Intranasal Budesonide Research Articles

A pilot study of the effects of intranasal budesonide delivered by NasoNeb® on patients with perennial allergic rhinitis

We investigated whether nebulization of budesonide via a NasoNeb® device would treat perennial allergic rhinitis. We performed a parallel, randomized, double-blind, placebo-controlled, pilot study in subjects (n = 40) with perennial allergic rhinitis. After recording baseline symptoms, subjects were randomized to budesonide respules (0.25 mg) or an equivalent placebo for 26 days. Nasal peak inspiratory flow (NPIF) and nasal symptoms (graded on a 0–3 scale) were recorded by the subjects twice daily. Rhinoconjunctivitis quality of life (RQOL) as well as nasal volume, measured by acoustic rhinometry, was obtained at baseline, after 2 weeks, and at the end of treatment. The average change from baseline in symptoms over the treatment period was greater for the group on budesonide (−3.33) compared to placebo (−1.98) (p = 0.45). When the average change from baseline over the treatment period was compared between the groups, budesonide resulted in higher NPIF (36.4 L/min) than placebo (18.7 L/min), p = 0.094. QOL improved in both groups compared to baseline with no significant difference between the groups. Although acoustic rhinometry indicated a larger volume in the group treated with budesonide on the last trial visit, the differences between the groups were not significant when accounting for the baseline values. Compared to placebo, administration of nebulized budesonide in subjects with perennial allergic rhinitis resulted in improvements in symptoms and objective measures of nasal congestion which approached but did not achieve statistical significance. A higher dose of active agent, a less effective placebo and a larger number of subjects might have improved statistical significance.

Oral plus nasal corticosteroids improve smell, nasal congestion, and inflammation in sino‐nasal polyposis

To assess the effect of oral plus intranasal corticosteroids on subjective outcomes (smell and nasal congestion) and objective outcomes (tissue eosinophilia and nitric oxide) in severe nasal polyposis (NP). After a 4-week steroid washout period (w0), severe NP were randomized into a treatment group (n = 67) that receive oral prednisone for 2 weeks (w2) plus intranasal budesonide for 12 weeks (w12), and a control group (n = 22) that received no steroid treatment. Barcelona Smell Test 24 (BAST-24), nasal congestion, tissue eosinophilia, and nasal nitric oxide (nNO) were assessed. Before treatment, patients showed a significant impairment of smell detection (30.7 ± 39.5%), identification (7.1 ± 16.1%), and forced choice (13.8 ± 23.3%) in BAST-24 compared to healthy population. At w2, the treatment group showed a significant improvement in detection, identification, and forced choice. Positive effect was also seen after 12 weeks of intranasal corticosteroids. A significant reduction of nasal congestion (1.17 ± 1.0 vs. 2.73 ± 0.5) and polyp tissue eosinophilia (10.9 ± 4.2 vs. 41.2 ± 12.2) with an increase of nNO (650 ± 317 vs. 420 ± 221 ppb) were observed at w2 compared to w0 and to the control group. These effects were also seen at w12. Combined oral and intranasal corticosteroids improve smell and nasal congestion and decrease nasal inflammation, as measured by reduced tissue eosinophilia and increased detection of nNO. Severity of smell loss correlates with degree of nasal congestion but not with inflammation, as measured by tissue eosinophilia or nasally exhaled nNO. Our findings suggest that improvement in smell may be related to improved conduction of odorants to the olfactory neuroepithelium.

Effect of intranasal budesonide irrigations on intraocular pressure

Intranasal and oral corticosteroids are widely used in the management of chronic rhinosinusitis with nasal polyps (CRSwNP). Higher-dose topical nasal steroids (HDTNS) such as budesonide irrigations are increasingly used for long-term maintenance in these patients. Oral steroids have the potential to cause increased intraocular pressure (IOP) and glaucoma. It is unclear whether HDTNS have the same potential. The objective of this study was to determine the effect of intranasal budesonide irrigations on IOP. Two groups of patients with CRSwNP treated with budesonide irrigations were prospectively enrolled. Patients with history of elevated IOP or glaucoma were excluded. Patients in group 1 had been using budesonide for at least 1 month and had IOP measured once at the time of enrollment. Group 2 consisted of patients who were placed on budesonide at the time of enrollment and had IOP measured both before and after at least 4 weeks of therapy. Ten patients in group 1 and 8 patients in group 2 completed the study. In group 1, the average duration of therapy at enrollment was 6.3 months (1-22 months). Only 1 patient had a single eye pressure above 21 mmHg. None of the patients in group 2 had a significant change in IOP or IOP over 21 mmHg. Intranasal budesonide irrigations given for a period of at least 1 month do not appear to increase IOP.

