Comparison of azelastine nasal spray and oral ebastine in treating seasonal allergic rhinitis

Summary

The efficacy and safety of the nasally administered histamine H₁ receptor blocking drug azelastine was investigated in a randomized comparative trial with ebastine. Patients were treated for 14 days and efficacy was assessed by the physician using a rating scale measuring 10 nasal and ocular symptoms of seasonal rhinitis (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Tolerability was measured on the basis of reported adverse events. Data from a total of 59 patients were included in the efficacy analysis. Both treatment groups had dramatic reductions in the physician's total symptom score following treatment. Mean scores in the azelastine group decreased from 12.4 pretreatment to 5.6, while the mean ebastine scores decreased from 13.6 to 6.6. There was no significant difference between the two groups (p= 0.86). Changes in individual rhinitis symptoms showed no differences between the two groups. The majority of patients in both treatment groups reported an initial relief of symptoms within 1?h of dosing. For seven patients treated with azelastine, the initial effect was already seen after 10?min (ebastine: two patients). Eight adverse events were reported in each treatment group; all were mild except one report of sedation in an ebastine patient, which was of moderate severity. Three patients reported somnolence during treatment with ebastine. A bitter taste was mentioned by four patients in the azelastine group, but neither somnolence nor sedation was reported with azelastine. In conclusion, the results of the study suggest that both azelastine and ebastine are effective treatments of the symptoms of seasonal allergic rhinitis. Both drugs were well tolerated.     

Meta-analysis of azelastine nasal spray for the treatment of allergic rhinitis

STUDY OBJECTIVE: To systematically review the efficacy of azelastine nasal spray for the treatment of allergic rhinitis. DESIGN: Meta-analysis of published randomized controlled trials reported in English. DATA SOURCE: Published literature from the PubMed-MEDLINE database. PATIENTS: Patients aged at least 12 (United States) or 16 years (Europe) with allergic rhinitis or nonallergic vasomotor rhinitis. MEASUREMENTS AND MAIN RESULTS: A global assessment of efficacy was used to estimate the number needed to treat for azelastine nasal spray compared with placebo or active comparators. The total symptom score was used to compare the effect size between azelastine and placebo. In five comparisons of azelastine and placebo, azelastine was most efficacious, with a summary number needed to treat of 5.0 (95% confidence interval [CI] 3.3-10.0). In reviewing 11 studies of azelastine versus active comparators, we found no significant difference between azelastine and active comparators (number needed to treat 66.7, 95% CI 14.3 to infinity to 25). Azelastine was more efficacious than placebo in terms of total symptom score (effect size of 0.36, 95% CI 0.26-0.46). CONCLUSION: Azelastine nasal spray was more efficacious than placebo in the treatment of allergic rhinitis. No significant differences were observed between azelastine and active comparators for the treatment of allergic rhinitis; however, when azelastine was compared with oral antihistamines as monotherapy, the trend favored azelastine. Because azelastine appears to be as efficacious as oral antihistamines, the choice of treatment for seasonal allergic rhinitis should depend on the patient's preference regarding the route of administration, adverse effects, and the cost of the drug.     

Review of azelastine nasal spray in the treatment of allergic and non-allergic rhinitis

Azelastine is a potent H(1)-antihistamine, which is available as a topical nasal spray and indicated for both seasonal allergic and non-allergic vasomotor rhinitis. In addition to its antihistaminic effects, it has also been shown to have a number of other potentially important attributes, including effects on cytokines, adhesion molecules and inflammatory cells. Azelastine nasal spray has been shown to benefit patients who have not responded adequately to loratadine and fexofenadine, and is significantly more efficacious than cetirizine and levocabastine in patients with seasonal allergic rhinitis. Given its unique pharmacologic properties and clinical profile, azelastine maintains an important role in the treatment of chronic rhinitis.     

Comparative efficacy and safety of azelastine and levocabastine nasal sprays in patients with seasonal allergic rhinitis.

The aim of the present investigation was to compare the efficacy and tolerability of azelastine (CAS 58581-89-8) (1.12 mg/day) and levocabastine (CAS 79547-78-7) (0.4 mg/day) nasal spray administered twice daily to patients with seasonal allergic rhinitis. A total of 180 patients participated in a 4-week, double-blind, parallel group (n = 90 each) study. Symptom severity of nasal, ocular and other symptoms were recorded, out of which a total symptom score (TSS) was calculated. Physicians assessed symptoms at baseline and at days 7, 14, and 28, patients and physicians evaluated the efficacy and tolerability. After 4 weeks of treatment with azelastine the mean overall TSS was reduced from a baseline score of 18.7 to 4.2, after levocabastine from 17.8 to 5.9. Patients morning scores for treatment days 1 to 28 gave a mean total score of 212.4 for the azelastine group and 230.6 for the levocabastine group; the equivalent evening scores yielded a mean total score of 115.5 and 175.6 respectively. Global efficacy was judged by physicians as either 'very good' or 'good' for 90% of azelastine patients and for 74% of the levocabastine group; 92% of azelastine patients and 76% of levocabastine patients judged treatment to be either 'very good' or 'good'. No serious adverse events were reported, all adverse events were related to nasal symptoms. Both azelastine and levocabastine administered twice daily as a nasal spray provide effective and well tolerated symptomatic treatment of seasonal allergic rhinitis. Azelastine, however, was statistically superior in efficacy as well as in safety (PWei-Lachin < 0.0001, combined results).     

盐酸氮卓斯汀片结合布地奈德鼻喷雾剂治疗变应性鼻炎的疗效观察

目的探讨盐酸氮卓斯汀结合布地奈德鼻喷雾剂治疗变应性鼻炎的临床疗效。方法选择我院2015年3月~2016年9月收治的81例变应性鼻炎患者为研究对象,以随机数字表法分为观察组(41例)与对照组(40例),对照组患者应用盐酸氮卓斯汀治疗,观察组采用盐酸氮卓斯汀联合布地奈德鼻喷雾剂治疗,对两组患者治疗后疗效、症状变化、炎症因子等进行观察。结果观察组治疗总有效率为95.12%,与对照组80.00%相比,差异有统计学意义(P<0.05);治疗前,两组患者症状评分无明显差异(P>0.05),治疗后,观察组症状评分较对照组低,差异有统计学意义(P<0.05);治疗前,两组患者血清炎性因子水平无明显差异(P>0.05)治疗后,观察组IL-6、TNF-α较对照组低,差异均有统计学意义(P<0.05)。结论盐酸氮卓斯汀联合布地奈德鼻喷雾剂治疗变应性鼻炎效果满意,可快速缓解临床症状,也能控制炎性因子水平,利于远期预后,值得临床推广。     

盐酸氮卓斯汀与布地奈德治疗持续性变应性鼻炎的临床疗效评价

目的：评价盐酸氮卓斯汀鼻喷剂和布地奈德鼻喷剂对成人持续性变应性鼻炎（ AR）生活质量的影响。方法将148例持续性鼻炎患者随机分为试验组50例、对照组50例和安慰剂组48例。试验组予以盐酸氮卓斯汀喷鼻,每日早、晚各1次,每次每侧鼻腔1喷,每喷0．14 mg;对照组予以布地奈德喷鼻,每日早上1次,每次每侧鼻腔2喷,每喷64μg;安慰剂组予以0．9％氯化钠喷鼻,每日早上1次,每次每侧鼻腔2喷,3组患者均持续用药4周。用鼻部症状评分、生活质量评价量表（ SF－36）和鼻结膜炎相关生活质量问卷（ RQLQ）比较3组患者鼻部症状改善和生活质量。结果最终共有133例持续性鼻炎患者入组,其中试验组46例、对照组45例、安慰剂组42例。试验组和对照组治疗后,第2,4周的鼻部症状评分、SF－36和RQLQ评分均较安慰剂组明显改善（ P＜0．05）。治疗4周后,对照组鼻部症状评分、SF－36和RQLQ评分改善均较试验组更为显著（ P＜0．05）。结论盐酸氮卓斯汀鼻喷剂和布地奈德鼻喷剂均能明显改善成人持续性鼻炎患者生活质量,但布地奈德鼻喷剂治疗4周对持续性鼻炎患者生活质量改善较盐酸氮卓斯汀鼻喷剂更显著。     

Olopatadine nasal spray for the treatment of seasonal allergic rhinitis in patients aged 6 years and older

Importance of the field: Allergic rhinitis is an IgE-mediated condition that produces inflammation of the mucosa of the nose, paranasal sinuses and, frequently, of the ocular conjunctiva. Allergic rhinitis causes a significant disease burden in terms of quality of life, lost productivity and medical treatment costs. One of the newest treatments approved by the FDA is Patanase^® (olopatadine hydrochloride) Nasal Spray, 665 μg/spray (OLO). Olopatadine is an antihistamine with selective H₁-receptor antagonist activity.

