Fluticasone Propionate Aqueous Nasal Spray Is Safe and Effective for Children With Seasonal Allergic Rhinitis

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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Effect of mometasone furoate nasal spray on moderate-to-severe nasal congestion in seasonal allergic rhinitis: A responder analysis

Allergy and Asthma Proceedings ◽

10.2500/aap.2019.40.4214 ◽

2019 ◽

Vol 40 (3) ◽

pp. 173-179 ◽

Cited By ~ 1

Author(s):

Eduardo Urdaneta ◽

Kaan Tunceli ◽

Davis Gates

Keyword(s):

Allergic Rhinitis ◽

Nasal Spray ◽

Seasonal Allergic Rhinitis ◽

Nasal Congestion ◽

Mometasone Furoate ◽

Double Blind ◽

Positive Skin ◽

Once Daily ◽

Responder Analysis ◽

End Point

Background: Nasal congestion is consistently identified as the most bothersome symptom of seasonal allergic rhinitis (SAR), and, in guidelines, intranasal corticosteroids are the preferred treatment for nasal congestion. Objective: The aim of this post hoc cumulative responder analysis was to examine the nasal congestion response in detail by depicting the level of response obtained in two double-blind, placebo controlled studies of mometasone furoate nasal spray (MFNS) therapy for SAR, conducted from August to October 2008 at U.S. sites, in which nasal congestion was prespecified as the primary end point. Methods: Patients ≥12 years of age with a ≥2-year SAR history, positive skin test result, and moderate or severe nasal congestion were randomly assigned to once-daily treatment in the morning with MFNS or placebo for 15 days. The primary end point was the change from baseline in morning and evening reflective nasal congestion scores averaged over days 1‐15. Treatment response, which ranged from >0% to >90% improvement, was evaluated at 10% intervals; >30% and >50% improvements were further evaluated by using the Mietinnen-Nurminen method weighted by study to test the differences of proportions. The Breslow-Day equal odds ratios test was used to justify pooling. Results: Of the 344 and 340 patients in the MFNS and placebo groups, respectively, the proportions of patients who experienced a >30% response in nasal congestion, averaged over 15 days, were 37% versus 19% in the MFNS and placebo groups, respectively (p < 0.001). Those who experienced a >50% response were 13% and 7%, respectively (p = 0.003). Among the patients treated with MFNS, the mean response was greater during the second versus the first week of treatment. There was no difference between responses in the morning versus evening or for patients with moderate versus severe nasal congestion at baseline. Conclusion: MFNS is effective in relieving moderate-to-severe nasal congestion in patients with SAR. The response to MFNS is maintained with once-daily administration and improves with continuous use over 2 weeks.

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Once- versus Twice-Daily Fluticasone Propionate Aqueous Nasal Spray for Seasonal Allergic Rhinitis

American Journal of Rhinology ◽

10.2500/105065893781976519 ◽

1993 ◽

Vol 7 (2) ◽

pp. 77-83 ◽

Cited By ~ 7

Author(s):

Robert J. Dockhorn ◽

Barry R. Paull ◽

Eli O. Meltzer ◽

Andre van As ◽

Suzanne Weakley ◽

...

Keyword(s):

Allergic Rhinitis ◽

Fluticasone Propionate ◽

Nasal Spray ◽

Seasonal Allergic Rhinitis ◽

Dosage Regimen ◽

Controlled Study ◽

Double Blind ◽

Once Daily ◽

Normal Ranges ◽

Daily Dosage Regimen

A new potent topical corticosteroid, fluticasone propionate aqueous nasal spray, has proved effective when administered twice daily for seasonal allergic rhinitis. The purpose of this study was to compare the efficacy and safety of a once-daily dosage with twice-daily administration of fluticasone propionate. A multicenter, double-blind, randomized, placebo-controlled study was conducted in adults with moderate to severe symptoms of allergic rhinitis during the autumn pollen season. Patients were treated for 4 weeks with fluticasone propionate aqueous nasal spray, 200 μg once daily or 100 μg twice daily or matching placebo. Fluticasone propionate administered once daily in the morning was as effective as the twice-daily dosage regimen, and both regimens were more effective than placebo. Nasal symptoms were improved by the second day of treatment and continued to improve throughout the study. Nasal eosinophils were reduced in more patients treated with either regimen of fluticasone propionate compared with placebo. Adverse events were similar in frequency and nature in all three groups. There was no evidence of hypothalamicpituitary-adrenal axis effects; mean morning plasma cortisol concentrations and response to cosyntropin stimulation remained within normal ranges and were similar across groups. We conclude that fluticasone propionate aqueous nasal spray administered once daily is safe and as effective as a twice-daily dosage regimen for treating 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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