pulmicort and Chronic-Disease

Asthma is characterised by chronic inflammation of the airways and recurrent exacerbations with wheezing, chest tightness, and cough. Treatment with inhaled steroids and bronchodilators can result in good control of symptoms, prevention of further morbidity, and improved quality of life. However, an increase in serious adverse events with the use of both regular formoterol and regular salmeterol (long-acting beta₂-agonists) compared with placebo for chronic asthma has been demonstrated in previous Cochrane Reviews. This increase was statistically significant in trials that did not randomise participants to an inhaled corticosteroid, but not when formoterol or salmeterol was combined with an inhaled corticosteroid. The confidence intervals were found to be too wide to ensure that the addition of an inhaled corticosteroid renders regular long-acting beta₂-agonists completely safe; few participants and insufficient serious adverse events in these trials precluded a definitive decision about the safety of combination treatments.. To assess risks of mortality and non-fatal serious adverse events in trials that have randomised patients with chronic asthma to regular formoterol and an inhaled corticosteroid versus regular salmeterol and an inhaled corticosteroid.. We searched the Cochrane Airways Register of Trials, CENTRAL, MEDLINE, Embase, and two trial registries to identify reports of randomised trials for inclusion. We checked manufacturers' websites and clinical trial registers for unpublished trial data, as well as Food and Drug Administration (FDA) submissions in relation to formoterol and salmeterol. The date of the most recent search was  24 February 2021.. We included controlled clinical trials with a parallel design, recruiting patients of any age and severity of asthma, if they randomised patients to treatment with regular formoterol versus regular salmeterol (each with a randomised inhaled corticosteroid) and were of at least 12 weeks' duration.. Two review authors independently selected trials for inclusion in the review, extracted outcome data from published papers and trial registries, and applied GRADE rating for the results. We sought unpublished data on mortality and serious adverse events from study sponsors and authors. The primary outcomes were all cause mortality and non-fatal serious adverse events. We chose not to calculate an average result from all the formulations of formoterol and inhaled steroid, as the doses and delivery devices are too diverse to assume a single class effect.. Twenty-one studies in 11,572 adults and adolescents and two studies in 723 children met the eligibility criteria of the review. No data were available for two studies; therefore these were not included in the analysis. Among adult and adolescent studies, seven compared formoterol and budesonide to salmeterol and fluticasone (N = 7764), six compared formoterol and beclomethasone to salmeterol and fluticasone (N = 1923), two compared formoterol and mometasone to salmeterol and fluticasone (N = 1126), two compared formoterol and fluticasone to salmeterol and fluticasone (N = 790), and one compared formoterol and budesonide to salmeterol and budesonide (N = 229). In total, five deaths were reported among adults, none of which was thought to be related to asthma. The certainty of evidence for all-cause mortality was low, as there were not enough deaths to permit any precise conclusions regarding the risk of mortality on combination formoterol versus combination salmeterol. In all, 201 adults reported non-fatal serious adverse events. In studies comparing formoterol and budesonide to salmeterol and fluticasone, there were 77 in the formoterol arm and 68 in the salmeterol arm (Peto odds ratio (OR) 1.14, 95% confidence interval (CI) 0.82 to 1.59; 5935 participants, 7 studies; moderate-certainty evidence). In the formoterol and beclomethasone studies, there were 12 adults in the formoterol arm and 13 in the salmeterol arm with events (Peto OR 0.94, 95% CI 0.43 to 2.08; 1941 participants, 6 studies; moderate-certainty evidence). In the formoterol and mometasone studies, there were 18 in the formoterol arm and 11 in the salmeterol arm (Peto OR 1.02, 95% CI 0.47 to 2.20; 1126 participants, 2 studies; moderate-certainty evidence). One adult in the formoterol and fluticasone studies in the salmeterol arm experienced an event (Peto OR 0.05, 95% CI 0.00 to 3.10; 293 participants, 2 studies; low-certainty evidence). Another adult in the formoterol and budesonide compared to salmeterol and budesonide study in the formoterol arm had an event (Peto OR 7.45, 95% CI 0.15 to 375.68; 229 participants, 1 study; low-certainty evidence). Only 46 adults were reported to have experienced asthma-related serious adverse events. The certainty of the evidence was low to very low due to the small number of events and the absence of independent assessment of causation. The two studies in children compared formoterol and fluticasone to salmeterol and fluticasone. No deaths and no asthma-rel. Overall, for both adults and children, evidence is insufficient to show whether regular formoterol in combination with budesonide, beclomethasone, fluticasone, or mometasone has a different safety profile from salmeterol in combination with fluticasone or budesonide. Five deaths of any cause were reported across all studies and no deaths from asthma; this information is insufficient to permit any firm conclusions about the relative risks of mortality on combination formoterol in comparison to combination salmeterol inhalers. Evidence on all-cause non-fatal serious adverse events indicates that there is probably little to no difference between formoterol/budesonide and salmeterol/fluticasone inhalers. However events for the other formoterol combination inhalers were too few to allow conclusions. Only 46 non-fatal serious adverse events were thought to be asthma related; this small number in addition to the absence of independent outcome assessment means that we have very low confidence for this outcome. We found no evidence of safety issues that would affect the choice between salmeterol and formoterol combination inhalers used for regular maintenance therapy by adults and children with asthma.

Topics: Administration, Inhalation; Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Chronic Disease; Drug Therapy, Combination; Fluticasone; Formoterol Fumarate; Glucocorticoids; Humans; Mometasone Furoate; Randomized Controlled Trials as Topic; Salmeterol Xinafoate

Topical therapies play an important role in the management of chronic rhinosinusitis (CRS). A detailed literature review was undertaken to appraise recent evidence surrounding current topical therapies and novel treatments used in the setting of recalcitrant CRS.. Effective sinus surgery aids in the delivery of topical therapies. Budesonide nasal rinses delivered by saline irrigation offer clinical and symptomatic improvements pre and postoperatively with a well-proven safety profile. Topical steroids may additionally offer direct antibacterial effects as per in-vitro testing. Topical antibiotics are not recommended in routine practice; however, they may be of benefit for short-term eradication therapy. Novel treatments are under keen investigation and include bacteriophage, colloidal silver and manuka honey. The evidence base for these treatments is not robust enough to recommend their routine use at present.. Topical steroids delivered in conjunction with saline nasal irrigation offer the best combination of treatments in CRS and should be considered a standard of care. Wide surgical access and aggressive surgical debridement of polyposis facilitates the delivery of steroid irrigations to sinonasal mucosa and is associated with improved long-term outcomes following endoscopic sinus surgery. The use of novel treatments remains within the research setting alone.

Topics: Administration, Intranasal; Administration, Topical; Budesonide; Chronic Disease; Debridement; Glucocorticoids; Humans; Nasal Lavage; Nasal Polyps; Rhinitis; Saline Solution; Sinusitis

Protein-losing enteropathy (PLE) is a chronic condition involving multiple organ systems that may develop any time following Fontan completion. The pathogenesis of PLE is complex and multifactorial. Chronic venous hypertension, low cardiac output, and abnormal lymphatics may all play a role in the pathogenesis of PLE. Common signs and symptoms include chronic diarrhea, abdominal pain, and ascites. Diagnosis is based on the presence of signs and symptoms in addition to hypoalbuminemia and elevated stool alpha 1 antitrypsin. Early identification and a comprehensive approach to evaluation and treatment are important, as they may affect survival. The initial evaluation should include cardiac catheterization for hemodynamic assessment. Although an evidence base for treatment is lacking, various medical, interventional, and surgical approaches have been described with variable degrees of success. Commonly used therapies include nutritional support, diuretics, subcutaneous unfractionated heparin, budesonide, and sildenafil. Limited data exist for Fontan conversion or takedown. Assessment for heart transplantation should be considered. PLE mortality is high-approximately 50%-but may be mitigated by aggressive investigation and management. The evolving understanding of the role of lymphatics in the pathophysiology of PLE and the emerging role of interventional lymphatic procedures may further improve outcomes in this patient population.

Topics: Abdominal Pain; Academic Medical Centers; Ascites; Budesonide; Chronic Disease; Combined Modality Therapy; Diagnosis, Differential; Diarrhea; Diuretics; Female; Fontan Procedure; Heart Defects, Congenital; Heparin; Humans; Male; Prognosis; Protein-Losing Enteropathies; Rare Diseases; Risk Assessment; Sildenafil Citrate; Treatment Outcome

Topics: Administration, Topical; Budesonide; Chronic Disease; Glucocorticoids; Humans; Nasal Lavage; Prospective Studies; Retrospective Studies; Rhinitis; Sinusitis; Treatment Outcome

Eosinophilic esophagitis (EoE) is a chronic inflammatory disease of the esophagus, which requires short- and long-term treatment. In addition, patients under long-term treatment for any chronic condition should have a structured follow-up. The mainstays in EoE treatment are drugs (such as swallowed topical corticosteroids [STC] and proton pump inhibitors), dietary exclusions, and endoscopic dilations. STC are the most widely used treatment and have proven efficacy in inducing clinical, endoscopic and histological remission in active EoE. However, data regarding maintaining disease remission and long-term management are limited. Ongoing disease activity and relapses despite STC treatment are frequently observed. This sheds light on the urgent need for adequate maintenance strategies, which have not been well defined. In terms of follow-up concepts, to date neither guidelines nor consensus recommendations have been published. To summarize the current knowledge on long-term diagnostic and therapeutic STC management of EoE, we conducted a literature search using PubMed and Embase applying the following key search items: Eosinophilic esophagitis, eosinophils, esophagus, swallowed topical corticosteroids, fluticasone, budesonide, long-term, treatment, therapy, and follow-up. In addition, we present empirically developed long-term management concepts applied at two large EoE centers, with a special focus on STC treatments. Finally, we highlight areas of future research and perspectives regarding the long-term management of EoE.

Topics: Administration, Oral; Adrenal Cortex Hormones; Budesonide; Chronic Disease; Eosinophilic Esophagitis; Eosinophils; Esophagoscopy; Esophagus; Fluticasone; Humans; Maintenance Chemotherapy; Randomized Controlled Trials as Topic; Remission Induction; Treatment Outcome

Antenatal steroid treatment to enhance fetal lung maturity and surfactant treatment to prevent or treat respiratory distress syndrome have been major advances in perinatal medicine in the past 40 years contributing to improved outcomes for preterm infants. Use of postnatal steroids to prevent or treat chronic lung disease in preterm infants has been less successful and associated with adverse neurodevelopmental outcomes. Although early (in the first week of life) postnatal steroid treatment facilitates earlier extubation and reduces the risk of chronic lung disease, it is associated with adverse effects, such as hyperglycemia, hypertension, gastrointestinal bleeding and perforation, hypertrophic cardiomyopathy, growth failure, and cerebral palsy, and cannot be recommended. Early treatment with hydrocortisone may also improve survival without chronic lung disease, but concerns remain about possible adverse effects such as gastrointestinal perforation and sepsis, particularly in very preterm infants. Early inhaled budesonide also reduces the incidence of chronic lung disease but there are concerns that this may occur at the expense of increased risk of death. More studies of early low-dose steroids with adequate long-term follow-up are needed before they can be recommended for the prevention of chronic lung disease. Late (after the first week of life) postnatal steroids may have a better benefit-to-harm ratio than early steroids. A Cochrane Review shows that late steroid treatment reduces chronic lung disease, the combination of death and chronic lung disease at both 28 days and 36 weeks' corrected age, and the need for later rescue dexamethasone. Adverse effects include hyperglycemia, hypertension, hypertrophic cardiomyopathy, and severe retinopathy of prematurity but without an increase in blindness. Long-term neurodevelopmental effects are not significantly increased by late postnatal steroid treatment. Current recommendations are that postnatal steroid treatment should be reserved for preterm infants who are ventilator-dependent after the first 7-14 days of life and any course should be low dose and of short duration to facilitate endotracheal extubation. Budesonide/surfactant mixtures show some promise as a means of reducing chronic lung disease in preterm infants with severe respiratory distress syndrome, but further larger studies with long-term follow-up are needed before this treatment can be recommended as a routine intervention.

Topics: Anti-Inflammatory Agents; Budesonide; Chronic Disease; Dexamethasone; Drug Administration Schedule; Humans; Hydrocortisone; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Infant, Very Low Birth Weight; Randomized Controlled Trials as Topic; Respiratory Distress Syndrome, Newborn; Steroids

Bronchopulmonary dysplasia (BPD) remains an important cause of mortality and morbidity in preterm infants and inflammation plays a significant role in its pathogenesis. The use of inhaled corticosteroids may modulate the inflammatory process without concomitant high systemic steroid concentrations and less risk of adverse effects. This is an update of a review published in 2012 (Shah 2012). We recently updated the related review on "Inhaled versus systemic corticosteroids for treating bronchopulmonary dysplasia in ventilated very low birth weight preterm neonates".. To determine the effect of inhaled versus systemic corticosteroids started within the first 7 days of life on preventing death or BPD in ventilated very low birth weight infants.. We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2017, Issue 1), MEDLINE via PubMed (1966 to 23 February 2017), Embase (1980 to 23 February 2017), and CINAHL (1982 to 23 February 2017). We searched clinical trials registers, conference proceedings and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-randomised trials.. Randomised or quasi-randomised controlled trials comparing inhaled versus systemic corticosteroid therapy (irrespective of dose and duration) starting in the first seven days of life in very low birth weight preterm infants receiving assisted ventilation.. Clinical outcomes data were extracted and analysed using Review Manager. When appropriate, meta-analysis was performed using typical relative risk (RR), typical risk difference (RD) and weighted mean difference (WMD). Meta-analyses were performed using typical relative risk, typical risk difference (RD), and weighted mean difference with their 95% confidence intervals (CI). If RD was statistically significant, the number needed to benefit or the number needed to harm was calculated. We assessed the quality of evidence was evaluated using GRADE principles.. We included two trials that involved 294 infants. No new studies were included for the 2017 update. The incidence of death or BPD at 36 weeks' postmenstrual age was not statistically significantly different between infants who received inhaled or systemic steroids (RR 1.09, 95% CI 0.88 to 1.35; RD 0.05, 95% CI -0.07 to 0.16; 1 trial, N = 278). The incidence of BPD at 36 weeks' postmenstrual age among survivors was not statistically significant between groups (RR 1.34, 95% CI 0.94 to 1.90; RD 0.11, 95% CI -0.02 to 0.24; 1 trial, N = 206). There was no statistically significant difference in the outcomes of BPD at 28 days, death at 28 days or 36 weeks' postmenstrual age and the combined outcome of death or BPD by 28 days between groups (2 trials, N = 294). The duration of mechanical ventilation was significantly longer in the inhaled steroid group compared with the systemic steroid group (typical MD 4 days, 95% CI 0.2 to 8; 2 trials, N = 294; I² = 0%) as was the duration of supplemental oxygen (typical MD 11 days, 95% CI 2 to 20; 2 trials, N = 294; I² = 33%).The incidence of hyperglycaemia was significantly lower with inhaled steroids (RR 0.52, 95% CI 0.39 to 0.71; RD -0.25, 95% CI -0.37 to -0.14; 1 trial, N = 278; NNTB 4, 95% CI 3 to 7 to avoid 1 infant experiencing hyperglycaemia). The rate of patent ductus arteriosus increased in the group receiving inhaled steroids (RR 1.64, 95% CI 1.23 to 2.17; RD 0.21, 95% CI 0.10 to 0.33; 1 trial, N = 278; NNTH 5, 95% CI 3 to 10). In a subset of surviving infants in the United Kingdom and Ireland there were no significant differences in developmental outcomes at 7 years of age. However, there was a reduced risk of having ever been diagnosed as asthmatic by 7 years of age in the inhaled steroid group compared with the systemic steroid group (N = 48) (RR 0.42, 95% CI 0.19 to 0.94; RD -0.31, 95% CI -0.58 to -0.05; NNTB 3, 95% CI 2 to 20).According to GRADE the quality of the evidence was moderate to low. Evidence was downgraded on the basis of design (risk of bias), consistency (heterogeneity) and precision of the estimates.Both studies received grant support and the industry provided aero chambers and metered dose inhalers of budesonide and placebo for the larger study. No conflict of interest was identified.. We found no evidence that early inhaled steroids confer important advantages over systemic steroids in the management of ventilator-dependent preterm infants. Based on this review inhaled steroids cannot be recommended over systemic steroids as a part of standard practice for ventilated preterm infants. Because they might have fewer adverse effects than systemic steroids, further randomised controlled trials of inhaled steroids are needed that address risk/benefit ratio of different delivery techniques, dosing schedules and long-term effects, with particular attention to neurodevelopmental outcome.

Topics: Administration, Inhalation; Anti-Inflammatory Agents; Beclomethasone; Bronchopulmonary Dysplasia; Budesonide; Chronic Disease; Dexamethasone; Humans; Infant; Infant, Newborn; Infant, Premature; Infant, Very Low Birth Weight; Randomized Controlled Trials as Topic; Respiration, Artificial; Respiratory System Agents; Steroids

Collagenous colitis is a cause of chronic diarrhea. This updated review was performed to identify therapies for collagenous colitis that have been assessed in randomized controlled trials (RCTs).. The primary objective was to assess the benefits and harms of treatments for collagenous colitis.. We searched CENTRAL, the Cochrane IBD Group Specialized Register, MEDLINE and EMBASE from inception to 7 November 2016.. We included RCTs comparing a therapy with placebo or active comparator for the treatment of active or quiescent collagenous colitis.. Data were independently extracted by two authors. The primary outcome was clinical response or maintenance of response as defined by the included studies. Secondary outcome measures included histological response, quality of life and the occurrence of adverse events. Risk ratios (RR) and 95% confidence intervals (CI) were calculated for dichotomous outcomes. The Cochrane risk of bias tool was used to assess bias. The overall quality of the evidence was assessed using the GRADE criteria.. Low quality evidence suggests that budesonide may be effective for inducing and maintaining clinical and histological response in patients with collagenous colitis. We are uncertain about the benefits and harms of therapy with bismuth subsalicylate, Boswellia serrata extract, mesalamine with or without cholestramine, prednisolone and probiotics. These agents and other therapies require further study.