Areas covered in this review: This review details the basic and clinical research on the olopatadine molecule and OLO nasal spray from 1996 to the present day.

What the reader will gain: The reader will gain a better understanding of the pharmacology of OLO nasal spray, the clinical trial data that have established the efficacy of OLO nasal spray and the overall role of OLO nasal spray in the management of allergic rhinitis.

Take home message: Olopatadine nasal spray is one of the newest treatments approved by the FDA for the management of allergic rhinitis. OLO has a rapid onset of action, efficacy comparable to intranasal steroid sprays and is approved for seasonal allergic rhinitis in patients aged ≥ 6 years.     

Fluticasone furoate nasal spray in allergic rhinitis

Fluticasone furoate is a novel glucocorticoid developed for the treatment of allergic rhinitis and other inflammatory diseases. Fluticasone furoate demonstrates high systemic clearance, low oral bioavailability and low absolute bioavailability after intranasal administration (<0.5%). The drug possesses a high receptor affinity. Fluticasone furoate is given once daily at a dose of 110 microg. Clinical studies tested the efficacy of fluticasone furoate in seasonal allergic rhinitis and perennial allergic rhinitis. Patients randomized to the drug experienced significant alleviation in their nasal and ocular symptoms as well as clinically relevant improvement in quality of life. The drug is well tolerated and has a good safety profile owing to reduced systemic exposure. Thus, fluticasone furoate might represent a single treatment option for nasal and ocular symptoms of allergic rhinitis.     

Ciclesonide nasal spray: in allergic rhinitis

Ciclesonide nasal spray delivers the corticosteroid ciclesonide as a hypotonic spray via a metered-dose manual pump. Systemic exposure to ciclesonide and its active metabolite desisobutyryl-ciclesonide is low after intranasal administration. High protein binding (approximately 99%) and rapid first-pass clearance further reduce systemic exposure to the drug. In well designed trials, intranasal ciclesonide 200 microg once daily for 2-4 weeks was more effective than placebo in terms of improving nasal symptoms in adolescents and adults with moderate to severe seasonal allergic rhinitis. Quality of life measures were statistically significantly improved in ciclesonide relative to placebo recipients during the first 2 weeks of therapy. Similarly, in adolescents and adults with moderately severe perennial allergic rhinitis, ciclesonide 200 microg once daily was more effective than placebo in terms of reducing nasal symptoms in well designed trials of 6 weeks' and 1 year's duration. Improvements relative to placebo in quality of life measures were not considered clinically relevant. Ciclesonide nasal spray was generally well tolerated in these clinical trials; most adverse events were mild to moderate in intensity.     

舌下含服尘螨滴剂联合盐酸西替利嗪滴剂、氮卓斯汀喷鼻在小儿变应性鼻炎中的治疗效果

目的　探讨尘螨滴剂联合西替利嗪、氮卓斯汀治疗小儿变应性鼻炎（AR）的临床价值。方法　选取2020年6月至2022年3月焦作市妇幼保健院160例AR患儿,根据治疗方案差异分为对照组（80例,接受西替利嗪治疗）和研究组（80例,接受西替利嗪联合舌下含服尘螨滴剂治疗）,疗程均为2个月。对比两组症状改善时间,治疗前后的C反应蛋白（CRP）、免疫球蛋白A、E、M（IgA、IgE、IgM）、白细胞介素6（IL-6）水平及不良反应。统计学方法采用t检验、χ²检验。结果　治疗后患儿症状改善情况：研究组患儿鼻塞、流涕、鼻痒、喷嚏改善时间均短于对照组（t=9.792、5.810、5.737、4.969,均P<0.05）;两组治疗前后免疫因子对比：治疗前两组IgM、IgA、IgE,差异均无统计学意义（t=0.714、0.529、0.474,均P>0.05）,治疗后研究组IgM、IgA、IgE水平均低于对照组,差异均有统计学意义（t=2.879、5.464、0.584,均P<0.05）;治疗前研究组与对照组CRP［（8.13±0.95）mg/L比（8.03±0.89）mg/L］、IL-6［（36.47±10.97）pg/ml比（30.52±6.23）pg/ml］对比,差异均无统计学意义（t=0.518、0.026,均P>0.05）,治疗后研究组的CRP、IL-6均低于对照组,差异均有统计学意义（t=13.871、4.912,均P<0.05）;两组总不良反应率对比：对照组总不良反应率为11.25%（9/80）,研究组总不良反应率为10.00%（8/80）,差异无统计学意义（χ²=0.066,P=0.798）。结论　尘螨滴剂联合盐酸西替利嗪、氮卓斯汀治疗可有效缩短AR患儿症状改善时间,改善患儿血清炎性因子及免疫因子水平。     

