Characteristics of Participants with Refractory Chronic Cough Enrolled in A Phase 2b Trial of BLU-5937
Bibliographic record
Abstract
<b>Aims:</b> 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. <b>Methods:</b> 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. <b>Results:</b> 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). <b>Conclusions:</b> 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.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
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 | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 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 teacher head, 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".