Safety and Tolerability of Fluticasone Furoate Nasal Spray Once Daily in Paediatric Patients Aged 6–11 Years with Allergic Rhinitis

Meltzer, Eli O.; Tripathy, Ita; Máspero, Jorge; Wu, Wei; Philpot, Ed

doi:10.2165/0044011-200929020-00002

Cited by 32 publications

(40 citation statements)

References 15 publications

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“…Fortunately, no clinically significant steroid adverse effects have been discovered in studies in children. [89][90][91][92][93][94][95][96] Saline Irrigation…”

Section: Intranasal Steroidsmentioning

confidence: 99%

Clinical Practice Guideline for the Diagnosis and Management of Acute Bacterial Sinusitis in Children Aged 1 to 18 Years

Wald,

Applegate,

Bordley

et al. 2013

Pediatrics

435

368

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OBJECTIVE: To update the American Academy of Pediatrics clinical practice guideline regarding the diagnosis and management of acute bacterial sinusitis in children and adolescents. METHODS: Analysis of the medical literature published since the last version of the guideline (2001). RESULTS: The diagnosis of acute bacterial sinusitis is made when a child with an acute upper respiratory tract infection (URI) presents with (1) persistent illness (nasal discharge [of any quality] or daytime cough or both lasting more than 10 days without improvement), (2) a worsening course (worsening or new onset of nasal discharge, daytime cough, or fever after initial improvement), or (3) severe onset (concurrent fever [temperature ≥39°C/102.2°F] and purulent nasal discharge for at least 3 consecutive days). Clinicians should not obtain imaging studies of any kind to distinguish acute bacterial sinusitis from viral URI, because they do not contribute to the diagnosis; however, a contrast-enhanced computed tomography scan of the paranasal sinuses should be obtained whenever a child is suspected of having orbital or central nervous system complications. The clinician should prescribe antibiotic therapy for acute bacterial sinusitis in children with severe onset or worsening course. The clinician should either prescribe antibiotic therapy or offer additional observation for 3 days to children with persistent illness. Amoxicillin with or without clavulanate is the first-line treatment of acute bacterial sinusitis. Clinicians should reassess initial management if there is either a caregiver report of worsening (progression of initial signs/symptoms or appearance of new signs/symptoms) or failure to improve within 72 hours of initial management. If the diagnosis of acute bacterial sinusitis is confirmed in a child with worsening symptoms or failure to improve, then clinicians may change the antibiotic therapy for the child initially managed with antibiotic or initiate antibiotic treatment of the child initially managed with observation. CONCLUSIONS: Changes in this revision include the addition of a clinical presentation designated as “worsening course,” an option to treat immediately or observe children with persistent symptoms for 3 days before treating, and a review of evidence indicating that imaging is not necessary in children with uncomplicated acute bacterial sinusitis.

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“…Fortunately, no clinically significant steroid adverse effects have been discovered in studies in children. [89][90][91][92][93][94][95][96] Saline Irrigation…”

Section: Intranasal Steroidsmentioning

confidence: 99%

Clinical Practice Guideline for the Diagnosis and Management of Acute Bacterial Sinusitis in Children Aged 1 to 18 Years

Wald,

Applegate,

Bordley

et al. 2013

Pediatrics

435

368

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“…The recent Cochrane review (92) failed to find evidence supporting the effectiveness of intranasal corticosteroids but it excluded all the recent high-quality randomized controlled trials as they allowed rescue medication. Several studies have shown that the effects of mometasone, fluticasone and ciclesonide commence within a day of starting therapy (93). Intranasal corticosteroids probably also improve coexisting asthma (94-96) (A), and fluticasone furoate and mometasone may be effective for conjunctivitis (77,82,97) …”

Section: Intranasal Corticosteroidsmentioning

confidence: 99%

Paediatric rhinitis: position paper of the European Academy of Allergy and Clinical Immunology

Roberts

Xatzipsalti

Borrego

et al. 2013

Allergy

312

248

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Rhinitis is a common problem in childhood and adolescence and impacts negatively on physical, social and psychological well-being. This position paper, prepared by the European Academy of Allergy and Clinical Immunology Taskforce on Rhinitis in Children, aims to provide evidence-based recommendations for the diagnosis and therapy of paediatric rhinitis. Rhinitis is characterized by at least two nasal symptoms: rhinorrhoea, blockage, sneezing or itching.

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“…Of these 19 included studies, 9 reported data outcome on IOP (3,6,11,13,(20)(21)(22)(23)(24) , 1 on lens opacity (25) , and 9 studies reported data on both IOP and lens opacity (14,(26)(27)(28)(29)(30)(31)(32)(33) . This then left 18 (94.7%) (3,6,11,13,14,(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33) studies on IOP, and 10 (55.6%) (14,(25)(26)(27)(28)(29)(30)(31)(32)(33) ) on lens opacity in clearly defined patient groups that could be used for comparison in this systematic review (14,...…”

Section: Included Studiesmentioning

confidence: 99%

“…This then left 18 (94.7%) (3,6,11,13,14,(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33) studies on IOP, and 10 (55.6%) (14,(25)(26)(27)(28)(29)(30)(31)(32)(33) ) on lens opacity in clearly defined patient groups that could be used for comparison in this systematic review (14,(26)(27)(28)(29)(30)(31)(32)(33) . The study characteristics of the 19 included manuscripts are described in Tables 4 and 5.…”

Section: Included Studiesmentioning

confidence: 99%

Intranasal corticosteroids do not affect intraocular pressure or lens opacity: a systematic review of controlled trials

Ahmadi

Snidvongs

Kalish

et al. 2015

Rhin

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Results: 665 articles were retrieved with 137 were considered for full-text review. Of these, 116 (85%) were literature reviews and two were case reports. 19 studies (10 RCTs, 1 case-control, 8 case series) were included for the qualitative review, of which 18 reported data on IOP and 10 on cataract/LO. None (n=0) of the 10 RCT reporting data on glaucoma or IOP demonstrated changes in IOP compared to control. Also none (n=0) of the 6 RCTs reporting cataract or lens opacity demonstrated changes compared to control. Conclusion:Data from studies with low levels of bias, do not demonstrate a clinically relevant impact of INCS on neither ocular pressure, glaucoma, lens opacity nor cataract formation.

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Safety and Tolerability of Fluticasone Furoate Nasal Spray Once Daily in Paediatric Patients Aged 6–11 Years with Allergic Rhinitis

Abstract: FFNS has a favourable safety and tolerability profile in patients aged 6-11 years with PAR or SAR.

Cited by 32 publications

References 15 publications

Clinical Practice Guideline for the Diagnosis and Management of Acute Bacterial Sinusitis in Children Aged 1 to 18 Years

Clinical Practice Guideline for the Diagnosis and Management of Acute Bacterial Sinusitis in Children Aged 1 to 18 Years

Paediatric rhinitis: position paper of the European Academy of Allergy and Clinical Immunology

Intranasal corticosteroids do not affect intraocular pressure or lens opacity: a systematic review of controlled trials

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