Oral and intranasal steroid treatments improve nasal patency and paradoxically increase nasal nitric oxide in patients with severe nasal polyposis

Recently, we demonstrated that acoustic rhinometry (AR) measurements correlated with nasal cavity volumes in patients with nasal polyposis (NP). The aim of the present study was to evaluate whether AR and nasal nitric oxide (nNO) are useful methods in monitoring and follow-up of medical treatment of NP. Patients with severe nasal polyps were randomized into two groups after a 4-week steroid washout period (w0): a treatment group received oral prednisone for 2 weeks (w2) and intranasal budesonide for 12 weeks (w12) while the control group received no steroid treatment. Nasal volume (Vol 0-6), minimum cross-sectional area (mCSA), nNO, peak nasal inspiratory flow (PNIF), nasal obstruction, and smell loss were evaluated. At w2, the treatment group showed a significant increase of vol 0-6 compared to w0 and the control group. The mCSA area also increased compared to w0 and the control group. At w12, the improvement in vol 0-6 and mCSA was maintained after intranasal steroids compared to w0. At w2, the treatment group showed a paradoxical increase of nNO compared to w0 and the control group. At w12, this increase was maintained by intranasal steroids. Both oral and intranasal steroid treatments improve nasal patency and paradoxically increase nNO, by opening the ostiomeatal complex. This suggests that AR and nNO are useful methods in the monitoring and follow-up of patients with NP.

Efficacy of Medical Therapy in Treatment of Chronic Rhinosinusitis

Uncomplicated chronic rhinosinusitis (CRS) is generally treated with medical therapy initially and surgery is contemplated only after medical therapy has failed. However, there is considerable variation in the medical treatment regimens used and studies defining their efficacy are few. The aim of this study was to determine the proportion of patients treated medically who responded sufficiently well so that surgery was not required. Subgroup analysis to identify clinical features that predicted a favorable response to medical therapy was also performed. Eighty patients referred to the Otorhinolaryngology Clinic at North Shore Hospital were treated with a standardized medical therapy protocol (oral prednisone for 3 weeks, oral antibiotics and ongoing saline lavage and intranasal budesonide spray). Symptom scores were collected before and after medical therapy. Clinical features such as presence of polyps, asthma, and aspirin hypersensitivity were recorded. Failure of medical therapy was defined as the persistence of significant CRS symptoms, and those patients who failed medical therapy were offered surgery. Follow-up data were available for 72 (90%) patients. Of this group, 52.5%, (95% CI, 42.7%, 62.2%) failed to respond adequately to medical therapy and were offered surgery. The remaining patients (37.5%) were successfully treated with medical therapy and did not require surgery at the time of follow-up. The premedical therapy symptom scores were significantly higher than the postmedical therapy symptom scores (p < 0.01). The symptom scores of those patients postmedical therapy who proceeded to have surgery were significantly higher than the group who responded well to maximum medical therapy (MMT) and did not require surgery (p < 0.0001). There were no significant differences in the proportion of patients with asthma, aspirin sensitivity, or polyps between the groups failing or not failing MMT. In approximately one-third of patients with CRS, medical therapy improved symptoms sufficiently so that surgical therapy was avoided. Patients with more severe symptoms tended not to respond as well as those with less severe symptoms. Long-term follow-up is required for the group of responders to determine how many will eventually relapse.

Lack of bone metabolism side effects after 3 years of nasal topical steroids in children with allergic rhinitis

