Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT03963167
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2019-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Triple Therapy in Real-life: Impact on Adherence and Health Status (TRITRIAL)
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 661}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-04', 'studyFirstSubmitDate': '2019-05-14', 'studyFirstSubmitQcDate': '2019-05-23', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in COPD Assessment Test (CAT) score', 'timeFrame': '12 months', 'description': "CAT consists of 8 items scored on a scale of 1 to 5, with a total score range of 0-40. A higher score denotes a more severe impact of COPD on the patient's life."}], 'secondaryOutcomes': [{'measure': 'Change in COPD Assessment Test (CAT) score', 'timeFrame': '6 months', 'description': "CAT consists of 8 items scored on a scale of 1 to 5, with a total score range of 0-40. A higher score denotes a more severe impact of COPD on the patient's life."}, {'measure': 'Change in 12-item Test of Adherence to Inhalers (TAI-12) score', 'timeFrame': '6 and 12 months', 'description': 'TAI comprises a patient domain (including 10 items) and a healthcare professional domain (including 2 items). Each item ranges from 1 (lowest adherence) to 5 (highest adherence) points. The patient domain score ranges from 10 to 50. Adherence is rated as good (score =50), intermediate (score = 46-49), or poor (score ≤45). The questions for healthcare professionals are scored with 1 or 2 points (poor or good knowledge of the regimen and/or inhalation technique).'}, {'measure': 'Change in COPD and Asthma Sleep Impact Scale (CASIS) score', 'timeFrame': '6 and 12 months', 'description': 'It is a self-administered 7-item scale scored on a five-point scale ranging from 0 if the item never applies, to 4 if the item applies very often. A total raw score is produced from the sum of the seven individual scores which is then linearly transformed to a 0-100 total scale score. Higher scores representing greater sleep deterioration in the previous week.'}, {'measure': 'Change in EuroQoL score', 'timeFrame': '6 and 12 months', 'description': "Il consists of 2 pages, a descriptive system and a visual Analogue scale. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each dimension having 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state.The VAS records the respondent's self-rated health on a 10 cm vertical VAS with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'."}, {'measure': 'Change of an 8-item questionnaire on satisfaction and usability of the device score from baseline (Visit 1)', 'timeFrame': '6 and 12 months', 'description': 'it contains 8 questions, each scored on a 0-5 Likert scale, which range from 0 (fully disagree) to 5 (fully agree), for a total maximum score of 40. Higher scores indicate a higher ease of use and satisfaction with the inhaler'}, {'measure': 'Forced Expiratory Volume in the first second (FEV1, L)', 'timeFrame': 'Baseline, 6 and 12 months'}, {'measure': 'Forced Vital Capacity (FVC, L)', 'timeFrame': 'Baseline, 6 and 12 months'}, {'measure': 'Mean forced expiratory flow between 25% and 75% of the FVC (FEF25-75)', 'timeFrame': 'Baseline, 6 and 12 months', 'description': 'Taken from the test with the highest values of FEV1 and FVC'}, {'measure': 'Ratio FEV1/FVC', 'timeFrame': 'Baseline, 6 and 12 months', 'description': 'Derived from these highest values of each parameter'}, {'measure': 'Use of rescue medication', 'timeFrame': 'Baseline, 6 and 12 months', 'description': 'Use of rescue medication'}, {'measure': 'Exacerbations', 'timeFrame': 'Baseline, 6 and 12 months', 'description': 'Moderate to severe exacerbations'}, {'measure': 'Adverse events', 'timeFrame': 'Baseline, 6 and 12 months', 'description': 'Number of adverse events'}, {'measure': 'Economic resources consumption', 'timeFrame': 'Baseline, 6 and 12 months', 'description': 'Number of hospitalizations, ER access, unscheduled visits'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'Adherence', 'HRQoL determinants'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'The mean objectives are to evaluate the impact of BDP/FF/G fixed combination on health-status and adherence'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COPD patients with symptoms and history of exacerbations despite of maintenance therapy', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Written informed consent to participate in the study;\n2. Adult patients of either sex aged ≥ 40 years;\n3. Patients with diagnosis of moderate to very severe COPD according to Gold Initiative for Chronic Obstructive Lung Disease (GOLD) updated 2019 (GOLD Stage 2-4);\n4. COPD assessment test (CAT) score ≥ 10 at initiation of BDP/FF/G fixed combination;\n5. History of \\>1 moderate or severe COPD exacerbation during the previous year.\n6. Patients in treatment with BDP/FF/G as per local clinical practice and according to Trimbow® Summary of Product Characteristics (SmPC).\n\nExclusion Criteria:\n\n1. According on Investigator's judgement, patients unable to comply with the requirements of the study (e.g. inability to attend all the planned study visits according to the time limits included) or patients with poorly controlled concomitant severe diseases or conditions that could interfere with the study participation;\n2. Participation in an interventional clinical trial within 30 days prior to enrolment into the present study."}, 'identificationModule': {'nctId': 'NCT03963167', 'briefTitle': 'Triple Therapy in Real-life: Impact on Adherence and Health Status (TRITRIAL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi Farmaceutici S.p.A.'}, 'officialTitle': 'The Impact on the Health Status and Adherence in a Real-life Setting of Italian Patients With Chronic Obstructive Pulmonary Disease in Treatment With Trimbow® pMDI b.i.d.: a 12-month Prospective Observational Study', 'orgStudyIdInfo': {'id': 'DFIDM-1802'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient in treatment with BDP/FF/G fixed combination', 'interventionNames': ['Drug: BDP/FF/G fixed combination']}], 'interventions': [{'name': 'BDP/FF/G fixed combination', 'type': 'DRUG', 'otherNames': ['Trimbow'], 'description': 'Fixed combination of Inhaled Corticosteroid (ICS) / Long-acting β2-agonist (LABA) / long-acting muscarinic antagonist (LAMA) that contains Beclometasone dipropionate (BDP), Formoterol fumarate (FF) and Glycopyrronium (G).', 'armGroupLabels': ['Patient in treatment with BDP/FF/G fixed combination']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rome', 'country': 'Italy', 'facility': 'Fondazione Policlinico Gemelli', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Luca Richeldi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Policlinico Gemelli, Roma (Italy)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi Italia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}