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Fluticasone propionate aqueous nasal spray improves nasal symptoms of seasonal allergic rhinitis when used as needed (prn).
Ann Allergy Asthma Immunol 2003; 91(1):44-8AA

Abstract

BACKGROUND

Few published clinical trials document the efficacy of intranasal corticosteroids used as needed for treatment of seasonal allergic rhinitis.

OBJECTIVE

To evaluate the efficacy and safety of 4 weeks' treatment with fluticasone propionate aqueous nasal spray 200 microg used as needed (FP200PRN) in patients with seasonal allergic rhinitis.

METHODS

A randomized, double-blind, placebo-controlled study in 241 patients (> or = 12 years of age) with a positive skin test result to a relevant fall allergen and who were symptomatic at randomization. The primary endpoint was the mean change from baseline in total nasal symptom score (TNSS; the sum of nasal congestion, rhinorrhea, sneezing, and nasal itching, each rated on a 4-point scale from 0 = none to 3 = severe).

RESULTS

The mean percentage of days that patients used the study medications in the FP200PRN and placebo groups was 61.8% (SD = 30.4%) and 70.1% (SD = 28.3%), respectively. Patients treated with FP200PRN had a significantly greater reduction from baseline in TNSS compared with those treated with vehicle placebo (mean +/- SE = -2.02 +/- 0.18 vs -1.06 +/- 0.22, P < 0.001), representing a 91% greater improvement with FP200PRN than vehicle placebo. The FP200PRN group also had a significantly greater (P < 0.001) mean reduction in individual nasal symptoms of rhinorrhea, sneezing, nasal itching, and nasal congestion compared with placebo. FP200PRN was well tolerated, with an incidence of adverse events comparable to vehicle placebo.

CONCLUSIONS

FP200PRN in patients 12 years and older is effective for treatment of nasal symptoms associated with seasonal allergic rhinitis. It has a lower incidence of adverse events than typically associated with regular once-daily use.

Authors+Show Affiliations

Division of Allergy and Immunology, Department of Internal Medicine, St. Louis University School of Medicine, St. Louis, Missouri 63104-1028, USA. dykewicz@slu.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

12877448

Citation

Dykewicz, Mark S., et al. "Fluticasone Propionate Aqueous Nasal Spray Improves Nasal Symptoms of Seasonal Allergic Rhinitis when Used as Needed (prn)." Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, vol. 91, no. 1, 2003, pp. 44-8.
Dykewicz MS, Kaiser HB, Nathan RA, et al. Fluticasone propionate aqueous nasal spray improves nasal symptoms of seasonal allergic rhinitis when used as needed (prn). Ann Allergy Asthma Immunol. 2003;91(1):44-8.
Dykewicz, M. S., Kaiser, H. B., Nathan, R. A., Goode-Sellers, S., Cook, C. K., Witham, L. A., ... Rickard, K. (2003). Fluticasone propionate aqueous nasal spray improves nasal symptoms of seasonal allergic rhinitis when used as needed (prn). Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, 91(1), pp. 44-8.
Dykewicz MS, et al. Fluticasone Propionate Aqueous Nasal Spray Improves Nasal Symptoms of Seasonal Allergic Rhinitis when Used as Needed (prn). Ann Allergy Asthma Immunol. 2003;91(1):44-8. PubMed PMID: 12877448.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Fluticasone propionate aqueous nasal spray improves nasal symptoms of seasonal allergic rhinitis when used as needed (prn). AU - Dykewicz,Mark S, AU - Kaiser,Harold B, AU - Nathan,Robert A, AU - Goode-Sellers,Stacey, AU - Cook,Cindy K, AU - Witham,Lori A, AU - Philpot,Edward E, AU - Rickard,Kathleen, PY - 2003/7/25/pubmed PY - 2003/8/15/medline PY - 2003/7/25/entrez SP - 44 EP - 8 JF - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology JO - Ann. Allergy Asthma Immunol. VL - 91 IS - 1 N2 - BACKGROUND: Few published clinical trials document the efficacy of intranasal corticosteroids used as needed for treatment of seasonal allergic rhinitis. OBJECTIVE: To evaluate the efficacy and safety of 4 weeks' treatment with fluticasone propionate aqueous nasal spray 200 microg used as needed (FP200PRN) in patients with seasonal allergic rhinitis. METHODS: A randomized, double-blind, placebo-controlled study in 241 patients (> or = 12 years of age) with a positive skin test result to a relevant fall allergen and who were symptomatic at randomization. The primary endpoint was the mean change from baseline in total nasal symptom score (TNSS; the sum of nasal congestion, rhinorrhea, sneezing, and nasal itching, each rated on a 4-point scale from 0 = none to 3 = severe). RESULTS: The mean percentage of days that patients used the study medications in the FP200PRN and placebo groups was 61.8% (SD = 30.4%) and 70.1% (SD = 28.3%), respectively. Patients treated with FP200PRN had a significantly greater reduction from baseline in TNSS compared with those treated with vehicle placebo (mean +/- SE = -2.02 +/- 0.18 vs -1.06 +/- 0.22, P < 0.001), representing a 91% greater improvement with FP200PRN than vehicle placebo. The FP200PRN group also had a significantly greater (P < 0.001) mean reduction in individual nasal symptoms of rhinorrhea, sneezing, nasal itching, and nasal congestion compared with placebo. FP200PRN was well tolerated, with an incidence of adverse events comparable to vehicle placebo. CONCLUSIONS: FP200PRN in patients 12 years and older is effective for treatment of nasal symptoms associated with seasonal allergic rhinitis. It has a lower incidence of adverse events than typically associated with regular once-daily use. SN - 1081-1206 UR - https://www.unboundmedicine.com/medline/citation/12877448/Fluticasone_propionate_aqueous_nasal_spray_improves_nasal_symptoms_of_seasonal_allergic_rhinitis_when_used_as_needed__prn__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1081-1206(10)62057-1 DB - PRIME DP - Unbound Medicine ER -