Phase 3, single-center, sequential and parallel-group, double-blind, randomized study evaluating the efficacy and safety of Fexofenadine Hydrochloride 180 mg (Allegra®/Telfast®) versus placebo in subjects suffering from Allergic Rhinitis with symptoms aggravated in presence of pollutants: analysis of individual symptom scores
Bibliographic record
Abstract
Study sponsored by Sanofi. The prevalence of Allergic Rhinitis (AR) has progressively increased and one potential contributing factor is air pollution.[1] Diesel Exhaust Particulate (DEP) in combination with allergen enhances allergen-induced degranulation in the immediate term, increasing histamine release and leading to worsening symptoms.[2] The NCT03664882 study, aimed to demonstrate the aggravation of AR symptoms in presence of pollutants (DEP) and evaluate the efficacy of fexofenadine HCl in AR subjects with symptoms aggravated in presence of pollutants. The study performed outside the pollen season used an Environmental Exposure Unit in 3 sequential exposure periods [1]. Ragweed Pollen (RP), 2. RP plus DEP, 3. RP plus DEP] to evaluate the exposure effect on AR symptoms. During the period 3, subjects received fexofenadine HCl 180 mg or placebo QD to assess efficacy and safety. Primary endpoints are described in abstract 257. We describe here secondary endpoints. Two hundred fifty-one AR subjects (median age: 40 years old, 66% females) were included in the mITT population. The mean (sd) AUC2-12 for individual symptom scores including rhinorrhea [(PBO:10.59(6.50), FEX 7.54(5.96)]; sneezing [(PBO:7.01(6.49), FEX:4.26 (4.75)]; nasal itching [(PBO:8.74(6.03), FEX:6.73 (5.63)], nasal congestion [(PBO: 11.27 (6.98), FEX:8.48 (5.81)]; itchy eyes [(PBO:5.92 (5.53), FEX:4.56(4.95)], watery eyes [(PBO: 4.44(5.61), FEX: 3.22 (4.00)]; red or burning eyes [(PBO:5.13 (6.14); FEX:3.86 (5.13)]; ear itching or palate or throat itching [(PBO:6.13 (5.75), FEX:4.99 (5.88)], was lower in fexofenadine HCl group vs placebo. Before fexofenadine or placebo treatment, 121/266 (45.5%) eligible subjects experienced at least one Adverse Event (AE), headache (4%) was the most frequent. One withdrew in Period 2 after 61 minutes of exposure, due to intolerable symptoms of chest discomfort and dyspnea. Frequency of Treatment Emergent AE is comparable between fexofenadine HCl [16 (12.6%)] and placebo [19 (15.1%)] groups, respectively. One subject (0.8%) in the fexofenadine HCl group reported a treatment related AE (dry mouth). Along with the primary endpoints, these data support the results that AR symptoms are aggravated by air pollutant (DEP). Moreover, they emphasize that fexofenadine HCl 180 mg is effective and well-tolerated in AR sufferers with symptoms aggravated in presence of DEP.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.003 | 0.002 |
| Meta-epidemiology (broad) | 0.006 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.005 |
| Insufficient payload (model declined to judge) | 0.009 | 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".