Triamcinolone acetonide (TAA) aerosol nasal inhaler is an effective and well-tolerated treatment for symptoms of perennial allergic rhinitis (PAR). This multicenter, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of once-daily administration of TAA aerosol nasal inhaler (220 mu g) in a pediatric population 6-11 years of age, with a documented history of PAR, a positive skin prick test for perennial allergens, and a minimum qualifying total rhinitis symptom score (greater than or equal to 24 points of a possible 48). One hundred thirty-seven patients received either TAA aerosol nasal inhaler (220 mu g/day) or placebo once daily for 4 weeks. Patients evaluated the severity of PAR symptoms (nasal stuffiness, discharge, sneezing, itching) daily according to a 4-point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Patients' and physicians' global evaluations of overall treatment effectiveness were assessed after the 4-week treatment period. Patients treated with TAA aerosol nasal inhaler had significantly (p < 0.05) greater reductions in all nasal symptom scores overall and in nasal stuffiness and nasal index at the end of weeks 1, 2, 3, and 4 compared with the placebo group. Both patients' and physicians' global evaluations of efficacy favored TAA aerosol nasal inhaler compared with placebo. Adverse events mere mild and comparable between the two groups. This study demonstrated that once-daily administration of TAA aerosol nasal inhaler (220 mu g) was well tolerated and effective in reducing the symptoms of PAR in pediatric patients.

CONTEXT:Topical corticosteroids are the recommended first-line treatment for all severities of persistent asthma and moderate to severe allergic rhinitis. Potential adrenal suppression resulting from corticosteroid administration necessitates monitoring of children participating in clinical studies. Measurement of pretreatment cortisol concentrations is necessary to assess effects on adrenal function.OBJECTIVE:Plasma cortisol concentrations are assay dependent; normal reference range values must be obtained for each assay. Our objective is to provide these values for children as determined by HPLC.DESIGN AND PATIENTS:Two multicenter, randomized, double-blind, placebo-controlled studies evaluating basal and cosyntropin-stimulated morning plasma cortisol concentrations for patients aged 5 to younger than 12 months with asthma and patients aged 2 to younger than 6 yr with allergic rhinitis using HPLC were conducted.MAIN OUTCOME MEASURES:Main planned outcomes of these studies are reported elsewhere. This manuscript reports plasma cortisol concentration reference range values.RESULTS:In general, mean basal plasma cortisol concentrations (n = 177) (mean +/- sd, nmol/liter) were similar among the 5 to younger than 9 months, 9 to younger than 12 months, 2 to younger than 3 yr, 3 to younger than 4 yr, 4 to younger than 5 yr, and 5 to younger than 6 yr age groups (218 +/- 149, 281 +/- 144, 257 +/- 105, 231 +/- 83, 298 +/- 118, and 237 +/- 65, respectively) and increased to comparable levels 60 min after cosyntropin stimulation (n = 178; 622 +/- 176, 638 +/- 176, 697 +/- 99, 655 +/- 103, 662 +/- 113, and 610 +/- 68, respectively). However, patients younger than 12 months had wider ranges of basal and stimulated values.CONCLUSIONS:Basal and cosyntropin-stimulated morning plasma cortisol concentrations of children aged 5 to younger than 12 months and 2 to younger than 6 yr were consistently measurable, with the large majority similar among the age groups examined, and comparable with those reported elsewhere for adults.