This study evaluated the effects on bone mineral status of long-term treatment with intranasal budesonide (INB) spray, using the recommended dose, in pediatric patients with allergic rhinitis (AR). This retrospective, case-control study of 230 prepubertal children with perennial AR, who had used nasal budesonide at a mean daily dose of 100 μg (range, 89-132 μg) for at least 3 years intermittently, was conducted from May 2007 through May 2010. The bone mineral density (BMD) of the lumbar spine was measured by dual-energy X-ray absorptiometry. Levels of serum calcium, phosphorus, alkaline phosphatase (ALP), parathyroid hormone, and osteocalcin were also assessed. The results were compared to sex- and age-matched controls (n = 140), who were newly diagnosed children with AR without any corticosteroid treatment. The 230 study patients (145 boys) were aged from 7 to 11 years. The average age (± SEM) was 8.7 ± 0.7 years; the mean (± SEM) steroid dosage used was 73.5 ± 7.0 μg daily, with 65.2 ± 5.2 g total steroid use during treatment. The 140 control patients (90 boys) were aged from 6 to 11 years. No significant differences were observed in BMD (P > 0.05) between the study and the control groups. Although mean serum ALP level was higher, and cortisol, phosphorus, and osteocalcin levels were lower, in the treatment group, these differences were not statistically significant. The findings suggest that long-term intermittent treatment for 3 years with INB spray, 50 μg twice daily, for children with perennial rhinitis revealed no negative effect on BMD and associated parameters.

Anti-inflammatory medications for obstructive sleep apnea in children

Obstructive sleep apnea (OSA) is characterized by partial or complete upper airway obstruction during sleep. Approximately 1% to 4% of children are affected by OSA, with adenotonsillar hypertrophy the most common underlying risk factor. Surgical removal of enlarged tonsils and adenoids is the most commonly used treatment for OSA. Given the perioperative risk of the intervention and an estimated recurrence rate of up to 20%, there has recently been an increased interest in non-surgical treatment modalities. As the enlarged adenoids and tonsils consist of hypertrophied lymphoid tissue, anti-inflammatory agents have been proposed as a useful non-invasive treatment option in children with OSA. To assess the efficacy of anti-inflammatory drugs for the treatment of OSA in children. We identified trials using searches of the Cochrane Airways Group Specialized Register, MEDLINE (1950 to 2010), EMBASE (1988 to 2010), CINAHL (1982 to 2010), CENTRAL (1964 to 2010), Web of Science (1900 to 2010), LILACS (1982 to 2010) and International Pharmaceutical Abstracts (IPA) (1970 to 2010). Randomized controlled trials (RCTs) comparing anti-inflammatory drugs against placebo, other anti-inflammatory drugs, or other treatment in children between one and 16 years with objectively diagnosed OSA (Apnea Hypopnea Index (AHI) ≥ 1/hour (h)). Both authors independently performed data extraction and quality assessment. It was not possible to combine data from the included studies; we summarized data in a narrative fashion. We included three RCTs. The first study was a six-week parallel-group trial (25 participants, mean age 3.8 years, mean AHI 10.8/h) of intranasal fluticasone versus placebo showed a statistically significant effect of the drug on improving the AHI. The second study compared intranasal budesonide with placebo in a six-week cross-over trial (62 participants, mean age 8.2 years, mean AHI 3.7/h). The authors reported an advantage of the drug over placebo in reducing the AHI. However, the patients were not analyzed as randomized so the result must be interpreted with caution. No valid group comparisons were reported for the third trial (30 participants, oral montelukast versus placebo in a 12-week parallel-group trial), which has so far only been published as an abstract. A single small study has found a short-term beneficial effect on the AHI in children with mild to moderate OSA. However, long-term safety and efficacy data are not available yet. Further RCTs are needed to evaluate anti-inflammatory drugs for OSA in children.

Lack of Ocular Side Effects After 2 Years of Topical Steroids for Allergic Rhinitis

The aim of this study was to investigate ocular side effects in children with allergic rhinitis taking chronic intermittent nasal corticosteroids. The study group included 150 children who had used intermittent intranasal budesonide for more than 2 years for allergic rhinitis. Ninety patients who were newly diagnosed as having allergic rhinitis without any treatment comprised the control group. Central corneal thickness, Schirmer test results, visual acuity, intraocular pressure, cataract formation, keratometry, and tear break-up time were compared in the two groups. The ages of the 150 study patients (85 boys) were between 8 and 15 years. The average age (± standard error of the mean [SEM]) was 11.7 ± 0.7 years and the mean (± SEM) steroid dosage used was 93.3 ± 7.0 μg daily with 42.2 ± 3.2 g total steroid use during treatment. The ages of the 90 control patients (54 boys) were between 7 and 15 years. There was no statistically significant difference between the study and control groups according to ocular findings (P > .05). Eye functions including cataract formation, corneal ectasia, ocular hypertension or glaucoma, and dry eye were not observed in any of the patients in the study group and were not correlated with total steroid dosage (r = 0.125, P = .447). A 2-year treatment of children with allergic rhinitis prescribed intermittent intranasal budesonide at an average daily dose of approximately 100 μg is not associated with ocular side effects such as cataract, glaucoma, corneal ectasia, and abnormal tear function.

