Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes
Bibliographic record
Abstract
Introduction QVA149 is a once-daily dual bronchodilator containing a fixed-dose combination of the long-acting β 2 -agonist indacaterol (IND) and the long-acting muscarinic antagonist glycopyrronium (GLY) in development for the treatment of COPD. Here we present the pooled analysis from the SHINE, ILLUMINATE and SPARK studies of QVA149. Methods The SHINE study randomized 2144 patients (pts) to QVA149 110/50µg, IND 150µg, GLY 50µg, open-label tiotropium (TIO) 18µg or placebo (PB) for 26wks. The SPARK study randomized 2224 pts for 64wks to QVA149, GLY 50µg and TIO 18µg. In ILLUMINATE, 523 pts received QVA149 or twice-daily salmeterol/fluticasone (SFC) 50/500μg for 26wks. SHINE and ILLUMINATE evaluated lung function, Transition Dyspnea Index (TDI), St George’s Respiratory Questionnaire (SGRQ) and rescue medication use. The SPARK study assessed annualized exacerbation rates, lung function, SGRQ and rescue medication use. Results QVA149 provided superior bronchodilation vs. all comparators with a rapid onset of action; improvements were sustained throughout the treatment periods. Significant treatment differences were observed for TDI focal score with QVA149 vs. PB (treatment difference=1.09; p<0.001), TIO (0.51; p=0.007) and SFC (0.76; p=0.003). SGRQ scores were significantly improved with QVA149 vs. PB, GLY and TIO. Pts in the QVA149 group used significantly less rescue medication vs. all comparators. Conclusion Once-daily QVA149 provides significantly superior, rapid and sustained bronchodilation vs. PB, IND, GLY, TIO and SFC, and significant symptomatic improvements in patients with moderate-to-severe COPD.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.006 | 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".