Positive results in Phase 3 study for Allegra®/Telfast® in patients with allergic rhinitis

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  • 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

New Delhi, December 17, 2019: The results of the Phase III , single center, 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.

“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.

[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

Corporate Comm India (CCI Newswire)