled, Cross-over Study to Investigate the Bronchodilator Efficacy and Safety After Single and Repeated Administrations of Different Doses of Glycopyrrolate Via pMDI in Moderate to Severe COPD Patients.', 'orgStudyIdInfo': {'id': 'CCD-0916-PR-0032'}, 'secondaryIdInfos': [{'id': '2010-018668-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glyco SD1', 'description': 'Single administration of Glyco pMDI dose level 1', 'interventionNames': ['Drug: Glycopyrrolate']}, {'type': 'EXPERIMENTAL', 'label': 'Glyco SD2', 'description': 'Single administration of Glyco pMDI dose level 2', 'interventionNames': ['Drug: Glycopyrrolate']}, {'type': 'EXPERIMENTAL', 'label': 'Glyco SD3', 'description': 'Single administration of Glyco pMDI dose level 3', 'interventionNames': ['Drug: Glycopyrrolate']}, {'type': 'EXPERIMENTAL', 'label': 'Glyco SD4', 'description': 'Single administration of Glyco pMDI dose level 4', 'interventionNames': ['Drug: Glycopyrrolate']}, {'type': 'EXPERIMENTAL', 'label': 'Glyco SD5', 'description': 'Single administration of Glyco pMDI dose level 5', 'interventionNames': ['Drug: Glycopyrrolate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo SP', 'description': 'Single administration of Placebo pMDI', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Glyco MD1', 'description': 'Multiple administration of Glyco pMDI dose level 1', 'interventionNames': ['Drug: Glycopyrrolate']}, {'type': 'EXPERIMENTAL', 'label': 'Glyco MD2', 'description': 'Multiple administration of Glyco pMDI dose level 2', 'interventionNames': ['Drug: Glycopyrrolate']}, {'type': 'EXPERIMENTAL', 'label': 'Glyco MD3', 'description': 'Multiple administration of Glyco pMDI dose level 3', 'interventionNames': ['Drug: Glycopyrrolate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo MP', 'description': 'Multiple administration of placebo pMDI', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tiotropium', 'description': 'Multiple administration of tiotropium', 'interventionNames': ['Drug: Tiotropium']}], 'interventions': [{'name': 'Glycopyrrolate', 'type': 'DRUG', 'otherNames': ['CHF 5259'], 'description': 'pressurized metered dose inhaler', 'armGroupLabels': ['Glyco MD1', 'Glyco MD2', 'Glyco MD3', 'Glyco SD1', 'Glyco SD2', 'Glyco SD3', 'Glyco SD4', 'Glyco SD5']}, {'name': 'Tiotropium', 'type': 'DRUG', 'otherNames': ['Spiriva'], 'description': 'inhalation powder, hard capsule', 'armGroupLabels': ['Tiotropium']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'pressurized metered dose inhaler', 'armGroupLabels': ['Placebo MP', 'Placebo SP']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M23 9QZ', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Medicines Evaluation Unit', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Dave Singh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medicines Evaluation Unit Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi Farmaceutici S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}