ANTES B+ Clinical Trial
Summary
Current guidelines recommend initial treatment with dual long-acting bronchodilator therapy (LABA-LAMA) in patients with Chronic Obstructive Pulmonary Disease (COPD) of group B (defined by CAT≥10 and none or 1 moderate exacerbation). However, the investigators hypothesize that there is a subgroup of B patients (B+) at a particularly high risk for poor clinical control, characterized by the following: * 1 moderate exacerbation in the previous year * CAT≥10 despite current treatment with LABA -LAMA * Blood eosinophil levels of ≥150 cells/ml the investigators further hypothesize that B+ patients could benefit from triple therapy treatment (LABA-LAMA + Inhaled Corticosteroids). Therefore, the main goal of this clinical trial is to compare the efficacy of Trelegy (triple therapy) in improving clinical control in GOLD B+ patients with chronic obstructive disease when compared to standard double therapy (LABA -LAMA). The clinical control is a validated composite endpoint that includes two domains, the patient's stability, and the impact of the disease. 1028 patients will be randomly allocated to receive either the standard therapy or Trelegy and will be monitored by the investigators for 1 year in 2 on-site visits + 2 remote visits.
Timeline
- Start
- 2024-02-29
- Primary completion
- 2025-01-23
- Completion
- 2025-01-23
Outcome
Outcome not reported
Stopped (Enrollment): “Delays in the opening and activation of participating sites, and a low recruitment rate, with only 48 participants enrolled over the course of one year”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trelegy Ellipta | Unknown | — | Inhaled |
| Comparator | Anoro | Unknown | — | — |
| Comparator | Beglan | Unknown | — | — |
| Comparator | Betamican | Unknown | — | — |
| Comparator | Braltus | Unknown | — | — |
| Comparator | Bretaris | Unknown | — | — |
| Comparator | Brimica | Unknown | — | — |
| Comparator | Broncoral | Unknown | — | — |
| Comparator | Duaklir | Unknown | — | — |
| Comparator | Eklira | Unknown | — | — |
| Comparator | Enurev | Unknown | — | — |
| Comparator | Formatris | Unknown | — | — |
| Comparator | Formoterol | Other / unclassified | — | — |
| Comparator | Formoterol Aldo | Unknown | — | — |
| Comparator | Formoterol stada | Unknown | — | — |
| Comparator | Glycopyrrolate | Small molecule | — | — |
| Comparator | Gregal | Unknown | — | — |
| Comparator | Hirobriz | Unknown | — | — |
| Comparator | Inaspir | Unknown | — | — |
| Comparator | Incruse | Unknown | — | — |
| Comparator | Indacaterol | Other / unclassified | — | — |
| Comparator | Laventair | Unknown | — | — |
| Comparator | Oslif | Unknown | — | — |
| Comparator | Rolufta | Unknown | — | — |
| Comparator | Sirkava | Unknown | — | — |
| Comparator | Soltel | Unknown | — | — |
| Comparator | Spiolto Respimat | Unknown | — | — |
| Comparator | Striverdi | Unknown | — | — |
| Comparator | Tavulus | Unknown | — | — |
| Comparator | Tiotropium | Other / unclassified | — | — |
| Comparator | Tovanor | Unknown | — | — |
| Comparator | Ultibro | Other / unclassified | — | — |
| Comparator | Ulunar | Unknown | — | — |
| Comparator | Xoterna | Unknown | — | — |
| Comparator | Yanimo | Unknown | — | — |
| Comparator | salmeterol xinafoate | Unknown | — | — |