title: Long-term, randomized safety study of MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate in an advanced delivery system) in subjects with chronic rhinitis.
abstract: BACKGROUND
  MP29-02 is a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate (FP) in an advanced delivery system for the treatment of seasonal allergic rhinitis.
  
  
  OBJECTIVE
  The objective of this study was to evaluate the long-term safety of MP29-02 in subjects with chronic allergic (perennial) or nonallergic (vasomotor) rhinitis.
  
  
  METHODS
  This was a 1-year, randomized, open-label, active-controlled, parallel-group study in subjects with chronic allergic or nonallergic rhinitis. A total of 612 subjects were randomized in a 2:1 ratio to (1) MP29-02, one spray per nostril twice daily (total daily doses of azelastine hydrochloride and FP were 548 mcg and 200 mcg, respectively); or (2) FP, 2 sprays per nostril once daily (total daily dose 200 mcg). Safety and tolerability assessments were made at months 1, 3, 6, 9, and 12.
  
  
  RESULTS
  The incidence of treatment-related adverse events was low with both MP29-02 (9.4%) and FP (11.1%), with no evidence of late-occurring adverse events. Nasal examinations showed no evidence of nasal mucosal ulcerations or septal perforations with MP29-02, and the overall incidence of adverse findings was reduced as the study progressed. There were no unusual or unexpected ocular examination findings and no clinically important laboratory findings or clinically important differences between groups in fasting AM serum cortisol levels after 12 months of treatment.
  
  
  CONCLUSIONS
  MP29-02 was well tolerated. There were no safety findings that would preclude the long-term use of MP29-02 in the treatment of allergic rhinitis.
authors.affiliation: Allergy and Asthma Associates of Southern California, Mission Viejo, Calif. Electronic address: weberger@uci.edu.
authors.forename: William E
authors.initials: WE
authors.lastname: Berger
authors.affiliation: Allergy and Asthma Consultants of NJ-PA PC, Collegeville, Pa.
authors.forename: Shailen
authors.initials: S
authors.lastname: Shah
authors.affiliation: University of Tennessee College of Medicine, Memphis, Tenn.
authors.forename: Phil
authors.initials: P
authors.lastname: Lieberman
authors.affiliation: Specialty Care Center, Physicians Regional Medical Center, Naples, Fla.
authors.forename: James
authors.initials: J
authors.lastname: Hadley
authors.affiliation: University of Aberdeen, Aberdeen, UK; Royal Nose, Throat, and Ear Hospital, London, UK.
authors.forename: David
authors.initials: D
authors.lastname: Price
authors.affiliation: Meda Pharma GmbH & Co. KG, Bad Homburg, Germany.
authors.forename: Ullrich
authors.initials: U
authors.lastname: Munzel
authors.affiliation: IRL-Synexus Clinical Research Centre, Chakala, Mumbai, India.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Bhatia
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000009:adverse effects*; D002648:Child; D002908:Chronic Disease; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D008297:Male; D008875:Middle Aged; D010793:Phthalazines / Q000009:adverse effects*; D012220:Rhinitis / Q000188:drug therapy*; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*; D013997:Time Factors
chemical_list: D000730:Androstadienes; D004338:Drug Combinations; C573864:MP29-02; D010793:Phthalazines; D006854:Hydrocortisone
keywords: Allergic rhinitis; Azelastine; Chronic rhinitis; Clinical trial; Fluticasone; Hypothalamic-pituitary-adrenal axis; Perennial allergic rhinitis; Vasomotor rhinitis