QAV680, cetirizine and their combination reduce nasal symptoms in patients with intermittent allergic rhinitis in an environmental exposure chamber
Bibliographic record
Abstract
Introduction QAV680 is an oral, selective, competitive, and reversible CRTh2 antagonist. This study assessed the effect of an antihistamine, QAV680 or a combination of the two in the treatment of ragweed pollen-induced allergic rhinitis in an environmental exposure chamber (EEC). Methods In this double-blind, 3-period incomplete crossover study ( NCT01103050 ), patients (pts) with seasonal allergic rhinitis were randomised (1:1:1:1) to either QAV680 500mg qid, cetirizine (CTZ) 10mg od, a combination of the two, or placebo (PBO) for 14 days. Efficacy on total nasal and ocular symptom score (TNSS and TOSS, respectively), PK and safety data was determined. Results Of the 60 pts randomised, 48 completed the study. The combination therapy QAV680+CTZ, and monotherapies (QAV680, CTZ) significantly reduced TNSS (averaged over last 2hrs of 8hrs of allergen exposure EEC, day 14) and TOSS compared with PBO (table). QAV680, CTZ and the combination were well tolerated with comparable numbers of subjects with adverse events in each treatment group (QAV680+CTZ=16.3%; QAV680=32.5%; CTZ=23.3%; PBO=15.8%). No deaths or SAEs were reported and PK data were consistent with previous phase I studies. Table: TNSS and TOSS scores averaged over last 2hrs of 8hr allergen exposure in the EEC on day 14 Parameters QAV680+CTZ vs PBO QAV680 vs PBO CTZ vs PBO TNSS –2.52; p<0.0001 –1.68; p=0.0022 –1.92; p=0.0004 TOSS –1.42; p=0.0019 –1.28; p=0.0062 –1.38; p=0.0027 Least square mean differences Conclusion QAV680, cetirizine and their combination were well tolerated and significantly reduced nasal and ocular symptoms versus placebo in patients with intermittent seasonal allergic rhinitis.
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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 | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 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) | 0.000 | 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".