Tiotropium respimat® add-on therapy reduces airflow obstruction in patients with symptomatic moderate asthma, independent of TH2 inflammatory status
Bibliographic record
Abstract
In two replicate Phase III, randomized, double-blind, placebo-controlled, parallel-group trials (NCT01172808/NCT01172821), patients with moderate symptomatic asthma, using medium-dose ICS (400-800 µg budesonide equivalent), were administered once-daily tiotropium Respimat 5 µg or 2.5 µg, placebo, or salmeterol (active comparator without inferential analysis). Co-primary endpoints included peak and trough FEV 1 response (difference from baseline) at 24 weeks. Pre-planned analyses (pooled population) were performed in T H 2-high and T H 2-low subgroups defined at baseline as total serum IgE ≤ or >430 µg/L) or blood eosinophils ≤ or >0.6×10 /L. Of 1545 patients in the full analysis set who received tiotropium or placebo, 915/1455 were reported with IgE >430 µg/L and 300/1461 with an eosinophil count of >0.6×10 /L. Peak FEV 1 improved with tiotropium versus placebo, independent of IgE (p<0.0001 both doses) and eosinophil count (p<0.0001 both doses). Trough FEV 1 also improved with tiotropium versus placebo, irrespective of IgE (p<0.0001 both doses) and eosinophil count (p<0.005 both doses). Once-daily tiotropium Respimat as add-on to ICS reduces airflow obstruction in patients with moderate symptomatic asthma, independent of T H 2 phenotype, and thus may potentially provide an important therapeutic option.
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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 | 0.000 | 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".