Safety of Mometasone Furoate Nasal Spray in Children with Allergic Rhinitis as Young as 2 Years of Age: A Randomized Controlled Trial
Bibliographic record
Abstract
Current treatment guidelines recommend intranasal corticosteroids or nonsedating antihistamines as first-line therapy for allergic rhinitis (AR). Because of concerns regarding the systemic safety of intranasal corticosteroids in children, the present study was conducted to evaluate systemic activity of mometasone furoate nasal spray (MFNS) in children as young as 2 years of age with AR. This was a randomized, third-party blind, parallel-group, placebo-controlled trial conducted at a single research center with 56 subjects from 2 to <6 years of age. Subjects were randomized to 100 µg MFNS or placebo once daily in the morning (one 50 µg spray/nostril) for 42 consecutive days. The primary variables were serum cortisol concentration and 24-hour urinary free cortisol, corrected for creatinine (UFC) at end of treatment. Baseline values for serum cortisol (AUC(0–24)) were comparable for MFNS and placebo (225.2 µg/hour/dL and 232.3 µg/hour/dL, respectively), as were baseline values for UFC (75.8 µg/gm per 24 hours, and 76.0 µg/gm per 24 hours, respectively). At end point, serum cortisol (AUC(0–24)) values were 216.7 µg/hour/dL in the MFNS group and 201.1 µg/hour/dL in the placebo group. The UFC values at end point were 51.6 µg/gm 24 hours and 98.4 µg/gm 24 hours in the MFNS and placebo groups, respectively. No significant differences were observed between treatments, and neither treatment was associated with significant changes from baseline in serum cortisol or urinary free cortisol. This study demonstrates that treatment with MFNS 100 µg once daily in the morning in patients as young as 2 years of age had negligible systemic exposure and did not appear to affect hypothalamic-pituitary-adrenal (HPA) axis function. (Pediatr Asthma Allergy Immunol 2006; 19[3]:146–153.
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
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".