Lung function improvements with twice-daily aclidinium/formoterol fixed-dose combination in two 24-week studies in patients with COPD
Bibliographic record
Abstract
BACKGROUND: Fixed-dose combinations (FDC) of different bronchodilators improve lung function through complementary mechanisms. AIM: To assess bronchodilation with an FDC comprising aclidinium bromide and formoterol fumarate in patients with moderate to severe COPD. METHODS: In 2 phase 3 trials, ACLIFORM COPD (S1) and AUGMENT COPD (S2), patients were randomized to 24 weeks of twice-daily inhaled aclidinium/formoterol 400µg/12µg (FDC 400/12), 400µg/6µg (FDC 400/6), aclidinium 400µg (ACL), formoterol 12µg (FOR), or placebo (PBO). Lung function coprimary outcomes were change from baseline to week 24 for 1-hr morning postdose FEV 1 (FDC vs ACL) and morning predose (trough) FEV 1 (FDC vs FOR). RESULTS: Baseline mean FEV 1 were 1.38L (S1) and 1.36L (S2) (54.2% and 53.5% predicted). At the first time point assessed, treatment with either FDC resulted in significant improvements in the coprimary endpoints that were generally maintained at study end (Table). Each FDC showed clinically significant improvements in both endpoints vs PBO that were evident as early as 5 min postdose on day 1 (range: 100–128 mL, p CONCLUSIONS: Fixed-dose combination of aclidinium/formoterol showed rapid and sustained improvements in bronchodilation compared with each monotherapy and placebo, with numerically greater improvements observed with FDC 400/12 vs FDC 400/6.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".