Administration Of Nasal Spray Research Articles

Prospective survey on patient satisfaction and quality-of-life impact concerning the administration of fentanyl pectin nasal spray for breakthrough pain in cancer: Qualipec study.

TPS6639 Background: Previous clinical trials have confirmed the efficacy and safety of fentanyl pectin nasal spray (PFNS), as a rapid analgesic agent in cases of Breakthrough pain in cancer (BTPc),...

Plasma oxytocin concentrations following MDMA or intranasal oxytocin in humans.

MDMA (±3,4-methylenedioxymethamphetamine, 'ecstasy') is reportedly used recreationally because it increases feelings of sociability and interpersonal closeness. Prior work suggests that the pro-social effects of MDMA may be mediated by release of oxytocin. A direct examination of plasma levels of oxytocin after acute doses of oxytocin and MDMA, in the same individuals, would provide further evidence for the idea that MDMA produces its pro-social effects by increasing oxytocin. Fourteen healthy MDMA users participated in a 4-session, double-blind study in which they received oral MDMA (0.75 and 1.5mg/kg), intranasal oxytocin (20IU or 40IU), and placebo. Plasma oxytocin concentrations, as well as cardiovascular and subjective effects were assessed before and at several time points after drug administration. MDMA (1.5mg/kg only) increased plasma oxytocin levels to a mean peak of 83.7pg/ml at approximately 90-120min, compared to 18.6pg/ml after placebo. Intranasal oxytocin (40IU, but not 20IU) increased plasma oxytocin levels to 48.0pg/ml, 30-60min after nasal spray administration. MDMA dose-dependently increased heart rate, blood pressure, feelings of euphoria (e.g., 'High' and 'Like Drug'), and feelings of sociability, whereas oxytocin had no cardiovascular or subjective effects. The subjective and cardiovascular responses to MDMA were not related to plasma oxytocin levels, although the N was small for this analysis. Future studies examining the effects of oxytocin antagonists on responses to MDMA will help to determine the mechanism by which MDMA produces pro-social effects.

Carrageenan nasal spray in virus confirmed common cold: individual patient data analysis of two randomized controlled trials.

BackgroundClinical trials applying iota-carrageenan nasal spray have previously shown to reduce duration of virus-confirmed common cold. The present study pooled data of two similar clinical trials to provide further evidence for the antiviral effectiveness of carrageenan.MethodsIndividual patient data were analyzed from two randomized double blind placebo controlled trials assessing the therapeutic effectiveness of carrageenan nasal spray in acute common cold. Patients with virus-confirmed common cold (n = 254, verum 126, placebo 128) were included and the following parameters were appraised: duration of disease, number of patients with relapses, number of respiratory viruses and viral titers at inclusion (visit 1) compared to days 3–5 (visit 2).ResultsCarrageenan treated patients showed a significant reduction in duration of disease of almost 2 days (p < 0.05) as well as significantly fewer relapses during 21 days of observation period (p < 0.05). The virus clearance between visit 1 and visit 2 was significantly more pronounced in the carrageenan group (p < 0.05). In both studies, virus-confirmed common cold was caused by three main virus subtypes: human rhinovirus (46%), human coronavirus (25%) and influenza A (14%) virus. Carrageenan nasal spray showed significant antiviral efficacy in all three virus subgroups, the highest effectiveness was observed in human corona virus-infected patients. The reduced duration of disease was 3 days (p < 0.01) and the number of relapses was three times less (p < 0.01) in carrageenan treated corona-virus-infected patients compared to control patients.ConclusionsAdministration of carrageenan nasal spray in children as well as in adults suffering from virus-confirmed common cold reduced duration of disease, increased viral clearance and reduced relapses of symptoms. Carrageenan nasal spray appeared as an effective treatment of common cold in children and adults.Trial registrationPooled data from ISRCTN52519535 and ISRCTN80148028

Improved Pharmacokinetics of Sumatriptan With Breath Powered™ Nasal Delivery of Sumatriptan Powder

