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The mean objectives are to evaluate the impact of BDP/FF/G fixed combination on health-status and adherence
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient in treatment with BDP/FF/G fixed combination |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BDP/FF/G fixed combination | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in COPD Assessment Test (CAT) score | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in COPD Assessment Test (CAT) score | 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. | 6 months |
| Change in 12-item Test of Adherence to Inhalers (TAI-12) score |
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Inclusion Criteria:
Exclusion Criteria:
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COPD patients with symptoms and history of exacerbations despite of maintenance therapy
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| Name | Affiliation | Role |
|---|---|---|
| Luca Richeldi, MD | Policlinico Gemelli, Roma (Italy) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Gemelli | Rome | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33536751 | Background | Richeldi L, Piraino A, Macagno F, Micarelli G, Ingrassia E. The Impact of Fixed Triple Therapy with Beclometasone/Formoterol/Glycopyrronium on Health Status and Adherence in Chronic Obstructive Pulmonary Disease (COPD) in an Italian Context of Real Life: The TRITRIAL Study Protocol. Int J Chron Obstruct Pulmon Dis. 2021 Jan 27;16:159-166. doi: 10.2147/COPD.S286559. eCollection 2021. | |
| 38435125 |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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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). |
| 6 and 12 months |
| Change in COPD and Asthma Sleep Impact Scale (CASIS) score | 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. | 6 and 12 months |
| Change in EuroQoL score | 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'. | 6 and 12 months |
| Change of an 8-item questionnaire on satisfaction and usability of the device score from baseline (Visit 1) | 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 | 6 and 12 months |
| Forced Expiratory Volume in the first second (FEV1, L) | Baseline, 6 and 12 months |
| Forced Vital Capacity (FVC, L) | Baseline, 6 and 12 months |
| Mean forced expiratory flow between 25% and 75% of the FVC (FEF25-75) | Taken from the test with the highest values of FEV1 and FVC | Baseline, 6 and 12 months |
| Ratio FEV1/FVC | Derived from these highest values of each parameter | Baseline, 6 and 12 months |
| Use of rescue medication | Use of rescue medication | Baseline, 6 and 12 months |
| Exacerbations | Moderate to severe exacerbations | Baseline, 6 and 12 months |
| Adverse events | Number of adverse events | Baseline, 6 and 12 months |
| Economic resources consumption | Number of hospitalizations, ER access, unscheduled visits | Baseline, 6 and 12 months |
| Result |
| Richeldi L, Schino P, Bargagli E, Ricci A, Rocca A, Marchesani F, Pennisi A, Camiciottoli G, D'Amato M, Macagno F, Scaffidi Argentina U, Ingrassia E, Piraino A. TRITRIAL: The Impact of Fixed Triple Therapy with Beclometasone/Formoterol/Glycopyrronium on Health Status and Adherence in Chronic Obstructive Pulmonary Disease in an Italian Context of Real Life. Int J Chron Obstruct Pulmon Dis. 2024 Feb 23;19:475-487. doi: 10.2147/COPD.S445858. eCollection 2024. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |