Efficacy and safety of a novel nasal steroid, S0597, in patients with seasonal allergic rhinitis.
BACKGROUND
Allergic rhinitis (AR) poses a significant global burden with increasing prevalence. Although intranasal glucocorticosteroids are effective, older agents can have limiting side effects. S0597, a novel intranasal glucocorticosteroid, has demonstrated good safety and tolerability during preclinical and phase 1 studies.


OBJECTIVE
To assess the clinical efficacy, safety, and tolerability of different doses of S0597 nasal spray vs placebo in patients with seasonal AR.


METHODS
This phase 2, randomized, double-blinded, placebo-controlled, parallel-group, single-center study randomized 159 patients 18 to 65 years old (mean age 37.8 years) with a positive skin prick test reaction for Dactylis glomerata to receive S0597 at 200, 400, or 800 μg/d or placebo for 15 days. On days 1 (baseline), 15, and 16, patients underwent a 4-hour pollen challenge to evaluate treatment efficacy measured by the change in total nasal symptom score (TNSS) from baseline to days 15 and 16 and changes in TNSS subscales and nasal secretion.


RESULTS
Statistically significant improvements in TNSS from baseline to days 15 and 16 were observed with all S0597 doses vs placebo (P = .0005 overall), with the greatest improvements observed in the highest-dose group (P < .0001). Significant decreases were observed in each S0597 dose group vs placebo for TNSS subscales and nasal secretion. Improvements in nasal secretion were related to dose, with the greatest decreases from baseline in the 800-μg/d group on days 15 and 16 (P < .0001).


CONCLUSIONS
Treatment with S0597 at 200, 400, and 800 μg/d by 2 divided doses for 2 weeks was safe and significantly more effective than placebo for improving nasal symptoms associated with grass pollen-induced seasonal AR in adults.


BACKGROUND
ClinicalTrials.gov, identifier NCT01614691.
Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover, Germany. Electronic address: philipp.badorrek@item.fraunhofer.de.
Philipp
P
Badorrek
Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover, Germany.
Jens M
JM
Hohlfeld
Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover, Germany.
Norbert
N
Krug
Clinical Research Department, Sun Pharma Advanced Research Company Ltd, Mumbai, India.
Abhijeet
A
Joshi
Clinical Research Department, Sun Pharma Advanced Research Company Ltd, Mumbai, India.
Atul
A
Raut
D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000485:Allergens / Q000276:immunology*; D018926:Anti-Allergic Agents / Q000627:therapeutic use*; D031745:Dactylis / Q000276:immunology; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D059085:Nasal Sprays; D010919:Placebos; D011058:Pollen / Q000276:immunology; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000276:immunology; D013256:Steroids / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
D000485:Allergens; D018926:Anti-Allergic Agents; D005938:Glucocorticoids; D059085:Nasal Sprays; D010919:Placebos; C000604489:S0597 steroid; D013256:Steroids