BACKGROUND:Recent guidelines recommend intranasal corticosteroids as first-line treatment for managing persistent symptoms of moderate to severe allergic rhinitis (AR). However, in children, long-term continual treatment with corticosteroids has raised concerns about potential growth suppression. OBJECTIVE:To evaluate the effects of the recommended once-daily dose of budesonide aqueous nasal spray on growth velocity, as measured with stadiometry, in children with perennial AR. METHODS:In this double-blind, placebo-controlled, multicenter study, 229 prepubertal children (mean age, 5.9 years; age range, 4-8 years) with perennial AR were randomized (2:1) to receive budesonide aqueous nasal spray, 64 microg (32 microg per nostril) once daily, or placebo for 1 year. The change from baseline in growth velocity, height after treatment, and the percentage of patients whose percentile for height decreased from baseline to the end of treatment were evaluated. RESULTS:Growth velocity was not significantly different between the 2 groups. The least-squares mean +/- SE growth velocity during treatment was 5.91 +/- 0.11 cm per year for children receiving budesonide and 6.19 +/- 0.16 cm per year for those receiving placebo. The mean difference in growth velocity between the 2 groups was 0.27 +/- 0.18 cm per year (95% confidence interval, -0.07 to 0.62 cm per year). After treatment, the mean +/- SD height was 128.8 +/- 8.7 cm for children receiving budesonide and 128.2 +/- 8.8 for those receiving placebo. The percentage of children whose percentile for height decreased during treatment was not significantly different between the 2 groups (budesonide, 59%, placebo, 54%; P = .64). The incidence and types of adverse events and the mean 24-hour urinary cortisol-creatinine ratio were similar for the 2 groups. CONCLUSIONS:Treatment with budesonide aqueous nasal spray, 64 microg once daily, for 1 year did not suppress growth velocity compared with placebo and was well tolerated in prepubertal children with perennial AR.

Rationale Rofleponide palmitate, a glucocorticosteroid, was developed into an aqueous nasal spray for treatment of AR symptoms. The aim of this study was to evaluate the efficacy of RPNS compared with placebo and MFNS, a reference standard, in relieving symptoms of seasonal AR. Methods In this multicenter, randomized, double-blind, placebo-controlled, parallel group study, 660 adults and adolescents ≥12 years of age with seasonal (mountain cedar) AR were treated with 1 of 3 concentrations of RPNS (20, 100, and 200 μg), matching placebo, or MFNS (200 μg) once daily for 2 weeks. Assessments included changes in morning and evening total nasal symptom score (TNSS), morning total instantaneous symptom score (TISS), and the monitoring of adverse events (AEs). Results Two doses of RPNS significantly reduced morning and evening TNSS (20 μg, P P P =.007; 100 μg, P =.025; 200 μg, P Conclusion All treatments were well tolerated, and the 200-μg dose of RPNS was significantly more effective than placebo and had a higher magnitude of improvement than MFNS 200 μg in relieving mountain cedar AR symptoms in adolescent and adults patients.

Rationale RPNS, a recently developed nasal glucocorticosteroid for AR, was compared to BANS with known efficacy for AR, and placebo, using the EEU, a controlled-pollen exposure setting. Methods This double-blind, randomized, placebo-controlled, parallel-group study of 291 adults ≥16 years of age with seasonal (ragweed) AR evaluated 3 doses of RPNS (20, 100, 200 μg) with BANS (128 μg) and placebo once daily for 8 days (3 pretreatment days followed by 5 days consisting of 3 hour EEU challenge sessions). Primary efficacy variables were changes in morning and evening total nasal symptom score (TNSS) and peak nasal inspiratory flow (PNIF). Results Only the 200-μg dose of RPNS significantly reduced morning TNSS compared with placebo (P=.007); no RPNS treatment group demonstrated significant differences in evening TNSS compared with placebo. However, BANS treatment significantly reduced morning TNSS compared with placebo (P Conclusion Rofleponide palmitate nasal spray was less effective than budesonide aqueous nasal spray 128 μg for the relief of symptoms of seasonal AR when compared with placebo and at doses up to 100 μg upon comparing both active medications. Both active medications were well tolerated.

