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| ID | Type | Description | Link |
|---|---|---|---|
| NIS 005 Pn | Other Identifier | International study code |
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| Name | Class |
|---|---|
| Gesellschaft für Therapieforschung mbH | INDUSTRY |
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TriMaximize is a non-interventional study aimed to collect prospective data from asthmatic patients under routine care, for whom their treating physician has decided to prescribe BDP/FF/G (beclomethasone/formoterol/glycopyrronium).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asthma patients | Adult patients with a diagnosis of moderate to severe asthma treated with BDP/FF/G medium strength or high strength as per clinical practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BDP/FF/G | Drug | BDP/FF/G is an extrafine single inhaler triple therapy available in two dosage strengths:
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| Measure | Description | Time Frame |
|---|---|---|
| Patient demographics | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of asthma control using Asthma Control Test (ACT) | Change from baseline in ACT scores. The ACT is a self-report questionnaire with scores ranging from 5-25 (higher is better). Scores of 20-25 are classified as well-controlled; 16-19 as not well-controlled; and 5-15 as very poorly controlled asthma. The minimum clinically important difference is considered to be 3 point. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with a diagnosis of moderate to severe asthma treated with BDP/FF/G as per clinical practice.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.O. Clinica Psichiatrica e SPDC. Ospedale Policlinico S. Martino - IRCCS, Genova | Genoa | Italy |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Assessment of quality of life using Mini Asthma Quality of Life Questionnaire (Mini AQLQ) | Change from baseline in MiniAQLQ scores. The MiniAQLQ is a disease specific questionnaire that consists of 15 asthma-related questions. Participants respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated better quality of life. A change in the score greater than 0.5 can be considered clinically important. | 12 months |
| Assessment of adherence to treatment using 12-item Test of Adherence to Inhalers (TAI-12) | Change from baseline in TAI-12 score. The 12-item TAI comprises a patient domain (10 items) and a healthcare professional domain (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). | 12 months |
| Incidence of asthma exacerbations | Number of exacerbations | 12 months |
| Asthma exacerbations | Occurrence of asthma exacerbations | 12 months |
| Adverse events | Number of AEs | 12 months |
| Adverse drug reactions to BDP/FF/G | Number of ADRs | 12 months |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |