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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.
J Allergy Clin Immunol Pract. 2014 Mar-Apr; 2(2):179-85.JA

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+Show Affiliations

Allergy and Asthma Associates of Southern California, Mission Viejo, Calif. Electronic address: weberger@uci.edu.Allergy and Asthma Consultants of NJ-PA PC, Collegeville, Pa.University of Tennessee College of Medicine, Memphis, Tenn.Specialty Care Center, Physicians Regional Medical Center, Naples, Fla.University of Aberdeen, Aberdeen, UK; Royal Nose, Throat, and Ear Hospital, London, UK.Meda Pharma GmbH & Co. KG, Bad Homburg, Germany.IRL-Synexus Clinical Research Centre, Chakala, Mumbai, India.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24607046

Citation

Berger, William E., et al. "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." The Journal of Allergy and Clinical Immunology. in Practice, vol. 2, no. 2, 2014, pp. 179-85.
Berger WE, Shah S, Lieberman P, et al. 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. J Allergy Clin Immunol Pract. 2014;2(2):179-85.
Berger, W. E., Shah, S., Lieberman, P., Hadley, J., Price, D., Munzel, U., & Bhatia, S. (2014). 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. The Journal of Allergy and Clinical Immunology. in Practice, 2(2), 179-85. https://doi.org/10.1016/j.jaip.2013.09.019
Berger WE, et al. 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. J Allergy Clin Immunol Pract. 2014 Mar-Apr;2(2):179-85. PubMed PMID: 24607046.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Berger,William E, AU - Shah,Shailen, AU - Lieberman,Phil, AU - Hadley,James, AU - Price,David, AU - Munzel,Ullrich, AU - Bhatia,Sanjay, Y1 - 2014/01/01/ PY - 2013/03/07/received PY - 2013/09/24/revised PY - 2013/09/25/accepted PY - 2014/3/11/entrez PY - 2014/3/13/pubmed PY - 2014/5/30/medline KW - Allergic rhinitis KW - Azelastine KW - Chronic rhinitis KW - Clinical trial KW - Fluticasone KW - Hypothalamic-pituitary-adrenal axis KW - Perennial allergic rhinitis KW - Vasomotor rhinitis SP - 179 EP - 85 JF - The journal of allergy and clinical immunology. In practice JO - J Allergy Clin Immunol Pract VL - 2 IS - 2 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. SN - 2213-2198 UR - https://www.unboundmedicine.com/medline/citation/24607046/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S2213-2198(13)00439-X DB - PRIME DP - Unbound Medicine ER -