Topics: Bismuth; Boswellia; Budesonide; Cholestyramine Resin; Chronic Disease; Colitis, Collagenous; Diarrhea; Glucocorticoids; Humans; Mesalamine; Organometallic Compounds; Plant Extracts; Prednisolone; Probiotics; Randomized Controlled Trials as Topic; Salicylates

The oral mucosa is commonly involved in chronic graft-versus-host disease (cGVHD). Oral mucosal cGVHD markedly affect individual's daily function and wellbeing. In some cases, it might become a life threating complication. Areas covered: This article describes the rationale for treatment, method of topical application in the oral cavity, evidence supporting the topical administration of dexamethasone and budesonide for oral cGVHD, and their adverse effects. Expert opinion: Evidence supports the use of topical dexamethasone and budesonide for treatment of oral cGVHD. Topical corticosteroid choice for oral cGVHD, takes into consideration the potency, bioavailability, preferred concentration, and possible adverse effects. Budesonide's pharmacological characteristics mark it as a preferable topical agent for oral cGVHD.

Topics: Administration, Topical; Budesonide; Chronic Disease; Dexamethasone; Female; Glucocorticoids; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Male; Mouth Mucosa

This review is one of six looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis is common and is characterised by inflammation of the lining of the nose and paranasal sinuses leading to nasal blockage, rhinorrhoea, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. The use of topical (intranasal) corticosteroids has been widely advocated for the treatment of chronic rhinosinusitis given the belief that inflammation is a major component of this condition.. To assess the effects of intranasal corticosteroids in people with chronic rhinosinusitis.. The Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 8); MEDLINE; EMBASE; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 11 August 2015.. Randomised controlled trials (RCTs) with a follow-up period of at least three months comparing intranasal corticosteroids (e.g. beclomethasone dipropionate, triamcinolone acetonide, flunisolide, budesonide) against placebo or no treatment in patients with chronic rhinosinusitis.. We used the standard methodological procedures expected by Cochrane. Our primary outcomes were disease-specific health-related quality of life (HRQL), patient-reported disease severity and the commonest adverse event - epistaxis. Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score and the adverse events of local irritation or other systemic adverse events. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.. We included 18 RCTs with a total of 2738 participants. Fourteen studies had participants with nasal polyps and four studies had participants without nasal polyps. Only one study was conducted in children. Intranasal corticosteroids versus placebo or no intervention Only one study (20 adult participants without polyps) measured our primary outcome disease-specific HRQL using the Rhinosinusitis Outcome Measures-31 (RSOM-31). They reported no significant difference (numerical data not available) (very low quality evidence).Our second primary outcome, disease severity , was measured using the Chronic Sinusitis Survey in a second study (134 participants without polyps), which found no important difference (mean difference (MD) 2.84, 95% confidence interval (CI) -5.02 to 10.70; scale 0 to 100). Another study (chronic rhinosinusitis with nasal polyps) reported an increased chance of improvement in the intranasal corticosteroids group (RR 2.78, 95% CI 1.76 to 4.40; 109 participants). The quality of the evidence was low.Six studies provided data on at least two of the individual symptoms used in the EPOS 2012 criteria to define chronic rhinosinusitis (nasal blockage, rhinorrhoea, loss of sense of smell and facial pain/pressure). When all four symptoms in the EPOS criteria were available on a scale of 0 to 3 (higher = more severe symptoms), the average MD in change from baseline was -0.26 (95% CI -0.37 to -0.15; 243 participants; two studies; low quality evidence). Although there were more studies and participants when only nasal blockage and rhinorrhoea were considered (MD -0.31, 95% CI -0.38 to -0.24; 1702 participants; six studies), the MD was almost identical to when loss of sense of smell was also considered (1345 participants, four studies; moderate quality evidence).When considering the results for the individual symptoms, benefit was shown in the intranasal corticosteroids group. The effect size was larger for nasal blockage (MD -0.40, 95% CI -0.52 to -0.29; 1702 participants; six studies) than for rhinorrhoea (MD -0.25, 95% CI -0.33 to -0.17; 1702 participants; six studies) or loss of sense of smell (MD -0.19, 95% CI -0.28 to -0.11; 1345 participants; four studies). There was heterogeneity in the analysis for facial pain/pressure (MD -0.27, 95% CI -0.56 to 0.02; 243 participants; two studies). The quality of the evidence was moderate for nasal blockage, rhinorrhoea and loss of sense of smell, but low for facial pain/pressure.There was an increased risk of. Most of the evidence available was from studies in patients with chronic rhinosinusitis with nasal polyps. There is little information about quality of life (very low quality evidence). For disease severity, there seems to be improvement for all symptoms (low quality evidence), a moderate-sized benefit for nasal blockage and a small benefit for rhinorrhoea (moderate quality evidence). The risk of epistaxis is increased (high quality evidence), but these data included all levels of severity; small streaks of blood may not be a major concern for patients. It is unclear whether there is a difference in the risk of local irritation (low quality evidence).

Topics: Administration, Intranasal; Adolescent; Adrenal Cortex Hormones; Adult; Beclomethasone; Budesonide; Child; Chronic Disease; Fluticasone; Humans; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Placebos; Quality of Life; Randomized Controlled Trials as Topic; Rhinitis; Severity of Illness Index; Sinusitis; Steroids

Chronic diarrhea is a very common problem in the general population. It requires a physician to differentiate its causes and depending on its etiology referring the patient to a hospital for diagnosis and subsequent treatment. One of the causes of chronic diarrhea may be microscopic colitis, which is characterized by the presence of clinical symptoms without endoscopic or radiological abnormalities. Diagnosis is based on a histopathological examination of the colon and thus clinical suspicion of the disease is so important for further diagnosis and treatment, which is primarily based on the use of topical steroids such as budesonide.

Topics: Anti-Inflammatory Agents; Budesonide; Chronic Disease; Colitis, Microscopic; Diarrhea; Humans

Microscopic colitis (MC) is a common cause of chronic, non-bloody diarrhoea in the elderly population. In Denmark the incidence has been rising for the last decades. Sufficient biopsy material from colon mucosa is essential for the diagnosis. Treatment is important to improve the patient's quality of life, which is significantly impaired in active MC. This paper reviews newly published data regarding epidemiology, diagnostic criteria and a new European treatment guideline and also includes updates on ongoing and future studies in MC.

Topics: Aged; Algorithms; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Colitis, Microscopic; Diarrhea; Humans

To determine whether the use of topical nasal therapies with saline alone and in combination with antibiotics, antifungals, or corticosteroids is effective in the treatment of patients with chronic rhinosinusitis (CRS).. A systematic literature search was performed utilizing the MEDLINE database (1966 to May 2012), EMBASE database (1980 to May 2012), and the Cochrane Central Register of Controlled Trials.. Electronic databases were searched by three otolaryngologists. Studies on five major categories of topical nasal therapies searched included saline (hypotonic, isotonic and hypertonic); topical antibiotics, topical steroids, and topical antifungals were obtained. Randomized controlled trials and meta-analyses of randomized controlled trials were included.. Sixteen randomized controlled trials were identified examining topical saline (hypertonic or isotonic) in CRS patients. Two randomized controlled trials were found studying the effect of topical antibiotics in patients with CRS. Four randomized controlled trials were identified studying topical antifungal treatment for CRS. Twenty-five randomized controlled trials were found studying topical steroids in CRS patients.. A high aggregate quality of evidence supports the effectiveness of saline irrigations in treating CRS. There is insufficient evidence to support a clear benefit of topical antibiotics in patients with chronic rhinosinusitis. Topical antifungal therapies have not been shown to be significantly different in efficacy than saline controls on CRS outcomes. Topical steroids are beneficial in the treatment of CRS with nasal polyps, but have not been shown to be effective in CRS without nasal polyps.

Topics: Antifungal Agents; Budesonide; Chronic Disease; Glucocorticoids; Humans; Nasal Sprays; Rhinitis; Sinusitis

Traditionally inhaled treatment for asthma has used separate preventer and reliever therapies. The combination of formoterol and budesonide in one inhaler has made possible a single inhaler for both prevention and relief of symptoms (single inhaler therapy or SiT).. To assess the efficacy and safety of budesonide and formoterol in a single inhaler for maintenance and reliever therapy in asthma compared with maintenance with inhaled corticosteroids (ICS) (alone or as part of current best practice) and any reliever therapy.. We searched the Cochrane Airways Group trials register in February 2013.. Parallel, randomised controlled trials of 12 weeks or longer in adults and children with chronic asthma. Studies had to assess the combination of formoterol and budesonide as SiT, against a control group that received inhaled steroids and a separate reliever inhaler.. We used standard methodological procedures expected by The Cochrane Collaboration.. We included 13 trials involving 13,152 adults and one of the trials also involved 224 children (which have been separately reported). All studies were sponsored by the manufacturer of the SiT inhaler. We considered the nine studies assessing SiT against best practice to be at a low risk of selection bias, but a high risk of detection bias as they were unblinded.In adults whose asthma was not well-controlled on ICS, the reduction in hospital admission with SiT did not reach statistical significance (Peto odds ratio (OR) 0.81; 95% confidence interval (CI) 0.45 to 1.44, eight trials, N = 8841, low quality evidence due to risk of detection bias in open studies and imprecision). The rates of hospital admission were low; for every 1000 people treated with current best practice six would experience a hospital admission over six months compared with between three and eight treated with SiT. The odds of experiencing exacerbations needing treatment with oral steroids were lower with SiT compared with control (OR 0.83; 95% CI 0.70 to 0.98, eight trials, N = 8841, moderate quality evidence due to risk of detection bias). For every 100 adults treated with current best practice over six months, seven required a course of oral steroids, whilst for SiT there would be six (95% CI 5 to 7). The small reduction in time to first severe exacerbation needing medical intervention was not statistically significant (hazard ratio (HR) 0.94; 95% CI 0.85 to 1.04, five trials, N = 7355). Most trials demonstrated a reduction in the mean total daily dose of ICS with SiT (mean reduction was based on self-reported data from patient diaries and ranged from 107 to 385 µg/day). Withdrawals due to adverse events were more common in people treated with SiT (OR 2.85; 95% CI 1.89 to 4.30, moderate quality evidence due to risk of detection bias).Three studies including 4209 adults compared SiT with higher dose budesonide maintenance and terbutaline for symptom relief. The studies were considered as low risk of bias. The run-in for these studies involved withdrawal of LABA, and patients were recruited who were symptomatic during run-in. The reduction in the odds of hospitalisation with SiT compared with higher dose ICS did not reach statistical significance (Peto OR; 0.56; 95% CI 0.28 to 1.09, moderate quality evidence due to imprecision). Fewer patients on SiT needed a course of oral corticosteroids (OR 0.54; 95% CI 0.45 to 0.64, high quality evidence). For every 100 adults treated with ICS over. Single inhaler therapy has now been demonstrated to reduce exacerbations requiring oral corticosteroids against current best practice strategies and against a fixed higher dose of inhaled steroids. The strength of evidence that SiT reduces hospitalisation against these same treatments is weak. There were more discontinuations due to adverse events on SiT compared to current best practice, but no significant differences in serious adverse events. Our confidence in these conclusions is limited by the open-label design of the trials, and by the unknown adherence to treatment in the current best practice arms of the trials.Single inhaler therapy can reduce the risk of asthma exacerbations needing oral corticosteroids in comparison with fixed dose maintenance ICS and separate relief medication. The reduced odds of exacerbations with SiT compared with higher dose ICS should be viewed in the context of the possible impact of LABA withdrawal during study run-in. This may have made the study populations more likely to respond to SiT.Single inhaler therapy is not currently licensed for children under 18 years of age in the United Kingdom and there is currently very little research evidence for this approach in children or adolescents.

Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adult; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Budesonide; Child; Chronic Disease; Drug Combinations; Ethanolamines; Formoterol Fumarate; Humans; Terbutaline

Chronic lung disease (CLD) remains an important cause of mortality and morbidity in preterm infants and inflammation plays an important role in its pathogenesis. The use of inhaled corticosteroids may modulate the inflammatory process without concomitant high systemic steroid concentrations and less risk of adverse effects.. To determine the effect of inhaled versus systemic corticosteroids started within the first two weeks of life on preventing CLD in ventilated very low birth weight (VLBW) infants.. Randomised and quasi-randomised trials were identified by searching The Cochrane Library, MEDLINE , EMBASE , CINAHL, reference lists of published trials and abstracts published in Pediatric Research or electronically on the Pediatric Academic Societies web site in June 2007.This search was updated in June 2011 and included additional searches of Clinicaltrials.gov, Controlled-trials.com and Web of Science.. Randomised or quasi-randomised clinical trials comparing inhaled versus systemic corticosteroid therapy (regardless of the dose and duration of therapy) started in the first two weeks of life in VLBW infants receiving assisted ventilation.. Outcomes including CLD at 28 days or 36 weeks postmenstrual age (PMA), mortality, the combined outcome of death or CLD at 28 days or 36 weeks PMA, other pulmonary outcomes and adverse effects were evaluated. All data were analysed using RevMan 5.1. Meta-analyses were performed using relative risk (RR), risk difference (RD), and mean difference (MD) with their 95% confidence intervals (CI). If RD was significant, the numbers needed to benefit (NNTB) or to harm (NNTH) were calculated.. No new trials were identified in this update. Two trials qualified for inclusion in this review. The incidence of CLD at 36 weeks PMA was increased (of borderline statistical significance) in the inhaled steroid group [RR 1.45 (95% CI 0.99 to 2.11); RD 0.11 (95% CI 0.00 to 0.21), p = 0.05, one trial, n = 278]. The incidence of CLD at 36 weeks PMA among all survivors [RR 1.34 (95% CI 0.94 to 1.90); RD 0.11 (95% CI -0.02 to 0.24), one trial, n = 206], oxygen dependency at 28 days (two trials, n = 294), death by 28 days (two trials, n = 294) or 36 weeks PMA (two trials, n = 294) and the combined outcome of death or CLD by 28 days (two trials, n = 294) or 36 weeks PMA (one trial, n = 278) did not differ significantly between the groups. The duration of mechanical ventilation was significantly longer in the inhaled steroid group as compared to the systemic steroid group [typical MD 4 days (95% CI 0.2 to 8); two trials, n = 294] as was the duration of supplemental oxygen [typical MD 11 days (95% CI 2 to 20); two trials, n = 294]. The incidence of hyperglycaemia was significantly lower in the group receiving inhaled steroids [RR 0.52 (95% CI 0.39 to 0.71); RD -0.25 (95% CI -0.37 to -0.14); one trial, n = 278; NNTB 4 (95% CI 3 to 7) to avoid one infant experiencing hyperglycaemia]. The rate of patent ductus arteriosus was increased in the group receiving inhaled steroids [RR 1.64 (95% CI 1.23 to 2.17); RD 0.21 (95% CI 0.10 to 0.33); one trial, n = 278; NNTH 5 (95% CI 3 to 10)]. No information was available on long-term neurodevelopmental outcomes.. This review found no evidence that early inhaled steroids confer important advantages over systemic steroids in the management of ventilator dependent preterm infants. Neither inhaled steroids nor systemic steroids can be recommended as a part of standard practice for ventilated preterm infants. Because they might have fewer adverse effects than systemic steroids, further randomised controlled trials of inhaled steroids are needed that address risk/benefit ratio of different delivery techniques, dosing schedules and long-term effects, with particular attention to neurodevelopmental outcome.

Topics: Administration, Inhalation; Anti-Inflammatory Agents; Beclomethasone; Budesonide; Chronic Disease; Dexamethasone; Humans; Infant; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Infant, Very Low Birth Weight; Lung Diseases; Randomized Controlled Trials as Topic; Respiration, Artificial; Respiratory System Agents; Steroids

Formoterol has a fast onset of action and can therefore be used to relieve symptoms of asthma. A combination inhaler can deliver formoterol with different doses of inhaled corticosteroid; when used as a reliever both drugs will be delivered more frequently when asthma symptoms increase. This has the potential to treat both bronchoconstriction and inflammation in the early stages of exacerbations.. To assess the efficacy and safety of combined inhalers containing both formoterol and an inhaled corticosteroid when used for reliever therapy in adults and children with chronic asthma.. We last searched the Cochrane Airways Group trials register in April 2008.. Randomised trials in adults and children with chronic asthma, where a combination inhaler containing formoterol and inhaled corticosteroid is compared with fast-acting beta2-agonist alone for the relief of asthma symptoms. This should be the only planned difference between the trial arms.. Two review authors independently extracted the characteristics and results of each study. Authors or manufacturers were asked to supply unpublished data in relation to primary outcomes.. Three trials involving 5905 participants were included. In patients with mild asthma who do not need maintenance treatment, no clinically important advantages of budesonide/formoterol as reliever were found in comparison to formoterol as reliever.Two studies enrolled patients with more severe asthma who were not controlled on high doses of inhaled corticosteroids (around 700 mcg/day in adults), and had suffered a clinically important asthma exacerbation in the past year. Hospitalisations related to asthma in the two studies comparing budesonide/formoterol for maintenance and relief with the same dose of budesonide/formoterol for maintenance with terbutaline for relief yielded an odds ratio of 0.68 (95% CI 0.40 to 1.16), which was not a statistically significant reduction. One adult study found a reduction in exacerbations requiring oral corticosteroids compared to terbutaline, odds ratio 0.56 (95% CI 0.42 to 0.74) and the study in children found less serious adverse events with budesonide/formoterol used for maintenance and relief. There was no significant difference in annual growth in children using budesonide/formoterol reliever in comparison to terbutaline.. In mild asthma it is not yet known whether patients who use a budesonide/formoterol inhaler for relief of asthma symptoms derive any clinically important benefits. In more severe asthma, one study that enrolled patients who were not controlled on quite high doses of inhaled corticosteroids, and had suffered an exacerbation in the previous year, demonstrated a reduction in the risk of exacerbations that require oral corticosteroids with budesonide/formoterol for maintenance and relief in comparison with budesonide/formoterol for maintenance and terbutaline or formoterol for relief. The incidence of serious adverse events in children was also less using budesonide/formoterol for maintenance and relief in one study, which similarly enrolled children who were not controlled on medium to high doses of inhaled corticosteroids, and compared to terbutaline relief with an explorative maintenance dose of budesonide/formoterol that is not approved for treatment.

