Figures
- FIGURE 1
Schematic of study design. DEP: diesel exhaust particles; H: hour; V: visit. Note: visit 5 on day 32 could be accomplished via a telephone contact.
- FIGURE 2
Subjects' disposition. TNSS: total nasal symptom score; ITT: intent-to-treat; mITT: modified intent-to-treat.
- FIGURE 3
Mean±se total nasal symptom score (TNSS) area under the curve between hour 0 and hour 12 (AUC0–12) in Periods 1 and 2 (evaluable population). #: p-value was obtained using a mixed model for repeated measures (MMRM) on log transformed values of TNSS AUC0–12 plus 0.1, adjusted on baseline TNSS (hour 0) for each period (1 and 2) and on pollen counts at each environmental exposure unit (EEU) session, with period as a fixed categorical effect. DEP: diesel exhaust particles.
- FIGURE 4
Mean±se total nasal symptom score (TNSS) area under the curve between hour 2 and hour 12 (AUC2–12) in Period 3 (modified intent-to-treat population). #: p-value was obtained using ANCOVA of log-transformed values of TNSS AUC2–12 plus 0.1, with treatment group as a fixed categorical effect and baseline TNSS (H2) as covariate.
- FIGURE 5
Mean±se total nasal symptom score (TNSS) area under the curve for hour 2 to hour 12 (AUC2–12) by time point in Period 3 (modified intent-to-treat (mITT) population).
- FIGURE 6
Mean±se area under the curve between hour 2 and hour 12 (AUC2–12) of individual symptom scores after pollen+diesel exhaust particles exposure (modified intent-to-treat population).
Tables
- TABLE 1
Subject demographics and baseline characteristics
Evaluable population Modified intent-to-treat population Placebo Fexofenadine HCl 180 mg All Subjects 257 125 126 251 Age years 40.8±0.78 41.5±1.12 40.0±1.12 40.7±0.79 Sex Male 90 (35.0) 37 (29.6) 49 (38.9) 86 (34.3) Female 167 (65.0) 88 (70.4) 77 (61.1) 165 (65.7) Smoking status Never smoked 173 (67.3) 77 (61.6) 92 (73.0) 169 (67.3) Quit smoking 52 (20.2) 30 (24.0) 22 (17.5) 52 (20.7) Currently smokes 32 (12.5) 18 (14.4) 12 (9.5) 30 (12.0) Allergic medical history Seasonal allergic rhinitis 257 (100.0) 125 (100.0) 126 (100.0) 251 (100.0) Perennial allergic rhinitis 183 (71.2) 85 (68.0) 92 (73.0) 177 (70.5) Mean allergen wheal diameter mm Control 0.5±0.06 0.5±0.09 0.4±0.07 0.5±0.06 Ragweed 12.4±0.4 11.9±0.47 12.9±0.62 12.4±0.39 TNSS Period 1 (H0)# 0.5±0.05 95% CI for the mean 0.40–0.62 Median (interquartile range) 0 (0.0–1.0) Range 0–5 Period 2 (H0)# 0.5±0.06 95% CI for the mean 0.39–0.61 Median (interquartile range) 0 (0.0–1.0) Range 0–5 Period 3 (H2)# 6.2±0.20 5.6±0.18 95% CI for the mean 5.77–6.55 5.27–6.00 Median (interquartile range) 6.0 (5.0–8.0) 6.0 (4.0–7.0) Range 0–9 0–9 Data are presented as n, mean±se or n (%). Percentages are calculated from non-missing data. #: For Period 1 and Period 2, the baseline is defined as the value at H0 (start of challenge), for Period 3 baseline is defined as the last available value after challenge and before treatment administration. TNSS: total nasal symptom score.
- TABLE 2
Incidence of treatment-emergent adverse events by primary system organ class and preferred term at an incidence of ≥2% (safety population)#
Primary system organ class (preferred term) Placebo Fexofenadine HCl Subjects 126 127 Any class 19 (15.1) 16 (12.6) Infections and infestations 3 (2.4) 2 (1.6) Upper respiratory tract infection 2 (1.6) 2 (1.6) Gastroenteritis 1 (0.8) 0 (0.0) Immune system disorders 7 (5.6) 6 (4.7) Seasonal allergic rhinitis 7 (5.6) 6 (4.7) Respiratory, thoracic and mediastinal disorders 5 (4.0) 2 (1.6) Nasal dryness 0 (0.0) 2 (1.6) Cough 1 (0.8) 0 (0.0) Nasal congestion 1 (0.8) 0 (0.0) Nasal pruritus 1 (0.8) 0 (0.0) Rhinorrhoea 1 (0.8) 0 (0.0) Sneezing 1 (0.8) 0 (0.0) Upper-airway cough syndrome 1 (0.8) 0 (0.0) Gastrointestinal disorders 0 (0.0) 3 (2.4) Dry mouth 0 (0.0) 1 (0.8) Enlarged uvula 0 (0.0) 1 (0.8) Nausea 0 (0.0) 1 (0.8) Data are presented as n or n (%). HCl: hydrochloride. #: Subjects may have experienced more than one type of adverse event within any primary system organ class.
Supplementary Material
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Supplementary material 00806-2020.SUPPLEMENT
