Effect of aclidinium bromide/formoterol fumarate fixed-dose combination (FDC) on night-time and early morning symptoms in COPD
Bibliographic record
Abstract
Background Aclidinium/formoterol FDC is in clinical development for the treatment of COPD. We studied the effects of twice-daily aclidinium/formoterol FDC on night-time and early morning symptoms in patients with stable, moderate to severe COPD. Methods ACLIFORM and AUGMENT were multinational, double-blind, placebo- and active-controlled, parallel-group studies. Patients were randomised to receive placebo, aclidinium 400 µg, formoterol 12 µg, FDC 400/6 µg or FDC 400/12 µg. Patients used an eDiary to report night-time and early morning symptoms, which also contained other questions related to symptom impacts. Results The ITT population included 3394 patients (mean age 63.5 years; 60.5% male; moderate COPD 58.6%; baseline night-time symptom severity [mean±SD] 1.1±0.7, early morning symptom severity 1.3±0.7). Over 24 weeks, overall night-time symptom severity significantly improved with FDC vs placebo (FDC 400/12 µg: -0.11; 400/6 µg: -0.14), formoterol (FDC 400/12 µg: -0.05; 400/6 µg: -0.08) and aclidinium (FDC 400/12 µg: -0.09; 400/6 µg: -0.12) (all p<0.05). Overall, early morning symptom severity also improved with FDC vs placebo (FDC 400/12 µg: -0.12; 400/6 µg: -0.14), formoterol (FDC 400/12 µg: -0.06; 400/6 µg: -0.08) and aclidinium (FDC 400/12 µg: -0.09; 400/6 µg: -0.11) (all p<0.01). Night-time and early morning cough, wheezing, breathlessness and difficulty bringing up phlegm were significantly improved with FDC vs placebo (all p<0.05, both doses). Conclusions These data suggest that aclidinium/formoterol FDC improves overall night-time and early morning symptom severity in patients with moderate to severe COPD compared with placebo and monotherapy.
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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 | 0.000 | 0.000 |
| Open science | 0.000 | 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".