Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-02-28 @ 11:20 AM
Study NCT ID:
NCT02127866
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2014-04-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triple in Asthma Dose Finding
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': 'D005581', 'term': 'Foster Home Care'}, {'id': 'D006024', 'term': 'Glycopyrrolate'}, {'id': 'D001507', 'term': 'Beclomethasone'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'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': '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'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}]}}, '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': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-06', 'studyFirstSubmitDate': '2014-04-09', 'studyFirstSubmitQcDate': '2014-04-29', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV1 AUC0-12h normalised by time on Day 42', 'timeFrame': 'Day 42'}], 'secondaryOutcomes': [{'measure': 'Peak FEV1 on Day 42', 'timeFrame': 'Day 42'}, {'measure': 'Adverse Events and Adverse Drug Reactions', 'timeFrame': 'Up at Week 24 (study end)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma, anticholinergics'], 'conditions': ['Asthma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-003043-36', 'label': 'Study Record on EU Clinical Trials Register including results'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the optimal dose of CHF 5259 (glycopyrrolate bromide) on top of Foster which provides the optimal additive bronchodilator effect to asthmatic patients whose symptoms are uncontrolled with medium dose of inhaled corticosteroids plus long acting beta2 agonists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients aged \\>=18 years\n* Uncontrolled asthma on medium doses of ICS+LABA with ACQ \\>=1.5\n* Pre-bronchodilator FEV1 ≥40% and \\<80% of their predicted normal value\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Diagnosis of COPD\n* Patients treated for asthma exacerbations in the 4 weeks prior to study entry\n* Patients who are in therapy for gastroesophageal reflux disease\n* Patients who have a clinically significant cardiovascular condition'}, 'identificationModule': {'nctId': 'NCT02127866', 'acronym': 'Triskel', 'briefTitle': 'Triple in Asthma Dose Finding', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi Farmaceutici S.p.A.'}, 'officialTitle': 'A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED, 3-WAY CROSS-OVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A FREE COMBINATION OF 3 DOSES OF CHF 5259 (GLYCOPYRROLATE) PLUS FOSTER® 100/6 µg (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL) IN A METERED DOSE INHALER FOR THE TREATMENT OF PATIENTS WITH UNCONTROLLED ASTHMA UNDER MEDIUM DOSES OF INHALED CORTICOSTEROIDS PLUS LONG-ACTING β2-AGONISTS', 'orgStudyIdInfo': {'id': 'CCD-1206-PR-0088'}, 'secondaryIdInfos': [{'id': '2013-003043-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CHF 5259 25 µg plus Foster 100/6 µg', 'interventionNames': ['Drug: CHF 5259 plus Foster 100/6 µg']}, {'type': 'EXPERIMENTAL', 'label': 'CHF 5259 50 µg plus Foster 100/6 µg', 'interventionNames': ['Drug: CHF 5259 plus Foster 100/6 µg']}, {'type': 'EXPERIMENTAL', 'label': 'CHF 5259 100 µg plus Foster 100/6 µg', 'interventionNames': ['Drug: CHF 5259 plus Foster 100/6 µg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Foster 100/6 µg', 'interventionNames': ['Drug: Foster 100/6 µg']}], 'interventions': [{'name': 'CHF 5259 plus Foster 100/6 µg', 'type': 'DRUG', 'otherNames': ['glycopyrrolate + beclometasone/formoterol'], 'description': 'Comparison of different doses of CHF 5259 (on top of Foster 100 /6 µg) versus Foster 100/6 µg over a treatment period of 6 weeks. Each subject will be allocated to 3 ouf of the 4 possible treatments performed in sequence during a cross over design (incomplete block)', 'armGroupLabels': ['CHF 5259 100 µg plus Foster 100/6 µg', 'CHF 5259 25 µg plus Foster 100/6 µg', 'CHF 5259 50 µg plus Foster 100/6 µg']}, {'name': 'Foster 100/6 µg', 'type': 'DRUG', 'otherNames': ['beclometasone dipropionate/formoterol'], 'description': 'Active comparator\n\nComparison of different doses of CHF 5259 (on top of Foster 100 /6 µg) versus Foster 100/6 µg over a treatment period of 6 weeks. Each subject will be allocated to 3 ouf of the 4 possible treatments performed in sequence during a cross over design (incomplete block)', 'armGroupLabels': ['Foster 100/6 µg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Dupnitsa', 'country': 'Bulgaria', 'facility': 'Chiesi Clinical Trial Site 0105', 'geoPoint': {'lat': 42.26478, 'lon': 23.11723}}, {'zip': '7002', 'city': 'Rousse', 'country': 'Bulgaria', 'facility': 'Chiesi Clinical Trial Site 0101', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'zip': '5400', 'city': 'Sevlievo', 'country': 'Bulgaria', 'facility': 'Chiesi Clinical Trial Site 0106', 'geoPoint': {'lat': 43.02295, 'lon': 25.10364}}, {'zip': '1233', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Chiesi Clinical Trial Site 0107', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1336', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Chiesi Clinical Trial Site 0108', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1407', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Chiesi Clinical Trial Site 