Efficacy and safety of triamcinolone acetonide aqueous nasal spray in children aged 2 to 5 years with perennial allergic rhinitis: a randomized, double-blind, placebo-controlled study with an open-label extension

Weinstein, Steven F.; Qaqundah, Paul Y.; Georges, George; Nayak, Anjuli

doi:10.1016/s1081-1206(10)60340-7

Cited by 22 publications

(19 citation statements)

References 27 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

426

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

426

368

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“…Glukokortikoid burun spreyi Mometazon furoat, flutikazon furoat ve triamsinolon asetonid FDA tarafından ≥2 yaş çocuklar için onaylanmıştır. Flutikazon propiyonat ≥4 yaş çocuklar için onaylanmıştır (58,59).…”

Section: Farmakoterapiunclassified

Allerjik Rinit

Şimşek¹,

Yılmaz²,

Yüksel³

2018

Asthma Allergy Immunol

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“…8 Previous studies conforming to these criteria have been conducted in patients with asthma treated with orally inhaled corticosteroids. [9][10][11] Although studies with TAA-AQ in children with AR have examined its efficacy and safety 12 as well as GV, 13,14 the long-term effect of TAA-AQ on growth has not been assessed in randomized controlled trials. This study, designed per the FDA guidance recommendations, evaluates the difference in the GV of children aged 3-9 years with PAR treated with intranasal TAA-AQ or placebo for 12 months.…”

Section: What This Study Addsmentioning

confidence: 99%

“…The TEAEs were comparable among treatment groups, similar to those reported in a previous study with TAA-AQ in children with PAR. 12 This first published study examining growth effects of INCs in pediatric patients with PAR in compliance with the new FDA guidance detected a small yet statistically significant effect of TAA-AQ on GV with, however, a few limitations. The relatively short follow-up period precludes extrapolations of the rebound growth or effect of pediatric TAA-AQ treatment to the adult height.…”

Section: Figurementioning

confidence: 99%

Intranasal Triamcinolone and Growth Velocity

et al. 2015

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BACKGROUND: Inadequate designs and conflicting results from previous studies prompted the US Food and Drug Administration to publish guidelines for the design of clinical trials evaluating the effects of orally inhaled and intranasal corticosteroids on the growth of children. This study conformed to these guidelines to evaluate the effect of triamcinolone acetonide aqueous nasal spray (TAA-AQ) on the growth of children with perennial allergic rhinitis (PAR).METHODS: This randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluated the effect of once-daily TAA-AQ (110 mg) on the growth velocity (GV) of children aged 3-9 years with PAR by using stadiometry at baseline (4-6 months), during treatment (12 months), and at follow-up (2 months). Hypothalamus-pituitary-adrenal (HPA) axis function was assessed by measuring urinary cortisol levels. Details of adverse events were recorded.RESULTS: Of 1078 subjects screened, 299 were randomized, and 216 completed the study (placebo, 107; TAA-AQ, 109). In the primary analysis (modified intent-to-treat: placebo, 133; TAA-AQ, 134), least-squares mean GV during treatment was lower in the TAA-AQ group (5.65 cm/year) versus placebo (6.09 cm/year). The difference (-0.45 cm/year; 95% confidence interval: -0.78 to -0.11; P = .01), although clinically nonsignificant, was evident within 2 months of treatment and stabilized thereafter. At follow-up, the GV approached baseline (6.70 cm/year) in the TAA-AQ group (6.59 cm/year) and decreased slightly in the placebo group (5.89 cm/year vs 6.06 cm/year at baseline). No HPA axis suppression was observed.CONCLUSIONS: By using rigorous Food and Drug Administration-recommended design elements, this study detected a small, statistically significant effect of TAA-AQ on the GV of children with PAR.

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Efficacy and safety of triamcinolone acetonide aqueous nasal spray in children aged 2 to 5 years with perennial allergic rhinitis: a randomized, double-blind, placebo-controlled study with an open-label extension

Cited by 22 publications

References 27 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

Allerjik Rinit

Intranasal Triamcinolone and Growth Velocity

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