Topics: Administration, Inhalation; Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Bronchial Diseases; Bronchodilator Agents; Budesonide; Child; Chronic Disease; Constriction, Pathologic; Drug Combinations; Ethanolamines; Formoterol Fumarate; Humans; Randomized Controlled Trials as Topic; Terbutaline

Traditionally inhaled treatment for asthma has been considered as preventer and reliever therapy. The combination of formoterol and budesonide in a single inhaler introduces the possibility of using a single inhaler for both prevention and relief of symptoms (single inhaler therapy).. The aim of this review is to compare formoterol and corticosteroid in single inhaler for maintenance and relief of symptoms with inhaled corticosteroids for maintenance and a separate reliever inhaler.. We last searched the Cochrane Airways Group trials register in September 2008.. Randomised controlled trials in adults and children with chronic asthma.. Two review authors independently assessed studies for inclusion and extracted the characteristics and results of each study. Authors or manufacturers were asked to supply unpublished data in relation to primary outcomes.. Five studies on 5,378 adults compared single inhaler therapy with current best practice, and did not show a significant reduction in participants with exacerbations causing hospitalisation (Peto OR 0.59; 95% CI 0.24 to 1.45) or treated with oral steroids (OR 0.83; 95% CI 0.66 to 1.03). Three of these studies on 4281 adults did not show a significant reduction in time to first severe exacerbation needing medical intervention (HR 0.96; 95% CI 0.85 to 1.07). These trials demonstrated a reduction in the mean total daily dose of inhaled corticosteroids with single inhaler therapy (mean reduction ranged from 107 to 267 micrograms/day, but the trial results were not combined due to heterogeneity). The full results from four further studies on 4,600 adults comparing single inhaler therapy with current best practice are awaited.Three studies including 4,209 adults compared single inhaler therapy with higher dose budesonide maintenance and terbutaline for symptom relief. No significant reduction was found with single inhaler therapy in the risk of patients suffering an asthma exacerbation leading to hospitalisation (Peto OR 0.56; 95% CI 0.28 to 1.09), but fewer patients on single inhaler therapy needed a course of oral corticosteroids (OR 0.54; 95% CI 0.45 to 0.64). These results translate into an eleven month number needed to treat of 14 (95% CI 12 to 18), to prevent one patient being treated with oral corticosteroids for an exacerbation. The run-in for these studies involved withdrawal of long-acting beta(2)-agonists, and patients were recruited who were symptomatic during run-in.One study included children (N = 224), in which single inhaler therapy was compared to higher dose budesonide. There was a significant reduction in participants who needed an increase in their inhaled steroids with single inhaler therapy, but there were only two hospitalisations for asthma and no separate data on courses of oral corticosteroids. Less inhaled and oral corticosteroids were used in the single inhaler therapy group and the annual height gain was also 1 cm greater in the single inhaler therapy group, [95% CI 0.3 to 1.7 cm].There was no significant difference found in fatal or non-fatal serious adverse events for any of the comparisons.. Single inhaler therapy can reduce the risk of asthma exacerbations needing oral corticosteroids in comparison with fixed dose maintenance inhaled corticosteroids. Guidelines and common best practice suggest the addition of regular long-acting beta(2)-agonist to inhaled corticosteroids for uncontrolled asthma, and single inhaler therapy has not been demonstrated to significantly reduce exacerbations in comparison with current best practice, although results of five large trials are awaiting full publication. Single inhaler therapy is not currently licensed for children under 18 years of age in the United Kingdom.

Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Budesonide; Child; Chronic Disease; Drug Therapy, Combination; Ethanolamines; Formoterol Fumarate; Humans; Terbutaline

Topics: Age Factors; Aged; Aged, 80 and over; Anti-Infective Agents; Anti-Inflammatory Agents; Antidiarrheals; Budesonide; Cholestyramine Resin; Chronic Disease; Clostridioides difficile; Colitis, Microscopic; Diagnosis, Differential; Diarrhea; Enterocolitis, Pseudomembranous; Glucocorticoids; Humans; Intestinal Diseases; Irritable Bowel Syndrome; Medical History Taking; Metronidazole; Randomized Controlled Trials as Topic; Time Factors

Inhaled corticosteroids (ICS) are an integral part of asthma management, and act as an anti-inflammatory agent in the airways of the lung. These agents confer both significant benefit in terms of symptom management and improvement in lung function, but may also cause harm in terms of local and systemic side-effects. Ciclesonide is a novel steroid that is metabolised to its active component in the lung, making it a potentially useful for reducing local side effects.. To assess the efficacy and adverse effects of ciclesonide relative to those of other inhaled corticosteroids in the management of chronic asthma.. We searched the Cochrane Airways Group register of trials with pre-defined terms. Additional searches of PubMed and Clinicalstudyresults.org were undertaken. The literature searches for this review are current up to June 2007.. Randomised parallel or crossover studies were eligible for the review. We included studies comparing ciclesonide with other steroids both at nominally equivalent dose or lower doses of ciclesonide.. Two review authors independently assessed trial quality and extracted data. Study authors were contacted for additional information. Adverse effects information was collected from the trials.. Twenty one trials involving 7243 participants were included. Equal daily doses of ciclesonide and beclomethasone (BDP) or budesonide (BUD) gave similar results for peak expiratory flow rates (PEF), although forced vital capacity (FVC) was higher with ciclesonide. Data on forced expired volume in one second (FEV1) were inconsistent. Withdrawal data and symptoms were similar between treatments. Compared with the same dose of fluticasone (FP), data on lung function parameters (FEV1, FVC and PEF) did not differ significantly. Paediatric quality of life score favoured ciclesonide. Candidiasis was less frequent with ciclesonide, although other side-effect outcomes did not give significant differences in favour of either treatment. When lower doses of ciclesonide were compared to BDP or BUD, the difference in FEV1 did not reach significance but we cannot exclude a significant effect in favour of BDP/BUD. Other lung function outcomes did not give significant differences between treatments. Paediatric quality of life scores did not differ between treatments. Adverse events occurred with similar frequency between ciclesonide and BDP/BUD. Comparison with FP at half the nominal dose was undertaken in three studies, which indicated that FEV1 was not significantly different, but was not equivalent between the treatments (per protocol: -0.05 L 95% confidence intervals -0.11 to 0.01).. The results of this review give some support to ciclesonide as an equivalent therapy to other ICS at similar nominal doses. The studies assessed low doses of steroids, in patients whose asthma required treatment with low doses of steroids. At half the dose of FP and BDP/BUD, the effects of ciclesonide were more inconsistent The effect on candidiasis may be of importance to people who find this to be problematic. The role of ciclesonide in the management of asthma requires further study, especially in paediatric patients. Further assessment against FP at a dose ratio of 1:2 is a priority.

Topics: Administration, Inhalation; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Child; Chronic Disease; Fluticasone; Humans; Pregnenediones; Randomized Controlled Trials as Topic

Microscopic colitis (MC) is an encompassing term for two diseases; collagenous colitis and lymphocytic colitis. The colon appears normal by colonoscopy and a diagnosis is only obtained with a biopsy. The histopathology of collagenous colitis is mainly characterized by a thickening of the subepithelial basement membrane of the colonic mucosa with a band of collagen. Lymphocytic colitis is mainly characterized by an intraepithelial lymphocytosis without the collagen thickening. Even though the two diseases have a distinctive pathology their clinical symptoms are characterized by chronic watery diarrhea without bleeding. Microscopic colitis is thought to cause about 4-13% of all chronic diarrhea but their relative frequency is much higher among older people. The mean annual incidence for collagenous and lymphocytic colitis has been increasing. Steroids are the most effective treatment for microscopic colitis and budesonide is the most studied and effective therapy for MC. The aim of this paper is to give a review of two relatively new diseases which are among the most common cause of chronic diarrhea, especially among older people.

Topics: Anti-Inflammatory Agents; Biopsy; Budesonide; Chronic Disease; Colitis, Microscopic; Colon; Colonoscopy; Diarrhea; Gastrointestinal Agents; Humans; Intestinal Mucosa; Treatment Outcome

A case-report of a man with chronic diarrhoea is presented. After an unsuccessful treatment of an intestinal yersioniosis, the diagnosis of collagenous intestinal disease affecting duodenum, ileum and colon was made. In addition, a IgG transient deficiency was observed. The literature about gastrointestinal involvement, concomintant infection by Yersinia and IgG deficiency in collagenous colitis is reviewed.

Topics: Anti-Bacterial Agents; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Ciprofloxacin; Colitis; Collagen; Diarrhea; Duodenitis; Humans; IgG Deficiency; Ileitis; Intestinal Mucosa; Male; Middle Aged; Yersinia enterocolitica; Yersinia Infections

The therapy of inflammatory bowel diseases is based on 5-aminosalicylates (5-ASAs) that are the forefront of treatment of mild-to-moderate active disease and maintenance; steroids are used for the treatment of moderate-to-severe active disease; immunosuppressives and sometimes antibiotics in moderate-to-severe disease; maintenance and for the treatment of selected complications. The last few years have witnessed a significant change in the treatment of Crohn's disease. Based on evidence from new clinical studies and recent meta-analyses, the role of and indications for conventional therapy have been reassessed. The 5-ASAs are nowadays less frequently used in both active disease and maintenance therapy. Instead, budesonide has been introduced in the treatment of mild-to-moderate ileal disease. Besides the modest use of 5-ASAs, steroids are prescribed for active colonic disease. Immunosuppressives, especially azathioprine, are more commonly used in moderate-to-severe disease as well as in maintenance. The preferred maintenance regimen following medically- and surgically-induced remission, in addition to relationship between medical and surgical therapies, has also changed. The recent introduction of new "biological" therapy represents a major, promising change in the therapy of resistant and penetrating disease.

Topics: Acute Disease; Adrenal Cortex Hormones; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Antibodies, Monoclonal; Azathioprine; Budesonide; Chronic Disease; Crohn Disease; Fistula; Gastrointestinal Agents; Humans; Immunosuppressive Agents; Inflammatory Bowel Diseases; Infliximab; Mesalamine; Methotrexate; Severity of Illness Index

Beclomethasone dipropionate (BDP) and budesonide (BUD) are commonly prescribed inhaled corticosteroids for the treatment of asthma. Fluticasone propionate (FP) is newer agent with greater potency in in-vitro assays.. To compare the efficacy and safety of Fluticasone to Beclomethasone or Budesonide in the treatment of chronic asthma.. We searched the Cochrane Airways Group trial register (January 2007) and reference lists of articles. We contacted trialists and pharmaceutical companies for additional studies and searched abstracts of major respiratory society meetings (1997 to 2006).. Randomised trials in children and adults comparing Fluticasone to either Beclomethasone or Budesonide in the treatment of chronic asthma.. Two reviewers independently assessed articles for inclusion and methodological quality. One reviewer extracted data. Quantitative analyses were undertaken using RevMan analyses 1.0.1.. Seventy-one studies (14,602 participants) representing 74 randomised comparisons met the inclusion criteria. Methodological quality was fair. Dose ratio 1:2: FP produced a significantly greater end of treatment FEV1 (0.04 litres (95% CI 0 to 0.07 litres), end of treatment and change in morning PEF, but not change in FEV1 or evening PEF. This applied to all drug doses, age groups, and delivery devices. No difference between FP and BDP/BUD were seen for trial withdrawals. FP led to fewer symptoms and less rescue medication use. When given at half the dose of BDP/BUD, FP led to a greater likelihood of pharyngitis. There was no difference in the likelihood of oral candidiasis. Plasma cortisol and 24 hour urinary cortisol was measured frequently but data presentation was limited. Dose ratio 1:1: FP produced a statistically significant difference in morning PEF, evening PEF, and FEV1 over BDP or BUD. The effects on exacerbations were mixed. There were no significant differences incidence of hoarseness, pharyngitis, candidiasis, or cough.. Fluticasone given at half the daily dose of beclomethasone or budesonide leads to small improvements in measures of airway calibre, but it appears to have a higher risk of causing sore throat and when given at the same daily dose leads to increased hoarseness. There are concerns about adrenal suppression with Fluticasone given to children at doses greater than 400 mcg/day, but the randomised trials included in this review did not provide sufficient data to address this issue.

Topics: Adult; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Chronic Disease; Fluticasone; Humans; Randomized Controlled Trials as Topic

Ciclesonide is a new inhaled corticosteroids licensed for the prophylactic treatment of persistent asthma in adults. Currently beclomethasone dipropionate, budesonide and fluticasone propionate are the most commonly prescribed inhaled corticosteroids for the treatment of asthma but there has been no systematic review comparing the effectiveness and safety ciclesonide to these agents. We therefore aimed to systematically review published randomised controlled trials of the effectiveness and safety of ciclesonide compared to alternative inhaled corticosteroids in people with asthma.. We performed literature searches on MEDLINE, EMBASE, PUBMED, the COCHRANE LIBRARY and various Internet evidence sources for randomised controlled trials or systematic reviews comparing ciclesonide to beclomethasone or budesonide or fluticasone in adult humans with persistent asthma. Data was extracted by one reviewer.. Five studies met the inclusion criteria. Methodological quality was variable. There were no trials comparing ciclesonide to beclomethasone. There was no significant difference between ciclesonide and budesonide or fluticasone on the following outcomes: lung function, symptoms, quality of life, airway responsiveness to a provoking agent or inflammatory markers. However, the trials were very small in size, increasing the possibility of a type II error. One trial demonstrated that the combined deposition of ciclesonide (and its active metabolite) in the oropharynx was 47% of that of budesonide while another trial demonstrated that the combined deposition of ciclesonide (and its active metabolite) in the oropharynx was 53% of that of fluticasone. One trial demonstrated less suppression of cortisol in overnight urine collection after ciclesonide compared to fluticasone (geometric mean fold difference = 1.5, P < 0.05) but no significant difference in plasma cortisol response.. There is very little evidence comparing CIC to other ICS, restricted to very small, phase II studies of low power. These demonstrate CIC has similar effectiveness and efficacy to FP and BUD (though equivalence is not certain) and findings regarding oral deposition and HPA suppression are inconclusive. There is no direct comparative evidence that CIC causes fewer side effects since none of the studies reported patient-based outcomes.

Topics: Administration, Inhalation; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Chronic Disease; Fluticasone; Humans; Pregnenediones; Randomized Controlled Trials as Topic

Topics: Administration, Intranasal; Androstadienes; Anti-Inflammatory Agents; Beclomethasone; Budesonide; Chronic Disease; Diagnosis, Differential; Drug Administration Schedule; Fluocinolone Acetonide; Fluticasone; Glucocorticoids; Humans; Nurse Practitioners; Nurse's Role; Patient Satisfaction; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Severity of Illness Index; Triamcinolone

Collagenous colitis is a disorder that is recognized as a cause of chronic diarrhea. Treatment has been based mainly on anecdotal evidence. This review was performed to identify therapies for collagenous colitis that have been proven in randomized trials.. To determine effective treatments for patients with clinically active collagenous colitis.. Relevant papers published between 1970 and June 2006 were identified via the MEDLINE and PUBMED databases. Manual searches from the references of identified papers, as well as review papers on collagenous or microscopic colitis were performed to identify additional studies. Abstracts from major gastroenterological meetings were searched to identify research submitted in abstract form only. Finally, the Cochrane Controlled Trials Register and the Cochrane Inflammatory Bowel Disease and Functional Bowel Disorders Group Specialized Trials Register were searched for other studies.. Seven randomized trials were identified. One trial studied bismuth subsalicylate (published in abstract form only), one trial studied Boswellia serrata extract (published in abstract form only), one trial studied probiotics, one trial studied prednisolone, and 3 trials studied budesonide for the therapy of collagenous colitis.. Data were extracted independently by each author onto 2x2 tables (treatment versus placebo and response versus no response). For therapies assessed in one trial only, p-values were derived using the chi-square test. For therapies assessed in more than one trial, summary test statistics were derived using the Peto odds ratio and 95% confidence intervals. Data were combined for analysis only if the outcomes were sufficiently similar in definition.. There were 9 patients with collagenous colitis in the trial studying bismuth subsalicylate (nine 262 mg tablets daily for 8 weeks). Those randomized to active drug were more likely to have clinical (p = 0.003) and histological (p = 0.003) improvement than those assigned to placebo. Eleven patients were enrolled in the trial studying prednisolone (50 mg daily for 2 weeks). There was a trend towards clinical response in patients on active medication compared to placebo (p = 0.064). The effect of prednisolone on histologic improvement was not studied. Thirty-one patients were enrolled in the Boswellia serrata extract trial. Clinical improvement was noted in 44% of patients who received active treatment compared to 27% of patients who received placebo (p = 0.32). Twenty-nine patients were enrolled in the probiotics trial. Clinical improvement was noted in 29% of patients who received probiotics compared to 13% of patients who received placebo (p = 0.635). A total of 94 patients were enrolled in 3 trials studying budesonide (9 mg daily or in a tapering schedule for 6 to 8 weeks). The pooled odds ratio for clinical response to treatment with budesonide was 12.32 (95% CI 5.53-27.46), with a number needed to treat of 2 patients. There was significant histological improvement with treatment in all 3 trials studying budesonide therapy. Budesonide also appears to improve patients' quality of life.. Budesonide is effective for the treatment of collagenous colitis. The evidence for benefit with bismuth subsalicylate is weaker. The effectiveness of prednisolone, Boswellia serrata extract, probiotics and other therapies for induction or maintenance of remission of collagenous colitis is unknown and requires further study.

