QVA149 showed significant improvements in lung function and health status and was well tolerated versus glycopyrronium and tiotropium in patients with severe COPD: The SPARK study
Bibliographic record
Abstract
Introduction QVA149 is an approved once-daily (OD) dual bronchodilator combination of the LABA indacaterol (IND) and LAMA glycopyrronium (GLY) for the maintenance treatment of patients (pts) with symptomatic COPD. We evaluated the effect of QVA149 versus GLY and tiotropium (TIO) on lung function, health status and safety in the subgroup of pts with severe COPD from the SPARK study. Methods SPARK was a 64-week, multicentre, double-blind, parallel-group, active-controlled study that randomised (1:1:1) severe-to-very severe pts with COPD to OD QVA149 110/50 µg, GLY 50 µg, or open-label TIO 18 µg. Efficacy parameters included pre-dose FEV 1 and health status (SGRQ). Safety data was also recorded. Results Of the 2224 randomised pts, 1742 (78.3%) had severe COPD (GOLD 2008) [QVA149=578; GLY=583; TIO=581]. In pts with severe COPD, pre-dose FEV 1 was significantly higher with QVA149 at all time-points compared with GLY and TIO (p<0.0001 for both, table). At Week 64, SGRQ total score was significantly lower in the QVA149 group than GLY (treatment difference [TD]: -2.56; p=0.002) or TIO (TD: -3.38; p<0.001) groups. The incidence of adverse events were similar across all groups (QVA149=92.9%; GLY=93.0%; TIO=94.1%). Pre-dose FEV 1 over 64 weeks (mL) Weeks TD (SE) of QVA149 vs. comparators in mL GLY TIO 12 80 (12) 80 (12) 26 90 (13) 80 (12) 38 80 (13) 90 (13) 52 80 (14) 80 (14) 64 80 (14) 70 (14) All p<0.0001 Conclusion In patients with severe COPD, QVA149 resulted in significant improvements in lung function and health status compared with GLY and TIO with a safety profile similar to that of both GLY and TIO.
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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 | 0.002 | 0.001 |
| 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 | 0.001 |
| Open science | 0.001 | 0.000 |
| 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".