Regulation of glucocorticoid receptor in nasal polyps by systemic and intranasal glucocorticoids

Poor response of nasal polyps to glucocorticoids (GCs) may be because of abnormal expression of GC receptors (GR) alpha and beta or to downregulation of GRalpha. We aimed to evaluate the in vivo regulation of GR isoforms in GC-treated nasal polyps and to assess the relationship between clinical response to GCs and GR levels. Patients with nasal polyps were randomly (3:1) treated (n = 51) or not (n = 14) with oral prednisone and intranasal budesonide for 2 weeks, plus intranasal budesonide for 10 additional weeks. Nasal symptoms were evaluated. Biopsies were obtained before (w0) and after 2 (w2) and 12 (w12) weeks of treatment, and analysed for their inflammatory content and GR mRNA (10(2) cDNA copies/mug total RNA) and protein (% immunoreactive inflammatory cells) expression. Healthy nasal mucosa (n = 11) was also investigated. Data are presented as median and 25-75th percentile. At w0, nasal polyps expressed less GRalpha mRNA (1343;683-2263; P < 0.05) and GR protein (41;29-54; P < 0.05) than nasal mucosa (2474;1346-2933; 60;51-72, respectively). GRbeta immunoreactivity was higher in nasal polyps (11;4-19; P < 0.05) than in nasal mucosa (5;2-5). At w2, increased GRalpha mRNA (2010;1037-2732; P < 0.01) and GR protein (56;27-71; P = 0.056) were found compared with w0 (1177;759-2058; 37;29-55, respectively). At w12, GRalpha mRNA and GR protein were similar to w0. GRbeta expression was unaltered by treatment. Neither GRalpha nor GRbeta correlated with nasal symptoms. GR immunoreactivity negatively correlated with eosinophils (r = -0.478; P < 0.001). GRalpha is downregulated in nasal polyps and upregulated by GC treatment. Neither GRalpha nor GRbeta appear to determine the sensitivity to GCs in nasal polyposis.

Corticosteroid therapy increases membrane‐tethered while decreases secreted mucin expression in nasal polyps

Mucus hypersecretion is a hallmark of nasal polyposis (NP). Corticosteroids (CS) are first-line treatment for NP, decreasing their size and inflammatory component. However, their effect on mucin production is not well-understood. The aim of this (pilot) study was to investigate CS effect on mucin expression in NP. Patients were randomized in control (n = 9) and treatment (oral prednisone for 2 weeks and intranasal budesonide for 12 weeks; n = 23) groups. Nasal polyposis from nonasthmatic (NP; n = 13), aspirin-tolerant (NP-ATA; n = 11) and aspirin-intolerant (NP-AIA; n = 8) asthmatics were studied. Nasal polyposis biopsies were obtained before (w0) and after 2 (w2) and 12 (w12) weeks of CS treatment. Secreted (MUC5AC, MUC5B and MUC8) and membrane-tethered (MUC1, MUC4) mucins (immunohistochemistry) and goblet cells (Alcian blue-periodic acid Schiff) were quantified in both epithelium and glands. Rhinorrea and nasal obstruction were also assessed. At w2, steroids increased MUC1 (from 70 to 97.5) and MUC4 (from 80 to 100) in NP-ATA patients' epithelium compared with baseline (w0). At w12, steroids decreased MUC5AC (from 40 to 5) and MUC5B (from 45 to 2.5) in NP-ATA patients' epithelium and glands, respectively, compared with baseline. No mucin presented significant changes in NP-AIA patients. MUC5AC and MUC5B expression correlated with goblet and mucous cell numbers, respectively, and MUC5AC also with rhinorrea score. These results suggest: (i) CS up-regulate membrane (MUC1, MUC4) while down-regulate secreted (MUC5AC, MUC5B) mucins; (ii) there exists a link between secreted mucin expression and goblet cell hyperplasia; and (iii) NP from AIA may develop resistance to CS treatment.

