Fluticasone propionate aqueous nasal spray improves nasal symptoms of seasonal allergic rhinitis when used as needed (prn)

Introduction. Fluticasone propionate aqueous nasal spray, a new topical corticosteroid preparation, is effective when given as 200 µg once daily in patients (> 12 years of age) with seasonal allergic rhinitis. Study objective. To evaluate the efficacy and safety of fluticasone propionate aqueous nasal spray in children aged 4 to 11 years with seasonal allergic rhinitis. Study design. Multicenter, randomized, double-blind, placebo-controlled, parallel-group. Patients. Two hundred fifty children aged 4 to 11 years with moderate-to-severe nasal symptoms, a positive skin test reaction to a late-summer or autumn allergen, a history of seasonal allergic rhinitis, and documentation of an unsatisfactory response to conventional treatment. Interventions. Children were randomly assigned to receive fluticasone propionate, either 100 µg or 200 µg, or placebo, given by intranasal spray once daily in the morning for 14 days. Measurements and results. Severity of nasal symptoms (obstruction, rhinorrhea, itching, and sneezing) was recorded on visual analog scales by investigators at weekly visits and by patients (or adult guardian) daily in the evening. According to investigator and patient ratings, both fluticasone propionate 100 µg/d and 200 µg/d lowered total nasal symptom scores when compared with placebo. Both dosages of fluticasone propionate were more effective than placebo on the basis of investigatorrated overall clinical evaluation of efficacy at the end of treatment, with significant improvement (as opposed to moderate or mild improvement, no change or worsening) noted in 21% to 29% of the active-treatment groups vs 9% in the placebo group. There were no significant differences between the two fluticasone propionate dosages in any efficacy measurement. Morning plasma cortisol concentrations and frequency of drug-related adverse events were similar in the fluticasone propionate and placebo groups. Conclusion. In children as young as 4 years, 100 µg of fluticasone propionate aqueous nasal spray given once daily is as effective as 200 µg given once daily, the usual adult dose for the treatment of seasonal allergic rhinitis. Both fluticasone propionate dosages were well tolerated and neither dosage appears to interfere with the hypothalamic-pituitary-adrenal axis in children.

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The efficacy and tolerability of fluticasone propionate aqueous nasal spray in children with seasonal allergic rhinitis

Allergy ◽

10.1111/j.1398-9995.1995.tb01185.x ◽

1995 ◽

Vol 50 (6) ◽

pp. 498-505 ◽

Cited By ~ 19

Author(s):

A. Boner ◽

L Sette ◽

L. Martinati ◽

R. K. Sharma ◽

D. H. Richards

Keyword(s):

Allergic Rhinitis ◽

Fluticasone Propionate ◽

Nasal Spray ◽

Seasonal Allergic Rhinitis

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Treatment of seasonal allergic rhinitis with fluticasone propionate aqueous nasal spray: review of comparator studies

Allergy ◽

10.1111/j.1398-9995.1995.tb02738.x ◽

1995 ◽

Vol 50 (s23) ◽

pp. 25-29 ◽

Cited By ~ 10

Author(s):

W.W. Storms

Keyword(s):

Allergic Rhinitis ◽

Fluticasone Propionate ◽

Nasal Spray ◽

Seasonal Allergic Rhinitis

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Once-daily Fluticasone Furoate∗ Nasal Spray (FF) Provides 24-hour Relief of the Nasal Symptoms of Seasonal Allergic Rhinitis (SAR) in Children ages 2-11 Years ∗USAN approved name

Journal of Allergy and Clinical Immunology ◽

10.1016/j.jaci.2006.12.566 ◽

2007 ◽

Vol 119 (1) ◽

pp. S305 ◽

Cited By ~ 1

Author(s):

E.O. Meltzer ◽

I. Tripathy ◽

J. Lee ◽

J. Lim ◽

A. Ellsworth ◽

...

Keyword(s):

Allergic Rhinitis ◽

Nasal Spray ◽

Seasonal Allergic Rhinitis ◽

Fluticasone Furoate ◽

Once Daily ◽

Nasal Symptoms

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A Comparison of Aqueous Suspensions of Budesonide Nasal Spray (128 μg and 256 μg Once Daily) and Fluticasone Propionate Nasal Spray (200 μg Once Daily) in the Treatment of Adult Patients with Seasonal Allergic Rhinitis

American Journal of Rhinology ◽

10.2500/105065897781446658 ◽

1997 ◽

Vol 11 (4) ◽

pp. 323-330 ◽

Cited By ~ 21

Author(s):

Martin A. Stern ◽

Ronald Dahl ◽

Lars P. Nielsen ◽

Bente Pedersen ◽

Camilla Schrewelius

Keyword(s):

Allergic Rhinitis ◽

Fluticasone Propionate ◽

Nasal Spray ◽

Seasonal Allergic Rhinitis ◽

Adult Patients ◽

Once Daily ◽

Treatment Groups ◽

Runny Nose ◽

Aqueous Suspensions ◽

Symptom Scores

The efficacy of aqueous suspensions of budesonide nasal spray and fluticasone propionate nasal spray, in the treatment of seasonal allergic rhinitis, was compared in a large, placebo-controlled, two-center study. A 1-week baseline period was followed by a 4- to 6-week treatment period during which 635 adult patients, aged 18–72 years, were randomized to receive either placebo, budesonide 128 μg, or 256 μg once daily, or fluticasone propionate, 200 μg once daily. Nasal and eye symptoms, overall treatment efficacy and safety assessments were made during the study period. Combined, as well as individual, nasal symptoms were significantly improved in all three active treatment groups compared with placebo therapy. Treatment with 256 μg/day of budesonide was found to be significantly more effective in reducing the sneezing score compared with 200 μg/day of fluticasone propionate. Analysis of symptom scores on days when the pollen count was greater than 10 grains/m3 revealed 256 μg/day of budesonide therapy to be significantly more effective in reducing combined symptom scores as well as the individual scores for sneezing and runny nose, compared with 200 μg/day fluticasone propionate. The higher dose of budesonide (256 μg/day) was also more effective than the lower dose (128 μg/day) in reducing sneezing scores and statistical significance was almost reached for the reduction in combined symptom and runny nose scores. Substantial or total control of symptoms was achieved by 31.4%, 85.3%, 88.4%, and 81.9% of patients receiving placebo, 128 μg/day of budesonide, 256 μg/day of budesonide, and 200 μg/day of fluticasone propionate, respectively. The incidence of adverse events was low in all treatment groups. In conclusion, both budesonide and fluticasone propionate treatments were effective and well-tolerated in the treatment of seasonal allergic rhinitis. However, 256 μg/day of budesonide tended to be more effective than 200 μg/day of fluticasone propionate and 128 μg/day of budesonide, especially when patients were exposed to a higher pollen load.

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