Topics: Anti-Inflammatory Agents; Bismuth; Budesonide; Chronic Disease; Colitis, Collagenous; Diarrhea; Humans; Organometallic Compounds; Probiotics; Randomized Controlled Trials as Topic; Salicylates

Asthma is the most common chronic illness among children, and inhaled corticosteroids (ICS) are the most effective long-term therapy available for suppressing airway inflammation in persistent asthma. While the primary aim of ICS therapy is good efficacy with minimal side effects, early diagnosis and treatment of asthma can also improve asthma control and normalize lung function, and may prevent irreversible airway injury. Poor patient compliance is a major barrier to treatment. Simplified dosing regimens (e.g., once-daily administration), good inhaler technique, and education of the patient/caregiver should improve patient compliance. Concerns over ICS therapy are often based on the potential for systemic effects associated with oral corticosteroids (e.g., effects on bone mineral density, or growth suppression in children). Since adverse events are associated with high doses of ICS, the dose in all patients should be titrated to the minimum effective dose required to maintain control. Optimal distribution of an ICS in the lungs rather than the systemic compartment is affected by several factors, including the drug's pharmacokinetic profile, inhaler type, inhaler technique, and drug particle size. For young patients unable to use a dry-powder inhaler or pressurized metered-dose inhaler, a nebulizer facilitates drug delivery through passive inhalation; ICS therapy in the form of budesonide inhalation suspension can be given to children with persistent asthma from 12 months of age. In conclusion, selecting a drug with good efficacy and minimal side effects, such as budesonide, together with an easy-to-use delivery system and ongoing patient/caregiver education, is important in optimizing ICS therapy for children with persistent asthma.

Topics: Administration, Inhalation; Adolescent; Asthma; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Chronic Disease; Drug Administration Schedule; Female; Humans; Infant; Male; Patient Compliance; Patient Education as Topic; Safety

Beclomethasone dipropionate (BDP) and budesonide (BUD) are commonly prescribed inhaled corticosteroids for the treatment of asthma. Fluticasone propionate (FP) is newer agent with greater potency in in-vitro assays.. To compare the efficacy and safety of Fluticasone to Beclomethasone or Budesonide in the treatment of chronic asthma.. We searched the Cochrane Airways Group trial register (January 2004) and reference lists of articles. We contacted trialists and pharmaceutical companies for additional studies and searched abstracts of major respiratory society meetings (1997 to 2003).. Randomised trials in children and adults comparing Fluticasone to either Beclomethasone or Budesonide in the treatment of chronic asthma.. Two reviewers independently assessed articles for inclusion and methodological quality. One reviewer extracted data. Quantitative analyses were undertaken using RevMan analyses 1.0.1.. Fifty six studies (12, 119 participants) met the inclusion criteria. Methodological quality was variable. Dose ratio 1:2: FP produced a significantly greater FEV1 (0.14 litres, 95% Confidence Interval (CI) 0.06 to 0.22), morning PEF (11.10 L/min, 95%CI 3.12 to 19.09 L/min) and evening PEF (9.31 L/min, 95%CI 5.12 to 13.5 L/min). This applied to all drug doses, age groups, and delivery devices. No difference between FP and BDP/BUD were seen for trial withdrawals. Symptoms and rescue medication use were widely reported but few trials provided sufficient data for analysis. When given at half the dose of BDP/BUD, FP led to a greater likelihood of pharyngitis. There was no difference in the likelihood of oral candidiasis. Plasma cortisol and 24 hour urinary cortisol was measured frequently but data presentation was limited. Dose ratio 1:1: FP produced a statistically significant difference in am PEF (9.58 L/min (95% CI 5.20 to 13.97)), pm PEF (7.41 L/min (95% CI 2.61 to 12.22)), and FEV1 (0.09 L (0.02 to 0.17)). The effects on exacerbations were mixed. There was an increase in the incidence of hoarseness, but no significant difference in pharyngitis, candidiasis, or cough.. Fluticasone given at half the daily dose of beclomethasone or budesonide leads to small improvements in measures of airway calibre, but it appears to have a higher risk of causing hoarseness when given at the same daily dose. Future studies should attempt to establish the relative efficacy of inhaled steroids delivered with CFC-free propellants.

Topics: Adult; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Chronic Disease; Humans; Randomized Controlled Trials as Topic

Topics: Anti-Inflammatory Agents; Budesonide; Chronic Disease; Colitis; Colonoscopy; Diagnosis, Differential; Diarrhea; Female; Humans; Incidence; Middle Aged; Osmosis; Quality of Life; Time Factors

Collagenous colitis is a disorder that is recognized as a cause of chronic diarrhea. Treatment has been based mainly on anecdotal evidence. This review was performed to identify therapies for collagenous colitis that have been proven in randomized trials.. To determine effective treatments for patients with clinically active collagenous colitis.. Relevant papers published between 1970 and June 2005 were identified via the MEDLINE and PUBMED databases. Manual searches from the references of identified papers, as well as review papers on collagenous or microscopic colitis were performed to identify additional studies. Abstracts from major gastroenterological meetings were searched to identify research submitted in abstract form only. Finally, the Cochrane Controlled Trials Register and the Cochrane Inflammatory Bowel Disease and Functional Bowel Disorders Group Specialized Trials Register were searched for other studies.. Six randomized trials were identified. One trial studied bismuth subsalicylate (published in abstract form only), one trial studied Boswellia serrata extract (published in abstract form only), one trial studied prednisolone, and 3 trials studied budesonide in the therapy of collagenous colitis.. Data were extracted independently by each author onto 2x2 tables (treatment versus placebo and response versus no response). For therapies assessed in one trial only, p-values were derived using the chi-square test. For therapies assessed in more than one trial, summary test statistics were derived using the Peto odds ratio and 95% confidence intervals. Data were combined for analysis only if the outcomes were sufficiently similar in definition.. There were 9 patients with collagenous colitis in the trial studying bismuth subsalicylate (nine 262 mg tablets daily for 8 weeks). Those randomized to active drug were more likely to have clinical (p = 0.003) and histological (p = 0.003) improvement than those assigned to placebo. Eleven patients were enrolled in the trial studying prednisolone (50 mg daily for 2 weeks). There was a trend towards clinical response in patients on active medication compared to placebo (p = 0.064). The effect of prednisolone on histologic improvement was not studied. Thirty-one patients were enrolled in the Boswellia serrata extract trial. Clinical improvement was noted in 44% of patients who received active treatment compared to 27% of patients who received placebo (p = 0.32). A total of 94 patients were enrolled in 3 trials studying budesonide (9 mg daily or in a tapering schedule for 6 to 8 weeks). The pooled odds ratio for clinical response to treatment with budesonide was 12.32 (95% CI 5.53 - 27.46), with a number needed to treat of 2 patients. There was significant histological improvement with treatment in all 3 trials studying budesonide therapy. Budesonide also appears to improve patients' quality of life.. Budesonide is effective for the treatment of collagenous colitis. The evidence for benefit with bismuth subsalicylate is weaker. The effectiveness of prednisolone and Boswellia serrata extract and other therapies for induction or maintenance of remission of collagenous colitis is unknown and requires further study.

Topics: Anti-Inflammatory Agents; Bismuth; Budesonide; Chronic Disease; Colitis; Collagen; Diarrhea; Humans; Organometallic Compounds; Randomized Controlled Trials as Topic; Salicylates

Collagenous colitis is a disorder that is recognized as a cause of chronic diarrhea. Treatment has been based mainly on anecdotal evidence. This review was performed to identify therapies for collagenous colitis that have been proven in randomized trials.. To determine effective treatments for patients with clinically active collagenous colitis.. Relevant papers published between 1970 and August 2003 were identified via the MEDLINE and PUBMED databases. Manual searches from the references of identified papers, as well as review papers on collagenous or microscopic colitis were performed to identify additional studies. Abstracts from major gastroenterological meetings were searched to identify research submitted in abstract form only. Finally, the Cochrane Controlled Trials Register and the Cochrane Inflammatory Bowel Disease Group Specialized Trials Register were searched for other studies.. Five randomized trials were identified. One trial studied bismuth subsalicylate (published in abstract form only), one trial studied prednisolone, and 3 trials studied budesonide in the therapy of collagenous colitis.. Data were extracted independently by each author onto 2x2 tables (treatment versus placebo and response versus no response). For therapies assessed in one trial only, p-values were derived using the chi-square test. For therapies assessed in more than one trial, summary test statistics were derived using the Peto odds ratio and 95% confidence intervals. Data were combined for analysis only if the outcomes were sufficiently similar in definition.. There were 9 patients with collagenous colitis in the trial studying bismuth subsalicylate (nine 262 mg tablets daily for 8 weeks). Those randomized to active drug were more likely to have clinical (p=0.003) and histological (p=0.003) improvement than those assigned to placebo. Eleven patients were enrolled in the trial studying prednisolone (50 mg daily for 2 weeks). There was a trend towards clinical response in patients on active medication compared to placebo (p=0.064). The effect of prednisolone on histologic improvement was not studied. A total of 94 patients were enrolled in 3 trials studying budesonide (9 mg daily or in a tapering schedule for 6 to 8 weeks). The pooled odds ratio for clinical response to treatment with budesonide was 12.32 (95% CI 5.53-27.46), with a number needed to treat of 2 patients. There was significant histological improvement with treatment in all 3 trials studying budesonide therapy.. Budesonide is effective for the treatment of collagenous colitis. The evidence for benefit with bismuth subsalicylate is weaker. Prednisolone may be effective for treatment of collagenous colitis, but only a single very small study has been reported. The effectiveness of these and other therapies for induction or maintenance of remission (as opposed to producing clinical or histological improvement) of collagenous colitis is unknown.

Topics: Anti-Inflammatory Agents; Bismuth; Budesonide; Chronic Disease; Colitis; Collagen; Diarrhea; Humans; Organometallic Compounds; Randomized Controlled Trials as Topic; Salicylates

Beclomethasone dipropionate (BDP) and budesonide (BUD) are commonly prescribed inhaled corticosteroids for the treatment of asthma, Fluticasone propionate (FP) is newer agent with greater potency in in-vitro assays.. To compare the efficacy and safety of Fluticasone to Beclomethasone or Budesonide in the treatment of chronic asthma.. We searched the Cochrane Airways Group trial register (January 2003) and reference lists of articles. We contacted trialists and pharmaceutical companies for additional studies and searched abstracts of major respiratory society meetings (1997 to 2003).. Randomised trials in children and adults comparing Fluticasone to either Beclomethasone or Budesonide in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and methodological quality.. One reviewer extracted data. Quantitative analyses were undertaken using RevMan analyses 1.0.1.. 48 studies (11,479 participants) met the inclusion criteria. Methodological quality was variable. When compared at a FP:BUD/BDP dose ratio of 1:2, fluticasone produced a significantly greater FEV1 (Weighted Mean Difference (WMD) 0.11 litres, 95% Confidence Interval (CI) 0.01 to 0.20 litres), morning PEF (WMD 13 L/min, 95%CI 5 to 22 L/min) and evening PEF (WMD 11 L/min, 95%CI 1 to 20 L/min). This applied to all drug doses, age groups, and delivery devices, although subgroup analyses suggested that the relative benefit of FP may be greater in more severe patients treated with higher doses of inhaled corticosteroid. No difference between fluticasone and beclomethasone or budesonide were seen for trial withdrawals (Peto OR 0.76, 95%CI 0.53 to 1.09). Symptoms and rescue medication use were widely reported but few trials provided sufficient data for analysis. A higher likelihood of pharyngitis (Peto Odds Ratio 2.16; 95% CI 1.43 to 3.24) was apparent when patients were treated with fluticasone at twice the dose of BDP/BUD, although there was unexplained heterogeneity in this effect between trials. There was no difference in the likelihood of oral Candidiasis. Plasma cortisol and 24 hour urinary cortisol were measured frequently but data presentation was limited.. Fluticasone given at half the daily dose of beclomethasone or budesonide leads to small improvements in measures of airway calibre, but it appears to have a higher risk of causing side-effects when given at the same daily dose.

Topics: Adult; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Chronic Disease; Fluticasone; Humans; Randomized Controlled Trials as Topic

Collagenous colitis is a disorder that is recognized as a cause of chronic diarrhea. Treatment has been based mainly on anecdotal evidence. This review was performed to identify therapies for collagenous colitis that have been proven in randomized trials.. To determine effective treatments for patients with clinically active collagenous colitis.. Relevant papers published between 1970 and October 2002 were identified via the MEDLINE, PUBMED, and EMBASE databases. Manual searches from the references of identified papers, as well as review papers on collagenous or microscopic colitis were performed to identify additional studies. Abstracts from major gastroenterological meetings were searched to identify research submitted in abstract form only. Finally, the Cochrane Controlled Trials Register and the Cochrane Inflammatory Bowel Disease Group Specialized Trials Register were searched for other studies.. Four randomized trials were identified. One trial studied bismuth subsalicylate (published in abstract form only), and 3 trials (1 published in abstract form only) studied budesonide in the therapy of collagenous colitis.. Data were extracted independently by each author onto 2x2 tables (treatment versus placebo and response versus no response). For therapies assessed in one trial only, p-values were derived using the chi-square test. For therapies assessed in more than one trial, summary test statistics were derived using the Peto odds ratio and 95% confidence intervals. Data were combined for analysis only if the outcomes were sufficiently similar in definition.. There were 9 patients with collagenous colitis in the trial studying bismuth subsalicylate (nine 262 mg tablets daily for 8 weeks). Those randomized to active drug were more likely to have clinical (p=0.003) and histological (p=0.003) improvement than those assigned to placebo. A total of 94 patients were enrolled in 3 trials studying budesonide (9 mg daily for 6 to 8 weeks). The pooled odds ratio for clinical response to treatment with budesonide was 12.32 (95% CI 5.53-27.46), with a number needed to treat of 2 patients. There was significant histological improvement with treatment in all 3 trials studying budesonide therapy.. Budesonide is effective in the treatment of collagenous colitis. The evidence for bismuth subsalicylate is weaker, but still important. The roles of these and other therapies in inducing or maintaining remission (as opposed to clinical or histological improvement) of collagenous colitis are unknown.

Topics: Anti-Inflammatory Agents; Bismuth; Budesonide; Chronic Disease; Colitis; Diarrhea; Humans; Organometallic Compounds; Salicylates

Collagenous colitis is a disorder that is recognized as a cause of chronic diarrhea. Treatment has been based mainly on anecdotal evidence. This review was performed to identify therapies for collagenous colitis that have been proven in randomized trials.. To determine effective treatments for patients with clinically active collagenous colitis.. Relevant papers published between 1970 and April 2003 were identified via the MEDLINE and PUBMED databases. Manual searches from the references of identified papers, as well as review papers on collagenous or microscopic colitis were performed to identify additional studies. Abstracts from major gastroenterological meetings were searched to identify research submitted in abstract form only. Finally, the Cochrane Controlled Trials Register and the Cochrane Inflammatory Bowel Disease Group Specialized Trials Register were searched for other studies.. Four randomized trials were identified. One trial studied bismuth subsalicylate (published in abstract form only), and 3 trials studied budesonide in the therapy of collagenous colitis.. Data were extracted independently by each author onto 2x2 tables (treatment versus placebo and response versus no response). For therapies assessed in one trial only, p-values were derived using the chi-square test. For therapies assessed in more than one trial, summary test statistics were derived using the Peto odds ratio and 95% confidence intervals. Data were combined for analysis only if the outcomes were sufficiently similar in definition.. There were 9 patients with collagenous colitis in the trial studying bismuth subsalicylate (nine 262 mg tablets daily for 8 weeks). Those randomized to active drug were more likely to have clinical (p=0.003) and histological (p=0.003) improvement than those assigned to placebo. A total of 94 patients were enrolled in 3 trials studying budesonide (9 mg daily or in a tapering schedule for 6 to 8 weeks). The pooled odds ratio for clinical response to treatment with budesonide was 12.32 (95% CI 5.53-27.46), with a number needed to treat of 2 patients. There was significant histological improvement with treatment in all 3 trials studying budesonide therapy.. Budesonide is effective in the treatment of collagenous colitis. The evidence for bismuth subsalicylate is weaker, but still important. The roles of these and other therapies in inducing or maintaining remission (as opposed to clinical or histological improvement) of collagenous colitis are unknown.

