P233 Efficacy and safety of once-daily glycopyrronium compared with blinded tiotropium in patients with COPD: the GLOW5 study
Bibliographic record
Abstract
<h3>Background</h3> Glycopyrronium, a once-daily long-acting muscarinic antagonist (LAMA), has demonstrated a similar efficacy and safety profile to open-label tiotropium in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).<sup>1</sup> The GLOW5 study compared the efficacy and safety of glycopyrronium with blinded tiotropium. <h3>Methods</h3> In this multicentre, 12-week, blinded study, patients ≥ 40 years with moderate-to-severe COPD (post-bronchodilator FEV<sub>1</sub> ≥ 30% and < 80% of the predicted normal, post-bronchodilator FEV<sub>1</sub>/FVC < 0.70) and a smoking history of ≥10 pack-years were randomised to glycopyrronium 50μg (via Breezhaler<sup>®</sup> device) or tiotropium 18μg (via HandiHaler<sup>®</sup> device). The primary objective was to demonstrate non-inferiority of glycopyrronium versus tiotropium for trough FEV<sub>1</sub> at Week 12 (non-inferiority margin: –50 mL). Other endpoints included FEV<sub>1</sub> area under the curve from 0 to 4 hours (AUC<sub>0–4hr</sub>) on Day 1, Transition Dyspnoea Index (TDI), St George9s Respiratory Questionnaire (SGRQ), rescue medication use, exacerbation rate, safety and tolerability. <h3>Results</h3> Of the 657 patients randomised, (glycopyrronium [n = 327]; tiotropium [n = 330]; mean age: 63.5 years, mean post-bronchodilator FEV<sub>1</sub>: 53.5% predicted), 95.9% completed the study. Glycopyrronium demonstrated non-inferiority to tiotropium for trough FEV<sub>1</sub> at Week 12 (Least Squares Mean [LSM] = 1.41L for both the groups; 95% confidence interval [CI]: –0.032, 0.031L). Glycopyrronium had a rapid onset of bronchodilation in the morning as demonstrated by a higher FEV<sub>1</sub> AUC<sub>0–4hr</sub> on Day 1 compared to tiotropium (LSM treatment difference [Td] = 58mL; p < 0.001). At Week 12, TDI total score (Td = –0.188; p = 0.385), SGRQ total score (Td = 0.65; p = 0.488) and percentage of days with no rescue medication use (Td = –1.5; p = 0.528) were comparable between the groups. No significant treatment difference was observed with respect to rate of moderate/severe COPD exacerbations per year (glycopyrronium 0.38 versus tiotropium 0.35 [rate ratio = 1.10, 95% CI: 0.62, 1.93]; p = 0.754). Overall, the incidence of adverse events was similar in the glycopyrronium (40.4%) and tiotropium (40.6%) groups. <h3>Conclusion</h3> Glycopyrronium and blinded tiotropium showed similar improvements in lung function, dyspnoea, health status, exacerbation rate and rescue medication use, with a similar safety and tolerability profile. Onset of bronchodilation with glycopyrronium was significantly more rapid following the first dose. <h3>Reference</h3> Kerwin, E. <i>et al.</i> Eur Resp J 2012;40:1106–1114.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".