Effects of a combination of vilanterol and umeclidinium on exercise endurance in subjects with COPD: Two randomised clinical trials
Bibliographic record
Abstract
Aims Two studies tested the effect of umeclidinium (UMEC)/vilanterol (VI) on exercise tolerance, lung function and safety in COPD. Methods Moderate to severe COPD subjects with hyperinflation were randomised into multi-centred (DB2114417 and DB2114418), double blind,incomplete block,crossover studies for 12-weeks. Subjects received two of the following, placebo (pbo), UMEC/VI (125/25mcg or 62.5/25mcg),UMEC(125mcg or 62.5mcg) or VI(25mcg). Co-primary outcomes were the change in exercise endurance time during the endurance shuttle walk test and trough FEV 1 at week 12 versus pbo. Safety assessments were carried out. Results 349 (study417) and 308 (study418) subjects randomised.Similar improvements in exercise duration from baseline at week 12 for both doses of UMEC/VI were observed. Table 1.Co-Primary Endpoints at week 12 UMEC/VI 62.5/25 UMEC/VI 125/25 STUDY417 STUDY418 STUDY417 STUDY418 Exercise Endurance Time(S) LS MeanΔfrom baseline(SE) 58.6(13.82) 69.5(17.09) 69.1(13.99) 65.9(17.48) Δfrom pbo(SD) 21.9(-14.2,58.0) 69.4(24.5,114.4)∗ 32.4(-3.9,68.8) 65.8(20.3,111.3)∗ TroughFEV1(L) LS MeanΔfrom baseline(SE) 0.178(0.0156) 0.200(0.0156) 0.136(0.0158) 0.218(0.0159) Δfrom pbo(95%CI) 0.211(0.172,0.249)† 0.243(0.202,0.284)† 0.169(0.129,0.209)† 0.261(0.220,0.303)† ∗p<0.01 † p<0.001 Change=Δ Significant changes in exercise duration vs pbo in 418 but not 417 were observed, a large pbo effect was seen in 417.Both doses improved lung function at week 12. Adverse events were 417,418 pbo 27%,39%,UMEC/VI 125/25, 23%,44% and 62.5/25, 32%,41%. Conclusions UMEC/VI improves exercise endurance from baseline, provides effective bronchodilation and appears safe over 12 weeks. GSK funded. NCT01328444 ,NCT01323660.
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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 | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 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".