Intranasal Budesonide Treatment for Children With Mild Obstructive Sleep Apnea Syndrome

Intranasal corticosteroids have been advanced as a nonsurgical therapeutic alternative for pediatric obstructive sleep apnea syndrome, particularly for patients with mild disease, and aims at reducing the size of hypertrophic adenotonsillar tissue. Of 71 possible candidates, 62 children with polysomnographically diagnosed mild obstructive sleep apnea syndrome were recruited onto a double-blind, randomized, crossover trial of intranasal budesonide (32 microg per nostril at bedtime) or placebo for 6 weeks followed by an additional 6-week treatment in the alternative treatment arm after allowing for a 2-week washout period. Polysomnographic assessment and radiographs for assessment of adenoid size were performed after completion of each phase. There were significant improvements in both polysomnographic measures (sleep latency, slow-wave sleep, and rapid-eye-movement sleep), in the magnitude of respiratory disturbance (apnea/hypopnea index, nadir pulse oxygen saturation), and in adenoid size among the 48 children who completed the treatment phase compared with 32 children who received placebo in their initial arm, with normalization of sleep measures in 54.1% of the treated children. Furthermore, discontinuation of treatment for 8 weeks for 25 children revealed a sustained duration of the initial treatment effect. A 6-week treatment with intranasal budesonide effectively reduced the severity of mild obstructive sleep apnea syndrome and the magnitude of the underlying adenoidal hypertrophy, and this effect persisted for at least 8 weeks after cessation of therapy. These findings justify the use of topical steroids as the initial therapeutic option in otherwise healthy children with mild obstructive sleep apnea.

Randomised, crossover clinical trial, in healthy volunteers, to compare the systemic availability of two topical intranasal budesonide formulations.

BackgroundBudesonide has a long history as intranasal drug, with many marketed products. Efforts should be made to demonstrate the therapeutic equivalence and safety comparability between them. Given that systemic availability significantly varies from formulations, the clinical comparability of diverse products comes to be of clinical interest and a regulatory requirement. The aim of the present study was to compare the systemic availability, pharmacodynamic effect, and safety of two intranasal budesonide formulations for the treatment of rhinitis.MethodsEighteen healthy volunteers participated in this randomised, controlled, crossover, clinical trial. On two separated days, subjects received a single dose of 512 μg budesonide (4 puffs per nostril) from each of the assayed devices (Budesonida nasal 64®, Aldo-Union, Spain and Rhinocort 64®, AstraZeneca, Spain). Budesonide availability was determined by the measurement of budesonide plasma concentration. The pharmacodynamic effect on the hypothalamic-adrenal axis was evaluated as both plasma and urine cortisol levels. Adverse events were tabulated and described. Budesonide availability between formulations was compared by the calculation of 90%CI intervals of the ratios of the main pharmacokinetic parameters describing budesonide bioavailability. Plasma cortisol concentration-time curves were compared by means of a GLM for Repeated Measures. Urine cortisol excretion between formulations was compared through the Wilcoxon's test.ResultsAll the enroled volunteers successfully completed the study. Pharmacokinetic parameters were comparable in terms of AUCt (2.6 ± 1.5 vs 2.2 ± 0.7), AUCi (2.9 ± 1.5 vs 2.4 ± 0.7), tmax (0.4 ± 0.1 vs 0.4 ± 0.2), Cmax/AUCi (0.3 ± 0.1 vs 0.3 ± 0.0), and MRT (5.0 ± 1.4 vs 4.5 ± 0.6), but not in the case of Cmax (0.9 ± 0.3 vs 0.7 ± 0.2) and t1/2 (3.7 ± 1.8 vs 2.9 ± 0.4). The pharmacodynamic effects, measured as the effect over plasma and urine cortisol, were also comparables between both formulations. No severe adverse events were reported and tolerance was comparable between formulations.ConclusionThe systemic availability of intranasal budesonide was comparable for both formulations in terms of most pharmacokinetic parameters. The pharmacodynamic effect on hypothalamic-pituitary-adrenal axis was also similar. Side effects were scarce and equivalent between the two products. This methodology to compare different budesonide-containing devices is reliable and easy to perform, and should be recommended for similar products intented to be marketed or already on the market.Trial registrationNo Eudra CT: 2005-003727-39

Efficacy of Odiosoft-Rhino in Assessment of Nasal Obstruction: A Comparative Study with Acoustic Rhinometry after Treatment with Budesonide Nasal Spray in Patients with Perennial Allergic Rhinitis

