P252 Once-daily NVA237 improves symptoms, and reduces COPD exacerbations and associated hospitalisations: the GLOW1 trial
Bibliographic record
Abstract
Introduction Symptoms profoundly impact daily life of COPD patients. We assessed the influence of the once-daily (qd) long-acting muscarinic antagonist (LAMA) NVA237 (glycopyrronium bromide) on symptoms and exacerbations in patients with moderate-to-severe COPD. Methods Patients were randomised (2:1) to 26 weeks double-blind treatment with NVA237 50 μg qd or placebo (PBO) via a single-dose dry powder inhaler (Breezhaler® device). Efficacy was assessed by bronchodilation (trough FEV1 at Week 12), breathlessness on the transition dyspnoea index (TDI), HRQoL via the St. George9s Respiratory Questionnaire (SGRQ), and rescue medication use. The effect on COPD exacerbations and related hospitalisations was also assessed. Results 822 patients were randomised; 80.5% completed. NVA237 significantly increased total TDI focal score vs PBO at Week 26 (difference 1.04, 95% CI 0.583 to 1.504; p<0.0001); exceeding the minimum clinically important difference ([MCID] =1 point). Significantly more patients achieved MCID in TDI score with NVA237 (61.3% vs 48.3%; OR 1.74, 95% CI 1.249 to 2.415; p=0.001). SGRQ total score was significantly reduced with NVA237 (−2.81; p=0.004); % of patients achieving a clinically meaningful improvement in SGRQ (=4 point reduction) was significantly higher with NVA237 (56.8% vs 46.3%; OR 1.58, 95% CI 1.138 to 2.196; p=0.006). NVA237 significantly reduced rescue medication use at Week 26 (−0.46 puffs/day, p=0.005). NVA237 significantly prolonged time to first moderate/severe COPD exacerbation by 31% (HR 0.69, 95% CI 0.50 to 0.949; p=0.023) and time to first severe COPD exacerbation necessitating hospitalisation (HR 0.35, 95% CI 0.141 to 0.857; p=0.022). NVA237 significantly reduced hospitalisations due to COPD exacerbation (OR 0.34; p=0.024). Conclusion Once-daily NVA237 provided significant improvements in dyspnoea and SGRQ total score, with lower rescue medication use, and reduced risk of exacerbation and associated hospitalisations vs PBO.
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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 | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
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".