Objectives.—The purpose of this study was to directly compare the pharmacokinetic (PK) profile of 22-mg sumatriptan powder delivered intranasally with a novel Breath Powered™ device (11 mg in each nostril) vs a 20-mg sumatriptan liquid nasal spray, a 100-mg oral tablet, and a 6-mg subcutaneous injection.Background.—A prior PK study found that low doses of sumatriptan powder delivered intranasally with a Breath Powered device were efficiently and rapidly absorbed. An early phase clinical trial with the same device and doses found excellent tolerability with high response rates and rapid onset of pain relief, approaching the benefits of injection despite significantly lower predicted drug levels.Methods.—An open-label, cross-over, comparative bioavailability study was conducted in 20 healthy subjects at a single center in the USA. Following randomization, fasted subjects received a single dose of each of the 4 treatments separated by a 7-day washout. Blood samples were taken pre-dose and serially over 14 hours post-dose for PK analysis.Results.—Quantitative measurement of residuals in used Breath Powered devices demonstrated that the devices delivered 8 ± 0.9 mg (mean ± standard deviation) of sumatriptan powder in each nostril (total dose 16 mg). Although the extent of systemic exposure over 14 hours was similar following Breath Powered delivery of 16-mg sumatriptan powder and 20-mg liquid nasal spray (area under the curve [AUC]0-∞ 64.9 ng*hour/mL vs 61.1 ng*hour/mL), sumatriptan powder, despite a 20% lower dose, produced 27% higher peak exposure (Cmax 20.8 ng/mL vs 16.4 ng/mL) and 61% higher exposure in the first 30 minutes compared with the nasal spray (AUC0-30 minutes 5.8 ng*hour/mL vs 3.6 ng*hour/mL). The magnitude of difference is larger on a per-milligram basis. The absorption profile following standard nasal spray demonstrated bimodal peaks, consistent with lower early followed by higher later absorptions. In contrast, the profile following Breath Powered delivery showed higher early and lower late absorptions. Relative to the 100-mg oral tablet (Cmax 70.2 ng/mL, AUC0-∞, 308.8 ng*hour/mL) and 6-mg injection (Cmax 111.6 ng/mL, AUC0-∞ 128.2 ng*hour/mL), the peak and overall exposure following Breath Powered intranasal delivery of sumatriptan powder was substantially lower.Conclusions.—Breath Powered intranasal delivery of sumatriptan powder is a more efficient form of drug delivery, producing a higher peak and earlier exposure with a lower delivered dose than nasal spray and faster absorption than either nasal spray or oral administration. It also produces a significantly lower peak and total systemic exposure than oral tablet or subcutaneous injection.

Nephrogenic Diabetes Insipidus is a Rare Complication of Chronic Kidney Disease - A Case Report

Nephrogenic Diabetes Insipidus (NDI) may occur as a complication of chronic kidney disease (CKD). The incidence of NDI is very rare. So recognition of this potential complication is very important. In our country, this rare complication is not yet reported. So, to make awareness among the paediatricians, we report a case of NDI as a rare complication of CKD. A 4-year old boy was admitted in the Department of Paediatric Nephrology, Bangabandhu Sheikh Mujib Medical University (BSMMU) with the complaints of failure to thrive, refusal to feed, nausea and vomiting since 18- months of his age. For the last six months, he had also complaints of polyuria and polydipsia. In addition to this, he developed muscle pain, constipation, bowing of leg and occasional unexplained fever. He was moderately pale with deep sighing respiration and his blood pressure was above 95th centile for age and sex. His creatinine level was high with low TCO2 and calcium level. His plasma osmolality was very high while urine osmolality was inappropriately low which did not increase after desmopressin (nasal spray) administration. Initial treatment with Indomethacin was ineffective while the combination of hydrochlorothiazide and Indomethacin was effective and well tolerated. DOI: http://dx.doi.org/10.3329/bjch.v37i1.15350 BANGLADESH J CHILD HEALTH 2013; VOL 37 (1) : 41-44

Effect of Beclomethasone Nasal Spray on Intraocular Pressure in Ocular Hypertension or Controlled Glaucoma

To evaluate the effect of 6 weeks administration of beclomethasone nasal spray on intraocular pressure (IOP) in patients with ocular hypertension or controlled primary open-angle glaucoma. Randomized double-masked controlled trial. Patients were randomized to twice daily beclomethasone versus placebo saline nasal spray. There were a total of 4 study visits: baseline and weeks 2, 4, 6 after starting the spray. Each study visit was at the same time within a 1-hour time window. Primary outcome measure was IOP. Secondary measures included visual acuity, anterior segment changes, patient reported side effects, and compliance. Study endpoint was 6 weeks from the start of treatment or an IOP increase of >20% from baseline. A sample size calculation suggested that 8 patients in each arm would be sufficient to detect a difference of 3.2 mm Hg with a power of 80%. Nineteen consecutive consenting patients completed the study-9 in the steroid arm and 10 in the placebo arm. There were no statistically significant differences between groups in baseline characteristics, IOP at each study visit, or change in IOP from baseline at any time point. At 6 weeks, the change in mean IOP from baseline was +0.50±1.52 versus +0.70±1.44 mm Hg in the steroid and saline nasal spray groups, respectively (P=0.77). Patients with ocular hypertension and primary open-angle glaucoma showed no evidence of IOP elevation after 6 weeks use of beclomethasone nasal spray.

