S3 Gefapixant efficacy and safety in participants with history of refractory or unexplained chronic cough for ≥1 vs <1 year
Bibliographic record
Abstract
Introduction and Objectives The efficacy, safety, and tolerability of gefapixant were previously studied in two phase 3 trials of individuals with refractory or unexplained chronic cough (RCC/UCC) for ≥1 year and in a phase 3b trial of individuals with cough history >8 weeks and RCC/UCC for <1 year. This analysis compared baseline characteristics and efficacy and safety profiles of gefapixant 45 mg twice daily (BID) after 12 weeks of treatment in these trial populations to assess how these variables compare in individuals with RCC/UCC for ≥1 vs <1 year. Methods Participants with RCC/UCC for ≥1 year in the phase 3 trials (NCT03449134 [COUGH-1], NCT03449147 [COUGH-2]; pooled) and with RCC/UCC for <1 year in the phase 3b trial (NCT04193202) who received gefapixant 45 mg BID or placebo were analyzed. Change from baseline in patient-reported outcomes, including Leicester Cough Questionnaire (primary endpoint for <1-year trial), cough severity visual analog scale, and Cough Severity Diary, were evaluated at Week 12. Safety was also evaluated at Week 12. Results Demographics and baseline cough characteristics were similar across trials (≥1 year: gefapixant 45 mg BID, n=682; placebo, n=678; <1 year: gefapixant 45 mg BID, n=206; placebo, n=209), with the exception of cough duration (mean [standard deviation]: 11 [9] years vs 7 [3] months; median [range]: 8 [2–65] years vs 8 [1–12] months). Compared with placebo, the efficacy of gefapixant 45 mg BID in improving patient-reported outcomes was similar, regardless of RCC/UCC duration (figure 1). Adverse event (AE) incidences for gefapixant 45 mg BID were 80% (≥1 year) and 64% (<1 year); taste-related AEs occurred in 64% (≥1 year) and 54% (<1 year) of participants, and >95% of AEs were mild or moderate in both data sets. Conclusions Results from this analysis suggest a similar and favorable response to gefapixant 45 mg BID regardless of RCC/UCC duration. Please refer to page A282 for declarations of interest related to this abstract.
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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 | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 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) | 0.046 | 0.002 |
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".