Inhaled Lidocaine for the Treatment of Asthma: Lack of Efficacy in Two Double-Blind, Randomized, Placebo-Controlled Clinical Studies
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Bibliographic record
Abstract
BACKGROUND: Asthma with severe or persistent exacerbations is treated with chronic oral corticosteroids (OCS), such as prednisone. Although efficacious, OCS treatment is often associated with side effects; thus, corticosteroid-sparing treatments are needed. METHODS: We conducted two double-blind, placebo-controlled, clinical studies assessing lidocaine solution for inhalation (LSI; 40 mg twice daily; eFlow(®) nebulizer) to treat asthma. Study 1-Mild/Moderate included 154 patients with mild-moderate asthma [forced expiratory volume in one second (FEV(1)) ≥60% predicted, and ≥12% improvement in FEV(1) (L) after short-acting, inhaled β-agonist; no OCS or inhaled corticosteroids (ICS) in previous month] and evaluated whether FEV(1) improved after 12 weeks of treatment. Study 2-OCS included 114 patients with more severe asthma (FEV(1) 35-85% of predicted values, treatment with OCS for ≥6 months, average daily dose between 5 and 70 mg prednisone or equivalent, stable ≥30 days) and evaluated whether 20 weeks of treatment had a corticosteroid-sparing effect, measured as reduced need for OCS. RESULTS: LSI did not improve pulmonary function in Study 1-Mild/Moderate, and did not have a corticosteroid-sparing effect in Study 2-OCS, when compared with placebo. Thus, the primary efficacy endpoints were not met. Significant improvements were not observed for asthma symptom scores, morning and evening peak expiratory flow values, FEV(1) % predicted, proportion of patients with asthma instability, and asthma quality-of-life scores at week 12 (Study 1-Mild/Moderate) or week 20 (Study 2-OCS). LSI was well tolerated. CONCLUSIONS: These results indicate that lidocaine solution for inhalation is not a useful treatment for asthma; it did not improve pulmonary function and did not have a corticosteroid-sparing effect.
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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 | 0.003 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| 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 it