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
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
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.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.003 |
| 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 it