Effect of 8 and 12 weeks' once-daily tiotropium and olodaterol, alone and combined with exercise training, on exercise endurance during walking in patients with COPD
Bibliographic record
Abstract
Introduction: Physical deconditioning is common in patients with COPD, limiting exercise tolerance. Aim: PHYSACTO® (NCT02085161) tested the effects of bronchodilators alone or with exercise training (ExT), combined with a standardised physical activity self-management behaviour-modification (BM) programme, on exercise endurance time (EET) in patients with COPD. Methods: A 12-week (wk) randomised, partially double-blind, placebo (P)-controlled, parallel-group trial at 34 sites in Australia, New Zealand, USA, Canada and Europe. Interventions (all with 12-wk BM): P; tiotropium (T) 5 µg; T + olodaterol (T+O) 5/5 µg; T+O 5/5 µg with 8 wks' ExT (T+O 5/5 µg + ExT). EET (log transformed) during an endurance shuttle-walk test (ESWT) to symptom limitation was assessed after 8 wks (primary end point) and 12 wks. Results: 303 patients (200 men) were randomised and treated (full analysis set n = 274). Mean post-bronchodilator FEV 1 was 1.59 L (56.7% predicted). EET significantly increased with T+O 5/5 µg and T+O 5/5 µg + ExT versus P at 8 wks (Fig); 13 patients reached test termination criteria (20 mins) without symptom limitation (P, n = 0; T, n = 3; T+O, n = 2; T+O + ExT, n = 8) at 8 wks. No safety concerns were identified. Conclusions: T+O 5/5 µg, alone and combined with ExT, improved EET during ESWT compared to P in moderate to severe COPD. Funding: Boehringer Ingelheim Fig. 1: † Geometric mean results reported as primary analysis based on log 10 -transformed data. ExT was stopped after 8 weeks but all groups continued study medication up to 12 weeks Geometric mean baseline endurance time: 242.73 s (Week 8); 241.96 s (Week 12) Patient numbers at Week 8: P + BM = 65; T 5 µg + BM = 67; T+O 5/5 µg + BM = 72: T+O 5/5 µg + ExT + BM = 70 Patient numbers at Week 12: P + BM = 62; T 5 µg + BM = 64; T+O 5/5 µg + BM = 71; T+O 5/5 µg + ExT + BM = 66 *p < 0.05; **p < 0.01; ***p < 0.001 for % improvement from P (p values at Week 12 were nominal) SE, standard error Content already presented at ERS congress 2016
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
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".