Topics: Anti-Inflammatory Agents; Bismuth; Budesonide; Chronic Disease; Colitis; Collagen; Diarrhea; Humans; Organometallic Compounds; Randomized Controlled Trials as Topic; Salicylates

Beclomethasone dipropionate (BDP) and budesonide (BUD) are commonly prescribed inhaled corticosteroids for the treatment of asthma, Fluticasone propionate (FP) is newer agent with greater potency in in-vitro assays.. To compare the efficacy and safety of Fluticasone to Beclomethasone or Budesonide in the treatment of chronic asthma.. We searched the Cochrane Airways Group Trial Register (1999) and reference lists of articles. We contacted trialists and pharmaceutical companies for additional studies and searched abstracts of major respiratory society meetings (1997-1999).. Randomised trials in children and adults comparing Fluticasone to either Beclomethasone or Budesonide in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and methodological quality.. One reviewer extracted data. Quantitative analyses where undertaken using Review Manager 4.0.3 with Metaview 3.1.. 42 studies (>10,000 patients) met the inclusion criteria. Methodological quality was variable. When compared at a FP:BUD/BDP dose ratio of 1:2, fluticasone produced a significantly greater FEV1 (Weighted Mean Difference (WMD) 0.11 litres, 95% Confidence Interval (CI) 0.01, 0.20 litres), morning PEF (WMD 13 L/min, 95%CI 5, 22 L/min) and evening PEF (WMD 11 L/min, 95%CI 1, 20 L/min). This applied to all drug doses, age groups, and delivery devices, although subgroup analyses suggested that the relative benefit of FP may be greater in more severe patients treated with higher doses of inhaled corticosteroid. No difference between fluticasone and beclomethasone or budesonide were seen for trial withdrawals (Peto OR 0.77, 95%CI 0.54, 1.10). Symptoms and rescue medication use were widely reported but few trials provided sufficient data for analysis. A higher likelihood of pharyngitis (Peto Odds Ratio 2.16; 95% CI 1.42, 3.28) was apparent when patients were treated with fluticasone at twice the dose of BDP/BUD, although was unexplained heterogeneity in this effect between trials. There was no difference in the likelihood of oral Candidiasis. Plasma cortisol and 24 hour urinary cortisol were measured frequently but data presentation was limited.. Fluticasone given at half the daily dose of beclomethasone or budesonide leads to small improvements in measures of airway calibre, but it appears to have a higher risk of causing side-effects when given at the same daily dose.

Topics: Adult; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Chronic Disease; Fluticasone; Humans; Randomized Controlled Trials as Topic

Beclomethasone dipropionate (BDP) and budesonide (BUD) are used widely in the treatment of chronic asthma. The two drugs have different in vitro pharmacokinetic characteristics. It is unclear whether this translates into clinically significant differences in efficacy or safety when treating children and adults with chronic asthma.. To assess clinical outcomes in studies which have compared inhaled BDP and BUD in the treatment of chronic asthma.. We searched the Cochrane Airways Group Trial Register (1999) and reference lists of articles. We contacted trialists and pharmaceutical companies for additional studies and searched abstracts of major respiratory society meetings (1997-1999).. Prospective, randomised trials comparing BDP to BUD in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and methodological quality.. One reviewer extracted data; authors were contacted to clarify missing information. Quantitative analyses where undertaken using Review Manager 4.0.3 with Metaview 3.1.. 24 studies met the criteria for inclusion (1174 subjects). Methodological quality was variable. A meta-analysis of crossover studies did not demonstrate a significant difference between BDP and BUD for FEV1, morning PEF, evening PEF, asthma symptoms or rescue beta2 agonist use, over a dose range of 400 to 1000 mcg/d. The majority of crossover trials had significant design flaws related to a lack of washout and/or failure to exclude carryover effects so the results must be viewed with caution. A single crossover study with adequate washout showed that BUD 400 mcg/d delivered via Turbohaler dry powder inhaler (DPI) may be more effective than BDP 400 mcg/d delivered via Rotahaler DPI in reducing histamine bronchial hyper-responsiveness: Weighted Mean Difference (WMD) 0.43 log10 PC20 FEV1 (95% Confidence Intervals (CI) 0.05, 0.81 log10 PC20 FEV1). A meta-analysis of two parallel group, dose down-titration studies (231 patients) showed that less BUD delivered via a Turbohaler DPI was required to maintain control in adults asthmatics compared to BDP delivered via metered dose inhaler with or without a spacer: WMD 444 mcg/d (95% CI 332, 556 mcg/d).. There is limited high quality randomised controlled trial data comparing the relative efficacy of BDP and BUD. Current guidelines (BTS 1997, GINA 1995, NHLBI 1997) assume BDP and BUD to have equal efficacy, such that for each defined level of asthma severity, the recommended doses BDP and BUD are the same. Although there is some data to suggest that BUD via Turbohaler is more effective than BDP via either Rotahaler or MDI (with and without spacer), these comparisons are confounded by use of different delivery devices, and are not sufficient to warrant a change in guideline recommendations.

Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Chronic Disease; Humans; Randomized Controlled Trials as Topic

Inhaled budesonide (BUD) is available in a range of doses for treating chronic asthma.. To quantitatively assess the efficacy and safety of budesonide at different doses in order to establish whether a clinically significant dose response profile exists.. A search was carried out for Controlled and Randomised Clinical Trials (RCTs) using the Cochrane Airways Group trial register, correspondence with trial authors and the manufacturer.. Randomised trials in children and adults comparing one dose of budesonide to a second dose in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and methodological quality.. One reviewer extracted data; authors were contacted to clarify missing information. Quantitative analyses where undertaken using Review Manager.. 24 studies were selected for inclusion in the review (3907 subjects). In non-oral steroid treated, mild to moderately severe asthma no clinically worthwhile differences in FEV1, morning PEFR, symptom scores or rescue beta2 agonist use were apparent across a dose range of 200-1600 mcg/d. However, in moderate to severe asthma there was a significant reduction in the likelihood of trial withdrawal due to asthma exacerbation with BUD 800 mcg/d compared to 200 mcg/d: RR 3.93 (95% CI, 1.4 to 10.9). This result was largely weighted by a single large high quality RCT. In a single study in patients receiving oral corticosteroids, clinically significant improvements favouring high dose BUD (1600 mcg/d) over low dose (200 mcg/d) were apparent for FEV1 and morning PEFR. In two studies there was no dose dependent oral steroid sparing effect for BUD 1600 mcg/d v 800 or 400 mcg/d. Statistically significant, dose dependent suppression of 24 hour urinary free cortisol excretion and serum cortisol post synthetic ACTH infusion over the dose range 800-3200 mcg/d were apparent but the clinical significance of these findings is unclear.. Budesonide exhibits a clinically significant dose response effect for improvement in FEV1 in severe asthma and reduction of exacerbations in moderate to severe asthma. No significant dose dependent improvements in FEV1, PEFR or symptoms are evident in non-oral steroid treated asthmatics with mild to moderate disease. Dose dependent alterations in sensitive measures of hypothalamic-pituitary-adrenal function were evident but the clinical significance of these changes is unclear.

Topics: Adult; Anti-Inflammatory Agents; Asthma; Bronchodilator Agents; Budesonide; Child; Chronic Disease; Humans; Randomized Controlled Trials as Topic

Inhaled budesonide is a widely used inhaled corticosteroid for asthma.. The objectives of this review was to compare the efficacy of budesonide with placebo in the treatment of chronic asthma.. The Cochrane Airways Group Trial Register and reference lists of articles was searched. We contacted trialists for additional studies and searched abstracts of major respiratory society meetings (1997-1999).. Randomised trials in children and adults comparing budesonide to placebo in the treatment of chronic asthma.. Two reviewers independently assessed articles for inclusion and methodological quality. One reviewer extracted data.. 43 studies met the inclusion criteria (2801 subjects). In non-oral steroid treated asthmatics, budesonide led to significant improvements in a number of measures of airway function. These included FEV1, Weighted Mean Difference (WMD) 3.7% predicted (95% CI 0.1, 7.2%); improvement in morning peak flow (PEF) from baseline WMD 29 L/min (95% CI 22, 36 L/min); improvement in evening PEF from baseline WMD 21 L/min (95% CI 13, 29 L/min). Varying methods of reporting symptoms limited the pooling of studies but all high methodological quality studies demonstrated significant improvements compared to placebo. Health status was not reported. Risk of trial withdrawal due to asthma exacerbation was lower with budesonide compared to placebo, relative risk 0.17 (95% CI 0.09, 0.33). Doses of 500-800 mcg/d appeared to have slightly larger effect sizes than lower doses, but no advantage for high doses were apparent. A single high quality RCT reported significant reductions in daily prednisolone requirement and the number of patients able to discontinue prednisolone completely in budesonide treated subjects compared to placebo. No difference in risk of oropharyngeal soreness/hoarseness or oral Candidiasis was apparent for budesonide compared to placebo. Long-term risk of adrenal insufficiency was not reported.. This review strongly supports use of budesonide in chronic asthma. Consensus guidelines for chronic asthma suggest titrating inhaled steroid dose to individual requirements. Evidence from this review of trials does not present a case for routine dose titration above 800 mcg/d.

Topics: Adult; Anti-Inflammatory Agents; Asthma; Bronchodilator Agents; Budesonide; Child; Chronic Disease; Humans; Randomized Controlled Trials as Topic

Topics: Asthma; Budesonide; Child; Chronic Disease; Cyclosporine; Drug Administration Routes; Glucocorticoids; Humans; Immunoglobulins, Intravenous; Leukotriene Antagonists; Methotrexate; Patient Compliance; Patient Education as Topic; Terbutaline; Treatment Failure

Contact allergy to corticosteroids has recently gained increased attention.. Five cases of contact dermatitis due to budesonide, a nonhalogenated steroid, are described. The Japanese literature was reviewed for reports on this allergy, and the occurrence due to budesonide was compared with that of other dermocorticosteroids.. Budesonide use can cause contact dermatitis.. Although budesonide may be beneficial because of its anti-inflammatory effects, clinicians should be alert to its potential for causing contact dermatitis.

Topics: Administration, Topical; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Dermatitis; Dermatitis, Allergic Contact; Dermatitis, Seborrheic; Drug Eruptions; Eczema; Erythema; Female; Glucocorticoids; Humans; Japan; Leg Dermatoses; Male; Pregnenediones; Psoriasis

Allergic fungal rhinosinusitis (AFRS) is a common disorder with a high prevalence and a very high incidence of recurrence. Management includes surgery and medical treatment in the form of local and/or systemic steroids. However, some cases are resistant to the action of steroids and further treatment is warranted. Being an immune-mediated disorder, targeting IgE seems a logical step. Immunotherapy drugs acting on the IgE (e.g. omalizumab) can modify the clinical course of the disease. This study aimed at evaluating the effect of omalizumab on the clinical course of patients undergoing surgery for AFRS.. This is a two-arm prospective, randomized, single blind clinical trial among patients with AFRS. Twenty patients were included and randomly divided into two groups: Group A; 10 patients received a single subcutaneous injection of omalizumab (Xolair ' Novartis) (150 mg) 2 weeks postoperatively. Group B: 10 patients received local steroids nasal sprays (budesonide or mometasone furoate, 100 μg twice daily for 6 months, starting 2 weeks postoperatively. All patients underwent history, examination, CT scan and IgE level estimation and were submitted to endoscopic sinus surgery. They were evaluated at 4 weeks interval for 6 months.. In both groups there were highly significant differences between pre/post-operative SNOT-20 scores, TNSS scores, total IgE level and Philpott-Javer staging scores. Comparison between the two study groups at 24 weeks showed a highly significant difference (p = 0.001) between post-operative SNOT 20 and TNSS scores in favour of group A. There was no statistically significant difference between the two study groups as regarding postoperative total IgE or Philpott-Javer scores. There were two recurrences in both arms, but no significant side effects.. We compared a single post operative injection of omalizumab with twice daily intranasal steroid spray for 6 months. Both treatments were effective, but the omalizumab group showed a more significant clinical and endoscopic response. There were no significant side effects in both arms. This novel approach used a single low dose injection of omalizumab increased the compliance of the patients with minimal complications. Longer follow-up of the patients is ongoing to determine the optimal time for re-injection. The only downside was the higher cost of omalizumab compared to that of local steroids.

Topics: Administration, Intranasal; Adolescent; Adult; Anti-Allergic Agents; Budesonide; Chronic Disease; Endoscopy; Female; Glucocorticoids; Health Status Indicators; Humans; Immunoglobulin E; Injections, Subcutaneous; Male; Mometasone Furoate; Mycoses; Nasal Polyps; Nasal Sprays; Omalizumab; Prospective Studies; Rhinitis, Allergic; Single-Blind Method; Sinusitis; Tomography, X-Ray Computed; Young Adult

Topics: Budesonide; Chronic Disease; Drugs, Chinese Herbal; Endoscopy; Fumigation; Humans; Medicine, Chinese Traditional; Rhinitis; Sinusitis

Neutrophilic chronic rhinosinusitis with nasal polyps (CRSwNP) occur predominantly in Asian subjects. Appropriate treatments for this endotype have not been elucidated. This study aimed to evaluate the efficacy of budesonide nasal spray on neutrophilic CRSwNP.. Fifteen neutrophilic CRSwNP patients were included, and then they received budesonide nasal spray treatment for 3 months. Biopsies of nasal polyps (NPs) were obtained from these subjects. Their clinical indexes were scored using Visual Analog Scale (VAS), Sino-Nasal Outcome Test (SNOT)-22, and Endoscopic Appearances (EAs). Histological analyses were used to assess numbers of neutrophils, goblet cells, and submucosal gland cells in NPs. Percentages of CD8+ T cells and CD4+CD25+Foxp3+ regulatory T cells (Tregs) were evaluated using flow cytometry. Mucin 5AC (MUC5AC), MUC5B, myeloperoxidase (MPO), interferon (IFN)-γ, and interleukin (IL)-1β and their mRNAs were also examined. After that, we cultured NP tissues in vitro and evaluated the abovementioned inflammatory parameters before and after the administration of budesonide.. Budesonide nasal spray did not improve clinical evaluations including VAS, SNOT-22, and EA scores. Numbers of neutrophils and goblet cells, the score of submucosal gland cells, percentages of CD8+ T cells and Tregs, MUC5AC, MUC5B, MPO, IFN-γ, and IL-1β and their mRNAs were not decreased in NPs after the budesonide treatment. Furthermore, the administration of budesonide into NP cultures also did not reduce their levels in comparison with those before the treatment.. These findings demonstrate that budesonide treatment may not alleviate the inflammatory condition in neutrophilic CRSwNP.

Topics: Adult; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Female; Humans; Male; Middle Aged; Nasal Polyps; Nasal Sprays; Neutrophils; Pilot Projects; Rhinitis; Sinusitis

Oral and topical corticosteroids, and antibiotics form the mainstay medical treatment of chronic rhinosinusitis (CRS). Clinical outcomes vary depending on the chosen therapy, resident microbiome and disease phenotype. We conducted a double- blinded, placebo-controlled Randomised Controlled Trial (RCT) to investigate effects of medical therapy on clinical outcomes and associated microbiome shifts.. Fifty eligible patients (CRS with and without polyps) were treated for 3 weeks after randomisation into 3 arms: na- mely oral prednisolone, topical budesonide irrigations and oral doxycycline; each with appropriate placebo. Clinical scoring and microbiome swabs were performed on enrolment, at treatment completion and 3-weeks post treatment completion. Microbiome analysis was performed using the llumina-MiSeq next generation sequencing platform and QIME-2 pipeline.. Significant improvement in clinical scores was observed in prednisolone and budesonide arms at treatment completion but not with antibiotic. Sub-group analysis showed more pronounced effects in patients with polyposis. Corynebacterium and Staphylococcus species predominated, with variable bacterial relative abundance among different treatments at all time-points. The only significant microbiome finding was an increase in bacterial diversity in topical budesonide group immediately after treatment, which returned to baseline 3-weeks post treatment.. Clinical improvement was significant with oral and topical steroid but not empirical antibiotic. Although there were some associated microbiome changes with the various treatments, we could not ascertain the consistency of these and whether they do have a clinical significance at all.

Topics: Budesonide; Chronic Disease; Double-Blind Method; Doxycycline; Humans; Microbiota; Prednisolone; Rhinitis; Sinusitis

In China, clarithromycin is considered an effective treatment option for chronic rhinosinusitis (CRS) due to its unique immunopathologic characteristics. Our study's aim was to determine whether a topical steroid and clarithromycin combination is better than a single topical steroid for Chinese patients with CRS.. Patients with CRS with/without nasal polyps were included in this study and randomly assigned to a clarithromycin plus budesonide aqua nasal spray group (CLM + BUD, clarithromycin 0.25 g/d and budesonide 256 μg/d) or a budesonide-alone group (BUD, budesonide 256 μg/d). The treatment period was 3 months. The primary outcome was visual analog scale (VAS) score for 5 major symptoms and a general nasal symptom. Other assessments included the 22-item Sino-Nasal Outcome Test (SNOT-22), computed tomography scan (Lund-Mackay score), and rigid nasal endoscopy (Lund-Kennedy score). Nasal secretion evaluation was the secondary outcome.. Seventy-four patients were included and randomly assigned to the CLM + BUD group (n = 38) or the BUD group (n = 36). VAS scores for nasal obstruction, rhinorrhea, smell reduction, headache, nasal pain, and general nasal symptom were markedly improved in both treatment arms, but the differences between groups were not significant. Furthermore, SNOT-22, Lund-Mackay, and Lund-Kennedy scores improved significantly after treatment in both groups, and were slightly better in the CLM + BUD group. For the responders in the CLM + BUD group, interleukin (IL)-6 and IL-8 were markedly reduced.. The combination of CLM + BUD for the treatment of first-time-diagnosed CRS in this Chinese population cohort did not show a better effect compared with a single BUD regimen, but it may have a better effect in some patients with increased IL-6 or IL-8.