Background: Intranasal corticosteroids are safe and effective for treating allergic rhinitis in adults. Since children may receive more systemic corticosteroid on a dose-per-weight basis than adults, the safety of corticosteroid therapy in pediatric patients is an important issue.Objective: To determine the effects of treatment with budesonide aqueous nasal spray using the recommended once-daily dose for adults and children 6 years and older on hypothalamic-pituitary-adrenal (HPA) axis function in pediatric patients with allergic rhinitis.Methods: In a 6-week, multicenter, double-blind, placebo-controlled study, 78 patients aged 2 to 5 years with allergic rhinitis were treated with budesonide aqueous nasal spray (64 mug/d) or placebo. Mean change in morning plasma cortisol levels from baseline to study end 0, 30, and 60 minutes after low-dose (10-mu/g) cosyntropin stimulation and mean change in the difference from 0 to 30 minutes and from 0 to 60 minutes after cosyntropin stimulation were used to evaluate HPA axis function.Results: Mean change from baseline to study end in plasma cortisol levels 0, 30, and 60 minutes after cosyntropin stimulation and the difference from 0 to 30 minutes and from 0 to 60 minutes were not significantly different between the treatment and placebo groups (P >.05 for all). At the end of the study, 3 budesonide aqueous nasal spray and 6 placebo patients were classified as having subnormal HPA axis function. The safety and tolerability profile of budesonide aqueous nasal spray was comparable to that of placebo.Conclusions: Administration of budesonide aqueous nasal spray for 6 weeks was well tolerated and safe and had no measurable suppressive effects on HPA axis function in patients aged 2 to 5 years with allergic rhinitis.

RATIONALE: Recent guidelines suggest that intranasal corticosteroids should be used as first-line treatment for controlling persistent symptoms of allergic rhinitis (AR), but long-term continual use of corticosteroids can raise growth concerns in a pediatric population.Effects of the recommended once-daily dose of budesonide aqueous nasal spray (BANS; Rhinocort Aqua ® ) on growth velocity were examined in pediatric patients with perennial AR.METHODS: In this 1-year, multicenter, double-blind, placebo-controlled study, 229 pediatric patients (aged 4 to 8 years) with perennial AR were treated with once-daily BANS (64 µg) or placebo.Change in growth velocity and in the percentage of patients whose percentile for height decreased from the 6-month baseline to end of treatment were examined using stadiometry.RESULTS: Mean growth velocity (± SE) during the treatment period was 5.91 ± 0.11 cm/year for the BANS group and 6.19 ± 0.16 cm/year for the placebo group.The difference in growth velocity between groups was not significantly different during the 1-year treatment period (0.27 ± 0.18 cm/year; 95% CI, -0.07 to 0.62).The percentage of patients whose percentile for height decreased during the study was also not significantly different between groups (58.5% BANS, 54.1% placebo; P=.64).The incidence and types of adverse events were similar between treatment groups.Five placebo patients and zero BANS patients reported serious adverse events during the treatment period.CONCLUSION: Administration of budesonide aqueous nasal spray 64 µg once daily for 1 year does not suppress growth velocity and is well tolerated in pediatric patients aged 4 to 8 years with perennial AR.

RATIONALE: Intranasal corticosteroids are effective in treating allergic rhinitis and do not cause significant systemic effects in adults at recommended dosages.However, children may receive more systemic corticosteroid on a microgram-per-kilogram basis than adults.The effects on HPA axis function of the recommended starting dose of BANS (Rhinocort| Aqua TM) for adults and children _>6 years of age were examined in pediatric patients with allergic rhinitis.METHODS: In this 6-week, multicenter, double-blind, placebo-controlled study, 78 patients (age, 2-5 years) with allergic rhinitis were treated with BANS (64 lag once daily) or placebo.Change from baseline to endpoint in plasma cortisol levels at 0, 30, and 60 minutes after low-dose (10 lag) cosyntropin stimulation was used to assess HPA axis function.RESULTS: Mean change from baseline to endpoint in plasma cortisol levels at 0, 30, and 60 minutes after cosyntropin stimulation were not significantly different (P > .05) between BANS (mean _+ SE : -22.4 _+ 16.0, 17.6 _+ 18.7, and -32.5 _+ 21.6 nmol/L, respectively) and placebo (-1.9 • 14.6, -27.8 • 19.7, and -48.9 • 21.8 nmol/L, respectively).At endpoint, 3 BANS and 6 placebo patients were classified as having subnormal HPA axis function (basal plasma cortisol level <148 nmol/L and/or 30-or 60minute post-cosyntropin value <498 nmol/L).The safety and tolerability profile of BANS was comparable to that of placebo.CONCLUSIONS: Once-daily BANS (64 lag) administered for 6 weeks has no suppressive effects on HPA axis function in pediatric patients aged 2-5 years with allergic rhinitis.