Amygdala response to negative images in postpartumvsnulliparous women and intranasal oxytocin

The neuroendocrine state of new mothers may alter their neural processing of stressors in the environment through modulatory actions of oxytocin on the limbic system. We predicted that amygdala sensitivity to negatively arousing stimuli would be suppressed in postpartum compared to nulliparous women and that this suppression would be modulated by administration of oxytocin nasal spray. We measured brain activation (fMRI) and subjective arousal in response to negatively arousing pictures in 29 postpartum and 30 nulliparous women who received either oxytocin nasal spray or placebo before scanning. Pre- and post-exposure urinary cortisol levels were also measured. Postpartum women (placebo) demonstrated lower right amygdala activation in response to negative images, lower cortisol and lower negative photo arousal ratings to nulliparous women. Nulliparous women receiving oxytocin had lower right amygdala activation compared to placebo. Cortisol levels in the placebo group, and ratings of arousal across all women, were positively associated with right amygdala activation. Together, these findings demonstrate reductions in both amygdala activation and subjective negative arousal in untreated postpartum vs nulliparous women, supporting the hypothesis of an attenuated neural response to arousing stimuli in postpartum women. A causal role of oxytocin and the timing of potential effects require future investigation.

Long-term oxytocin administration improves social behaviors in a girl with autistic disorder

BackgroundPatients with autism spectrum disorders (ASDs) exhibit core autistic symptoms including social impairments from early childhood and mostly show secondary disabilities such as irritability and aggressive behavior based on core symptoms. However, there are still no radical treatments of social impairments in these patients. Oxytocin has been reported to play important roles in multiple social behaviors dependent on social recognition, and has been expected as one of the effective treatments of social impairments of patients with ASDs.Case presentationWe present a case of a 16-year-old girl with autistic disorder who treated by long-term administration of oxytocin nasal spray. Her autistic symptoms were successfully treated by two month administration; the girl’s social interactions and social communication began to improve without adverse effects. Her irritability and aggressive behavior also improved dramatically with marked decreases in aberrant behavior checklist scores from 69 to 7.ConclusionThis case is the first to illustrate long-term administration of oxytocin nasal spray in the targeted treatment of social impairments in a female with autistic disorder. This case suggests that long-term nasal oxytocin spray is promising and well-tolerated for treatment of social impairments of patients with ASDs.

Oxytocin plasma concentrations after single intranasal oxytocin administration – A study in healthy men

The neuropeptide oxytocin has become a subject of great interest in studies investigating human social cognition. Single intranasal administration of the hormone has been reported to have positive behavioral effects, such as increasing trust or facilitating social approach, 45-80 min after administration. However, little is still known about the long-term pharmacokinetics of oxytocin nasal spray application in humans. This study addressed the question how long oxytocin plasma levels remain elevated following nasal spray administration. Another goal was to examine the influence of oxytocin administration on endogenous steroid hormones since such alterations might modulate social behavior via an indirect way. Eight healthy Caucasian men were challenged with a single intranasal application of 26 international units of oxytocin. Changes in oxytocin blood plasma levels, as well as steroid hormone levels of progesterone, testosterone and estradiol were assessed at 5 consecutive time points over a period of 3.5 h (-5, +30, +90, +150, +210 min relative to oxytocin administration). Results gave evidence for a substantial rise of oxytocin plasma levels 30 min after intranasal administration, observed in 7 of 8 participants. Group mean oxytocin plasma level was found to have returned to baseline already 90 min post administration, though in some individuals the plasma levels was still elevated relative to sampling at post 150 min. Steroid hormone analyses yielded a slight augmentation of endogenous testosterone levels 210 min after oxytocin administration. Our data confirms previous findings that oxytocin administered as a nasal spray enters the blood circulation, elevating oxytocin plasma levels for a limited time. Our findings suggest that this time window differs between individuals, but that, for the used dose, it does not extend beyond 150 min post administration. The data further provides preliminary evidence that intranasal oxytocin has an enhancing effect on testosterone in healthy men.