盐酸氮卓斯汀与丙酸氟替卡松喷鼻剂治疗变应性鼻炎临床对比观察

目的观察并比较盐酸氮卓斯汀与丙酸氟替卡松喷鼻剂在治疗变应性鼻炎中的效果。方法 146例变应性鼻炎患者,随机分为观察组和对照组,观察组应用盐酸氮卓斯汀喷鼻剂,对照组应用丙酸氟替卡松喷鼻剂(辅舒良),比较两组疗效及不良反应。结果两组治疗效果比较差异无统计学意义。但观察组起效快、不良反应明显少于对照组。结论对于常年性变应性鼻炎的治疗,应首选盐酸氮卓斯汀,该药起效快、安全有效,值得临床推广应用。     

A comparative study of beclomethasone dipropionate aqueous nasal spray with terfenadine tablets in seasonal allergic rhinitis

Forty-nine patients participated in a randomized double-blind, parallel group comparison of beclomethasone dipropionate aqueous nasal spray with terfenadine tablets in the treatment of hay fever. Symptom scores for nasal and ocular symptoms as well as grass pollen counts were registered daily for at least 1 month. Evaluation of daily symptom scores and the physicians' and patients' assessments of treatment demonstrated that both treatments were effective in controlling the symptoms of hay fever, with a similar incidence of side-effects. The beclomethasone dipropionate group, in general, had lower nasal symptom scores than the terfenadine group and this reached statistical significance on high pollen count days. In contrast, the terfenadine group had lower eye symptom scores than the other group and these were statistically significant during the first half of the study period. However, the use of additional medication for control of eye symptoms was similar in both groups. It is concluded that treatment with both beclomethasone dipropionate and terfenadine throughout the season was effective in controlling hay fever symptoms, but beclomethasone dipropionate is likely to provide better overall control since it prevented breakthrough of troublesome nasal symptoms during high pollen count days.     

A comparative study of beclomethasone dipropionate aqueous nasal spray with terfenadine tablets in seasonal allergic rhinitis

Summary

Forty-nine patients participated in a randomized double-blind, parallel group comparison of beclomethasone dipropionate aqueous nasal spray with terfenadine tablets in the treatment of hay fever. Symptom scores for nasal and ocular symptoms as well as grass pollen counts were registered daily for at least 1 month. Evaluation of daily symptom scores and the physicians' and patients' assessments of treatment demonstrated that both treatments were effective in controlling the symptoms of hay fever, with a similar incidence of side-effects. The beclomethasone dipropionate group, in general, had lower nasal symptom scores than the terfenadine group and this reached statistical significance on high pollen count days. In contrast, the terfenadine group had lower eye symptom scores than the other group and these were statistically significant during the first half of the study period. However, the use of additional medication for control of eye symptoms was similar in both groups. It is concluded that treatment with both beclomethasone dipropionate and terfenadine throughout the season was effective in controlling hay fever symptoms, but beclomethasone dipropionate is likely to provide better overall control since it prevented breakthrough of troublesome nasal symptoms during high pollen count days.     

Safety, tolerability, and exposure of ciclesonide nasal spray in healthy and asymptomatic subjects with seasonal allergic rhinitis

Ciclesonide is an intranasal corticosteroid in development for the treatment of allergic rhinitis. To assess the safety, tolerability, and pharmacokinetics of ciclesonide, adult healthy volunteers and asymptomatic subjects with seasonal allergic rhinitis were randomized to receive intranasal ciclesonide or placebo for 14 days. Serum concentrations of ciclesonide and its active metabolite, desisobutyryl-ciclesonide, were measured using high-performance liquid chromatography assay with tandem mass spectrometric detection, with lower limits of quantification of 25 and 10 pg/mL, respectively. Adrenal function was monitored by diurnal serum free and 24-hour urine cortisol concentrations. Despite the use of a sensitive assay and a high ciclesonide dose (800 microg/d), serum levels of ciclesonide and desisobutyryl-ciclesonide were below the lower limits of quantification for the majority of samples assayed. Ciclesonide was well tolerated and did not appear to affect serum or urine free cortisol levels. The low systemic exposure and favorable safety profile support the continued clinical development of ciclesonide nasal spray.     