Study object-res: This multicenter, randomized, double-blind, placebo-controlled, parallel study compared the efficacy and safety of the hydrofluoroalkane (HFA) formulation of cromolyn sodium metered-dose inhaler (MDI) with the chlorofluorocarbon (CFC) formulation in asthmatic patients greater than or equal to 12 years old over a 12-week period.Design: Stable asthmatics using only currently marketed cromolyn sodium and as-needed inhaled beta(2)-agonists were randomly assigned to treatment with HFA cromolyn sodium, CFC cromolyn sodium, or placebo, administered as two inhalations (2 mg) qid for 12 weeks. Prior to randomization, all patients were required to meet minimum symptom and/or pulmonary function test criteria after discontinuation of cromolyn sodium. Efficacy was assessed by changes in daily symptom scores, albuterol use, peak expiratory flow, pulmonary function measurements, and overall opinions of effectiveness.Results: A total of 280 patients in 29 centers were randomly assigned to treatment with HFA cromolyn sodium (n = 94), CFC cromolyn sodium (n = 91), or placebo (n = 95), Patients treated with the HFA formulation of cromolyn sodium demonstrated a 28 to 33% improvement over symptom scores (p < 0.05) and a 35% improvement over placebo in the use of placebo for (p < 0.05), The patients' opinions of overall effectiveness favored HFA cromolyn;n sodium (p = 0.011) and CFC cromolyn sodium (p = 0.006) over placebo, The investigators' opinions indicated a statistically significant difference favoring CFC cromolyn sodium compared with both placebo (p < 0.001) and HFA cromolyn sodium (p = 0.042). No statistically significant differences existed among groups in the incidence of treatment-related adverse events.Conclusion: The HFA formulation of cromolyn sodium MDI is a well-tolerated and effective treatment for asthma patients greater than or equal to 12 years old. The safety and efficacy profile of the HFA formulation is comparable to that of the CFC formulation.

