JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today announced positive findings from a Phase III clinical study that examined the safety and efficacy of QNASL® (beclomethasone dipropionate) Nasal Aerosol 80 μg/day in children 4-11 years of age with perennial – or "year round" – allergic rhinitis (PAR). QNASL is a waterless aerosol intranasal corticosteroid spray currently available for the treatment of PAR and seasonal allergic rhinitis (SAR) in patients 12 years of age and older. The data will be presented at the 2014 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in Atlanta, Georgia on Saturday, November 8 and Sunday, November 9.
"As a company deep-rooted in its commitment to helping people living with respiratory conditions, such as allergic rhinitis, we look forward to the potential for bringing this new, specially formulated treatment option to market," said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. "It is our goal at Teva to address patients' unmet needs and we believe these findings support QNASL as a prospective treatment for children suffering from the symptoms associated with nasal allergies."
On May 13, 2014, the U.S. Food and Drug Administration (FDA) accepted the supplemental new drug application (sNDA) for a lower dose QNASL for the treatment of PAR and SAR in children 4-11 years of age. The submission was based on a comprehensive clinical development program consisting of three Phase III clinical trials designed to evaluate the safety and efficacy of QNASL 80 μg/day in children with allergic rhinitis (AR). If approved, QNASL will be the first and only waterless HFA nasal allergy treatment available for patients as young as four years of age.
"Since there are limited new treatment options available to help manage allergic rhinitis in the pediatric patient population, it is certainly exciting to see these results for QNASL," said study investigator Dr. William Berger of the Allergy and Asthma Associates of Southern California in Mission Viejo, California. "This treatment features a low-dose formulation and 'waterless' aerosol delivery, making it a promising option for children with allergic rhinitis."
The 12-week, Phase III, randomized, double-blind, placebo-controlled, parallel-group clinical trial enrolled 547 patients ages 4 to 11 to receive two actuations (one 40 μg/actuation per nostril) of QNASL or placebo nasal aerosol once daily. Symptoms were measured at 6 weeks and 12 weeks using average morning (AM) and evening (PM) reflective and instantaneous nasal symptom scores. Results indicate that patients treated with QNASL experienced a significantly greater improvement in PAR symptoms than patients treated with placebo. Overall, QNASL was well tolerated throughout the duration of the study with a safety profile comparable to placebo.
About the Study
A total of 547 patients, 4-11 years of age, were randomized to receive two actuations (one 40 μg/actuation per nostril) of QNASL or placebo nasal aerosol once daily. The primary endpoint was change from baseline in average morning (AM) and evening (PM) reflective total nasal symptom score (rTNSS) through the first six weeks of treatment in patients 6-11 years of age. Additional efficacy endpoints included change from baseline in average AM and PM instantaneous TNSS (iTNSS) in children 6-11 years of age and change from baseline in average rTNSS and iTNSS in children ages 4-11.
Results from the study revealed improvement was significantly greater with QNASL than with placebo over the first six weeks of treatment in children 6-11 years of age AM and PM rTNSS and iTNSS (mean [95% CI] treatment difference: –0.66 [–1.08, –0.24], P = 0.002 and –0.58 [–0.99, –0.18], P = 0.004, respectively). Improvement in PAR symptoms in children ages 4-11 was significantly greater with QNASL than placebo in average AM and PM rTNSS and iTNSS at week six (P = 0.002 and P = 0.004, respectively). Similar results were observed over 12 weeks (P < 0.001). In addition, improvement in average AM and PM reflective individual nasal symptoms over the first six weeks of treatment in children ages 6-11 was significantly greater for rhinorrhea (P = 0.004), nasal congestion (P = 0.001) and sneezing (P = 0.002) with QNASL versus placebo. Overall, QNASL was well-tolerated throughout the duration of the study with a safety profile comparable to placebo.