Odiosoft-Rhino (OR) is new software and equipment that can be used to measure changes in nasal obstruction after intranasal steroid treatment. OR is a promising method for measuring the degree of nasal obstruction. OR can precisely analyze nasal sound spectra in decibels, which is generated by nasal airflow. We studied the reliability of OR for assessing declining nasal obstruction after budesonide nasal spray treatment. Sixty-five patients with perennial allergic rhinitis (PAR) were enrolled in the study, and 52 of these patients completed the study. Nasal endoscopic examination, acoustic rhinometry (AR), and OR were performed and symptom scores were compared before and after 3 months of treatment with intranasal budesonide. All of the patients received 7 days of placebo treatment before receiving budesonide. There was a significant difference in the visual analog scores of nasal obstruction and in the examination scores before and after the treatment for both the right and the left nasal cavities. Pretreatment AR findings and OR findings in the 2000- to 4000-Hz and 4000- to 6000-Hz intervals for both sides were significantly different from the posttreatment measurements (p = 0.000). Both AR and OR can assess the efficacy of budesonide nasal spray treatment for nasal obstruction in patients with PAR. Both AR and OR are effective for assessing nasal obstruction and monitoring treatment efficacy but, as a simple and noninvasive test, OR can be used with confidence.

A Short Course of Oral Prednisone Followed by Intranasal Budesonide Is an Effective Treatment of Severe Nasal Polyps

A Short Course of Oral Prednisone Followed by Intranasal Budesonide Is an Effective Treatment of Severe Nasal Polyps

A Short Course of Oral Prednisone Followed by Intranasal Budesonide Is an Effective Treatment of Severe Nasal Polyps

Nasal polyposis is an inflammatory disease of unknown etiology. This study aimed to evaluate the effect of a short course of oral prednisone followed by intranasal budesonide on nasal symptoms, polyp size, nasal flow, and computed tomography scan. Eighty-four patients with severe nasal polyps were included. After a steroid washout period, patients were randomized into two groups: group A (n = 63) received oral prednisone for 2 weeks and group B (n = 21) did not receive any steroid treatment. Patients from group A received intranasal budesonide for 12 weeks. Atopy was positive in 36.8% of patients. Blood eosinophilia was higher in asthmatic (7.2 +/- 0.7%, P < .05) than in nonasthmatic (3.0 +/- 0.4%) patients. Asthmatic patients showed higher scores on nasal obstruction and loss of smell than nonasthmatics. Oral steroids caused a significant improvement in all nasal symptoms and improved polyp size (2.1 +/- 0.1, P < .05) and nasal flow (560 +/- 35 cm/s, P < .05) compared with nontreated patients (2.8 +/- 0.1 and 270 +/- 34 cm/s, respectively). Intranasal budesonide maintained the improvement on nasal symptoms, polyp size, and nasal flow. Steroid treatment reduced the computed tomography scan score (15.4 +/- 1, P < .05) compared with before treatment (18.2 +/- 0.8). A short course of oral steroids improved all nasal symptoms, polyp size, and nasal flow, whereas intranasal steroid maintain this effect.

Lack of Directly Observed Treatment Affects Tuberculosis Relapse Rates

Conflict of Interest Statement : A.D.G. does not have a financial relationship with a commercial entity that has an interest in the subject of this manuscript. D.G. is currently the recipient of an investigator-initiated grant from AstraZeneca Ltd. for an unrelated research project on the effect of intranasal budesonide in mild sleep-disordered breathing in children. He serves on the national speaker bureau of Merck

Lack of Directly Observed Treatment Affects Tuberculosis Relapse Rates

Conflict of Interest Statement : A.D.G. does not have a financial relationship with a commercial entity that has an interest in the subject of this manuscript. D.G. is currently the recipient of an investigator-initiated grant from AstraZeneca Ltd. for an unrelated research project on the effect of intranasal budesonide in mild sleep-disordered breathing in children. He serves on the national speaker bureau of Merck

Intranasal Steroids and Oral Leukotriene Modifier Therapy in Residual Sleep-Disordered Breathing After Tonsillectomy and Adenoidectomy in Children

