SOUTH AFRICA – January 13, 2020   – The results of the Phase III, single-centre, sequential and parallel-group, double-blind, randomised, placebo-controlled FEXPOLSAR study evaluating the efficacy and safety of Allegra®/Telfast® (fexofenadine hydrochloride) in adults with allergic rhinitis (AR) symptoms aggravated by a common component of air pollution were announced at the World Allergy Congress (WAC) in Lyon, France. The study demonstrated that Allegra®/Telfast® 180 mg significantly decreased pollution-exacerbated AR symptoms by 21% (p = 0.0148) in adult allergic rhinitis patients.

 

“For allergic rhinitis patient, symptoms such as a blocked or runny nose and itchy eyes can prevent a person from performing at their best in everyday life,” commenting on the results, Dr. Anne Ellis, the investigator of the FEXPOLSAR study, Professor and Chair of the Division of Allergy & Immunology, Department of Medicine at Queen’s University in Kingston Ontario and the Director of the Environmental Exposure Unit (EEU) said, “The FEXPOLSAR study has confirmed the impact of air pollution contributing to allergen-induced AR symptoms, and for the first time there’s strong clinical evidence that an allergy treatment can decrease these symptoms.”

During his speech at the Sanofi symposium during the Congress, Prof. Ignacio J. Ansotegui, Chairman and President of the World Allergy Organization (WAO) also addressed the prevalence of allergic rhinitis, “Many dismiss allergic rhinitis as trivial, yet its symptoms do have a major impact on those who suffer. Air pollution can have a serious impact on allergic rhinitis, as it aggravates the symptoms of the condition.”

Currently, 400 million people suffer from allergic rhinitis worldwide.[1] Allergy epidemic affects more than one billion patients with a global rise in prevalence, which may reach up to 4 billion affected individuals in 2050.[2] Allergies can increase in frequency and severity depending upon one’s immediate environment. Air pollution can also contribute to the severity of allergen-induced symptoms. The study aimed to understand the impact of a common constituent of air pollution, DEP, on the severity of pollen-induced AR symptoms and to determine whether Allegra®/Telfast® (fexofenadine hydrochloride) 180mg could provide significant benefit in alleviating AR symptoms in the presence of both pollen and DEP. The study has confirmed both the adverse impact of air pollution on pollen-induced AR symptoms and the positive effect of Allegra®/Telfast® 180mg in reducing these symptoms.

During the congress, the international consensus statement on the “Management of Allergic Rhinitis aggravated by air pollution” endorsed by WAO was officially released.  Authored by 23 experts in the field and led by Professor Robert Naclerio from Johns Hopkins, Baltimore, Maryland, U.S., the statement highlights the key findings of the FEXPOLSAR study and explains what needs to be done to improve the health of AR patients and the impact of this condition on society as a whole.

 

About the study

The FEXPOLSAR study compared and evaluated the exposure effect on AR symptoms on allergen alone (ragweed pollen (RP), and allergen plus air pollutants (diesel exhaust particulates [DEP]). It evaluated the efficacy and safety of Allegra®/Telfast® (fexofenadine hydrochloride) 180 mg versus placebo in adults with allergic rhinitis (AR) symptoms aggravated in presence of air pollutants.

It was a Phase III, single-center, sequential and parallel-group, double-blind, randomised, placebo-controlled study. It involved 261 participants with AR symptoms aged 40 years old; the total duration of the study was 8 weeks and 3 days (from 5 November 2018 to 3 January 2019). Fexofenadine hydrochloride was administrated in single-dose, 180 mg.

The study was performed outside the pollen season using an environmental exposure unit (EEU). It found a significant increase in total nasal symptom score (TNSS) in subjects exposed to both ragweed pollen (RP) and diesel exhaust particles (DEP), compared to RP alone. These findings are consistent with in vitro and biomarker data which have demonstrated that DEP can directly induce mast cells to degranulate, which can increase histamine levels and lead to increased AR symptom severity.[3]

 

About allergic rhinitis

Allergic rhinitis (AR) occurs when a person’s immune system reacts to allergens – such as pollen, dust mites, moulds and pet dander – in the air, causing the lining of the inside of the nose to become inflamed.[4] Typical symptoms include blocked or runny nose, itchy or watery eyes, sneezing and an itchy nose and throat.[5] Air pollutants can aggravate these symptoms.[3]

Allergic rhinitis is a common allergy that affects 400 million people worldwide.[6]

 

About fexofenadine hydrochloride

Fexofenadine hydrochloride (fexofenadine HCL) is a second-generation, non-sedating antihistamine used to relieve allergy symptoms such as sneezing, runny nose, itchy, watery eyes, itchy nose or throat. It works by blocking the natural substance histamine released during the that is made by the body during an allergic reaction.

In most of the countries, fexofenadine hydrochloride is registered with 120 mg and/or 180 mg dosages and it is indicated in allergic rhinitis and/or urticaria.

The FEXPOLSAR study has been performed with fexofenadine hydrochloride 180 mg which is marketed as Telfast® in Australia, and as Allegra® in the United States, as examples.

* Sanofi does not recommend the use of any product outside of their approved indications. Please consult your local prescribing information before prescribing.

 

About the World Allergy Congress

The World Allergy Organization (WAO) holds its World Allergy Congress (WAC) every two years. Since its first establishment in 1951 in Zurich, the Congress attracts over 4 000 experts and scientists working and interested in the fields of allergy, immunology and other related fields every year for exchanging and updating knowledge.

 

References:

[1] Bousquet, J., Burney, P.G., Zuberbier, T. et al. (2009). GA2 LEN (Global Allergy and Asthma European Network) addresses the allergy and asthma epidemic. Allergy. 64: 969–977.

[2]] Global Atlas of Allergic Rhinitis and Chronic Rhinosinusitis EAACI 2015/ http://www.eaaci.org/globalatlas/ENT_Atlas_web

[3] Diaz–Sanchez D. et al. Diesel exhaust particles directly induce activated mast cells to degranulate and increase histamine levels and symptom severity. J Allergy Clin Immunol. 2000 Dec;106(6):1140-6.

[4] https://www.nhs.uk/conditions/allergic-rhinitis/causes/

[5] https://www.worldallergy.org/UserFiles/file/WhiteBook2-2013-v8.pdf (page 34)

[6] https://www.worldallergy.org/education-and-programs/education/allergic-disease-resource-center/professionals/in-depth-review-of-allergic-rhinitis

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