Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-01-29 @ 3:34 PM
Study NCT ID:
NCT01786720
Status:
UNKNOWN
Last Update Posted:
2014-05-01
First Post:
2013-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of the Time Taken to Triple Therapy (NOVARTIS)
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20154}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-04-30', 'studyFirstSubmitDate': '2013-02-06', 'studyFirstSubmitQcDate': '2013-02-06', 'lastUpdatePostDateStruct': {'date': '2014-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Triple Therapy Status', 'timeFrame': '1 year', 'description': 'The proportion of patients prescribed triple therapy and whether they were prescribed it prior to, at, or after initial date of COPD diagnosis.'}, {'measure': 'Initial date of COPD diagnosis', 'timeFrame': '1 year', 'description': 'The date that patients were initially diagnosed with COPD. Categorised into cohorts- 1997-2001, 2002-2006, 2007-2010.'}], 'secondaryOutcomes': [{'measure': 'Lung function grade', 'timeFrame': '1 year', 'description': 'Patient lung function grade, calculated by GOLD I, II, III, IV criteria.'}, {'measure': 'Asthma Diagnosis', 'timeFrame': '1 year', 'description': 'Proportion of patients with a co-morbid asthma diagnosis'}, {'measure': 'COPD patient group', 'timeFrame': '1 year', 'description': 'Patients COPD patient group, calculated by GOLD A, B, C, D criteria dependent on symptoms and risk of patient.'}, {'measure': 'COPD exacerbations (Clinical experience based)', 'timeFrame': '1 year', 'description': 'Number of the following: (i) Asthma/copd-related\\*: a. Hospital attendance / admissions OR b. A\\&E attendance OR (ii) GP consultations for lower respiratory related tract infections'}, {'measure': 'Smoking Status', 'timeFrame': '1 year', 'description': 'Patient smoking status, taken from routine and questionnaire data'}, {'measure': 'BMI', 'timeFrame': '1 year', 'description': 'Patient BMI class'}, {'measure': 'COPD co-morbidities', 'timeFrame': '1 year', 'description': 'COPD co-morbidities are identified via Read codes that are recorded at any time.\n\nCo-morbidities are: GERD, Rhinitis, Heart Failure, Ischaemic Heart Disease, Diabetes, Osteoporosis, Chronic Renal Failure, Chronic Kidney Disease and Anxiety-Depression'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Triple Therapy', 'ICS', 'LABA', 'LAMA'], 'conditions': ['COPD']}, 'referencesModule': {'references': [{'pmid': '23135217', 'type': 'BACKGROUND', 'citation': 'Price D, Yawn B, Brusselle G, Rossi A. Risk-to-benefit ratio of inhaled corticosteroids in patients with COPD. Prim Care Respir J. 2013 Mar;22(1):92-100. doi: 10.4104/pcrj.2012.00092.'}, {'pmid': '19688142', 'type': 'BACKGROUND', 'citation': 'Price D, Crockett A, Arne M, Garbe B, Jones RC, Kaplan A, Langhammer A, Williams S, Yawn BP. Spirometry in primary care case-identification, diagnosis and management of COPD. Prim Care Respir J. 2009 Sep;18(3):216-23. doi: 10.4104/pcrj.2009.00055.'}]}, 'descriptionModule': {'briefSummary': 'The proposed study will evaluate (for newly diagnosed Chronic Obstructive Pulmonary Disease (COPD) patients)the time taken to prescription of triple therapy by aiming to answer these following research questions:\n\n1. The percentage of patients prescribed triple therapy, and when they first started receiving triple therapy.\n2. For patients prescribed triple therapy, the time taken to triple therapy from initial diagnosis of COPD.\n3. The variation in treatment pathways.\n4. The factors associated with time taken to triple therapy.', 'detailedDescription': 'Triple therapy consists of long-acting beta agonist (LABA) + inhaled corticosteroids (ICS) + long-acting muscarinic antagonist (LAMA) and typically should be reserved for patients who have severe to very severe (FEV1 \\<50%) COPD symptoms or for patients who have two or more exacerbations per year. However previous research from RiRL indicate that 50% of patients at GOLD stage II (moderate) receive ICS of which half were on triple therapy.\n\nTo allow for multiple analysis regarding the factors that influence the likelihood of being prescribed triple therapy, a bespoke COPD dataset will be created to include:\n\n1. Disease severity markers:\n2. Confirmation of a COPD diagnosis at initial date of COPD diagnosis\n3. Standard co-morbidities fields\n4. Demographic fields\n\nThis retrospective, observational study using data of COPD patients will assess treatment pathways (changes/step up) from initial date of COPD diagnosis with the prescription of triple therapy as the endpoint.\n\nSpecific questions that will be asked are:\n\n1. Does the percentage of COPD patients prescribed triple therapy vary dependent on time of initial date of COPD diagnosis?\n2. Does the time taken to the prescription of triple therapy vary dependent on initial date of COPD diagnosis?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will have a QoF approved COPD read code and must be aged ≥ 40.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥40 years at initial date of COPD diagnosis\n* COPD diagnosis with Quality Outcome Framework (QoF) approved read code\n* has spirometry data supportive of a COPD diagnosis in the 5 years around initial date diagnosis of COPD (FEV1 % predicted)\n* Patient has one year of data prior to initial date of COPD diagnosis\n* Patient has a minimum of two years of data post initial date of COPD diagnosi\n\nExclusion Criteria:\n\n* Patients whose initial date of COPD diagnosis is before 1997'}, 'identificationModule': {'nctId': 'NCT01786720', 'briefTitle': 'Analysis of the Time Taken to Triple Therapy (NOVARTIS)', 'organization': {'class': 'NETWORK', 'fullName': 'Research in Real-Life Ltd'}, 'officialTitle': 'Analysis of the Time Taken for Newly Diagnosed COPD Patients to be Prescribed Triple Therapy', 'orgStudyIdInfo': {'id': 'R04512'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prior Triple Therapy', 'description': 'Patients prescribed triple therapy prior to initial date of COPD diagnosis'}, {'label': 'Triple therapy at COPD diagnosis', 'description': 'Patients prescribed triple therapy on date of initial COPD diagnosis'}, {'label': 'Triple therapy after COPD diagnosis', 'description': 'Patients prescribed triple therapy after initial date of COPD diagnosis'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB24 3BA', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Research in Real Life Ltf', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'overallOfficials': [{'name': 'David Price, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aberdeen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Research in Real-Life Ltd', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}