title: Solubilized nasal steroid (CDX-947) when combined in the same solution nasal spray with an antihistamine (CDX-313) provides improved, fast-acting symptom relief in patients with allergic rhinitis.
abstract: Studies indicate that allergy sufferers remain dissatisfied with available antiallergic therapies. A new convenient formulation of solubilized steroid combined in the same nasal spray solution with antihistamine may provide added symptom relief. The objective was to evaluate effects of CDX-947 (solubilized budesonide) and CDX-313 (solubilized azelastine + budesonide) against their suspension-type comparators (budesonide [Rhinocort Aqua {RA}] or azelastine + budesonide [Astelin] {AS} + RA]) and placebo on nasal allergy symptoms of patients exposed to controlled levels of ragweed pollen in an environmental exposure chamber (EEC). Two separate EEC studies that enrolled 173 patients were analyzed. Total nasal symptom score (TNSS) and onset of action were captured. Mean change from baseline of TNSS was compared with analysis of covariance and the onset of action determined. Meta-analysis was performed to allow cross-comparisons between studies. All active treatments significantly reduced TNSS when compared with placebo and both CDX-947 and CDX-313 showed increased improvement over the suspension-type comparators. CDX-313 provided significantly faster onset of action for itchy nose and sneezing. No clinically significant adverse events were reported in this study. The novel combination product, CDX-313, provided fast, long-lasting relief for allergic rhinitis symptoms. Compared with products where corticosteroid remains suspended, the new solubilized nasal spray formulation provides added benefit including faster onset of action and superior, convenient dosing of two therapeutics in one convenient product.
authors.affiliation: Cetero Research, Mississauga, Ontario, Canada. annemarie.salapatek@cetero.com
authors.forename: Anne Marie
authors.initials: AM
authors.lastname: Salapatek
authors.forename: Joanne
authors.initials: J
authors.lastname: Lee
authors.forename: Deepen
authors.initials: D
authors.lastname: Patel
authors.forename: Pina
authors.initials: P
authors.lastname: D'Angelo
authors.forename: Jianhua
authors.initials: J
authors.lastname: Liu
authors.forename: Rupert O
authors.initials: RO
authors.lastname: Zimmerer
authors.forename: James D
authors.initials: JD
authors.lastname: Pipkin
mesh_terms: D000328:Adult; D000485:Allergens / Q000009:adverse effects / Q000276:immunology; D031164:Ambrosia; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects; D018450:Disease Progression; D004338:Drug Combinations; D005260:Female; D006633:Histamine Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D059085:Nasal Sprays; D010793:Phthalazines / Q000008:administration & dosage* / Q000009:adverse effects; D011058:Pollen / Q000009:adverse effects; D011537:Pruritus; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000503:physiopathology; D013256:Steroids / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000485:Allergens; D004338:Drug Combinations; D006633:Histamine Antagonists; D059085:Nasal Sprays; D010793:Phthalazines; D013256:Steroids; D019819:Budesonide; C020976:azelastine