Real-World Effectiveness of Triple Extrafine Fixed-Dose Combination with Beclomethasone/Formoterol/Glycopyrronium on Symptoms and Lung Function in COPD: A Systematic Review and Meta-Analysis
Bibliographic record
Abstract
Paola Rogliani,1 Gian Marco Manzetti,1 Mario Cazzola,1 Luigino Calzetta2 1Unit of Respiratory Medicine, Department of Experimental Medicine, University of Rome “Tor Vergata”, Rome, Italy; 2Respiratory Disease and Lung Function Unit, Department of Medicine and Surgery, University of Parma, Parma, ItalyCorrespondence: Paola Rogliani, Unit of Respiratory Medicine, Department of Experimental Medicine, University of Rome “Tor Vergata”, Via Montpellier 1, Rome, 00133, Italy, Tel +39 06 2090 4656, Email paola.rogliani@uniroma2.itIntroduction: Chronic obstructive pulmonary disease (COPD) is a significant global health issue characterized by persistent airflow limitation and inflammation. Triple fixed-dose combinations (FDCs) of inhaled corticosteroids (ICS), long-acting β 2-agonists (LABA), and long-acting muscarinic antagonists (LAMA) show promise by potentially enhancing bronchodilation and anti-inflammatory effects. Although randomized controlled trials (RCTs) provide efficacy data, they may not fully represent real-world clinical practice, highlighting the value of real-world evidence (RWE).Methods: This study conducted a systematic review and meta-analysis of prospective observational multicenter studies to evaluate the real-world effectiveness of a triple extrafine FDC containing beclomethasone dipropionate (BDP), formoterol fumarate (FF), and glycopyrronium (G) in moderate-to-severe COPD patients. Databases MEDLINE and SCOPUS were searched for relevant studies reporting on the COPD Assessment Test (CAT) score and forced expiratory volume in one second (FEV1).Results: The meta-analysis included seven studies with 5952 patients, indicating high methodological quality with Newcastle–Ottawa Scale scores ≥ 7. Results showed significant improvement in CAT scores (− 5.82 95% CI − 7.61 - − 4.03; P < 0.001) and FEV1 (127 mL 95% CI 42– 212; P < 0.001) for extrafine BDP/FF/G FDC compared to any prior treatments (ICS/LABA, ICS+LABA, LABA/LAMA, LABA+LAMA, multiple-inhaler triple therapy, single-inhaler triple therapy), exceeding minimal clinically important differences. Heterogeneity was significant, but Egger’s test suggested no significant publication bias.Conclusion: The triple extrafine BDP/FF/G FDC effectively improves health status and lung function in real-world COPD patients, supporting its use as a viable therapeutic strategy. Further research should explore long-term outcomes and investigate specific patient subgroups to optimize individualized treatment approaches.Keywords: COPD, symptoms, lung function, real-world evidence, meta-analysis
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.010 | 0.016 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.016 | 0.035 |
| Bibliometrics | 0.004 | 0.005 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.002 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".