Enhancement of nose-to-brain delivery of basic fibroblast growth factor for improving rat memory impairments induced by co-injection of β-amyloid and ibotenic acid into the bilateral hippocampus

Basic fibroblast growth factor (bFGF) delivery to the brain of animals appears to be an emerging potential therapeutic approach to neurodegenerative diseases, such as Alzheimer's disease (AD). The intranasal route of administration could provide an alternative to intracerebroventricular infusion. A nasal spray of bFGF had been developed previously and the objective of the present study was to investigate whether bFGF nasal spray could enhance brain uptake of bFGF and ameliorate memory impairment induced by co-injection of β-amyloid(25-35) and ibotenic acid into bilateral hippocampus of rats. The results of brain uptake study showed that the AUC(0-12h) of bFGF nasal spray in olfactory bulb, cerebrum, cerebellum and hippocampus was respectively 2.47, 2.38, 2.56 and 2.19 times that of intravenous bFGF solution, and 1.11, 1.95, 1.40 and 1.93 times that of intranasal bFGF solution, indicating that intranasal administration of bFGF nasal spray was an effective means of delivering bFGF to the brain, especially to cerebrum and hippocampus. In Morris water maze tasks, intravenous administration of bFGF solution at high dose (40 μg/kg) showed little improvement on spatial memory impairment. In contrast, bFGF solution of the same dose following intranasal administration could significantly ameliorate spatial memory impairment. bFGF nasal spray obviously improved spatial memory impairment even at a dose half (20 μg/kg) of bFGF solution, recovered their acetylcholinesterase and choline acetyltransferase activity to the sham control level, and alleviated neuronal degeneration in rat hippocampus, indicating neuroprotective effects on the central nerve system. In a word, bFGF nasal spray may be a new formulation of great potential for treating AD.

Hydrophilic Nasal Gel of Lidocaine Hydrochloride

Intranasal lidocaine hydrochloride (LID, CAS 73-78-9) has been widely and commonly used in the treatment of a series of symptoms such as migraine, cluster headache and trigeminal neuralgia in clinical studies. Nevertheless, rapid nasal mucociliary clearance of intranasal solution presents the predominant obstacle impacting its efficiency. In order to prolong the residence time of LID in the nasal cavity and increase its absorption, a LID nasal gel had been developed previously using hydroxypropyl methyl cellulose (HPMC) as base material. The LID nasal gel formulation has been optimized through central composite design and its in vitro release behavior has been investigated. In the present study, safety studies employing in situ toad palate model and in vivo rat nasal mucosa model showed that compared with LID nasal spray, LID nasal gel was less toxic to mucocilia. The pharmacokinetic parameters, along with olfactory and ventricle delivery of LID from nasal gel were compared with those of LID from nasal spray, intravenous injections and oral solutions in rats using microdialysis, and the drug targeting index (DTI) was used to evaluate their brain delivery. The absolute bioavailability of the optimized LID nasal gel was about 1.5 times of that of LID nasal spray which suggested a better absorption of LID from nasal gel. Moreover, the drug targeting index (DTI) of olfactory/ventricle after nasal gel and spray administration was 2.15/1.51 and 1.66/1.26, respectively. This suggested that a fraction of the LID dose could be transported directly from the nasal cavity into the central nervous system (CNS), and the brain delivery of LID can be enhanced by nasal gel.

Negative reinforcement smoking outcome expectancies are associated with affective response to acute nicotine administration and abstinence

Background Negative affect is an important predictor of smoking behavior, and many smokers believe that smoking reduces negative affect. However, it is unclear whether such beliefs, known as negative reinforcement smoking outcome expectancies (NRSOE), are associated with changes in negative affect in response to nicotine deprivation and administration. Methods Smokers ( N = 114) participated in 4 sessions that balanced overnight smoking deprivation (12-h deprived vs. ad lib) and nasal spray administration (nicotine vs. placebo). Corrugator supercilii (COR) EMG, skin conductance (SCR), and in-session ratings were collected while the participants viewed affective, cigarette-related, and neutral slides. Retrospective questionnaire data were collected prior to slide viewing. NRSOE were determined using the Smoking Consequences Questionnaire – Adult Nicotine Affect Reduction scale (SCQ-NAR). Results High scores on the SCQ-NAR were associated with smaller COR EMG to unpleasant slides following nicotine nasal spray administration compared to placebo spray, regardless of overnight deprivation. Smokers who had high scores on the SCQ-NAR had smaller SCR, following nicotine nasal spray administration compared to placebo spray, but only after overnight deprivation. The in-session ratings and retrospective questionnaire measures indicated that smokers who had high scores on the SCQ-NAR experienced greater negative affect and craving, and less positive affect, than smokers with low scores on the SCQ-NAR, regardless of nicotine exposure. Conclusions Our questionnaire results suggest that while smokers who have high NRSOE self-report greater overall levels of negative affect and craving, while the psychophysiological data suggest that such smokers may experience negative affect reduction when blindly administered a dose of nicotine.