Topics: Administration, Topical; Adult; Anti-Bacterial Agents; Budesonide; China; Chronic Disease; Clarithromycin; Cytokines; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Nasal Polyps; Nasal Sprays; Rhinitis; Single-Blind Method; Sinusitis; Treatment Outcome; Young Adult

Recent studies suggest that budesonide added to saline nasal lavage can be an effective treatment for patients with chronic rhinosinusitis (CRS).. To evaluate the incremental effect of adding budesonide to large-volume, low-pressure saline sinus irrigation.. This double-blind, placebo-controlled, randomized clinical trial was conducted at a quaternary care academic medical center between January 1, 2016, and February 16, 2017. A total of 80 adult patients with CRS were enrolled; 74 completed baseline assessments; and 61 remained in the trial to complete all analyses. Data analysis was conducted from March 2017 to August 2017.. All study participants were provided with a sinus rinse kit including saline and identical-appearing capsules that contained either budesonide (treatment group) or lactose (control group). Patients were instructed to dissolve the capsules in the saline and use the resulting solution to irrigate both nasal cavities, using half the solution for each cavity, once daily for 30 days.. The primary outcome measure was the change in Sino-Nasal Outcome Test (SNOT-22) scores, pretreatment to posttreatment, in the budesonide group compared with the control group. Secondary outcome measures included patient-reported response to treatment, as measured with a modification of the Clinical Global Impressions scale, and endoscopic examination scored by the Lund-Kennedy grading system.. Of the 74 participants who completed baseline assessments (37 in each study arm), mean (SD) age, 51 (14.7) years, 50 (68%) were women. Of the 61 who remained in the trial to complete all analyses, 29 were randomized to budesonide treatment, and 32 to saline alone. The average change in SNOT-22 scores was 20.7 points for those in the budesonide group and 13.6 points for those in the control group, for a mean difference of 7 points in favor of the budesonide group (95% CI, -2 to 16). A total of 23 participants (79%) in the budesonide group experienced a clinically meaningful reduction in their SNOT-22 scores compared with 19 (59%) in the control group, for a difference of 20% (95% CI, -2.5% to 42.5%). The average change in endoscopic scores was 3.4 points for the budesonide group and 2.7 points for the control group. There were no related adverse events.. This study shows that budesonide in saline nasal lavage results in clinically meaningful benefits beyond the benefits of saline alone for patients with CRS. Given the imprecision in the treatment effect, further research is warranted to define the true effect of budesonide in saline nasal lavage.. ClinicalTrials.gov Identifier: NCT02696850.

Topics: Administration, Intranasal; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Middle Aged; Patient Reported Outcome Measures; Quality of Life; Rhinitis; Saline Solution; Sinusitis; Therapeutic Irrigation; Treatment Outcome

The objective of the study is to investigate the impact of receiving daily WeChat services on one's cell phone on adherence to corticosteroid nasal spray treatment in chronic rhinosinusitis (CRS) patients after functional endoscopic sinus surgery (FESS). This study was a two-arm, randomized, follow-up investigation. Patients with chronic rhinosinusitis with/without nasal polyps following bilateral FESS were randomised to receive, or to not receive, daily WeChat service on their cell phone to take corticosteroid nasal spray treatment. A prescription of budesonide aqueous nasal spray 128 µg bid was given to all the subjects. Then they returned to the clinic after 30, 60, 90 days. The primary study outcome was adherence to nasal spray treatment, whereas secondary outcomes were change in endoscopic findings and SinoNasal Outcome Test-20 (SNOT-20). On the whole, there was a significant inter-group difference in the change of adherence rate (F = 90.88, p = 0.000). The WeChat group had much higher adherence rate than the control group during the follow-up. In terms of postoperative endoscopic scores and SNOT-20, except granulation score, no significant differences were observed between the two randomization groups. WeChat services are already after a short period of observation associated with improved adherence to corticosteroid nasal spray treatment in CRS patients after FESS.

Topics: Adult; Budesonide; China; Chronic Disease; Endoscopy; Female; Follow-Up Studies; Glucocorticoids; Humans; Male; Medication Adherence; Middle Aged; Mobile Applications; Nasal Sprays; Rhinitis; Sinusitis

Cysteinyl leukotriene (LT) has been proposed in the pathogenesis of chronic rhinosinusitis with nasal polyps (CRSwNP). This study sought to examine the expression of the LT receptor (LTR) in CRSwNP patients and evaluate the potential role of LTR antagonist (LTRA) in the management of eosinophilic CRSwNP (ECRS) patients.. Nasal polyps and uncinate process tissues were collected from 18 ECRS patients, 13 non-eosinophilic CRSwNP (non-ECRS) patients, and 16 control subjects. The messenger RNA (mRNA) and protein expression of LTR (cysteinyl leukotriene receptor 1 [CysLT1R] and cysteinyl leukotriene receptor 2 [CysLT2R]) was examined using quantitative reverse-transcription polymerase chain reaction (qRT-PCR), immunohistochemistry, and Western blot analysis. Moreover, the effects of LTRA and steroids on total nasal symptom scores (TNSS) of uncontrolled ECRS patients were evaluated.. The mRNA and protein expression of CysLT1R and CysLT2R was significantly increased in polyp tissues compared with healthy controls (p < 0.05). Compared with the non-ECRS subset, the ECRS subset showed significantly increased expression of CysLT1R and CysLT2R, as well as leukotriene C4 (LTC4) and leukotriene D4 (LTC4) levels (p < 0.05). Moreover, combined LTRA and steroids significantly decreased TNSS more than steroids alone in uncontrolled ECRS patients (p < 0.01).. Our findings indicate that LTR was differentially expressed between ECRS and non-ECRS patients, and that LTRA may be used as an additional therapy for ECRS patients.

Topics: Acetates; Adult; Anti-Inflammatory Agents; Biomarkers; Blotting, Western; Budesonide; Case-Control Studies; Chronic Disease; Cyclopropanes; Drug Therapy, Combination; Eosinophils; Female; Humans; Leukotriene Antagonists; Leukotrienes; Male; Middle Aged; Nasal Polyps; Prospective Studies; Quinolines; Receptors, Leukotriene; Reverse Transcriptase Polymerase Chain Reaction; Rhinitis; Sinusitis; Sulfides; Treatment Outcome

Nasal steroids are a critical part of the management of patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) after endoscopic sinus surgery (ESS). Increasingly, practitioners are using budesonide respules delivered to the sinonasal cavities, which is an off-label use, in lieu of traditional nasal steroids. There has been little research comparing budesonide with traditional nasal steroids and the most effective delivery method of budesonide.. A randomized controlled trial was performed on patients after ESS for CRSwNP in a tertiary care center. Patients were randomized into 1 of 3 groups: group A received fluticasone nasal spray twice daily; group B received budesonide respules via a mucosal atomization device (MAD) twice daily; and group C received budesonide respules instilled via the vertex-to-floor (VF) position twice daily. Primary endpoints were 22-item Sino-Nasal Outcome Test (SNOT-22) and Lund-Kennedy scores at 6 months.. Thirty-two patients were enrolled in the study, 23 of whom completed the 6-month trial. There were no significant differences among groups A, B, and C with respect to age, gender, asthma, aspirin sensitivity, or previous ESS. Group B had a statistically significant greater reduction in SNOT-22 and Lund-Kennedy scores at the primary endpoint of 6 months compared to groups A and C. Group C had the next greatest reduction, which was statistically significant, followed by group A.. Patients treated with budesonide after ESS for CRSwNP had greater improvement in SNOT-22 and Lund-Kennedy scores compared to fluticasone at 6 months. The data supports the use of budesonide respules, particularly with a MAD, over fluticasone for CRSwNP patients after ESS.

Topics: Adult; Budesonide; Chronic Disease; Endoscopy; Female; Fluticasone; Humans; Male; Middle Aged; Nasal Polyps; Nasal Sprays; Nebulizers and Vaporizers; Paranasal Sinuses; Rhinitis; Rhinoplasty; Sinusitis; Treatment Outcome

The recommended drug for moderate to severe chronic rhinitis is intranasal steroids (INS). However, nasal congestion could be refractory and need additional treatments.. We sought to explore the benefit of oxymetazoline (Oxymet) plus INS on nasal congestion without inducing rhinitis medicamentosa.. We performed a 60-week, randomised, double-blind clinical trial in 50 patients, 18 years of age or greater, with chronic rhinitis who had used INS and cetirizine and still had nasal congestion. Subjects were randomised to receive 2 sprays of 0.05% Oxymet in each nostril twice daily or placebo for 4 weeks. All patients received 2 sprays of budesonide (100 μg/spray) in each nostril twice daily and 10 mg cetirizine once daily from entry throughout the study. Nasal symptom scores, nasal peak inspiratory flow (NPIF) and Rhinoconjunctivitis Quality of Life (Rcq) scores were measured.. Oxymet significantly reduced nasal congestion in subjects with chronic rhinitis compared with placebo on the day of 15-28 and 29-42. In subjects with allergic rhinitis, nasal congestion scores in the Oxymet group were significantly reduced compared with those in the placebo group on days 4-7, days 8-14, days 15-28 and days 29-42. In the Oxymet group, post hoc analysis showed that subjects with allergic rhinitis significantly improved their nasal congestion scores compared to non-allergic individuals (N, allergic/non-allergic = 18/7, p < 0.05). The combination of INS and Oxymet was not associated with rhinitis medicamentosa.. The combination of INS and Oxymet provides additional benefit compared to INS monotherapy in relieving nasal congestion in subjects with chronic rhinitis and allergic rhinitis without developing rhinitis medicamentosa.

Topics: Administration, Intranasal; Adult; Budesonide; Chronic Disease; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Oxymetazoline; Rhinitis

To investigate the long term clinical effect of budesonide treatment in middle meatus for chronic rhinosinusitis(CRS) following endoscopic sinus surgery (ESS).. A total number of 53 patients with CRS received ESS were divided into two groups according to budesonide treatment: budesonide-treated group with 21 cases (39.6%) and control group with 32 cases (60.4%). Gelatin sponges soaked with 1 ml budesonide suspension were put in middle meatus in budesonide-treated group, while only gelatin sponges were put in middle meatus in control group. Visual analogy score (VAS), sino-nasal outcome test-22 (SNOT-22) and Lund-Kennedy endoscopic scale were carried out before ESS and two years after ESS.. In budesonide-treated group, there were a statistical difference before and after ESS in the VAS, SNOT-20 and Lund-Kennedy score (P<. 05). In control group, difference was also significant in VAS, SNOT-20 and Lund-Kennedy score before and after ESS (P < 0.05). The VAS gap of post-operative and pre-operative in two groups are significantly different (P<. 05). However, there was no significant difference in the SNOT-20 and Lund-Kennedy endoscopic scale gap before or after the operation between two groups.. It is safe, convenient and practicable to perform budesonide treatment in middle meatus following ESS, which can significantly ease the post-operative discomfort of nose.

Topics: Budesonide; Chronic Disease; Endoscopy; Humans; Nose; Paranasal Sinuses; Postoperative Period; Rhinitis; Sinusitis

Olfactory dysfunction is deemed to be a significant contributor to poor quality of life in chronic rhinosinusitis (CRS).. To assess and to compare the effectiveness of three modalities of corticosteroids administration in patients with CRS.. A prospective randomized controlled study. Thirty patients with CRS were randomized in three groups depending on the route of corticosteroids administration: 16 days by oral route (Medrol (Pfizer, Belgique), 32 mg/8 days -16 mg/4 days-8 mg/4 days); nasal spray (Rhinocort (AstraZeneca, Belgique), 2 × 2 × 64 µg/nostril); or sonic nebulization (Pulmicort (AstraZeneca, Belgique), 2 × 1 mg/4 mL) (Sonic nebulizer, AOHBOX-NL11SN, DTF, France). Olfactory function was assessed using orthonasal threshold discrimination identification and retronasal psychophysical olfactory tests (RNT) before and after the treatment. Same intranasal modalities were previously tested for in vitro airways scintigraphic deposition.. In vitro differences in drug deposition pattern between both intranasal modalities were demonstrated. Threshold discrimination identification and RNT were similar between three groups at baseline. Threshold discrimination identification improved by 5.5, 5.8, and -1.1 for sonic nebulization, oral, and nasal spray groups, respectively (P = 0.010). This improvement was clinically relevant for oral and nebulized administration. It was similar between oral and nebulized administration but significantly higher than nasal spray administration. Retronasal psychophysical olfactory tests improved similarly for the three groups (P = 0.231) CONCLUSION: Effectiveness of sonic nebulized and oral administration is demonstrated on orthonasal olfactory. The clinical benefit is better than with nasal spray.

Topics: Administration, Intranasal; Administration, Oral; Adult; Aerosols; Budesonide; Chronic Disease; Dose-Response Relationship, Drug; Drug Delivery Systems; Female; Follow-Up Studies; Glucocorticoids; Humans; Male; Middle Aged; Nasal Sprays; Nebulizers and Vaporizers; Olfaction Disorders; Prospective Studies; Quality of Life; Sinusitis; Smell; Treatment Outcome

To compare the acute effects of single nebulized amphotericin B and budesonide in treating cough-related laryngeal sensations in chronic cough patients, a randomized, single-blind, placebo-controlled, parallel-group trial was performed between two groups with positive and negative results of basidiomycetous (BM) fungi in their sputum culture.. Forty patients presenting with chronic cough lasting 8 weeks or longer, whose sputum could be obtained, were recruited for this study. At the first visit, all patients underwent fungal culture sampling of sputum, capsaicin cough inhalation test, pulmonary function tests, and cough-related laryngeal sensation questionnaire (C-LSQ) consisting of 6 items with a severity scale of 0-5 for each item: (1) a sensation of irritation in the throat (SIT); (2) tickle in the throat; (3) throat clearing; (4) urge to cough; (5) a sensation of something stuck in the throat; and (6) a sensation of mucus in the throat (SMIT). The patients were randomly assigned to receive either nebulizer inhalation of 2.5 mg of amphotericin B (Group A) or nebulizer inhalation of 0.5 mg of budesonide (Group B). The efficacies of each therapy were estimated by the change in C-LSQ score.. There were significant differences in the delta score of item 1 (SIT) and item 2 in the BM-negative group and item 6 (SMIT) in the BM-positive group at 60 min after inhalation between Groups A and B (P<0.05).. The results of this study suggested that appropriate use of single inhalation of budesonide or amphotericin B, which would be selected based on the results of sputum culture, may lead to suppression of cough-related laryngeal sensations, such as SIT or SMIT.

Topics: Administration, Inhalation; Adult; Aged; Amphotericin B; Anti-Inflammatory Agents; Antifungal Agents; Basidiomycota; Budesonide; Case-Control Studies; Chronic Disease; Cough; Female; Humans; Laryngeal Diseases; Lung Diseases, Fungal; Male; Middle Aged; Nebulizers and Vaporizers; Paresthesia; Sensation; Single-Blind Method; Sputum; Surveys and Questionnaires; Treatment Outcome; Young Adult

There is little evidence on the efficacy of glucocorticoid transnasal nebulization therapy in patients with eosinophilic chronic rhinosinusitis with nasal polyps (CRSwNP).. We sought to evaluate the immunologic and remodeling effects of budesonide transnasal nebulization in patients with eosinophilic CRSwNP.. Sixty patients with eosinophilic CRSwNP were randomized to receive budesonide or placebo treatment for 14 days by means of transnasal nebulization in a double-blind manner. Endoscopic polyp size scores (maximum = 6 points, Kennedy score) and visual analog scale scores for nasal symptoms were assessed before and after treatment. Similarly, polyp samples were evaluated for inflammatory cytokines, matrix metalloproteinases (MMPs), and tissue inhibitors of metalloproteinases (TIMPs) by using an immunoassay; collagen by using histochemistry; eosinophils by using hematoxylin and eosin stain; and T-cell subsets by using flow cytometry.. Budesonide transnasal nebulization significantly reduced polyp size compared with placebo (mean difference between groups, -0.73 units; 95% CI, -1.15 to -0.32 units; P = .002) and improved symptoms. Polyp IL-5 and eotaxin expression decreased significantly, whereas TGF-β and IL-10 expression increased. Expression of IFN-γ and IL-17 was not altered. Budesonide transnasal nebulization consistently reduced eosinophil infiltration and TH2 cell frequency and increased natural regulatory T-cell and type 1 regulatory T-cell frequencies. Indices of remodeling, including albumin, MMP-2, MMP-7, MMP-8, and MMP-9, were significantly decreased, whereas collagen deposition and TIMP-1, TIMP-2, and TIMP-4 levels were significantly increased. Budesonide transnasal nebulization did not suppress the hypothalamic-pituitary-adrenal axis or cause any serious side effects.. Short-term budesonide transnasal nebulization is an effective and safe treatment option in patients with eosinophilic CRSwNP, achieving clinical improvement by regulating remodeling, cytokine expression, and T-cell subset distribution.

