Effect of QVA149 on lung function in the subgroup of patients with a history of exacerbations in the previous year and baseline ICS use from the SHINE study
Bibliographic record
Abstract
Introduction QVA149 is an approved, once-daily dual bronchodilator combination of LABA, indacaterol (IND), and LAMA, glycopyrronium bromide (GLY), for the maintenance treatment of symptomatic COPD. The SHINE study compared QVA149 with its mono-components, open-label tiotropium (OL TIO) and placebo (PBO). Here, we report the subgroup analysis of patients (pts) with history of ≥1 exacerbation and who used inhaled corticosteroids (ICS) at baseline in SHINE. Methods SHINE was a 26-wk, multicentre, parallel-group study that randomised pts with moderate-to-severe COPD (2:2:2:2:1) to receive QVA149 110/50μg, IND 150μg, GLY 50μg, OL TIO 18μg or PBO. This post-hoc analysis studied the effect of QVA149 on trough (t) FEV 1 and tFVC vs comparators using a linear mixed model in pts with ≥1 exacerbation (in the previous year) and baseline ICS use. Results In total, 542 pts (out of 2135 in full-analysis set; 25.4%) had a history of exacerbations. Of them, 465 (85.8%) pts were included in this subgroup analysis who used ICS at baseline and were continued on fixed ICS doses (Table). At Wk 26, QVA149 significantly improved tFEV 1 and tFVC vs comparators with the exception of non-significant improvement vs GLY for tFVC (Table). Table: Lung function at Wk 26 Least squares mean treatment differences (standard error) versus QVA149 (n=110), mL Trough FEV 1 Trough FVC IND (n=105) 80 (26)* 120 (47)* GLY (n=111) 110 (26)** 60 (46) TIO (n=102) 110 (26)** 150 (47)* PBO (n=37) 230 (36)** 280 (65)** *p<0.05; **p<0.0001 Conclusion In pts with a history of ≥1 exacerbation and baseline ICS use, QVA149 provided greater improvement in lung function vs IND, GLY, OL TIO or 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 | 0.005 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.009 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".