Date: 2014-11-07
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 2014 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in Atlanta, Georgia
Company: Teva Pharmaceutical Industries (Israel)
Product: QNASL® (Beclomethasone Dipropionate) Nasal Aerosol
Action
mechanism: QNASL® is an intranasal corticosteroid in development for the treatment of allergic rhinitis symptoms. The product utilizes the same chemical formulation as QVAR® (beclomethasone dipropionate HFA) Inhalation Aerosol, an inhaled corticosteroid (ICS) approved by the FDA for the maintenance treatment of asthma. QNASL® is administered as a non-aqueous or \"dry” spray delivered by hydrofluoroalkane (HFA), an environmentally friendly propellant. 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.
Disease: perennial allergic rhinitis (PAR)
Therapeutic area: Allergic diseases - Immunological diseases
Country:
Trial details:
Latest
news: * On November 7, 2014, Teva Pharmaceutical Industries 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). 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 . 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. Patients 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.
On May 13, 2014 , the 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.
