ACCORD COPD I: Twice-daily aclidinium bromide improves quality of life and dyspnea in COPD patients
Bibliographic record
Abstract
Introduction: Aclidinium bromide is a long-acting muscarinic antagonist in development for treatment of COPD. In this Phase III study, the effects of twice-daily aclidinium on health outcomes were assessed. Methods: In this 12-week, double-blind study, moderate to severe COPD patients were randomised to receive aclidinium 200 μg, 400 μg, or placebo BID. Health outcomes were assessed monthly via SGRQ and TDI. Results: Of the 561 patients randomised, 467 (83%) completed the study. At baseline, the mean (SD) pre-bronchodilator FEV 1 and percent predicted were 1.36 (0.54) L and 47.2 (14.1)%, respectively. Baseline mean (SD) SGRQ total score and BDI focal score were 46.5 (17.1) and 6.4 (2.1), respectively. Adjusted mean differences vs placebo in change from baseline in SGRQ total score at Week 12 were -2.7 (p=0.01) and -2.5 (p=0.02) for aclidinium 200 μg and 400 μg, respectively. At all time points, statistically greater percentages of aclidinium patients achieved clinically significant improvements in SGRQ vs placebo (≥4 points; p<0.05 for all except Week 12, 400 μg group). Both aclidinium doses provided significant improvements vs placebo in TDI focal score (p<0.05, range 0.6 to 1.4) throughout the study; with the exception of aclidinium 200 μg at Week 8 (p=0.06). Significantly greater percentages of patients achieved clinically meaningful improvements in TDI (≥1 unit) with both aclidinium doses at all time points vs placebo (p<0.05). Conclusions: In this 12-week study, aclidinium 200 μg and 400 μg BID significantly improved quality of life and reduced dyspnea for 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 | 0.001 | 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) | 0.006 | 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".