Topics: Adult; Aged; Bronchodilator Agents; Budesonide; Chronic Disease; Cytokines; Eosinophils; Female; Humans; Inflammation Mediators; Male; Middle Aged; Nasal Polyps; Nebulizers and Vaporizers; Rhinitis; Sinusitis; Treatment Outcome; Young Adult

To evaluate the effect of patient education on patients with allergic rhinitis (AR).. From January 2009 to December 2013, 100 cases of allergic rhinitis were treated. The patients were randomly divided into experimental group or control group by Stochastic tables law,50 patients in control group accepted only drug treatment, 50 patients in experimental group accepted both drug treatment and patient education. The difference in compliance with treatment, treatment effect, incidence of adverse drug reactions and complications, average costs and times of treatment between two groups were evaluated by the rhinoconjunctivitis quality of life questionnaire (RQLQ) score. The independent sample t-test and χ2 test were used for statistical analysis.. The patients of experimental group showed more positive attitude to treatment compared to the patients of control group (P < 0.01). The average scores of each classification and overall symptoms after treatment in experimental group were lower than those in control group (P < 0.05). The incidence of adverse drug reactions (nose-bleed, dry nose,nasal mucosa ulcer)and complications in patients with AR (asthma, chronic cough, secretory otitis media) in experimental group was lower than that in control group, with statistically differences (P < 0.05). The average times of treatment and costs of diagnosis and treatment(calculation of budesonide nasal spray)in experimental group were significantly lower than those in control group (P < 0.01). The total score for RQLQ and the scores of seven dimensions in experimental group were lower than those in control group (P < 0.05).. Patient education can help the patients with AR to cooperate actively with treatment, to reduce the incidence of adverse drug reactions and AR complications, and to save medical costs and improve the quality of life.

Topics: Budesonide; Chronic Disease; Humans; Incidence; Patient Education as Topic; Patient Participation; Quality of Life; Rhinitis, Allergic; Surveys and Questionnaires

To evaluate the efficacy and safety of a short course of nebulized budesonide via transnasal inhalation in chronic rhinosinusitis with nasal polyps.. Fifty patients with severe eosinophilic nasal polyps were randomized devided into study group (n = 25) and control group (n = 25). The study group received budesonide inhalation suspension (1 mg twice daily) via transnasal nebulization for one week and the control group received oral prednisone (24 mg QD). Visual analogue scales (VAS) of nasal symptoms, endoscopic polyp scores (kennedy scores) and morning serum cortisol concentrations were assessed in both groups pre- and post-treatment. Operation time and surgical field bleeding were evaluated.. Four subjects dropped out in control group. Budesonide transnasal nebulization caused a significant improvement in all nasal symptoms especially nasal obstruction (baseline: 8.25 ± 0.53; after treatment: 4.97 ± 0.97, P < 0.01) and reduced polyp size significantly (baseline: 4.64 ± 0.63; after treatment: 3.40 ± 0.76, P < 0.01) compared to pre-treatment. The patients treated with oral prednisone, however, showed more obvious improvement in nasal symptoms and polyp size, shorter operation time and better surgical field than budesonide group. Additionally, the morning serum cortisol concentration was mildly decreased after one week treatment in budesonide group [baseline (17.18 ± 2.83) μg/dl, after treatment (16.24 ± 2.93) μg/dl, P > 0.05], but all values were still located in normal range (normal range: 5-25 μg/dl). Conversely, the morning serum cortisol concentration in oral prednisone group was lower than normal limit [baseline (18.19 ± 2.81) μg/dl, after treatment (2.26 ± 0.70) μg/dl, P < 0.01].. Twice daily budesonide transnasal nebulization is an effective and safe treatment as evidenced by significant improvements in nasal symptoms and reduction in polyp size, coupled with an absence of hypothalamic-pituitary-adrenal axis suppression, which is safer than the systemic corticosteroids. Budesonide transnasal nebulization offers a viable treatment option for CRSwNP before operation.

Topics: Administration, Inhalation; Budesonide; Chronic Disease; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Nasal Obstruction; Nasal Polyps; Pituitary-Adrenal System; Prednisone; Rhinitis; Sinusitis; Suspensions

To compare normal saline (NS) vs. NS+budesonide irrigations in post- functional endoscopic sinus surgery (FESS) patients with chronic rhinosinusitis with polyposis (CRSwNP). Currently, no evidence exists for NS+budesonide irrigation over NS irrigation alone.. Prospective, single-blind, randomized controlled trial.. Subjects were prospectively enrolled to NS or NS+budesonide arms. Patients were evaluated at pre-operative and three post-operative visits (POV): POV1 (1-2 weeks post-op), POV2 (3-8 weeks post-op), and POV3 (3-6 months post-op). Patients were evaluated by three quality of life (QOL) questionnaires (SNOT-22, RSOM-31, and RSDI) and two olfaction scores (UPSIT and the PEA test).. Fifty patients were randomized, with 25 patients in the NS arm and 25 patients in the NS+budesonide arm. Two patients had unexpected pathology and were excluded from the study. By POV2 and POV3, patients experienced a significant improvement in all three QOL surveys, although the degree of improvement between arms was not significant up through POV3. Neither arm experienced significant olfactory improvement up through POV3.. While both NS and NS+budesonide treatments improve QOL for post-FESS patients, neither intervention significantly increases QOL as compared to the other. Olfaction was not significantly improved in either treatment group.

Topics: Adult; Budesonide; Chronic Disease; Female; Glucocorticoids; Humans; Male; Middle Aged; Nasal Polyps; Postoperative Care; Prospective Studies; Quality of Life; Recovery of Function; Rhinitis; Single-Blind Method; Sinusitis; Smell; Therapeutic Irrigation; Treatment Outcome

Budesonide is a potent corticosteroid commonly prescribed for management of inflammation in chronic rhinosinusitis (CRS). The standard for prescribing budesonide is via impregnated nasal saline irrigation (INSI), although recently the mucosal atomization device (MAD) has emerged as a theoretically superior method of distributing medication into the sinuses. The MAD atomizes medication into small droplets and this is thought to enhance absorption and improve bioavailability. However, no studies have shown whether enhanced absorption and improved bioavailability of budesonide via MAD causes adrenal suppression. The objective of this study is to determine whether budesonide via MAD affects the hypothalamic-pituitary-adrenal (HPA) axis.. Twenty CRS patients were recruited from a tertiary rhinology clinic and randomized to take budesonide (1 mg) via MAD or via INSI twice a day for 60 days. The adrenocorticotropic hormone (ACTH) stimulation test and 22-item Sinonasal Outcomes Test (SNOT-22) questionnaire were administered on days 1, 30, and 60 of the study. Plasma budesonide and cortisol levels were simultaneously quantified using a high-performance liquid chromatography-tandem mass spectrometry technique.. There was no indication of adrenal suppression in either group (n = 20) based on ACTH stimulation test results nor was there significant plasma budesonide levels detected in either group. Quality of life, as indicated by SNOT-22, did not differ between groups at 60 days (p = 0.404; 95% confidence interval [CI], -37.2 to 15.9), but SNOT-22 scores for patients using MAD did show statistically significant improvement at 60 days compared to baseline (p = 0.02).. The MAD is likely a safe and effective method of delivering budesonide to the sinuses in the short term.

Topics: Administration, Mucosal; Anti-Inflammatory Agents; Budesonide; Canada; Chronic Disease; Female; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Nasal Polyps; Nebulizers and Vaporizers; Pituitary-Adrenal System; Prospective Studies; Quality of Life; Rhinitis; Sinusitis; Time Factors; Treatment Outcome

The results of a prospective study of topical budesonide versus topical dexamethasone therapy for oral manifestations of chronic graft-versus-host disease (cGVHD) are presented.. In a prospective single-center investigation, a cohort of patients who developed oral symptoms of cGVHD after allogeneic stem cell transplantation were assigned to topical treatment with 0.03% budesonide rinse (group A, n = 26) or 0.01% dexamethasone rinse (group B, n = 24). Diagnosis of oral cGVHD symptoms, clinical staging, and treatment response scoring were performed at baseline and one month later according to current National Institutes of Health consensus criteria.. At one-month follow-up, there was a significant decrease in the median oral cGVHD examination score in both groups (p < 0.001); the decrease in the median examination score was greater with budesonide versus dexamethasone therapy (2.5 points versus 1.0 point, p = 0.045). The rates of overall treatment response, including complete and partial responses, were 53.8% and 29.2% in groups A and B, respectively (p = 0.093). In addition, there was a significant decrease from baseline in the median self-rated oral pain severity score in group A (p < 0.001).. Patients who received topical budesonide or dexamethasone rinse to treat oral manifestations of cGVHD had decreased cGVHD severity and pain scores after 30 days compared with baseline scores, though no statistical differences were seen between groups.

Topics: Budesonide; Chronic Disease; Dexamethasone; Female; Graft vs Host Disease; Humans; Immunosuppressive Agents; Male; Medication Adherence; Middle Aged; Mouth Diseases; Mouthwashes

Chronic graft-versus-host disease (cGVHD) frequently involves oral tissues. Although the mucosal changes may be painful and impair oral function, there is currently no topical therapy available for oral cGVHD that has been proven to work in an evidence-based manner. The aims of this study were to (1) assess the response of patients with oral cGVHD to various doses of a new topical budesonide formulation; (2) evaluate the efficacy and safety of the new topical budesonide formulation in these patients. An open, randomized, multicenter phase II pilot study with 4 treatment arms differing in application frequency and duration was performed. Response to treatment was scored by the clinician and patient using several scales. Oral cGVHD improved in all patients, with a median reduction of 70%. Pain reduction was similar in all study arms. The rate of objective improvement (defined as ≥50%) was not significantly different among the 4 study arms. The safety profile was satisfactory. Topical budesonide mouthwash (3 mg/10 mL) improved oral cGVHD in all patients when applied for 5 or 10 minutes, 2 or 3 times daily. The response was similar in all treatment arms. Safety analysis supported a dosing schedule of 3 mg of budesonide 3 times a day for 10 minutes.

Topics: Administration, Topical; Adult; Budesonide; Chronic Disease; Drug Administration Schedule; Female; Graft vs Host Disease; Humans; Male; Middle Aged; Mouthwashes; Pilot Projects; Tablets

Budesonide at 800 μg/d is generally suggested for treatment of nonasthmatic eosinophilic bronchitis (NAEB). In asthma, adjunctive therapy with montelukast has been shown to confer addictive anti-inflammatory effects to inhaled corticosteroid (ICS). However, whether such effects could be extrapolated to NAEB is not known.. To study the efficacy and tolerability of add-on therapy with montelukast as compared to double-dose ICS in suppressing airway eosinophilia and decreasing cough severity in NAEB.. In a randomized controlled trial, 26 nonsmoking, steroid-naïve NAEB patients presenting with chronic cough were treated with 800 μg/d budesonide or 400 μg/d budesonide plus montelukast 10 mg/d for 4 weeks. Cough visual analogue scale (CVAS) and eosinophil differential ratio in induced sputum (Eos) were monitored at baseline, Week 1, 2 and 4. Adverse events during treatment were recorded.. The two groups were comparable in age, gender distribution, cough duration, FEV(1)% predicted, FEV(1)/FEV ratio, baseline CVAS and geometric mean of Eos. Both regimens significantly reduced Eos and CVAS throughout the treatment course, with abrogation of sputum eosinophilia at end of therapy. There was no significant difference between the two groups in reduction of Eos and CVAS at all time points. Both regimens were well tolerated.. This preliminary study demonstrated that add-on montelukast might be an effective and well tolerated alternative to the generally suggested dose of ICS in treating steroid-naive NAEB, with suppression of eosinophilic inflammation, reduction of cough severity and sparing of ICS doses. (NCT01121016).

Topics: Acetates; Adult; Aged; Bronchitis; Bronchodilator Agents; Budesonide; Chronic Disease; Cough; Cyclopropanes; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Leukotriene Antagonists; Male; Middle Aged; Pilot Projects; Pulmonary Eosinophilia; Quinolines; Sulfides; Treatment Outcome; Young Adult

Topical corticosteroids are effective in inducing clinical and histologic remission in patients with eosinophilic esophagitis (EoE). However, the best long-term management strategy for this chronic inflammatory disease has not been determined.. In a randomized, double-blind, placebo-controlled, 50-week trial, we evaluated in 28 patients the efficacy of twice-daily swallowed budesonide (0.25 mg each) to maintain quiescent EoE in remission. Pretreatment and posttreatment activity was assessed clinically, endoscopically, histologically, immunohistologically, and by endosonography. The primary end point was the therapy's ability to maintain EoE in histologic remission. Secondary end points were efficacy in symptom control, prevention of tissue remodeling, and safety.. In patients given low-dose budesonide, the load of esophageal eosinophils increased from 0.4 to 31.8 eosinophils/high-power field (P = .017). In patients given placebo, the load increased from 0.7 to 65.0 eosinophils/high-power field (P = .0001); this increase was significantly greater than in patients given budesonide (P = .024). The symptom scores developed in a similar manner in the 2 groups. Budesonide, but not placebo, reduced noneosinophilic markers of inflammation, epithelial cell apoptosis, and remodeling events. Compared with control individuals, patients had significantly thickened esophageal walls, based on endosonography (3.05 vs 2.18 mm; P < .0001). Budesonide therapy was associated with a significant reduction in mucosal thickness (0.75-0.45 mm; P = .025), but epithelial thickness remained stable (261.22 vs 277.23 μm; P = .576). No serious adverse events occurred.. Low-dose budesonide is more effective than placebo in maintaining EoE in histologic and clinical remission. Signs of esophageal remodeling showed a trend toward normalization. Long-term administration of topical corticosteroids was well tolerated without induction of epithelial atrophy.

Topics: Administration, Oral; Adult; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Double-Blind Method; Eosinophilic Esophagitis; Esophagus; Female; Histocytochemistry; Humans; Immunohistochemistry; Male; Middle Aged; Placebos; Secondary Prevention; Treatment Outcome

Sequential three-step empirical therapy is useful for the management of chronic cough. The purpose of this study was to evaluate the efficacy and safety of modified sequential three-step empirical therapy.. Consecutive patients (n = 240) with chronic cough were recruited and randomly assigned to receive modified (modified group) or primary (primary group) sequential three-step empirical therapy. The primary end-point was the overall rate of control of chronic cough. Secondary end-points were the rate of control of chronic cough at each step of therapy, the duration of treatment required, changes in cough symptom score, health-related quality of life and possible adverse effects.. The study was completed by 106 patients in the modified group and 108 patients in the primary group. The overall rate of control of chronic cough was 88.7% in the modified group and 91.7% in the primary group (chi(2) = 0.54, P > 0.05). There were no obvious differences in the rate of control of cough at each step of therapy, the duration of treatment required, patterns of cough symptom scores or improvements in the health-related quality of life between the modified and primary groups. However, the incidence of drowsiness was significantly lower in the modified group than in the primary group (11.7% vs 21.7%, chi(2) = 4.32, P = 0.04).. Modified three-step empirical therapy was as efficacious as primary three-step therapy for chronic cough, but was preferable because it had fewer side-effects.

Topics: Adult; Aminophylline; Antitussive Agents; Budesonide; Cetirizine; Chlorpheniramine; Chronic Disease; Cough; Domperidone; Drug Therapy, Combination; Empirical Research; Humans; Methamphetamine; Middle Aged; Noscapine; Omeprazole; Prednisone; Prospective Studies; Quality of Life; Sleep Stages; Treatment Outcome

Buccal administration of budesonide (mouthwash) may be effective as a topical add-on therapy in patients with oral chronic graft-versus-host disease (cGVHD). Safety of approved oral budesonide is based on high intestinal and hepatic extraction by cytochrome P450 3A (CYP3A) enzymes. The purpose of this study was to evaluate the presystemic extraction and pharmacodynamic action of buccal budesonide. Oral budesonide (3 mg) was taken as reference to which various single and multiple dose regimens of buccal budesonide were compared. Budesonide and the 2 main CYP3A-dependent metabolites (6beta-hydroxybudesonide, 16alpha-hydroxyprednisolone) were analyzed in blood and urine along with the drug's effect on endogenous cortisol in 12 healthy subjects and 7 patients with oral cGVHD. We assessed CYP3A-dependent metabolites in both healthy subjects and patients after buccal budesonide. Whereas systemic exposure to budesonide was markedly lower in healthy subjects after the mouthwash compared to oral dosing (mean relative bioavailability 18%-36%), the systemic concentrations thereafter in patients were as high as those after the identical dose of oral budesonide. Reduced buccal CYP3A activity (lower inactivation of budesonide) in patients contributed to this remarkable difference. Endogenous cortisol was suppressed in some patients during 1 week of continuous treatment with buccal budesonide (3 x 3 mg per day). We are the first to report the biotransformation of budesonide via CYP3A enzymes after buccal drug administration. Only 2% of a buccal dose of budesonide achieves systemic circulation in healthy individuals; that fraction is 10% in patients with oral cGVHD, probably because of alterations in drug uptake and metabolization.

Topics: Administration, Buccal; Administration, Oral; Adult; Biological Availability; Biotransformation; Budesonide; Case-Control Studies; Chronic Disease; Cytochrome P-450 CYP3A; Drug Administration Schedule; Female; Graft vs Host Disease; Humans; Hydrocortisone; Male; Mouthwashes; Prednisolone

To evaluate whether nasal administration of budesonide in adults with chronic rhinosinusitis for 30 days suppresses adrenal function and to assess its clinical efficacy.. An open-label prospective study.. Academic medical center.. We assessed adrenal function in 9 patients using the cosyntropin test before and after budesonide therapy.. Budesonide respule therapy.. Scores from the Sino-Nasal Outcome Test-20 (SNOT-20), a tool for assessing rhinosinusitis health and quality of life, were used to assess efficacy of budesonide treatment.. All of our patients showed adequate adrenal response to cosyntropin stimulation before and after the budesonide trial. The mean difference in SNOT-20 scores was -1 (95% confidence interval, -1.77 to -0.23; P = .02), indicating clinically significant improvement after therapy.. Our findings suggest that using budesonide nasal wash may be clinically effective in decreasing the symptoms of chronic rhinosinusitis and does so without suppression of the hypothalamic-pituitary-adrenal axis in patients with chronic rhinosinusitis.