0102', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Chiesi Clinical Trial Site 0110', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1432', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Chiesi Clinical Trial Site 0109', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '6003', 'city': 'Stara Zagora', 'country': 'Bulgaria', 'facility': 'Chiesi Clinical Trial Site 0103', 'geoPoint': {'lat': 42.43205, 'lon': 25.64262}}, {'zip': '5600', 'city': 'Troyan Municipality', 'country': 'Bulgaria', 'facility': 'Chiesi Clinical Trial Site 0104', 'geoPoint': {'lat': 42.89427, 'lon': 24.71589}}, {'zip': '10787', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Chiesi Clinical Trial Site 0208', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12165', 'city': 'Berlin', 'country': 'Germany', 'facility': 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'lon': 7.35258}}, {'zip': '2660', 'city': 'Balassagyarmat', 'country': 'Hungary', 'facility': 'Chiesi Clinical Trial Site 0307', 'geoPoint': {'lat': 48.07296, 'lon': 19.29614}}, {'zip': '1122', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Chiesi Clinical Trial Site 0302', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '6772', 'city': 'Deszk', 'country': 'Hungary', 'facility': 'Chiesi Clinical Trial Site 0304', 'geoPoint': {'lat': 46.21802, 'lon': 20.24322}}, {'zip': '2100', 'city': 'Gödöllő', 'country': 'Hungary', 'facility': 'Chiesi Clinical Trial Site 0305', 'geoPoint': {'lat': 47.59657, 'lon': 19.35515}}, {'zip': '2900', 'city': 'Komárom', 'country': 'Hungary', 'facility': 'Chiesi Clinical Trial Site 0303', 'geoPoint': {'lat': 47.74318, 'lon': 18.11913}}, {'zip': '8600', 'city': 'Siófok', 'country': 'Hungary', 'facility': 'Chiesi Clinical Trial Site 0301', 'geoPoint': {'lat': 46.90413, 'lon': 18.058}}, {'zip': '5540', 'city': 'Szarvas', 'country': 'Hungary', 'facility': 'Chiesi Clinical Trial Site 0306', 'geoPoint': {'lat': 46.86667, 'lon': 20.55}}, {'zip': '25123', 'city': 'Brescia', 'country': 'Italy', 'facility': 'Chiesi Clinical Trial Site 0403', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '43125', 'city': 'Parma', 'country': 'Italy', 'facility': 'Chiesi Clinical Trial Site 0402', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '56124', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Chiesi Clinical Trial Site 0401', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '34149', 'city': 'Trieste', 'country': 'Italy', 'facility': 'Chiesi Clinical Trial Site 0408', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'zip': '37134', 'city': 'Verona', 'country': 'Italy', 'facility': 'Chiesi Clinical Trial Site 0404', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '15-430', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Chiesi Clinical Trial Site 0510', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '80-847', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Chiesi Clinical Trial Site 0507', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '11-500', 'city': 'Giżycko', 'country': 'Poland', 'facility': 'Chiesi Clinical Trial Site 0502', 'geoPoint': {'lat': 54.03811, 'lon': 21.76441}}, {'zip': '31-637', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Chiesi Clinical Trial Site 0511', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '90-141', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Chiesi Clinical Trial Site 0505', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '90-153', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Chiesi Clinical Trial Site 0509', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '20-718', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Chiesi Clinical Trial Site 0512', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '14-100', 'city': 'Ostróda', 'country': 'Poland', 'facility': 'Chiesi Clinical Trial Site 0503', 'geoPoint': {'lat': 53.69671, 'lon': 19.96486}}, {'zip': '32-600', 'city': 'Oświęcim', 'country': 'Poland', 'facility': 'Chiesi Clinical Trial Site 0501', 'geoPoint': {'lat': 50.03437, 'lon': 19.21037}}, {'zip': '32-100', 'city': 'Proszowice', 'country': 'Poland', 'facility': 'Chiesi Clinical Trial Site 0506', 'geoPoint': {'lat': 50.19275, 'lon': 20.28909}}, {'zip': '35-241', 'city': 'Rzeszów', 'country': 'Poland', 'facility': 'Chiesi Clinical Trial Site 0508', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'zip': '51-162', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Chiesi Clinical Trial Site 0504', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': 'W1G 8HU', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Chiesi Clinical Trial Site 0602', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M23 9QZ', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Chiesi Clinical Trial Site 0601', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Dave Singh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of South Manchester, MANCHESTER M23 9 QZ, UK'}]}, 'ipdSharingStatementModule': {'url': 'https://www.chiesi.com/en/chiesi-clinical-trial-data-request-portal/', 'ipdSharing': 'YES', 'description': 'Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information.\n\nChiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.', 'accessCriteria': 'Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi Farmaceutici S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}