Commentary on Haberstick et al. (2011): Dizziness upon initial experimentation with cigarettes – implications for smoking persistence

Haberstick and colleagues [1], in a study published elsewhere in this issue, utilized a genetically informative same- and opposite-sex twin and sibling sample involving 2482 subjects in an attempt to tease out environmental and heritable differences in susceptibility for smoking and nicotine dependence. The focus was upon subjective responses to initial exposure to tobacco smoke using the Early Smoking Experiences (ESE) questionnaire [2,3], a nine-item self-report instrument that asks participants to rate retrospectively the following responses: global pleasant sensations, global unpleasant sensations, nausea, relaxation, dizziness, buzz/rush, coughing, difficulty inhaling and heart pounding. Responses were dichotomized as present or absent. The authors found that pleasant and unpleasant sensations demonstrated high internal reliability. Further, effects rated as pleasant were associated with greater likelihood of regular smoking, whereas those rated as unpleasant were associated with inconsistent use of cigarettes or not smoking. The overall findings of this well controlled and carefully executed study support and strengthen prior research on early smoking experiences. Hereditability of positive experiences, negative experiences and dizziness was 35%, 18% and 31%, respectively. Multivariate genetic modeling by the authors revealed an underlying factor with 37% hereditability that loaded strongly with reports of dizziness at the first cigarette. The identification of dizziness as a gateway variable that serves as a common pathway to regular cigarette smoking is an important finding as a precursor for further exploration of genetic mechanisms in smoking and more precise delineation of genetic differences between smokers and non-smokers. In our initial reports on the ESE [2,3], while dizziness differentiated smokers from never-smokers and was seldom reported by people who did not go on to become smokers, the sensation seemed to be affectively neutral. In subsequent studies using more sophisticated analytical techniques, however, dizziness emerged as a latent factor that correlated with both pleasant and unpleasant sensations [4]—a finding replicated in the study by Haberstick and colleagues. The distinction between ‘pleasant dizziness’ and ‘unpleasant dizziness’[5] and the contribution of affective valence to the continuation of smoking clearly deserves further investigation. Haberstick and colleagues were able to rule out sex differences in the affective valence of dizziness. A complication not addressed, however, is the possibility that the enjoyment of dizziness may, like novelty-seeking, decline with age—a shortcoming of retrospective assessment that may be relevant. Retrospective reports of dizziness upon initial experimentation have been shown to serve as good predictors of response to the administration of nicotine nasal spray [6]. Studies of life-span variability in the affective valence of dizziness, and the possible effect of other person variables as well, should enhance the utility of this measure. An additional potential threat to validity in earlier studies—including our own—is the failure to provide participants with a precise definition of the term ‘dizziness’. Roget's online thesaurus [7] offers a list of synonyms that includes some that few people would find pleasant (e.g. ‘vertigo’, ‘wooziness’) but others that many might endorse as positive (e.g. ‘giddiness’, ‘lightheadedness’). Future research on dizziness and smoking will be well-served by efforts to refine the item-set to ensure that all participants are ‘on the same page’. Overall, Haberstick and colleagues have made a very good start towards the disentangling of key issues. Continued refinement of the variables involved will certainly contribute to a better understanding of the mechanisms underlying the development of regular smoking and nicotine dependence—and possibly of other types of substance use as well [8]. None. The authors' research on early smoking experimentation was funded by National Institutes of Health Grants DA017640 and DA006529.