盐酸氮(卓)司汀与丙酸氟替卡松治疗青少年季节性变应性鼻炎疗效比较

目的 研究盐酸氮(卓)司汀与丙酸氟替卡松治疗青少年季节性变应性鼻炎(SAR)的疗效及安全性.方法 选取2009年3月至2012年3月在我院诊治的SAR青少年患者76例,随机分为盐酸氮(革)司汀组和丙酸氟替卡松组,各38例,分别给予盐酸氮(卓)司汀鼻喷剂和丙酸氟替卡松鼻喷剂治疗,评价2组疗效,并通过鼻部症状总评分(TNSS)和服部症状总评分(TOSS)比较2组临床症状改善情况.结果 盐酸氮革司汀组和丙酸氟替卡松组总有效率分别为76.3％ (29/38)和81.6％ (31/38),组间差异无统计学意义(x2=0.32,P＞0.05).盐酸氮(卓)司汀组治疗前后TNSS分别为(8.7±2.3)分和(5.5±1.6)分,TOSS分别为(6.5±1.8)分和(3.9±1.2)分;丙酸氟替卡松组治疗前后TNSS评分分别为(8.4±2.2)分和(4.6±1.6)分,TOSS分别为(6.6±1.6)分和(4.5±1.3).2组治疗前后TNSS和TOSS的差异均有统计学意义(P＜0.05);治疗后,盐酸氮(卓)司汀组与丙酸氟替卡松组的TNSS和TOSS差异均无统计学意义(P＞0.05).盐酸氮革司汀组有2例患者发生嗜睡,丙酸氟替卡松组1例鼻出血.结论 盐酸氮(草)司汀与丙酸氟替卡松在治疗青少年SAR中均安全有效,二者在改善患者鼻部及眼部症状中效果相似.     

Dose-ranging study of fluticasone furoate nasal spray for Japanese patients with perennial allergic rhinitis

ABSTRACT

Background: This study was designed to evaluate the efficacy and safety of fluticasone furoate nasal spray (FFNS), a novel enhanced-affinity intranasal corticosteroid, in Japanese patients with perennial allergic rhinitis (PAR), and to determine the optimal dose.

Methods: In this phase II, multicenter, double-blind, randomized, placebo-controlled, parallel-group, dose-ranging study, 240 patients (aged ≥ 16 years) received once-daily (od) treatment for 2 weeks with either FFNS 110 μg (n = 80), 220 μg (n = 81) or placebo (n = 79). Patients evaluated 3 nasal symptoms using a 4-point scale. Efficacy was assessed as the mean change from baseline in total nasal symptom score (TNSS).

Results: Treatment with FFNS resulted in a significantly greater decrease over the treatment period in the mean 3TNSS (sneezing, rhinorrhea, and nasal congestion; p < 0.001 each dose vs. placebo), compared with placebo. More patients receiving FFNS had a markedly or moderately improved impression of treatment than placebo recipients (48% and 49% for FFNS 110 μg and 220 μg, respectively, vs. 18% for placebo; p < 0.001). Nasal rhinoscopy findings revealed significant improvements in mucosal swelling of the inferior turbinate (110 μg: p = 0.004; 220 μg: p = 0.011) and amount of watery rhinorrhea (110 μg: p = 0.003; 220 μg: p < 0.001), compared with placebo. Both doses of FFNS were well tolerated.

Conclusions: Both FFNS 110 µg and 220 µg od were effective in alleviating nasal symptoms in Japanese patients with PAR over the 2-week duration of this study. FFNS 110 µg od was selected as the optimal dose for further evaluation in phase III clinical trials.     

