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Double-blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device.
Ann Allergy Asthma Immunol 2010; 105(2):168-73AA

Abstract

BACKGROUND

A proof-of-concept study suggested that combination therapy with commercial azelastine hydrochloride nasal spray and fluticasone propionate nasal spray significantly improved nasal symptoms of seasonal allergic rhinitis compared with either agent alone.

OBJECTIVE

To compare an azelastine-fluticasone combination nasal spray administered in a single-delivery device with a commercially available azelastine nasal spray and fluticasone nasal spray.

METHODS

This 14-day, multicenter, randomized, double-blind study was conducted during the Texas mountain cedar season. After a 5-day placebo lead-in, 610 patients with moderate-to-severe nasal symptoms were randomized to treatment with (1) azelastine nasal spray, (2) fluticasone nasal spray, (3) combination azelastine and fluticasone nasal spray, or (4) placebo nasal spray. All treatments were given as 1 spray per nostril twice daily. The primary efficacy variable was the change from baseline in the total nasal symptom score (TNSS), consisting of nasal congestion, runny nose, itchy nose, and sneezing.

RESULTS

All 3 active groups were statistically superior (P <or= .02) to placebo, and the combination was statistically superior (P <or= .003) to either agent alone. The TNSS improved by 28.4% with combination azelastine-fluticasone, 20.4% with fluticasone, 16.4% with azelastine, and 11.2% with placebo. All 3 treatments were well tolerated.

CONCLUSIONS

The combination azelastine-fluticasone nasal spray provided statistically significant improvement in the TNSS and additive clinical benefit compared with either agent alone in patients with moderate-to-severe seasonal allergic rhinitis.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00660517.

Authors+Show Affiliations

Central Texas Health Research, New Braunfels, Texas, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

20674829

Citation

Hampel, Frank C., et al. "Double-blind, Placebo-controlled Study of Azelastine and Fluticasone in a Single Nasal Spray Delivery Device." Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, vol. 105, no. 2, 2010, pp. 168-73.
Hampel FC, Ratner PH, Van Bavel J, et al. Double-blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device. Ann Allergy Asthma Immunol. 2010;105(2):168-73.
Hampel, F. C., Ratner, P. H., Van Bavel, J., Amar, N. J., Daftary, P., Wheeler, W., & Sacks, H. (2010). Double-blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device. Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, 105(2), pp. 168-73. doi:10.1016/j.anai.2010.06.008.
Hampel FC, et al. Double-blind, Placebo-controlled Study of Azelastine and Fluticasone in a Single Nasal Spray Delivery Device. Ann Allergy Asthma Immunol. 2010;105(2):168-73. PubMed PMID: 20674829.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Double-blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device. AU - Hampel,Frank C, AU - Ratner,Paul H, AU - Van Bavel,Julius, AU - Amar,N J, AU - Daftary,Pramila, AU - Wheeler,William, AU - Sacks,Harry, PY - 2010/02/22/received PY - 2010/05/03/revised PY - 2010/06/08/accepted PY - 2010/8/3/entrez PY - 2010/8/3/pubmed PY - 2010/11/4/medline SP - 168 EP - 73 JF - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology JO - Ann. Allergy Asthma Immunol. VL - 105 IS - 2 N2 - BACKGROUND: A proof-of-concept study suggested that combination therapy with commercial azelastine hydrochloride nasal spray and fluticasone propionate nasal spray significantly improved nasal symptoms of seasonal allergic rhinitis compared with either agent alone. OBJECTIVE: To compare an azelastine-fluticasone combination nasal spray administered in a single-delivery device with a commercially available azelastine nasal spray and fluticasone nasal spray. METHODS: This 14-day, multicenter, randomized, double-blind study was conducted during the Texas mountain cedar season. After a 5-day placebo lead-in, 610 patients with moderate-to-severe nasal symptoms were randomized to treatment with (1) azelastine nasal spray, (2) fluticasone nasal spray, (3) combination azelastine and fluticasone nasal spray, or (4) placebo nasal spray. All treatments were given as 1 spray per nostril twice daily. The primary efficacy variable was the change from baseline in the total nasal symptom score (TNSS), consisting of nasal congestion, runny nose, itchy nose, and sneezing. RESULTS: All 3 active groups were statistically superior (P <or= .02) to placebo, and the combination was statistically superior (P <or= .003) to either agent alone. The TNSS improved by 28.4% with combination azelastine-fluticasone, 20.4% with fluticasone, 16.4% with azelastine, and 11.2% with placebo. All 3 treatments were well tolerated. CONCLUSIONS: The combination azelastine-fluticasone nasal spray provided statistically significant improvement in the TNSS and additive clinical benefit compared with either agent alone in patients with moderate-to-severe seasonal allergic rhinitis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00660517. SN - 1081-1206 UR - https://www.unboundmedicine.com/medline/citation/20674829/Double_blind_placebo_controlled_study_of_azelastine_and_fluticasone_in_a_single_nasal_spray_delivery_device_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1081-1206(10)00605-8 DB - PRIME DP - Unbound Medicine ER -