Intranasal mometasone furoate therapy for allergic rhinitis symptoms and rhinitis-disturbed sleep

Allergic rhinitis (AR) and related nasal congestion cause rhinitis-disturbed sleep (RDS). Intranasal corticosteroids reduce nasal congestion and improve sleep quality in AR but have not been extensively studied in RDS. To evaluate the efficacy of mometasone furoate nasal spray (NS) on nasal symptoms, nasal patency, sleep variables, quality of life, and daytime functioning in perennial AR (PAR) and concomitant RDS. In this double-blind 4-week study, 30 adults with PAR and moderate RDS were randomized 2:1 to receive mometasone furoate NS, 200 microg, or placebo each morning. The primary end point was the apnea-hypopnea index. Secondary outcome measures included changes in total nasal symptom score (TNSS), nighttime symptom score, daytime peak nasal inspiratory flow, nighttime flow limitation index, Rhinoconjunctivitis Quality of Life Questionnaire-Standardized (RQLQ-S) score, Epworth Sleepiness Scale score, and Work Productivity and Activities Impairment-Allergy Specific (WPAI-AS) questionnaire score. Analysis of covariance was used for all efficacy end points. The apnea-hypopnea index at study end was not statistically significantly different between groups. However, mometasone furoate NS therapy significantly improved morning (P = .04) and evening (P = .01) TNSSs, morning (P = .049) and evening (P = .03) nasal obstruction/blockage/congestion, daily peak nasal inspiratory flow (P = .03), flow limitation index (P = .02), Epworth Sleepiness Scale score (P = .048), RQLQ-S score (P = .03), and 2 of 5 WPAI-AS domains. Among patients receiving mometasone furoate NS, TNSS improvements were significantly correlated with improved work- and non-work-related productivity. In patients with PAR and RDS, mometasone furoate NS use improved nasal symptoms, sleepiness, and impairment in daily activities. Correlated reduced nasal symptoms and improved performance suggest that improving AR symptoms with mometasone furoate NS administration can benefit sleep and daytime functioning.

Citrus/Cydonia comp. for seasonal allergic rhinitis: A randomized study to compare treatment effects of the subcutaneous and the nasal routes of administration

Objectives Allergic rhinitis is a condition characterized by sneezing, watery nasal discharge, nasal obstruction and itching. It is an increasingly prevalent condition, particularly in the Western world where it affects around 20% of the adult population. Citrus/Cydonia comp. is an anthroposophic medicine, which contains extracts of lemon (Citrus lemon) and quince (Cydonia oblongata). Several observational studies have shown that Citrus/Cydonia comp. solution either as a subcutaneous injection or as a nasal spray might be an effective treatment for seasonal allergic rhinitis (SAR) patients. In addition, in vitro is has been shown that it has a selective effect on the differentiation of T-cells by producing relatively more IL-10 than IL-12. By that, it also seems to have an effect on the induction of regulatory (IL-10 producing) T-cell subsets. Therefore, it has been concluded that Citrus/Cydonia comp., at least in vitro, is capable of neutralizing (to some extent) the changes, characteristic to allergic rhinitis, with regard to the maturation, differentiation, and activity of the immune system. The aim of the present study is to compare the efficacy and safety of subcutaneous versus nasal spray administration in SAR patients by specifically investigating which route of administration is more effective in the differentiation and inductions of (regulatory) T-cells. Methods A national, randomized, comparative clinical trial with two parallel groups. A total of 28 patients with grass pollen SAR are recruited at primary care practices or through advertisements. After a 2-week run-in period without allergy medication, patients are randomized to a 6 weeks treatment period with either Citrus/Cydonia comp. 1% subcutaneous injections (2 injections per week) or Citrus/Cydonia comp. 1% nasal spray (1–2 sprays in each nostril, 4 times a day). The primary outcome variables are changes in immunological parameters such as IL-10, IL-12 and IL-5 at week 6, as studied in PBMCs isolated from the blood of the patients. Further objectives are to investigate the influence of Citrus/Cydonia comp. subcutaneous injections versus Citrus/Cydonia comp. nasal spray on the change in clinical symptoms by means of nasal and non-nasal symptom scores. The safety and tolerability of both injections and nasal spray will be investigated by determining adverse events surveillance. Results and conclusions The outcome of this randomized comparative study will be presented at the congress.

