Teva Pharmaceutical Industries Ltd. announced results from a phase III study of Qnaze (Beclomethasone Dipropionate [BDP]) HFA, a nasal aerosol corticosteroid in development for the treatment of Seasonal Allergic Rhinitis (SAR), that demonstrated significantly greater symptom relief compared with placebo. The results, presented at the 2010 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Phoenix, Ariz., showed that the non-aqueous formulation met all primary and secondary efficacy endpoints, and that the product demonstrated safety similar to placebo.

In addition to the phase III SAR trial, Teva is also evaluating the safety and efficacy of Qnaze in the treatment of Perennial Allergic Rhinitis (PAR). The PAR studies are still underway at the time of this release.

“The results of this pivotal clinical trial suggest that Qnaze HFA may be efficacious and safe for individuals seeking relief from the nasal symptoms associated with their seasonal allergies,” said Jay van Bavel, MD, Allergy and Asthma Associates, Austin, Texas, and lead investigator for the study.

Intranasal corticosteroids are often used as first-line therapy for the treatment of allergic rhinitis. Currently, the only Intranasal Steroids (INS) available are products with an aqueous or "wet" spray. Aerosol spray formulations became unavailable in the US following the US Food and Drug Administration's (FDA) decision to phase out all Metered Dose Inhalers (MDIs) that used ozone-depleting chlorofluorocarbon (CFC) propellants. Qnaze is delivered in an aerosol formulation propelled by hydrofluoroalkane (HFA). This formulation is "dry" and the propellant is environmentally friendly.

“We embarked on the Qnaze development programme because we know there remain unmet needs amongst the 60 million Americans who suffer with allergic rhinitis that could be addressed by an aerosolized delivery of an intranasal steroid,” said Prof. Yitzhak Peterburg, Teva's Group vice president, global branded products.

This phase III, randomized, double-blind, placebo-controlled, parallel-group study assessed the efficacy and safety of Qnaze HFA in the treatment of SAR in subjects 12 years of age and older. At four US investigational sites, 340 SAR patients were randomized to receive 320 mcg daily of Qnaze HFA or placebo as a nasal aerosol over a two-week period during the Mountain Cedar pollen season.

For the primary endpoint, the results showed a significant (p<0.001) change from baseline in the average morning and evening subject-reported reflective Total Nasal Symptom Score (rTNSS), a standard instrument for measuring nasal allergy symptoms. The symptom improvements were evident by day two and were maintained throughout the treatment period. Similarly, the change in instantaneous TNSS (iTNSS), a secondary endpoint, was significantly greater versus placebo. Additionally, for both of these measures, all four individual nasal symptom scores of sneezing, runny nose, nasal itching and nasal congestion demonstrated significant improvement with Qnaze HFA versus placebo.

Qnaze HFA was also well tolerated and the safety profile was similar to that of placebo. The most common treatment-emergent adverse event was nasal discomfort that was similarly reported for both Qnaze HFA (n=11) and placebo (n=10).

Additional results from a phase I study that evaluated the pharmacokinetics, safety and tolerability of Qnaze HFA, showed that the systemic exposure following administration of the treatment (up to 320 mcg/day) was approximately 27 per cent of orally inhaled BDP HFA, which is marketed by Teva as the asthma treatment Qvar (beclomethasone dipropionate HFA) Inhalation Aerosol. All doses of Qnaze and Qvar were well tolerated and no treatment-related adverse events were reported. Based on these results, the established Qvar safety data may provide further supportive evidence for the development of this non-aqueous nasal formulation for the treatment of allergic rhinitis.

Allergic Rhinitis (AR) is a chronic inflammatory disease characterized by sneezing, nasal itch, rhinorrhea, and nasal congestion as symptoms, in addition to allergic conjunctivitis in many subjects. For many AR patients, a stuffy nose may be the most irritating symptom; however, a recent survey reported almost half (46%) of parents of children with allergic rhinitis reported severe symptoms such as headache and ear and facial pain. Based on the available evidence, intranasal corticosteroids are the most effective treatment options for patients with AR. Morbidity associated with AR can be significant. Effective treatment of AR may improve asthma control when both diseases coexist.

In the US, the prevalence of AR has increased during the past three decades; it is recently estimated at 20% in the general adult population and closer to 40% in children. Of the estimated 60 million Americans affected with AR, approximately 20% have SAR, 40% have PAR, and 40% have a combination of the two (i.e., PAR with seasonal exacerbation) depending on the allergen sensitivity. Because of its prevalence and health effect, AR is associated with considerable direct and indirect costs. An estimate of $11.2 billion in healthcare costs, 12 million physician office visits, 2 million days of school absences and 3.5 million lost work days per year are attributed to AR. In addition, the presence of co-morbidities such as asthma and sinusitis further increase AR-related treatment costs.


Teva Pharmaceutical Industries Ltd. is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients.