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

William E Berger, Shailen Shah, Phil Lieberman, James Hadley, David Price, Ullrich Munzel, Sanjay Bhatia

Research output: Contribution to journalArticle

39 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)179-185
Number of pages7
JournalThe Journal of Allergy and Clinical Immunology: In Practice
Volume2
Issue number2
Early online date1 Jan 2014
DOIs
Publication statusPublished - Mar 2014

Fingerprint

azelastine
Rhinitis
Safety
Nose
Vasomotor Rhinitis
Seasonal Allergic Rhinitis
Incidence
Fluticasone
MP29-02
Hydrocortisone
Fasting

Keywords

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Androstadienes
  • Child
  • Chronic Disease
  • Drug Combinations
  • Female
  • Humans
  • Hydrocortisone
  • Male
  • Middle Aged
  • Phthalazines
  • Rhinitis
  • Rhinitis, Allergic, Perennial
  • Time Factors
  • Clinical Trial
  • Allergic Rhinitis
  • Chronic Rhinitis
  • Azelastine
  • Fluticasone
  • hypothalamic-Pituitary-Adrenal Axis
  • Perennial Allergic Rhinitis
  • Vasomotor Rhinitis

Cite this

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. / Berger, William E; Shah, Shailen; Lieberman, Phil; Hadley, James; Price, David; Munzel, Ullrich; Bhatia, Sanjay.

In: The Journal of Allergy and Clinical Immunology: In Practice, Vol. 2, No. 2, 03.2014, p. 179-185.

Research output: Contribution to journalArticle

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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.",
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AU - Shah, Shailen

AU - Lieberman, Phil

AU - Hadley, James

AU - Price, David

AU - Munzel, Ullrich

AU - Bhatia, Sanjay

N1 - Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

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N2 - 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.

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KW - Middle Aged

KW - Phthalazines

KW - Rhinitis

KW - Rhinitis, Allergic, Perennial

KW - Time Factors

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KW - Chronic Rhinitis

KW - Azelastine

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KW - hypothalamic-Pituitary-Adrenal Axis

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