Treatment of allergic rhinitis with asthma by different ways of inhaling corticosteroids

To observe the therapeutical effect on allergic rhinitis with asthma by different ways of inhaling corticosteroids. Ninety patients suffering from allergic rhinitis with asthma were classified into three groups in random and treated with budesonide (BUD) by nasal spray, inhaling and nasal spray-inhaling combined administration for 12 weeks, respectively. The concentration of serum total IgE, eosinophil cationic protein (ECP) and IL-5, pulmonary functions were examined before and after treatment. The improvement of symptom scores of rhinitis and asthma in three groups were significant (P < 0.05). The concentration of serum total IgE, ECP and IL-5 in three groups decreased greatly after treatment (P < 0.05). There were significant improvement in FEV1, FEV1/FVC and FEF25%-75% in inhaling group before and after treatment (P < 0.05): FEV1 from (2.04 +/- 0.45) L to (2.47 +/- 0.54) L, FEV1/FVC from (72.73 +/- 5.59)% to (75.42 +/- 5.94)% and FEF25%-75% from 1.69 +/- 0.52 to 2.06 +/- 0.77. There was also significant improvement in nasal spray-inhaling combined groups before and after treatment (P < 0.05): FEV1 from (2.32 +/- 0.56) L to (2.76 +/- 0.58) L, FEV1/FVC from (73.80 +/- 4.17)% to (76.04 +/- 4.49)% and FEF25%-75% from 2.09 +/- 0.45 to 2.34 +/- 0.64. The significant difference of FEV1 among the three treatment groups was observed (P = 0.041). The symptoms of rhinitis and asthma in three groups by three ways of inhaling BUD were greatly improved, no significant difference in symptom scores and serum parameters was found.

Effects of desmopressin on platelet membrane glycoproteins and platelet aggregation in volunteers on clopidogrel

The use of clopidogrel is standard in interventional cardiology. Haemorrhage occurs in some patients, which implies a need for a non-transfusional therapy. Desmopressin showed its efficacy as an antidote of acetylsalicylic acid. In this trial the effects of desmopressin on platelet glycoproteins and the platelet's ability to aggregate under the influence of clopidogrel are studied. The trial was conducted as an open, prospective, single-centre, randomised pilot study with n=17 healthy volunteers in a parallel-group design. 1 h after an oral loading dose of 375 mg clopidogrel the effects of a single-dose of 300 mug of Octostim nasal spray (n=9) on platelet aggregation, activity of platelets on the density of membrane-bound receptors are measured. Ristocetin cofactor and platelet reactivity rose significantly after the administration of Octostim nasal spray with 31.9% and 5.3%, respectively (p=0.0329; p=0.0414). The ADP-induced platelet aggregation increased after the administration of Octostim nasal spray by approximately 20% (p=0.0564). The fraction of CD62- and CD63-positive platelets did not change after clopidogrel nor after desmopressin (p=0.4203; p=0.6774). The density of GPIIb/IIIa receptors per platelet did not change after desmopressin (p=0.9652). The density of GPIb/IX receptors per platelet rose after desmopressin without reaching the level of significance (p=0.0802). In the desmopressin group alone the receptor density rose by 5.5% (p=0.0783). The administration of desmopressin improved the primary haemostasis when given in addition to a clopidogrel therapy. Patients undergoing a heart catheter procedure with clopidogrel might benefit from the use of desmopressin when having a bleeding episode.

Influence of allergy in patients with nasal polyposis after endoscopic sinus surgery

Conclusion. Allergy does not modify the symptoms and steroid consumption (oral and local) of nasal polyposis (NP) patients after functional endoscopic sinus surgery (FESS). Objectives. To assess the role of allergy in the evolution after FESS of patients presenting with the diagnosis of NP. Patients and methods. This was a prospective study of 63 consecutive patients with NP (57% males, mean age 45.8 years), who were analyzed to detect whether the results of a surgical treatment of NP were influenced by the presence of positive allergic tests (Phadiatop®). Three nasal criteria were scored: nasal obstruction, posterior rhinorrhea, and the loss of smell. The frequency of asthma was evaluated. Medical treatment of NP after FESS consisted of washing of the nasal cavities, steroid spray, and oral steroid administration. The amount of consumption of steroids (prednisolone and beclomethasone) was studied. Results. Decrease of all nasal symptoms was not statistically different in the two groups of patients with and without allergy. Cumulative consumption of prednisolone and beclomethasone after surgery was similar in the two groups.

