Sanofi Allegra shows positive results in phase 3 study for allergic rhinitis

"The study demonstrated that Allegra/Telfast 180mg significantly decreased pollution- exacerbated AR symptoms by 21% (p=0.0148) in adult allergic rhinitis patients," Sanofi said.

New Delhi: Drugmaker Sanofi recently announced the results of Phase III single-centre sequential and parallel-group, double-blind, randomized, 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 180mg significantly decreased pollution- exacerbated AR symptoms by 21% (p=0.0148) in adult allergic rhinitis patients, Sanofi said in its recent release.

The first primary endpoint found that Diesel Exhaust Particles (DEP), a common component of air pollution, significantly increased the severity of pollen-induced Allergic Rhinitis (AR) symptoms. The second primary endpoint demonstrated that treatment with Allegra/Telfast (fexofenadine hydrochloride) 180mg significantly reduced the severity of pollen-induced AR symptoms aggravated by pollution, compared to placebo.

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) 180mg versus placebo in adults with Allergic Rhinitis (AR) symptoms aggravated in the presence of air pollutants.

It was a Phase III, single-centre, 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, 180mg.

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.

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.

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.

“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.

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.”

The recent release by Sanofi mentioned that currently, 400 million people suffer from allergic rhinitis worldwide. 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, the US, 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.

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