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Effect of fexofenadine hydrochloride on allergic rhinitis aggravated by air pollutants

Anne K. Ellis, Margarita Murrieta-Aguttes, Sandy Furey, Pascaline Picard, Christopher Carlsten
ERJ Open Research 2021 7: 00806-2020; DOI: 10.1183/23120541.00806-2020
Anne K. Ellis
1Division of Allergy and Immunology, Dept of Medicine, Queen's University, Kingston, ON, Canada
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  • For correspondence: ellisa@queensu.ca
Margarita Murrieta-Aguttes
2Sanofi Consumer Health Care, Gentilly, France
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Sandy Furey
3Sanofi Consumer Health Care, Bridgewater, MA, USA
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Pascaline Picard
4Ividata, Levallois Perret, France
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Christopher Carlsten
5Air Pollution Exposure Laboratory, University of British Columbia, Vancouver, BC, Canada
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  • ORCID record for Christopher Carlsten
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  • FIGURE 1
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    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
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    FIGURE 2

    Subjects' disposition. TNSS: total nasal symptom score; ITT: intent-to-treat; mITT: modified intent-to-treat.

  • FIGURE 3
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    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
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    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
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    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
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    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

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  • TABLE 1

    Subject demographics and baseline characteristics

    Evaluable populationModified intent-to-treat population
    PlaceboFexofenadine HCl 180 mgAll
    Subjects257125126251
    Age years40.8±0.7841.5±1.1240.0±1.1240.7±0.79
    Sex
     Male90 (35.0)37 (29.6)49 (38.9)86 (34.3)
     Female167 (65.0)88 (70.4)77 (61.1)165 (65.7)
    Smoking status
     Never smoked173 (67.3)77 (61.6)92 (73.0)169 (67.3)
     Quit smoking52 (20.2)30 (24.0)22 (17.5)52 (20.7)
     Currently smokes32 (12.5)18 (14.4)12 (9.5)30 (12.0)
    Allergic medical history
     Seasonal allergic rhinitis257 (100.0)125 (100.0)126 (100.0)251 (100.0)
     Perennial allergic rhinitis183 (71.2)85 (68.0)92 (73.0)177 (70.5)
    Mean allergen wheal diameter mm
     Control0.5±0.060.5±0.090.4±0.070.5±0.06
     Ragweed12.4±0.411.9±0.4712.9±0.6212.4±0.39
    TNSS
     Period 1 (H0)#0.5±0.05
      95% CI for the mean0.40–0.62
      Median (interquartile range)0 (0.0–1.0)
      Range0–5
     Period 2 (H0)#0.5±0.06
      95% CI for the mean0.39–0.61
      Median (interquartile range)0 (0.0–1.0)
      Range0–5
     Period 3 (H2)#6.2±0.205.6±0.18
      95% CI for the mean5.77–6.555.27–6.00
      Median (interquartile range)6.0 (5.0–8.0)6.0 (4.0–7.0)
      Range0–90–9

    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)PlaceboFexofenadine HCl
      Subjects126127
      Any class19 (15.1)16 (12.6)
      Infections and infestations3 (2.4)2 (1.6)
       Upper respiratory tract infection2 (1.6)2 (1.6)
       Gastroenteritis1 (0.8)0 (0.0)
      Immune system disorders7 (5.6)6 (4.7)
       Seasonal allergic rhinitis7 (5.6)6 (4.7)
      Respiratory, thoracic and mediastinal disorders5 (4.0)2 (1.6)
       Nasal dryness0 (0.0)2 (1.6)
       Cough1 (0.8)0 (0.0)
       Nasal congestion1 (0.8)0 (0.0)
       Nasal pruritus1 (0.8)0 (0.0)
       Rhinorrhoea1 (0.8)0 (0.0)
       Sneezing1 (0.8)0 (0.0)
       Upper-airway cough syndrome1 (0.8)0 (0.0)
      Gastrointestinal disorders0 (0.0)3 (2.4)
       Dry mouth0 (0.0)1 (0.8)
       Enlarged uvula0 (0.0)1 (0.8)
       Nausea0 (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 Materials

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        Supplementary material 00806-2020.SUPPLEMENT

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      Effect of fexofenadine hydrochloride on allergic rhinitis aggravated by air pollutants
      Anne K. Ellis, Margarita Murrieta-Aguttes, Sandy Furey, Pascaline Picard, Christopher Carlsten
      ERJ Open Research Apr 2021, 7 (2) 00806-2020; DOI: 10.1183/23120541.00806-2020

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      Effect of fexofenadine hydrochloride on allergic rhinitis aggravated by air pollutants
      Anne K. Ellis, Margarita Murrieta-Aguttes, Sandy Furey, Pascaline Picard, Christopher Carlsten
      ERJ Open Research Apr 2021, 7 (2) 00806-2020; DOI: 10.1183/23120541.00806-2020
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