Effectiveness and Satisfaction with Zolmitriptan 5mg Nasal Spray for??Treatment of Migraine in??Real-Life Practice

Addressing the needs of migraineurs by actively seeking patient feedback on disease-related disability and treatment satisfaction may lead to improved management and treatment outcomes. Patient feedback can be collected in postmarketing surveillance (PMS) studies. The objective of this PMS study was to evaluate the efficacy and tolerability of zolmitriptan 5 mg nasal spray in the acute treatment of migraine attacks. Patients received zolmitriptan 5 mg nasal spray to treat migraine attacks of any severity and were followed up after a maximum of 4 months. Patients evaluated the efficacy and tolerability of zolmitriptan nasal spray, and were asked whether they wished to continue using zolmitriptan nasal spray and their preference compared with previous treatments. Physicians also assessed the efficacy and tolerability of zolmitriptan nasal spray. A total of 1838 patients (84.8% females) participated in the study. Within 30 minutes of administration of zolmitriptan nasal spray, 85.0% of patients reported improvements in headache pain, with 25.1% reporting an improvement within 10 minutes. At 1 hour post-dose, 57.9% of patients were pain free and 61.7% were able to resume usual daily activities. Most patients (72.9%) rated zolmitriptan nasal spray as 'better' than previous therapy. The majority (88.8%) expressed a wish to continue using zolmitriptan nasal spray. Physicians evaluated the efficacy of zolmitriptan nasal spray as 'excellent' or 'good' in 89.4% of patients. Tolerability was evaluated as 'excellent' or 'good' in 91.6% of patients. Zolmitriptan 5 mg nasal spray provides favourable efficacy and tolerability in the acute treatment of migraine attacks. Most patients assessed zolmitriptan nasal spray as 'better' than previous treatment, with nearly all wishing to continue using it.

Analgesic effects of intranasal butorphanol tartrate administered via a unit-dose device in the dental impaction pain model: A randomized, double-blind, placebo-controlled, parallel-group study

Background: Butorphanol tartrate (BT) nasal spray is currently marketed as a multidose spray pump product. However, access to excessive amounts of drug in a single bottle (up to 15 doses) creates the potential for misuse, diversion, and abuse. Objective: This study evaluated the efficacy and tolerability of a sterile, unpreserved BT nasal spray administered via a unit-dose device in the treatment of moderate to severe pain after dental impaction surgery. Methods: This was a single-site, single-dose, randomized, double-blind, placebo-controlled, parallel-group pilot study of unit-dose BT nasal spray 1 and 2 mg compared with vehicle in patients who received standard anesthesia and underwent surgery to remove impacted third molars. When patients reported experiencing moderate or severe postoperative pain, they were assigned to receive the respective treatments in a 2:2:1 ratio. Patients rated pain intensity and pain relief and performed other assessments of analgesic efficacy before dosing and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, and 6 hours after receipt of study medication. They could request rescue medication from 1 hour after the administration of nasal spray. The primary efficacy variables were summed pain intensity difference (SPID) at 2, 4, and 6 hours after administration of study medication and total pain relief at 6 hours (TOTPAR-6). Vital signs, pulse oximetry, and adverse events were monitored on the same schedule as pain assessments. Results: Thirty men and 30 women were enrolled (mean [SD] age, 22.5 [3.8] years; mean body weight, 168 [41.3] lb) and completed the trial. Pain relief was recorded in most patients within 15 minutes of receiving active treatment. A dose response was observed in SPID scores, with the 2-mg dose of BT providing the greatest response compared with placebo ( P < 0.05). Overall, 52 (86.7%) patients requested rescue medication: 22 of 24 (91.7%) in the 1-mg group, 19 of 24 (79.2%) in the 2-mg group, and 11 of 12 (91.7%) in the placebo group. The time to use of rescue medication occurred a median of 75 to 110 minutes after nasal spray dosing. The analysis of TOTPAR-6 showed no significant differences overall or in pairwise comparisons. On the global assessment, 58.3% of patients in each of the active-treatment groups and 83.3% of patients in the placebo group evaluated the study drug as “poor.” The unit-dose BT nasal spray was well tolerated, with central nervous system adverse effects being most common in the active-treatment groups compared with placebo ( P = 0.029). Dizziness occurred in 11 (45.8%) patients who received BT 1 mg, 14 (58.3%) who received BT 2 mg, and 4 (33.3%) who received placebo; for headache, the corresponding numbers were 11 (45.8%), 7 (29.2%), and 2 (16.7%). There were no significant changes from baseline in vital signs, pulse oximetry, reported nasal irritation, or pathology (eg, irritation, epistaxis, ulceration). Conclusions: In this small pilot study, sterile BT nasal spray administered via a unit-dose device provided effective postsurgical analgesia in approximately half of patients who had undergone surgery to remove impacted third molars. The results are similar to those of previous studies of BT nasal spray administered via multidose pump for postsurgical analgesia in the dental impaction pain model. The outcomes of this study are limited to the population studied.