Safety of nasal budesonide in the long‐term treatment of children with perennial rhinitis

Möller, Christian; Ahlström, H; Henricson, Kent Ake; Malmqvist, Lasse; Åkerlund, Anders; Hildebrand, Hans

doi:10.1046/j.1365-2222.2003.01689.x

Cited by 72 publications

(46 citation statements)

References 32 publications

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“…Ocular side effects such as evidence of cataracts, glaucoma or increased ocular pressure have not been shown in clinical trials to be associated with intranasal corticosteroid therapy [37,38,39,40] with the exception of 1 study with budesonide [41] and 1 study of fluticasone furoate [42]. …”

Section: Discussionmentioning

confidence: 99%

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Intranasal Mometasone Furoate Alleviates the Ocular Symptoms Associated with Seasonal Allergic Rhinitis: Results of a Post Hoc Analysis

Anolik

Nathan

Schenkel³

et al. 2008

Int Arch Allergy Immunol

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Background: Burdensome symptoms of allergic rhinitis (AR) include nasal and ocular symptoms such as itching, tearing and redness. Intranasal corticosteroids are efficacious in the treatment of nasal symptoms of AR. Objective: It was the aim of this study to determine the efficacy of the intranasal corticosteroid mometasone furoate nasal spray (MFNS) in relieving ocular symptoms associated with seasonal AR (SAR). Methods: Ocular symptom data were analyzed for subjects ≧12 years of age, randomized to MFNS 200 µg q.d. (n = 176) or placebo (n = 177) in a placebo-controlled, double-blind clinical trial. Post hoc efficacy analysis assessed the mean change from baseline in subject-reported total ocular symptom scores (TOSS) averaged over the treatment period. Results: Mean baseline TOSS was 4.91 for the MFNS group and comparable (5.05) for the placebo group – combined average for individual symptoms such as itching, tearing and redness ranged from 0 (no symptoms) to 9 (all symptoms, severe). Mean change from baseline in TOSS averaged over days 1–15 was –1.42 for the MFNS group and –0.94 for the placebo group (p = 0.02), for an observed treatment difference of 0.49 (statistical data rounded to 2 decimal positions). Improvement in individual symptoms (eye itching, tearing and redness) contributed to this treatment effect; the greatest improvement occurred with tearing, which decreased –0.52 from the baseline score 1.59 in the MFNS group and –0.31 from 1.67 in those receiving placebo (p < 0.01), for an observed treatment difference of 0.21. Treatment with MFNS was safe and well tolerated. Conclusion: MFNS is effective in reducing ocular symptoms of SAR, in addition to its established efficacy in reducing nasal symptoms of SAR.

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Section: Discussionmentioning

confidence: 99%

“…in 78 children with perennial AR, lenticular changes were found in 6 children [41]. Small lenticular opacities were present in 2 children at the start of the study and persisted through 12 months of treatment.…”

Section: Discussionmentioning

confidence: 99%

Intranasal Mometasone Furoate Alleviates the Ocular Symptoms Associated with Seasonal Allergic Rhinitis: Results of a Post Hoc Analysis

Anolik

Nathan

Schenkel³

et al. 2008

Int Arch Allergy Immunol

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“…Systemic absorption negligible with mometasone and fluticasone, modest for the remainder and high for betamethasone and dexamethasone -these should be used short term only [84][85][86]. Long-term growth studies in children using fluticasone, mometasone and budesonide have reassuring safety data, unlike beclomethasone [87][88][89][90][91]. Concomitant treatment with CYP3A inhibitors such as itraconazole or ritonivir may increase systemic bioavailability of intranasal corticosteroids [92,93].…”

Section: Topical Intranasal Corticosteroidsmentioning

confidence: 99%

BSACI guidelines for the management of allergic and non‐allergic rhinitis

Scadding

Durham

Mirakian

et al. 2007

Clin Experimental Allergy

348

292

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SummaryThis guidance for the management of patients with allergic and non-allergic rhinitis has been prepared by the Standards of Care Committee (SOCC) of the British Society for Allergy and Clinical Immunology (BSACI). The guideline is based on evidence as well as on expert opinion and is for use by both adult physicians and paediatricians practicing in allergy. The recommendations are evidence graded. During the development of these guidelines, all BSACI members were included in the consultation process using a web-based system. Their comments and suggestions were carefully considered by the SOCC. Where evidence was lacking, consensus was reached by the experts on the committee. Included in this guideline are clinical classification of rhinitis, aetiology, diagnosis, investigations and management including subcutaneous and sublingual immunotherapy. There are also special sections for children, co-morbid associations and pregnancy. Finally, we have made recommendations for potential areas of future research.

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“…Among studies based upon stadiometry measurements, only one reported a smaller mean increase in height among children treated with high-dose intranasal beclomethasone for 1 year compared with placebo (42). One-year studies involving mometasone furoate, fluticasone propionate, budesonide, and ciclesonide did not report any significant negative effects on height (43)(44)(45)(46). A 12-month double-blind study of ciclesonide in children found no significant difference in standing height between treated children and those using placebo (46).…”

Section: Derendorf and Meltzermentioning

confidence: 99%

Molecular and clinical pharmacology of intranasal corticosteroids: clinical and therapeutic implications

Derendorf

Meltzer

2008

Allergy

200

139

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Intranasal corticosteroids (INSs) are effective treatments for allergic rhinitis, rhinosinusitis, and nasal polyposis. In recent years, increased understanding of corticosteroid and glucocorticoid receptor pharmacology has enabled the development of molecules designed specifically to achieve potent, localized activity with minimal risk of systemic exposure. Pharmacologic potency studies using affinity and other assessments have produced similar rank orders of potency, with the most potent being mometasone furoate, fluticasone propionate, and its modification, fluticasone furoate. The furoate and propionate ester side chains render these agents highly lipophilic, which may facilitate their absorption through nasal mucosa and uptake across phospholipid cell membranes. These compounds demonstrate negligible systemic absorption. Systemic absorption rates are higher among the older corticosteroids (flunisolide, beclomethasone dipropionate, triamcinolone acetonide, and budesonide), which have bioavailabilities in the range of 34–49%. Studies, including 1‐year studies with mometasone furoate, fluticasone propionate, and budesonide that evaluated potential systemic effects of INSs in children have generally found no adverse effects on hypothalamic–pituitary–adrenal axis function or growth. Clinical data suggest no significant differences in efficacy between the INSs. Theoretically, newer agents with lower systemic availability may be preferable, and may come closer to the pharmacokinetic/pharmacologic criteria for the ideal therapeutic choice.

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Safety of nasal budesonide in the long‐term treatment of children with perennial rhinitis

Abstract: Long-term treatment for 1-2 years with intranasal budesonide 256-400 microg daily in children with perennial rhinitis revealed no negative effects on growth or endogenous cortisol production. Local side-effects were mild and patient symptoms decreased.

Cited by 72 publications

References 32 publications

Intranasal Mometasone Furoate Alleviates the Ocular Symptoms Associated with Seasonal Allergic Rhinitis: Results of a Post Hoc Analysis

Intranasal Mometasone Furoate Alleviates the Ocular Symptoms Associated with Seasonal Allergic Rhinitis: Results of a Post Hoc Analysis

BSACI guidelines for the management of allergic and non‐allergic rhinitis

Molecular and clinical pharmacology of intranasal corticosteroids: clinical and therapeutic implications

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