曲安奈德喷雾剂对变应性鼻炎的作用

目的研究曲安奈德鼻腔局部给药对实验性变应性鼻炎动物模型的治疗作用及对组胺致大鼠鼻气道阻力增加的缓解作用。方法以实验性变应性鼻炎模型豚鼠和组胺致鼻气道阻力增加模型大鼠为试验对象 ,以豚鼠鼻腔分泌物量、喷嚏次数、搔鼻次数、鼻组织学及大鼠鼻气道阻力为指标 ,全面考察曲安奈德喷雾剂对变应性鼻炎的作用。结果曲安奈德鼻喷雾剂 (5 0、10 0、2 0 0 μg·kg-1,对卵蛋白致敏实验性变态反应性鼻炎豚鼠模型的各种变应性鼻炎的症状和体症均有明显改善作用 ;与模型对照组比较 ,各给药组动物鼻腔分泌物量、喷嚏次数、抓鼻次数明显减少 ,并可对抗组胺所致大鼠鼻气道阻力的增加。结论曲安奈德鼻喷雾剂鼻腔局部给药对实验性变应性鼻炎有显著改善作用     

辅舒良水溶性鼻喷雾剂治疗变应性鼻炎的疗效观察

目的　观察辅舒良 (丙酸氟替卡松 )水溶性鼻喷雾剂对常年性和季节性变应性鼻炎的临床疗效。方法　按随机抽样的方法对 36例 10～ 6 0岁常年性和季节性变应性鼻炎患者使用辅舒良水溶性鼻喷雾剂治疗 ,于治疗前、治疗后 2、4周各项指标观察记分。结果　 36例在治疗后 2、4周平均记分均明显降低 ,统计学分析差异均有显著性 (P均 <0 0 1) ;治疗 2周后总有效率高达 10 0 % ,无 1例发生明显的毒副反应。结论　辅舒良水溶性鼻喷雾剂使用方便 ,起效快 ,效果好 ,无明显毒副作用 ,是治疗变应性鼻炎的全新选择     

曲安奈德鼻喷雾剂治疗变应性鼻炎的疗效观察

目的观察曲安奈德鼻喷雾剂对变应性鼻炎的临床疗效。方法用曲安奈德鼻喷雾剂治疗42例12-60岁常年性变应性鼻炎患者,治疗时间1个月。在治疗前以及治疗后1周、1个月、6个月分别观察记录并评分。结果42例在治疗后1周、1个月、6个月各项观察指标记分均明显降低,分析差异有统计学意义（P均〈0.05）;治疗后1周、1个月、6个月的有效率有统计学差异（P〈0.05）。无1例发生明显的毒副反应。结论曲安奈德鼻喷雾剂是治疗过敏性鼻炎安全、有效的药物。     

Effect of fluticasone propionate nasal spray on bioavailability of intranasal hydromorphone hydrochloride in patients with allergic rhinitis

STUDY OBJECTIVE: To investigate the effect of the nasal corticosteroid fluticasone propionate on the bioavailability and pharmacokinetics of single-dose intranasal hydromorphone hydrochloride in patients with allergic rhinitis. DESIGN: Randomized, three-way, crossover pharmacokinetic study. SETTING: University clinical research unit. PATIENTS: Twelve patients with allergic rhinitis. INTERVENTION: Hydromorphone hydrochloride 2.0 mg was administered by intravenous infusion (treatment A), intranasal spray without allergic rhinitis treatment (treatment B), and intranasal spray after 6 days of fluticasone propionate (treatment C). Blood samples were collected serially from 0-16 hours. MEASUREMENTS AND MAIN RESULTS: Pharmacokinetic parameters were determined by noncompartmental methods. An analysis of variance (ANOVA) model was used for statistical analysis. Mean (% coefficient of variation) absolute bioavailability of intranasal hydromorphone was 51.9% (28.2) and 46.9% (30.3) in patients with allergic rhinitis with and without treatment with fluticasone propionate, respectively. Mean maximum concentration (Cmax) values were 3.02 and 3.56 ng/ml, respectively. No statistical differences in Cmax and area under the concentration versus time curve were detected between intranasal treatments. Bioavailability values for both intranasal treatments were lower than those in healthy volunteers (57%). Median time to Cmax (Tmax) values were significantly different (p=0.02) for treatments B and C (15 and 30 min, respectively) using rank-transformed Tmax for ANOVA. Adverse effects were consistent with known effects of hydromorphone administered by other routes, with the exception of bad taste after intranasal administration. CONCLUSION: Hydromorphone was rapidly absorbed after nasal administration, with maximum concentrations occurring for most subjects within 30 minutes. Allergic rhinitis may affect pain management strategies for intranasal hydromorphone, with a delay in onset of action for patients treated with fluticasone propionate.