title: MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate) in the treatment of seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial of efficacy and safety.
abstract: Many patients with allergic rhinitis (AR) have uncontrolled symptoms despite available treatment options. This study was designed to evaluate the efficacy and safety of MP29-02 (a novel intranasal formulation of fluticasone propionate [FP] and azelastine [AZ] hydrochloride), compared with monotherapy with FP, AZ, and placebo sprays for the treatment of seasonal allergic rhinitis (SAR). This 2-week randomized, double-blind, placebo-controlled trial was conducted in 779 patients with moderate-to-severe SAR. Treatments were administered 1 spray/nostril twice daily in the same vehicle and delivery device. Daily doses of AZ and FP were 548 and 200 micrograms, respectively. The primary efficacy variable was the 12-hour reflective total nasal symptom score (rTNSS), consisting of nasal congestion, sneezing, itchy nose, and runny nose. Secondary efficacy variables were (1) 12-hour reflective individual nasal symptom scores; (2) onset of action; (3) 12-hour reflective total ocular symptom score (rTOSS), including itchy eyes, watery eyes, and red eyes; and (4) the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) overall score. MP29-02 significantly reduced the mean rTNSS from baseline by -5.54 points compared with FP (-4.55; p = 0.038), AZ (-4.54; p = 0.032), and placebo (-3.03; p < 0.001), improving the rTNSS by 39% beyond the contribution of FP. All individual nasal symptoms contributed to the efficacy of MP29-02. Onset of action was within 30 minutes. MP29-02 significantly improved rTOSS compared with placebo, provided a clinically important improvement in the overall RQLQ score, and was well tolerated. In this study, MP29-02 provided more complete symptom relief than two widely used first-line AR treatments and was well tolerated.
authors.affiliation: Allergy and Asthma Medical Group and Research Center, San Diego, California 92123, USA. EOMELTZER@aol.com
authors.forename: Eli O
authors.initials: EO
authors.lastname: Meltzer
authors.forename: Craig
authors.initials: C
authors.lastname: LaForce
authors.forename: Paul
authors.initials: P
authors.lastname: Ratner
authors.forename: David
authors.initials: D
authors.lastname: Price
authors.forename: David
authors.initials: D
authors.lastname: Ginsberg
authors.forename: Warner
authors.initials: W
authors.lastname: Carr
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D000068298:Fluticasone; D006801:Humans; D008297:Male; D008875:Middle Aged; D010793:Phthalazines / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D011788:Quality of Life; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000503:physiopathology; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000730:Androstadienes; D018926:Anti-Allergic Agents; D004338:Drug Combinations; C573864:MP29-02; D010793:Phthalazines; D000068298:Fluticasone; C020976:azelastine