Efficacy in SOOTHE, A Phase 2b Trial of BLU-5937 In Refractory Chronic Cough, Was Not Dependant of Taste Disturbance Adverse Events
Bibliographic record
Abstract
Aims: Taste disturbances adverse events (TDAE) in studies of P2X3 antagonists for the treatment of refractory chronic cough (RCC) may be due to off-target inhibition of the related receptor P2X2/3. Novel antagonists with higher selectivity may have lower incidences of TDAEs. TDAEs may unblind participants to treatment, confounding measurement of efficacy. Here we characterize the TDAEs and impact on efficacy in SOOTHE, a phase 2b trial of the selective P2X3 antagonist BLU-5937 in the treatment of RCC. Methods: The primary endpoint in SOOTHE was the change from baseline in 24H cough frequency in RCC participants with a baseline awake cough frequency ≥25 coughs/h. Treatment-emergent AEs were collected throughout the randomized treatment period. Results: Treatment-emergent TDAEs were reported by 4.8, 6.5, 4.8 and 0% of participants in the 12.5, 50, 200 mg BID and placebo groups, respectively. Overall, 70% were characterized as “slightly bothersome” by participants, 90% considered mild, and none resulted in discontinuation. Changes in 24H cough frequency over placebo of -21.1, -34.4, and -34.2% were observed in the main population after 28 days of BLU 5937 treatment at 12.5, 50, and 200 mg BID, respectively. Participants who did not report TDAEs saw similar placebo-adjusted reductions in 24H cough frequency of -19.3, -31.9, and -33.2%, respectively. Conclusions: The limited incidence and mild nature of TDAEs reported during treatment with BLU-5937 in SOOTHE does not appear to have significantly confounded assessment of treatment effect.
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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) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.009 | 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".