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.

Next-generation Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines for allergic rhinitis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE) and real-world evidence

“…Recommendations have been refined with RWE and chamber studies (Table IV). [20][21][22][23][24]38,39,41,42,45,50 The algorithm proposed in Fig 3 is also supported by the present data.…”

“…37 In the Ontario and Vienna allergen exposure chambers, several medications have been tested (Table III). 26,27,[38][39][40][41][42][43][44][45][46][47][48][49][50][51] The Ontario chamber studies show the rapid onset of efficacy for azelastine and its combinations. There does not seem to be a difference between azelastine alone or in combination.…”

Allergen exposure chambers: harmonizing current concepts and projecting the needs for the future – an EAACI Position Paper

“…If conditions are tightly controlled, repetition of the same protocol on separate occasions should yield the same results. This reproducibility has been reported with the Vienna Challenge Chamber (VCC) (Vienna, Austria), the EEC (Mississauga, Canada), the Environmental Exposure Unit (EEU) (Kingston, Canada), the Chamber at Department of Public Health, Aarhus University (Aarhus, Denmark), Biogenics Research Chamber LLC (San Antonio, TX, USA), Mobile Chamber Experts (MCX) (Berlin, Germany) and the Fraunhofer Allergen Challenge Chamber (Hannover, Germany) . Other facilities should publish their reproducibility data.…”

Controlled Allergen Challenge Facilities and Their Unique Contributions to Allergic Rhinitis Research

“…A study comparing the solubilized form with the suspended form of budesonide, in combination with azelastine, found all active treatments demonstrated significant decreases in TNSS, compared to placebo, but the solubilized forms offered greater relief and demonstrated a faster onset of action [68]. Thus, CACF models have been instrumental in demonstrating the efficacy of intranasal steroids, their relative efficacy compared to medications targeting other pathways, determining their onset of action, and exploring characteristics of different formulations.…”