Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-01-12 @ 10:31 PM
Study NCT ID:
NCT03627858
Status:
COMPLETED
Last Update Posted:
2021-11-29
First Post:
2018-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fixed Dose Triple Therapy in Severe Chronic Obstructive Pulmonary Disease in a Real World Setting
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': 'D001507', 'term': 'Beclomethasone'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'D006024', 'term': 'Glycopyrrolate'}], 'ancestors': [{'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'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-25', 'studyFirstSubmitDate': '2018-05-29', 'studyFirstSubmitQcDate': '2018-08-08', 'lastUpdatePostDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of moderate and severe exacerbations at baseline (12 months prior to start) and last follow-up visit', 'timeFrame': 'up to 6 months', 'description': 'The number of moderate and severe exacerbations that occurred within the previous year is collected at the baseline visit and the number of moderate and severe exacerbations occurring during the study is collected at the final visit. Moderate exacerbations are defined as exacerbations that require oral corticosteroid and/or antibiotic treatment. Severe exacerbations are defined as exacerbations that require oral corticosteroid and/or antibiotic treatment plus hospital admission.'}], 'primaryOutcomes': [{'measure': 'Inhalation technique score', 'timeFrame': 'up to 6 months', 'description': 'Change in Inhalation Technique Score, measured as percentage of correct steps on the Inhalation Checklist (itemized instructions of inhaler correct use per respective Summaries of Product Characteristics) at each routine follow-up visit up to 6 months versus baseline.\n\nThis is an hypothesis generating study. No formal primary endpoint is defined; parameters are evaluated in an exploratory or descriptive manner.'}], 'secondaryOutcomes': [{'measure': 'Treatment adherence score', 'timeFrame': 'up to 6 months', 'description': 'Degree of treatment adherence measured via the mean score on the Test of Adherence to Inhalers (TAI) questionnaire, including 5 questions completed by the patient (each item scored from 1 (worst) to 5 (best) with a range from 10 to 50) and 2 items completed by the physician (each item scored 1 (bad) or 2 (good) with a range from 2 to 4) at baseline and each routine follow-up visit up to 6 months versus baseline.'}, {'measure': 'Number of inhaled doses recorded by dose counter since previous visit', 'timeFrame': 'up to 6 months', 'description': 'Number of inhaled doses recorded by dose counter of the inhaler since previous visit, at the first and second routine follow-up visit.'}, {'measure': "Patient's treatment satisfaction score using visual analogue scale (0-10)", 'timeFrame': 'up to 6 months', 'description': "The patient's treatment satisfaction score measured on a visual analogue scale from 0 (worst) to 10 (best), at baseline and each routine follow-up visit."}, {'measure': 'Number of rescue medication used within 7 days prior to each visit', 'timeFrame': 'up to 6 months', 'description': 'The number of rescue medication used within 7 days prior to each visit, recorded at baseline and each routine follow-up visit.'}, {'measure': "Patient's lung function as measured by spirometry", 'timeFrame': 'up to 6 months', 'description': 'The pre and post bronchodilator forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) are measured at baseline and each routine follow-up visit.'}, {'measure': 'Symptoms score by the Chronic obstructive pulmonary disease Assessment Test (CAT) questionnaire', 'timeFrame': 'up to 6 months', 'description': 'Patients complete the 8-item CAT questionnaire at baseline and each follow-up visit. Total scores range from 0 to 40 and higher scores indicate a worse health status.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The rationale for this non-interventional study in confirmed moderate to severe chronic obstructive pulmonary disease patients aged 40 years and above, is to assess real-life effectiveness and safety of Trimbow® in clinical practice, and to bridge the gap with the existing clinical data.', 'detailedDescription': 'This non-interventional study assesses the real-life effectiveness and safety of the fixed triple therapy Trimbow® compared to free triple therapy, considering patient individual data, in clinical practice at second and thirdline centres in patients with confirmed moderate to severe chronic obstructive pulmonary disease.\n\nThis is an hypothesis generating study. No formal primary endpoint is defined; parameters are evaluated in an exploratory or descriptive manner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients aged 40 years or above diagnosed with chronic obstructive pulmonary disease confirmed by spirometry (post-bronchodilation) who were prescribed Trimbow®', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has provided written informed consent\n* Patient is aged 40 years or older at time of initiation of Trimbow® treatment\n* Patient is diagnosed with moderate or severe chronic obstructive pulmonary disease confirmed by spirometry (post-bronchodilation) based on the Global Initiative for chronic obstructive lung disease (GOLD) 2018 classification\n* Patient treated with double inhalation or free triple therapy (using at least 2 devices) who are prescribed Trimbow®\n\nExclusion Criteria:\n\n• Hypersensitivity to the active substances or to any of the excipients listed below:\n\n* Ethanol anhydrous\n* Hydrochloric acid\n* Norflurane (propellant)'}, 'identificationModule': {'nctId': 'NCT03627858', 'acronym': 'TRIVOLVE', 'briefTitle': 'Fixed Dose Triple Therapy in Severe Chronic Obstructive Pulmonary Disease in a Real World Setting', 'organization': {'class': 'OTHER', 'fullName': 'Chiesi SA/NV'}, 'officialTitle': 'A Prospective Non-interventional Study in Patients With Chronic Obstructive Pulmonary Disease That Evolve to Fixed Long-acting Muscarinic Antagonist/Long-acting beta2-agonist/Inhaled Corticosteroid Triple Therapy, Trimbow®', 'orgStudyIdInfo': {'id': 'CHIESI_NIS_0001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'beclomethasone / formoterol / glycopyrronium', 'type': 'DRUG', 'otherNames': ['Trimbow®'], 'description': 'As this is a non-interventional study, all treatment decisions will be made at the discretion of the treating physician prior to enrolment in the study and during the entire period of the study. Treatment will be prescribed according to the product label in the summary of product characteristics.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'ZNA Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '2650', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Antwerp', 'country': 'Belgium', 'facility': 'GZA Campus Sint-Vincentius', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hôpital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '6000', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'Grand Hôpital de Charleroi', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'city': 'Charleroi', 'country': 'Belgium', 'facility': 'Clinique Notre-Dame de Grâce ASBL Gosselies', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Kortrijk', 'country': 'Belgium', 'facility': 'AZ Groeninge', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'CHR de la Citadelle', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Mechelen', 'country': 'Belgium', 'facility': 'AZ Sint-Maarten', 'geoPoint': {'lat': 51.02574, 'lon': 4.47762}}, {'city': 'Montigny-le-Tilleul', 'country': 'Belgium', 'facility': 'Hôpital André Vésale', 'geoPoint': {'lat': 50.38056, 'lon': 4.37582}}, {'city': 'Namur', 'country': 'Belgium', 'facility': 'Clinique Saint-Luc Bouge', 'geoPoint': {'lat': 50.4669, 'lon': 4.86746}}, {'city': 'Roeselare', 'country': 'Belgium', 'facility': 'AZ Delta', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'city': 'Tournai', 'country': 'Belgium', 'facility': 'Hospital Center De Wallonie Picarde', 'geoPoint': {'lat': 50.60715, 'lon': 3.38932}}], 'overallOfficials': [{'name': 'Guy Brusselle, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi SA/NV', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}