Symptomatic benefit of olodaterol QD delivered via Respimat® vs placebo and formoterol BID in patients with COPD: Combined analysis from two 48-week studies
Bibliographic record
Abstract
Background: The novel LABA olodaterol (O) has 24-h bronchodilator activity. Objective: To evaluate the symptomatic benefit of O QD in patients (pts) with GOLD 2-4 COPD. Methods: In replicate, randomised, double-blind, placebo (P)-controlled, parallel-group studies, pts with post-bronchodilator FEV 1 <80% predicted normal and FEV 1 /FVC <70% received O (5 or 10 µg) QD via Respimat®, formoterol (F; 12 μg) BID via Aerolizer® or P for 48 weeks (wks; Study A: NCT00793624 ; Study B: NCT00796653 ). Pts continued to receive usual care background COPD maintenance therapy, including SAMA, LAMA, ICS and xanthines. In addition to FEV 1 -based primary end points, TDI and SGRQ after 24 wks were identified as co-primary and key secondary symptomatic end points, respectively. Results: 904 (Study A) and 934 (Study B) pts were treated. In the primary analysis using a mixed model for repeated measures (MMRM; combined dataset), there was no significant difference in TDI focal score after 24 wks for O or F vs P. A post hoc analysis using pattern mixture modelling (PMM) to account for discontinued pts demonstrated statistical significance for O vs P. There were significant improvements in SGRQ total score with O, but not F, vs P after 24 wks using MMRM and PMM. Adjusted mean difference vs P after 24 wks (combined dataset) TDI focal score SGRQ total score MMRM PMM MMRM PMM O 5 μg 0.3* 0.5 † -2.8 † -2.3 † O 10 μg 0.2* 0.5 † -3.4 † -3.1 † F 12 μg 0.2* 0.4* -1.2* -1.2* *p=ns; † p<0.05 Conclusions: Lung function improvements with O QD translated into symptomatic benefit in COPD pts receiving usual care background therapy. Funding: Boehringer Ingelheim.
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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 | 0.008 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.007 | 0.011 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".