NVA237 once daily reduces the percentage of patients with exacerbations of COPD and associated hospitalizations: The GLOW1 trial
Bibliographic record
Abstract
Introduction: COPD exacerbations, especially those leading to hospitalization, have a significant impact on patients' quality of life and long-term prognosis. We examined the influence of the once-daily (QD) long-acting muscarinic antagonist NVA237 (glycopyrronium bromide) on exacerbations of COPD. Methods: Patients with moderate-to-severe COPD were randomized (2:1) to double-blind NVA237 50 μg QD or placebo (PBO) via a low-resistance single-dose dry powder inhaler (Concept1 device) for 26 wks. In addition to bronchodilation (primary efficacy endpoint was trough FEV 1 at 12 wks), the effect on COPD exacerbations and related hospitalizations was assessed using a Cox regression model. Results: 822 patients were randomized; 80.5% completed. Mean age was 63.9 yrs, mean post-bronchodilator FEV 1 54.6% predicted (FEV 1 /FVC 0.5). Compared with PBO, NVA237 significantly prolonged the time to first moderate/severe COPD exacerbation (hazard ratio [HR] 0.69, 95% confidence interval [CI]: 0.50–0.949; p=0.023) and the time to first severe COPD exacerbation leading to hospitalization (HR 0.35, 95% CI: 0.141–0.857; p=0.022). NVA237 also significantly reduced the percentage of hospitalizations due to COPD exacerbation (odds ratio [OR] 0.34; p=0.024). NVA237 numerically reduced the rate of moderate/severe exacerbations with NVA237 vs PBO (0.43 vs 0.59/yr; rate ratio [RR] 0.72; p=0.071). Conclusion: In patients with moderate-to-severe COPD, compared with placebo, NVA237 50 μg once daily significantly prolonged the time to first moderate/severe COPD exacerbation and reduced the percentage of hospitalizations due to a COPD exacerbation.
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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 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".