Onset of Action of Ciclesonide Once Daily in the Treatment of Seasonal Allergic Rhinitis
Bibliographic record
Abstract
Ciclesonide is an intranasal corticosteroid approved for the treatment of allergic rhinitis. We conducted a randomized, double-blind, parallel-group, placebo-controlled study to evaluate the time to onset of action of ciclesonide 200 microg once daily in 502 adults with seasonal allergic rhinitis of at least 2 years' duration. To trigger immunologic priming, patients underwent between one and five priming sessions with exposure to 3,500 grains/m(3) (+/-500) of ragweed pollen in an environmental exposure chamber. The criteria for a successful priming session were a patient-assessed instantaneous total nasal symptom score of at least 6 (of a possible 12) and a nasal congestion or rhinorrhea score of at least 2 (of a possible 3) 90 minutes after allergen exposure during at least two consecutive priming sessions. Patients were then randomly assigned to receive either a single dose of ciclesonide 200 microg (n = 251) or placebo (n = 251) administered intranasally. The difference in the change from baseline total nasal symptom scores in the two groups was assessed hourly for 12 hours after administration. Onset of action was determined to have taken place the first time that the effects of ciclesonide, as reflected in the total nasal symptom score, were significantly greater than those of placebo at a particular hourly assessment, provided that the subsequent hourly assessment also showed a statistically significant difference. The onset of action of ciclesonide occurred within 1 hour of administration (p = 0.01 vs. placebo), and the significant difference in total nasal symptom scores between ciclesonide and placebo was maintained through post-treatment hour 12 (p = 0.018).
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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 | 0.000 | 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".