Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT00929851
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
2009-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BDP/FF Versus Formoterol Fumarate (FF) in Patients With Severe COPD (Lung Function and Exacerbation Rate)
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': 'D005581', 'term': 'Foster Home Care'}, {'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': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1199}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '2009-06-29', 'studyFirstSubmitQcDate': '2009-06-29', 'lastUpdatePostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exacerbation rate Change in pre-dose FEV1', 'timeFrame': '0-4-12-24-36-48 weeks'}], 'secondaryOutcomes': [{'measure': "Pulmonary function parameters(FEV1 - FVC) St George's Questionnaire Use of rescue medication", 'timeFrame': '0-4-12-24-36-48 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '29138555', 'type': 'BACKGROUND', 'citation': 'Singh D, Vezzoli S, Petruzzelli S, Papi A. The efficacy of extrafine beclomethasone dipropionate-formoterol fumarate in COPD patients who are not "frequent exacerbators": a post hoc analysis of the FORWARD study. Int J Chron Obstruct Pulmon Dis. 2017 Nov 3;12:3263-3271. doi: 10.2147/COPD.S141416. eCollection 2017.'}, {'pmid': '30464449', 'type': 'BACKGROUND', 'citation': 'Siddiqui SH, Pavord ID, Barnes NC, Guasconi A, Lettis S, Pascoe S, Petruzzelli S. Blood eosinophils: a biomarker of COPD exacerbation reduction with inhaled corticosteroids. Int J Chron Obstruct Pulmon Dis. 2018 Nov 6;13:3669-3676. doi: 10.2147/COPD.S179425. eCollection 2018.'}, {'pmid': '24953015', 'type': 'RESULT', 'citation': 'Wedzicha JA, Singh D, Vestbo J, Paggiaro PL, Jones PW, Bonnet-Gonod F, Cohuet G, Corradi M, Vezzoli S, Petruzzelli S, Agusti A; FORWARD Investigators. Extrafine beclomethasone/formoterol in severe COPD patients with history of exacerbations. Respir Med. 2014 Aug;108(8):1153-62. doi: 10.1016/j.rmed.2014.05.013. Epub 2014 Jun 6.'}, {'pmid': '22653766', 'type': 'RESULT', 'citation': 'Singh D, Kampschulte J, Wedzicha JA, Jones PW, Cohuet G, Corradi M, Higenbottam T, Petruzzelli S, Vestbo J. A trial of beclomethasone/formoterol in COPD using EXACT-PRO to measure exacerbations. Eur Respir J. 2013 Jan;41(1):12-7. doi: 10.1183/09031936.00207611. Epub 2012 May 31.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/search?query=2009-012546-23', 'label': 'Study Record on EU Clinical Trials Register including results'}, {'url': 'https://www.chiesi.com/clinic/30_CSR_Synopsis_CCD-0906-PR-0016.pdf', 'label': 'CSR Synopsis available in the CHIESI Clinical Study Register'}]}, 'descriptionModule': {'briefSummary': 'a 48-week, 2-arm parallel group, "fixed combination" beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease', 'detailedDescription': 'a 48-week, double blind, randomized, multinational, multicentre, 2-arm parallel group, reference treatment controlled clinical trial of "fixed combination" beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe COPD\n* At least one COPd exacerbation in previous year\n\nExclusion Criteria:\n\n* Asthma, allergic rhinitis or other atopic disease\n* Unstable concurrent disease:\n* Evidence of heart failure'}, 'identificationModule': {'nctId': 'NCT00929851', 'briefTitle': 'BDP/FF Versus Formoterol Fumarate (FF) in Patients With Severe COPD (Lung Function and Exacerbation Rate)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi Farmaceutici S.p.A.'}, 'officialTitle': 'a 48-week, Double Blind, Randomized, Multinational, Multicentre, "Fixed Combination" Beclomethasone Dipropionate Plus Formoterol Fumarate Versus Formoterol in Patients With Severe Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'CCD-0906-PR-0016'}, 'secondaryIdInfos': [{'id': '2009-012546-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BDP/FF', 'description': 'Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose inhaler', 'interventionNames': ['Drug: CHF1535']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Formoterol fumarate', 'description': 'Formoterol fumarate 12 µg per metered dose', 'interventionNames': ['Drug: Formoterol fumarate']}], 'interventions': [{'name': 'CHF1535', 'type': 'DRUG', 'otherNames': ['Foster, Fostair'], 'description': 'Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose', 'armGroupLabels': ['BDP/FF']}, {'name': 'Formoterol fumarate', 'type': 'DRUG', 'otherNames': ['Atimos'], 'description': 'Formoterol fumarate 12 µg per metered dose', 'armGroupLabels': ['Formoterol fumarate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'UCL Medical School', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Jadwiga A Wedzicha, MD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCL MEDICAL SCHOOL'}]}, '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'}}}}