P295 Efficacy and safety of tiotropium/olodaterol in patients with copd by ats category
Bibliographic record
Abstract
<h3>Rationale</h3> The once-daily combination of tiotropium (T), a long-acting muscarinic antagonist, and olodaterol (O), a long-acting β<sub>2</sub>-agonist, has demonstrated efficacy and safety in chronic obstructive pulmonary disease (COPD).<sup>1</sup> Recently, it has been demonstrated that patients with milder disease (GOLD 2) have better bronchodilator responses compared to those with more severe disease. This <i>post hoc</i> analysis investigated whether the response to T/O and to T alone is influenced by forced expiratory volume in 1 second (FEV<sub>1</sub>) American Thoracic Society (ATS) category (mild, moderate or severe). <h3>Methods</h3> In total, 5162 patients were randomised to O 5 µg, T 2.5 µg, T 5 µg, T/O 2.5/5 µg or T/O 5/5 µg (via Respimat<sup>®</sup> inhaler) in two 52-week, parallel-group, double-blind studies (TONADO<sup>®</sup> 1 and 2: NCT01431274; NCT01431287). This <i>post hoc</i> analysis focuses on the T 5 µg and T/O 5/5 µg analyses. Primary efficacy end points were trough FEV<sub>1</sub> response (ie, change from baseline) and FEV<sub>1</sub> area under the curve from 0–3 hours (AUC<sub>0–3</sub>) response. Data are presented for patients by ATS category subgroups: mild (predicted FEV<sub>1</sub> ≥50%), moderate (35 ≤ 50%) and severe (<35%), using data pooled from both of the TONADO<sup>®</sup> studies. <h3>Results</h3> In all disease-severity categories, the improvements in trough FEV<sub>1</sub> and FEV<sub>1</sub> AUC<sub>0–3</sub> were larger with T/O compared to T alone. However, trough FEV<sub>1</sub> and FEV<sub>1</sub> AUC<sub>0–3</sub> responses were generally greater in patients with mild (T/O versus T: both p < 0.0001) or moderate (T/O versus T: p < 0.001 and p < 0.0001, respectively) COPD versus those with severe COPD (T/O versus T: p < 0.01 and p < 0.0001, respectively) at baseline (Table). Treatments were well tolerated across all ATS categories and similar responses were observed in both of the studies individually. <h3>Conclusions</h3> These data build on the analysis of the GOLD 2 population from TONADO<sup>®</sup> and confirm that patients with mild to moderate disease derive greater benefits with T/O than with T. There was an overall trend towards greater lung-function improvement with T/O or T alone in patients with mild/moderate versus severe airflow obstruction. <h3>Funding</h3> Boehringer Ingelheim. <h3>Reference</h3> Buhl R, <i>et al</i>. <i>Eur Respir J</i> 2015;<b>45</b>:969–979. Please refer to page A273 for declarations of interest in relation to abstract P295.
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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".