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FexPolSar Study

Background – Allergic Rhinitis and air pollution

  • Allergic Rhinitis (AR) is a multifactorial disease, with some evidence supporting a correlation between air pollutants and AR1
  • A recent Lancet Commission suggests that pollution is the largest environmental cause of death and disease globally, with the burning of combustible fuel and biomass accounting for around 85% of airborne particulate pollution2
  • Diesel exhaust particles (DEP) have been estimated to account for up to 80% of human exposure to particulate matter (PM) and most airborne PM in the world’s largest cities3
  • Epidemiological studies have shown a relationship between air pollutants and an increase in allergic/respiratory symptoms4
  • Individuals with AR may develop nasal hyper-responsiveness from various stimuli, rendering them more responsive to airborne irritants - likely to be involved in exacerbating symptoms of AR4

Reference

  1. London NR et al. World J Otorhinolaryngol Head Neck Surg 2018;4:209-15.
  2. Landrigan PJ et al. Lancet 2018;391:462-512.
  3. Huang S-K et al. J Thorac Dis 2015;7:23-33.
  4. Dunlop J et al. Immunol Allergy Clin North Am 2016;36:367-77.

FexPolSar Study: Schematic of Study Design

Screening:

  • Eligibility criteria

  • Informed consent

  • Skin prick test

  • Blood sampling

  • Vital signs

  • Physical Exam

  • Nasal Exam

Period 1:

  • H0 to H+3: Challenge to pollen (266 subjects)

  • H0 to H+3: Symptoms evaluation every 30min (TNSS ≥ 3 verification)

  • H+3: Discharge from EEU

  • H+3 to H+12: At home, symptoms evaluation every 60 min

  • H+12: End of symptoms evaluation; AE evaluation and concomitant medication recording

Period 2:

  • H0 to H+3: Challenge to pollen + DEP (261 subjects)

  • H0 to H+3: Symptoms evaluation every 30min

  • H+3: Discharge from EEU H+3 to H+12: At home, symptoms evaluation every 60 min

  • H+12: End of symptoms evaluation; AE evaluation and concomitant medication recording

Period 3:

  • H0 to H+3: Challenge to pollen + DEP (253 subjects)

  • H+2: Randomization and IMP administration

  • H+3: Subjects discharge from EEU

  • H+3 to H+12: At home, symptoms evaluation every 60 min

  • H+12: End of symptoms evaluation; AE evaluation and concomitant medication recording

Adapted from Ellis A K et al. WAO J, 2020, abstract in press; Ellis AK et al, EAACI 2020

Abbreviations

AE=adverse event, D=day, DEP=diesel exhaust particles, EEU=environmental exposure unit, H=hour, IMP=investigational medical product, mITT=modified intent-to-treat, TNSS=total nasal symptom score, V=visit. Note: V5 D32 was allowed to be attended by a phone call

FexPolSar Study: Schematic

Transmission electron microscope images of ragweed pollen and DEP at 1000x magnification

Adapted from Ellis A K et al. WAO J, 2020, abstract in press; Ellis AK et al, EAACI 2020

Abbreviation

DEP=diesel exhaust particles

FexPolSar Study: Subject disposition

Adapted from Ellis A K et al. WAO J, 2020, abstract in press; Ellis AK et al, EAACI 2020

Abbreviations

ITT=intent-to-treat, mITT=modified intent-to-treat, TNSS=total nasal symptom score

 FexPolSar Study: Subject Demographics at Baseline

  Evaluable population   mITT population  
Demographics All
N=257		 Placebo
N=125		 Fexofenadine HCI
180 mg N=126		 All
N=251
Mean age, years (SD) 40·8 (12·6) 41·5 (12·5) 40·0 (12·6) 40·7 (12·5)
Sex, n (%)        
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, n (%)        
Seasonal Allergy 257 (100·0) 125 (100·0) 126 (100·0) 251 (100·0)
Perennial Rhinitis 183 (71·2) 85 (68·0) 92 (73·0) 177 (70·5)

Adapted from Ellis A K et al. WAO J, 2020, abstract in press; Ellis AK et al, EAACI 2020

Reference

  1. Ellis A K et al. WAO J, 2020, abstract in press; Ellis AK et al, EAACI 2020

FexPolSar Study: Mean + SE TNSS for AUC from H0 to H12 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 AUC (H0-H12) plus 0.1, adjusted on baseline TNSS (H0) for each period (1 and 2) and on pollen counts at each EEU session, with period as a fixed categorical effect.

Abbreviations

AUC=area under the curve, DEP=diesel exhaust particles, H=hour, SE=standard error , TNSS=total nasal symptom score

Fexpolsar Study: Mean TNSS + SE from H+2 to H+12

*p: Analysis of covariance (ANCOVA) of Log transformed values of TNSS AUC2-12 plus 0.1, with treatment group as a fixed categorical effect and baseline TNSS (H+12) as covariate

Abbreviations

 AUC=area under the curve, H=hour, HCl=hydrochloride; mITT=modified intent-to-treat, SE=standard error, TNSS=total nasal symptom score

FexPolSar Study: Individual symptom scores

Abbreviations

 *Secondary endpoint; Foot note:  DEP= diesel exhaust particles, mITT= modified intent-to-treat; SE, standard error

Reference

  1. Ellis A K et al. WAO J, 2020, abstract in press; Ellis AK et al, EAACI 2020

FexPolSar Study: Adverse events occurring in ≥2% of patients in either treatment group

Primary system organ class (preferred term) Placebo, n (%)
N=126		 Fexofenadine HCI, n (%)
N=127
Any class 19 (15·1) 16 (12·6)
Immune system disorders 7 (5·6) 6 (4·7)
Seasonal allergy 7 (5·6) 6 (4·7)
Respiratory, thoracic and mediastinal disorders 5 (4·0) 2 (1·6)
Infections and infestations 3 (2·4) 2 (1·6)
Gastrointestinal disorders 0 (0·0) 3 (2·4)

Reference

  1. Ellis A K et al. WAO J, 2020, abstract in press; Ellis AK et al, EAACI 2020

FexPolSar Study - Conclusions

  • Among adults with documented ragweed allergy, controlled exposure to DEP + ragweed pollen in the EEU significantly increased SAR symptoms compared to ragweed exposure alone
  • DEP rapidly aggravated pollen-induced SAR symptoms and this effect persisted beyond the end of the DEP + pollen exposure period
  • Fexofenadine HCl 180 mg significantly reduced these pollution-aggravated symptoms, compared with placebo
  • Based on these data, we conclude that
    • Air pollutants can significantly exacerbate SAR symptoms
  • and that
    • Fexofenadine HCl 180 mg is an effective and well-tolerated treatment that has been shown to significantly alleviate these pollution-aggravated symptoms

Reference

  1. Telfast® 180mg film-coated tablets Patient Information leaflet; Revision date November 2020

Disclaimer

*Fexofenadine HCI 180 mg is registered in both markets of UAE and KSA please refer to the respective Patient Information leaflet in the reference tab

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MAT-AE-2300065/V3/Feb 2023