Characteristics of Participants with Refractory Chronic Cough Enrolled in A Phase 2b Trial of BLU-5937
Bibliographic record
Abstract
Aims: The SOOTHE study assessed the safety and efficacy of BLU-5937 in a refractory chronic cough (RCC) population enriched for cough frequency. Here, we report the baseline demographics and characteristics of this population. Methods: SOOTHE was a phase 2b, dose-finding trial in patients with RCC. Participants with baseline awake cough frequency ≥25 coughs/h were randomized in the main population, 1:1:1:1 to BLU-5937 12.5, 50,200 mg BID or placebo. Participants with awake cough frequency 10-25 coughs/h were randomized 1:1 in an exploratory population to 200 mg BID BLU-5937 or placebo. Results: The main population (n=249) was 82% women with a mean age of 60.9 ±10.6 years, BMI 28.2 ±6.0 kg/m2, mean cough duration 11.7 ±9.9 years, and mean geometric 24H cough frequency at baseline of 38.9 coughs/h. Overall, the exploratory population (n=61) presented similar demographics, except for a slightly lower proportion of women (61%) and a trend toward a higher BMI (30.1 ±5.3 kg/m2), and had a baseline geometric mean 24H cough frequency of 11.2 coughs/h. The main and exploratory populations had similar baseline cough severity VAS (72.9 ±14.8 vs 69.5 ±16.0 mm, respectively), with a minimal difference in cough-related quality of life reported by the LCQ (10.6 ±3.1 vs 11.8 ±3.0). Conclusions: The SOOTHE trial main population baseline demographics were consistent with other RCC studies. Despite a large difference in baseline cough frequency, stratification of patients demonstrated similar demographics and baseline characteristics in both high and low frequency cough count populations.
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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 | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 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".