Efficacy and safety of fluticasone furoate nasal spray in adult and adolescent subjects with uncomplicated acute rhinosinusitis
Bibliographic record
Abstract
Uncomplicated acute rhinosinusitis (ARS) is usually a self-limiting inflammatory condition often treated with antibiotics. This study evaluated an alternative treatment for symptomatic relief of uncomplicated ARS, fluticasone furoate nasal spray (FFNS). This randomized, double-blind, placebo-controlled, parallel-group, multicenter, 2-week treatment study evaluated FFNS 110 mcg once daily, twice daily vs. placebo in adults/adolescents with uncomplicated ARS. Eligibility criteria reflected a clinical diagnosis and eliminated confounding conditions like common cold, symptomatic allergic rhinitis (AR), and other sinonasal conditions. Subjects with daily major symptom score (MSS; a composite score of 3 symptoms [nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip on a 0-3 scale]) >4.5 at baseline were randomized. The study demonstrated a statistically significant reduction in daily MSS by both FFNS doses compared to placebo (LS mean differences vs. placebo of -0.357 [p=0.014] and -0.386 [p=0.008] for BID and QD, respectively). The differences in median time to symptom improvement between placebo (8 days) and each FFNS dose (7 days) were not statistically significant. There were no treatment differences in antibiotic use due to the development of possible fulminant bacterial rhinosinusitis (3% in each group). The safety profile of FFNS was similar to placebo. FFNS reduced symptoms of uncomplicated ARS compared to placebo and was well tolerated, providing support for withholding antibiotics in selected patients. (FFR113203/ GSK funded)
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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 | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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 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".