Otolaryngology–Head and Neck SurgeryVolume 113, Issue 2 p. P136-P136 Original Article Poster 30: Triamcinolone Acetonide Aqueous Nasal Spray (Nasacort Aqueous) Relieves the Symptoms of Seasonal Ragweed Allergic Rhinitis Guy A. Settipane MD, presenter, Guy A. Settipane MD, presenter Providence, Rhode Island St. Louis, Missouri Sylvania, Ohio Dallas, Texas San Antonio, Texas Collegeville, PennsylvaniaSearch for more papers by this authorPhilip E. Korenblat MD, Philip E. Korenblat MD Providence, Rhode Island St. Louis, Missouri Sylvania, Ohio Dallas, Texas San Antonio, Texas Collegeville, PennsylvaniaSearch for more papers by this authorJohn Winder MD, John Winder MD Providence, Rhode Island St. Louis, Missouri Sylvania, Ohio Dallas, Texas San Antonio, Texas Collegeville, PennsylvaniaSearch for more papers by this authorWilliam R. Lumry MD, William R. Lumry MD Providence, Rhode Island St. Louis, Missouri Sylvania, Ohio Dallas, Texas San Antonio, Texas Collegeville, PennsylvaniaSearch for more papers by this authorJean Murphree MD, Jean Murphree MD Providence, Rhode Island St. Louis, Missouri Sylvania, Ohio Dallas, Texas San Antonio, Texas Collegeville, PennsylvaniaSearch for more papers by this authorVivian B. Alderfer PhD, Vivian B. Alderfer PhD Providence, Rhode Island St. Louis, Missouri Sylvania, Ohio Dallas, Texas San Antonio, Texas Collegeville, PennsylvaniaSearch for more papers by this authorBrandon Simpson, Brandon Simpson Providence, Rhode Island St. Louis, Missouri Sylvania, Ohio Dallas, Texas San Antonio, Texas Collegeville, PennsylvaniaSearch for more papers by this authorJoseph A. Smith MD, Joseph A. Smith MD Providence, Rhode Island St. Louis, Missouri Sylvania, Ohio Dallas, Texas San Antonio, Texas Collegeville, PennsylvaniaSearch for more papers by this author Guy A. Settipane MD, presenter, Guy A. Settipane MD, presenter Providence, Rhode Island St. Louis, Missouri Sylvania, Ohio Dallas, Texas San Antonio, Texas Collegeville, PennsylvaniaSearch for more papers by this authorPhilip E. Korenblat MD, Philip E. Korenblat MD Providence, Rhode Island St. Louis, Missouri Sylvania, Ohio Dallas, Texas San Antonio, Texas Collegeville, PennsylvaniaSearch for more papers by this authorJohn Winder MD, John Winder MD Providence, Rhode Island St. Louis, Missouri Sylvania, Ohio Dallas, Texas San Antonio, Texas Collegeville, PennsylvaniaSearch for more papers by this authorWilliam R. Lumry MD, William R. Lumry MD Providence, Rhode Island St. Louis, Missouri Sylvania, Ohio Dallas, Texas San Antonio, Texas Collegeville, PennsylvaniaSearch for more papers by this authorJean Murphree MD, Jean Murphree MD Providence, Rhode Island St. Louis, Missouri Sylvania, Ohio Dallas, Texas San Antonio, Texas Collegeville, PennsylvaniaSearch for more papers by this authorVivian B. Alderfer PhD, Vivian B. Alderfer PhD Providence, Rhode Island St. Louis, Missouri Sylvania, Ohio Dallas, Texas San Antonio, Texas Collegeville, PennsylvaniaSearch for more papers by this authorBrandon Simpson, Brandon Simpson Providence, Rhode Island St. Louis, Missouri Sylvania, Ohio Dallas, Texas San Antonio, Texas Collegeville, PennsylvaniaSearch for more papers by this authorJoseph A. Smith MD, Joseph A. Smith MD Providence, Rhode Island St. Louis, Missouri Sylvania, Ohio Dallas, Texas San Antonio, Texas Collegeville, PennsylvaniaSearch for more papers by this author First published: August 1995 https://doi.org/10.1016/S0194-5998(05)80806-X (Supported by a grant from Rhĉne-Poulenc Rorer Pharmaceuticals Inc.) Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume113, Issue2August 1995Pages P136-P136 RelatedInformation

Purpose: Topical corticosteroids are recommended as first-line treatment for all severities of asthma and allergic rhinitis except mild intermittent. The potential for adrenal suppression in pediatric patients necessitates monitoring of adrenal function in clinical trials evaluating these treatments. To adequately assess effects of corticosteroids on adrenal function, it is necessary to know what are the normal basal and stimulated cortisol ranges for pediatric patients. Reference cortisol values and response to cosyntropin stimulation were evaluated in pediatric patients 5 months to 5 years of age. Methodology: Morning plasma cortisol levels before and 60 minutes after cosyntropin stimulation (125 µg in study 1 and 10 µg in study 2) were determined for 118 patients with asthma aged 5 to 11 months in study 1 and 67 patients with allergic rhinitis aged 2 to 5 years in study 2. Patients in study 2 also had plasma cortisol levels evaluated 30 minutes after cosyntropin stimulation.

Methods: In this 1-year, multicenter, double-blind, placebo-controlled study, 229 pediatric patients (aged 4 to 8 years) with perennial AR were treated with once-daily BANS (64 µg) or placebo. Change in growth velocity and in the percentage of patients whose percentile for height decreased from the 6-month baseline to end of treatment were assessed by stadiometry. Results: Mean growth velocity (± SE) during the treatment period was 5.91 ± 0.11 cm/year for the BANS group and 6.19 ± 0.16 cm/year for the placebo group. The difference in growth velocity between groups was not significantly different during the 1-year treatment period (0.27 ± 0.18 cm/year; 95% CI, -0.07 to 0.62). The percentage of patients whose percentile for height decreased during the study was also not significantly different between groups (58.5% BANS, 54.1% placebo; P = .64). The incidence and types of adverse events were similar between treatment groups. Five placebo patients and zero BANS patients reported serious adverse events during the treatment period.