Tonsillectomy and adenoidectomy (T&A) is the primary therapeutic approach for sleep-disordered breathing (SDB) in children. However, residual mild SDB will be found in more than one third of these patients after T&A. We hypothesized that combined therapy with the leukotriene receptor antagonist montelukast and intranasal budesonide would result in normalization of residual SDB after T&A. During the period of October 2002 to February 2005, children who underwent T&A for SDB underwent a routine postoperative (second) overnight polysomnographic evaluation (PSG) 10 to 14 weeks after T&A surgery. In children with residual apnea hypopnea index (AHI) >1 and <5/hour of total sleep time (TST), treatment with montelukast and intranasal budesonide aqueous solution was administered for a period of 12 weeks (M/B group), at which time a third PSG was performed. Children who had residual SDB and did not receive M/B therapy from their treating physicians were recruited as control subjects. Twenty-two children received M/B, and 14 children served as control subjects. Mean age, gender distribution, ethnicity, and BMI were similar in the 2 treatment groups. The mean AHI at the second PSG was 3.9 +/- 1.2/hour of TST and 3.6 +/- 1.4/hour of TST in M/B-treated and control patients, respectively. Similar nadir arterial oxygen saturation (87.3 +/- 1.2%) and respiratory arousal index (4.6 +/- 0.7/hour of TST) were recorded for both groups. However, the M/B group demonstrated significant improvements in AHI (0.3 +/- 0.3/hour of TST), in nadir arterial oxygen saturation (92.5 +/- 3.0%), and in respiratory arousal index (0.8 +/- 0.7/hour of TST) on the third PSG, whereas no significant changes occurred over time in control subjects. Combined anti-inflammatory therapy that consists of oral montelukast and intranasal budesonide effectively improves and/or normalizes respiratory and sleep disturbances in children with residual SDB after T&A.

Nasal polyposis and its impact on quality of life: comparison between the effects of medical and surgical treatments

Nasal polyposis (NP) is not a life-threatening disorder but may have a great impact on the quality of life (QoL). The objective of this study: (i) to investigate the health burden incurred by NP compared with the Spanish general population using the Short Form-36 Health Survey (SF-36) questionnaire; (ii) to compare the QoL outcome after medical or surgical treatment; and (iii) to assess and compare the effect of medical and surgical treatment on nasal symptoms. About 109 patients with nasal polyps were included. Fifty-three patients were randomly allocated to receive oral prednisone for 2 weeks and 56 to undergo endoscopic sinus surgery. All patients administered intranasal budesonide for 12 months. Patients were evaluated for nasal symptoms, polyp size, and QoL. In comparison with the Spanish general population, patients with NP had worse scores on all SF-36 domains except for physical functioning. Nonasthmatic patients with NP had better QoL than asthmatic patients with NP on role physical functioning, body pain, and vitality (P <0.05). At 6 and 12 months, a significant improvement on all of SF-36 domains was observed after both medical and surgical treatment reaching the levels of general population (P <0.05). Nasal symptoms and polyp size improved after both medical and surgical treatment at 6 and 12 months (P <0.05). These results suggest that NP has considerable impact on a patient's QoL and that both medical and surgical treatment led to similar effects in improving QoL.

Fetal Safety of Drugs Used in the Treatment of Allergic Rhinitis

Allergic rhinitis is the most common allergic disease. Pharmacological interventions are often not used in pregnancy because of alarming information in drug labels and patient information, even when evidence for safety exists.Low-risk therapies could include immunotherapy, intranasal sodium cromoglycate (cromolyn sodium), beclometasone, budesonide and first-generation antihistamines. In a meta-analysis examining the safety of first-generation antihistamines in pregnancy, 200 000 first trimester exposures failed to show increased teratogenic risk. Loratadine is the most studied second-generation antihistamine (with a total patient cohort of 2147 women who were exposed) and does not appear to increase the risk of major congenital malformations; however, it has not been as well studied as the earlier antihistamines. Since desloratadine is the principal metabolite of loratadine, it can be assumed that a similar safety profile would fit for desloratadine as was described for loratadine although no direct human studies have been done. Decongestants have not been conclusively proven to affect the fetal outcome and may be used for short-term relief when no other safer alternatives are available. Intranasal corticosteroids have not been associated with an increase in congenital malformations in humans. Based on efficacy and the fact that there would be little systemic absorption, they can be considered a first-line treatment over oral antihistamines, decongestants and mast cell stabilisers; however, the number of controlled trials in pregnancy is limited. Intranasal corticosteroids are associated with minimal systemic effects in adults and are the most effective therapy for allergic rhinitis. Benefit-risk considerations must, therefore, be done but favour their first-line use during pregnancy. Because fetal safety is paramount, recommendations should be based both on the safety of the drugs during pregnancy and the comparative efficacy of the agent in the treatment of the underlying condition. This review exemplifies the fact that there are many safe treatment options for the clinician when dealing with allergic rhinitis during pregnancy.