NVA237 once daily provides rapid, clinically meaningful and sustained 24-h bronchodilation in patients with COPD: The GLOW1 trial
Bibliographic record
Abstract
Introduction: NVA237 (glycopyrronium bromide) is a once-daily (QD) inhaled long-acting muscarinic antagonist in development for the treatment of COPD. Methods: Patients with moderate-to-severe COPD were randomized (2:1) to double-blind NVA237 50 μg QD or placebo (PBO) for 26 wks. Study medication was administered via a low-resistance single-dose dry powder inhaler (Concept1 device). The primary efficacy endpoint was trough FEV 1 (mean of 23 h 15 min and 23 h 45 min post-dose values) vs PBO after 12 wks. Results: A total of 822 patients were randomized; 80.5% completed the study. Mean age was 63.9 yrs, mean post-bronchodilator FEV 1 was 55% predicted. At Wk 12 there was a statistically significant and clinically relevant difference between NVA237 vs PBO in mean trough FEV 1 (108 mL; p<0.001). Trough FEV 1 was also significantly higher at Day 1 and Wk 26 (treatment difference: 105 mL and 113 mL, respectively; p<0.001). At all time points on Day 1, Wk 12 and Wk 26, NVA237 demonstrated statistically superior (p<0.001) and clinically meaningful improvement in FEV 1 compared with PBO. NVA237 had a rapid onset of action with an increased FEV 1 of 93 mL at 5 min and 144 mL at 15 min vs PBO after the first dose on Day 1 (p<0.001). The incidence of adverse events (AEs) was similar between NVA237 and PBO (57.5% vs 65.2%, respectively). Serious AEs were reported by 7.5% of NVA237- vs 9.0% of PBO-treated patients. Conclusion: NVA237 50 μg once daily was safe and well tolerated, and produced clinically meaningful bronchodilation that was rapid in onset and maintained for 24 hrs throughout the study.
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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 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| 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 | 0.002 |
| 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".