Topics: Administration, Intranasal; Adolescent; Adrenal Cortex; Adult; Aged; Budesonide; Chronic Disease; Dose-Response Relationship, Drug; Female; Follow-Up Studies; Glucocorticoids; Humans; Hydrocortisone; Immunoassay; Male; Middle Aged; Patient Satisfaction; Prospective Studies; Rhinitis; Sinusitis; Surveys and Questionnaires; Treatment Outcome; Young Adult

To determine the effects of budesonide and formoterol administered via one pressurized metered-dose inhaler (budesonide/formoterol pMDI) on patient-reported outcomes (PROs) and to determine the contributions of budesonide and formoterol to those effects in adults with asthma.. A 12-week, randomized, double-blind, double-dummy, placebo-controlled, multicenter study was conducted in 480 patients aged > or = 12 years with mild-to-moderate persistent asthma. After a 2-week run-in period during which current asthma therapy was discontinued, patients were randomized to receive two inhalations twice daily of budesonide/formoterol pMDI 80/4.5 microg (160/9 microg), budesonide pMDI 80 microg (160 microg), formoterol via dry powder inhaler (DPI) 4.5 microg (9 microg), or placebo.. Analyses included a subpopulation of 405 patients aged > or = 18 years. PROs included the standardized Asthma Quality of Life Questionnaire (AQLQ(S)), the Medical Outcomes Study (MOS) Sleep Scale, the Patient Satisfaction with Asthma Medication (PSAM) questionnaire, and asthma control variables (recorded via electronic diaries), such as asthma symptoms, rescue medication use, and nighttime awakenings due to asthma. Patient and physician global assessments were collected at the end of the study.. Patients aged > or = 18 years receiving budesonide/formoterol pMDI reported significantly greater improvements from baseline in AQLQ overall and domain scores, MOS Sleep Scale domain scores, and asthma control variables than patients receiving placebo (p < or = 0.033). Improvements from baseline in AQLQ(S) overall and domain scores, daily asthma symptoms scores, percentage of symptom-free days, percentage of rescue medication-free days, and percentage of asthma control days were significantly greater in patients receiving budesonide/formoterol pMDI versus formoterol DPI (p < or = 0.042). Patients receiving budesonide/formoterol pMDI reported significantly greater PSAM scores than did patients in all other treatment arms (p < or = 0.004). Study limitations may include the fact that the formoterol-alone arm used a different device and formulation than the other active arms as well as the absence of a treatment arm with budesonide and formoterol administered concomitantly in separate inhalers. In addition, these results may not be generalized to all patients with asthma, as this analysis included only patients aged > or = 18 years.. Patients receiving treatment with budesonide/formoterol pMDI experienced significantly greater improvements from baseline in asthma-related quality of life, quality of sleep, and asthma control and greater satisfaction with treatment than patients receiving placebo. The combination of budesonide and formoterol in one pMDI is beneficial in improving how a patient feels and functions as a result of treatment.

Topics: Adolescent; Adrenergic beta-Agonists; Adult; Aged; Anti-Inflammatory Agents; Asthma; Bronchodilator Agents; Budesonide; Chronic Disease; Double-Blind Method; Drug Therapy, Combination; Ethanolamines; Female; Formoterol Fumarate; Health Surveys; Humans; Male; Metered Dose Inhalers; Middle Aged; Patient Satisfaction; Pressure; Quality of Life; Surveys and Questionnaires; Time Factors; Treatment Outcome

Budesonide is an inhaled steroid with a strong topical effect but with minimal systemic effects; it has been effectively delivered to animal lungs using surfactant as a vehicle. The purposes of this study were to determine whether early intratracheal instillation of budesonide using surfactant as a vehicle would improve pulmonary status, reduce mortality, and reduce chronic lung disease morbidity.. We conducted a prospective, randomized blind trial in 116 very low birth weight infants (< 1500 g) who had severe radiographic respiratory distress syndrome and required mechanical ventilation with fraction of inspired oxygen > or = 0.6 shortly after birth: 60 were in the treated group (intratracheal instillation of a mixture of 0.25 mg/kg of budesonide and 100.00 mg/kg of survanta, every 8 hours) and 56 were in the control group (100 mg/kg of survanta only, every 8 hours). The end point assessment was the number of infants who would die or develop chronic lung disease at 36 weeks' postconceptional age.. Infants in the treatment group required significantly lower mean airway pressure on day 1 and day 3 and had significantly lower oxygen index and PCO(2) during the first 3 days than infants in the control group. More infants were extubated in the treatment group than controls at 1 and 2 weeks. The combined outcome of deaths or chronic lung disease was significantly lower in the treatment group than in the control group (19 of 60 vs 34 of 56). No clinically significant adverse effects were observed during the study.. This pilot study indicated that early postnatal intratracheal instillation of budesonide using surfactant as vehicle significantly improved the combined outcome of death or chronic lung disease in small premature infants without causing immediate adverse effects. The results are encouraging, and a large sample multicenter trial is warranted.

Topics: Biological Products; Budesonide; Chronic Disease; Double-Blind Method; Female; Glucocorticoids; Humans; Infant, Newborn; Infant, Very Low Birth Weight; Instillation, Drug; Lung Diseases; Male; Pharmaceutical Vehicles; Prednisolone; Pulmonary Surfactants; Respiration, Artificial; Respiratory Distress Syndrome, Newborn; Survival Rate

Pouchitis is the major long-term complication after ileal-pouch nal anastomosis for ulcerative colitis. Ten to 15% of patients develop a chronic pouchitis, either treatment responsive or treatment refractory.. To evaluate the efficacy of oral budesonide in inducing remission and improving quality of life in patients with chronic refractory pouchitis.. Twenty consecutive patients with active pouchitis, not responding after 1 month of antibiotic treatment were treated with budesonide controlled ileal release 9 mg/day for 8 weeks. Symptomatic, endoscopic and histological evaluations were undertaken before and after treatment according to Pouchitis Disease Activity Index. Remission was defined as a combination of Pouchitis Disease Activity Index clinical score of < or = 2, endoscopic score of < or = 1 and total Pouchitis Disease Activity Index score of < or = 4. The quality of life was assessed with the Inflammatory Bowel Disease Questionnaire.. Fifteen of 20 patients (75%) achieved remission. The median total Pouchitis Disease Activity Index scores before and after therapy were, respectively, 14 (range 9-16) and 3 (range 2-10) (P < 0.001). The median Inflammatory Bowel Disease Questionnaire score also significantly improved from 105 (range 77-175) to 180 (range 85-220) (P < 0.001).. Eight-week treatment with oral budesonide appears effective in inducing remission in patients with active pouchitis refractory to antibiotic treatment in this open-label study.

Topics: Administration, Oral; Adult; Anti-Bacterial Agents; Anti-Infective Agents; Budesonide; Chronic Disease; Colitis, Ulcerative; Delayed-Action Preparations; Female; Humans; Male; Middle Aged; Patient Compliance; Pouchitis; Quality of Life; Treatment Outcome

Guidelines recommend daily controller therapy for mild persistent asthma. Montelukast has demonstrated consistent benefit in controlling symptoms of asthma and may be an alternative, orally administered, nonsteroidal agent for treating mild asthma.. To determine whether montelukast is as effective as budesonide in controlling mild persistent asthma as determined by FEV(1).. Between November 2003 to October 2005, participants aged 5-15 years with recently diagnosed mild persistent asthma (n = 62) were randomized to oral montelukast (5 mg daily) [N(1) = 30] or inhaled budesonide (400 microg per day in two doses) [N(2) = 32] in a single center, double-blind study.. Baseline demographic and spirometric parameters were comparable. The median (95% confidence interval) percentage predicted FEV(1) was similar in the two groups after 12 weeks of treatment (budesonide: 76.70 (67.96-90.53%), montelukast: 75 (67.40-88.47)%; p = 0.44). There was similar improvement in spirometric parameters and clinical symptom scores in both the groups. There was no statistically significant difference between the groups in the need for rescue drugs as well as side effects reported by parents.. Montelukast is as effective as inhaled budesonide in the treatment of mild persistent asthma in children aged 5-15 years. Montelukast may be used as an alternative to low dose inhaled corticosteroids for management of mild persistent asthma.

Topics: Acetates; Administration, Inhalation; Adolescent; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Budesonide; Child; Child, Preschool; Chronic Disease; Cyclopropanes; Double-Blind Method; Female; Forced Expiratory Volume; Humans; India; Male; Quinolines; Sulfides

Budesonide/formoterol maintenance and reliever therapy (Symbicort SMART) improves asthma control compared with fixed-dose inhaled corticosteroid/long-acting beta(2)-agonist (ICS/LABA) regimens, but its efficacy has not been assessed in comparison with sustained high-dose salmeterol/fluticasone (Seretide) plus a short-acting beta(2)-agonist (SABA).. Patients (N=2309) with symptomatic asthma (aged 12 years; forced expiratory volume in 1s 50% predicted), who had experienced an asthma exacerbation in the previous year, were randomised to receive budesonide/formoterol 160/4.5 microg two inhalations twice daily and as needed, or one inhalation of salmeterol/fluticasone 50/500 microg twice daily plus terbutaline as needed, for 6 months.. Time to first severe exacerbation, the pre-specified primary outcome, was not significantly prolonged (risk ratio 0.82; 95% confidence interval 0.63, 1.05). Budesonide/formoterol maintenance and reliever therapy reduced total exacerbations from 31 to 25 events/100 patients/year (P=0.039), and exacerbations requiring hospitalisation/emergency room (ER) treatment from 13 to 9 events/100 patients/year (P=0.046). The treatments showed no difference in measures of lung function or asthma symptoms. The mean dose of ICS received was lower using budesonide/formoterol maintenance and reliever therapy (792 microg/day budesonide [1238 microg/day beclomethasone dipropionate (BDP) equivalent] versus 1000 microg/day fluticasone [2000 microg/day BDP equivalent] with salmeterol/fluticasone therapy; P<0.0001). Both treatments were well tolerated.. In the treatment of uncontrolled asthma, budesonide/formoterol maintenance and reliever therapy reduces the incidence of severe asthma exacerbations and hospitalisation/ER treatment with similar daily symptom control compared with sustained high-dose salmeterol/fluticasone plus SABA. This benefit is achieved with substantially less ICS exposure.

Topics: Administration, Inhalation; Adolescent; Adrenergic beta-Agonists; Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Azides; Budesonide; Child; Chronic Disease; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Ethanolamines; Female; Fluticasone-Salmeterol Drug Combination; Formoterol Fumarate; Hospitalization; Humans; Lung; Male; Middle Aged; Proportional Hazards Models; Respiratory Function Tests; Serotonin; Treatment Outcome

To evaluate the recent clinical efficiency of nebulized Pulmicort respimat after FESS.. Forty-four patients with chronic sinusitis who received FESS, 21 cases were treated with aerosol therapy: Pulmicort respimat , the other 23 cases were treated with Budesonide aqueous nasal spray. All the patients were asked for return at the day 14. Efficacy was evaluated by measurement of nasal symptom scores and sign scores at day 2 and day 14, the biopsy of the membrane on the gap of sinus maxillary were taken to count the eosinophil cell and neutrophil cell in per hundred inflammation cells under microscope and analyze the statistic of the symptom scores, sign scores, efficiency, percentage of the eosinophil cell and the neutrophil cell between two groups at day 14.. There was no significant differences on the total score between two groups at the day 2, while the therapy group was remarkably lower than that in the control group at the day 14 (P < 0.01). The therapy group had a higher efficacity than the control group but no significance (P > 0.05). The percentage of the eosinophil was no significant differences between two groups (P > 0.05), while the percentage of the neutrophil was lower in the therapy group (P < 0.01).. Pulmicort respimat and Budesonide are the same type hormones, butPulmicort respimat is a fine granule mixed liquid, with PARI SINUS nasal spray, it can arrive at the whole cavity of the sinus maxillary and be absorbed faster and in a larger space. We consider that nebulized Pulmicort respimat after FESS can relieve the acute inflammation and oedema, it can also reduce the complication of the surgery. The recent clinical efficiency of the Pulmicort respimat is much better than other aqueous nasal spray.

Topics: Administration, Inhalation; Administration, Intranasal; Adolescent; Adult; Aged; Budesonide; Chronic Disease; Endoscopy; Female; Humans; Intraoperative Period; Male; Middle Aged; Nasal Sprays; Sinusitis; Young Adult

To investigate the effective method in treatment of pediatric chronic sinusitis.. Two hundred and ten children were clinically diagnosed as chronic sinusitis and randomly divided into three groups as pulmicort, rhinocort and routine treatment group, respectively. All the patients in different group were systemic treated by corresponding method for two weeks.. The effective rates were 84% for pulmicort treatment group, 61% for rhinocort treatment group and 48% for routine treatment group, so the effective rate for the patients treated with pulmicort were significantly higher than that with either rhinocort or routine treatment.. Pulmicort can be used to treat pediatric chronic sinusitis with higher effective rate.

Topics: Anti-Inflammatory Agents; Budesonide; Child; Child, Preschool; Chronic Disease; Female; Humans; Male; Sinusitis

Whether inhalation of pulmicort into the sinus of chronic rhinosinusitis patients could improve reepithelization after endoscopic sinus surgery was assessed.. Prospective study 60 patients with chronic rhinosinusitis after endoscopic sinus surgery were divided into 2 groups randomized, the one was treatment group, and the other was control group. The patients in treatment group received inhalation of pulmicort 2 ml plus 0.5% Aeuromycin solution 10 ml by oxygen driving force, once a day, persisting for 3 weeks. The patients in control group received Rhinocort. Besides the different therapies above mentioned above therapy was different, two groups received the same conventional route therapy. To observe the time of reepithelization under nasal endoscope, was observed, respectively.. The average time of reepithelization in treatment group was (5.3333 +/- 0.9942) weeks. The other group was (6.6667 +/- 1.3476) weeks, the statistical difference between the two groups was very significant.. Inhalation of pulmicort into the sinus can promote reepithelization and shorten the time of treatment.

Topics: Administration, Inhalation; Adolescent; Adult; Budesonide; Chronic Disease; Endoscopy; Humans; Middle Aged; Prospective Studies; Sinusitis; Treatment Outcome; Young Adult

While it is widely accepted that inhaled glucocorticosteroids represent an effective treatment for allergic rhinitis, little is known on the specific effects of this therapeutic approach in other upper airway disorders of childhood. The aim of the study was to evaluate the improvement of clinical symptoms and changes in local cellular inflammatory reaction induced by budesonide inhalation suspension in children with recurrent nasal infections using budesonide inhalation suspension delivered by Rinowash, a nebulizer designed to treat upper airway structures.. In a randomized, controlled-open study, 14 children (5.88+/-0.56 years of age) with recurrent upper airway infections and chronic nasal obstruction were enrolled and randomly treated for 7-10 days either with budesonide inhalation suspension (250 microg/bidie) (nine patients) or with saline solution (five patients). Before and after treatment, inflammatory cells in nasal brushing and nasal symptom score were evaluated.. Out of the nine patients treated with budesonide, two were excluded from the analysis because of acute respiratory infections requiring systemic antibiotic treatment. A significant decrease in nasal brushing neutrophil percentage was observed after treatment with budesonide (P=0.016) but not after saline solution treatment (P=1.00). No significant changes in nasal brushing mononuclear cell or eosinophil proportions were observed after treatment with budesonide inhalation suspension or saline solution (P=NS, each comparison). Treatment with budesonide, but not with saline solution, was associated with a significant reduction in nasal obstruction (P=0.016).. These preliminary data indicate that short-term treatment with budesonide inhalation suspension, used for an indication out of label, may significantly reduce local neutrophilic inflammation and nasal obstruction in children with recurrent upper airway infections.

Topics: Administration, Inhalation; Anti-Inflammatory Agents; Antigens, Dermatophagoides; Budesonide; Child; Child, Preschool; Chronic Disease; Female; Humans; Immunization; Immunoglobulin E; Male; Nasal Obstruction; Neutrophils; Prevalence; Recurrence; Respiratory Tract Infections; Rhinitis, Allergic, Perennial; Time Factors

An open randomized comparative study was conducted in order to observe the efficacy and safety about intranasal Budesonide in the treatment of chronic nonallergic rhinitis.. Forty-two patients with chronic nonallergic rhinitis were treated with Budesonide aqueous nasal spray (256 microg once daily intranasally) for 8 weeks. All the patients were asked for return at week 1 and week 8. Efficacy was evaluated by measurement of nasal symptom scores and sign scores at week 0, week 1 and week 8.. All the parameters measured were improved after treatment. Specifically, from week 0 to week 1, the scores of nasal secretions, itchy feeling of the nose and headache showed a significant decrease than that before treatment. From week 0 to week 8, the scores of nasal obstruction, nasal secretions, itchy feeling of the nose, closed rhinolalia and headache were significantly less than the record at week 0. However, there were not significant influences on the smell disturbances, dryness of the throat. No serious adverse events were reported in the study.. Intranasal Budesonide is effective and safe in alleviating the symptoms of chronic nonallergic rhinitis.

Topics: Administration, Intranasal; Adult; Aged; Budesonide; Chronic Disease; Female; Glucocorticoids; Humans; Male; Middle Aged; Nose; Rhinitis; Treatment Outcome

To investigate the bacteriological character and pH value in nasal cavity and observe the efficacy following 8 week treatment with Budesonide aqueous nasal spray in chronic nonallergic rhinitis.. Forty-two patients with chronic nonallergic rhinitis were treated with Budesonide aqueous nasal spray (256 microg once daily intranasal) for 8 weeks. Bacteriological character was measured before and 8 weeks after treatment All the swab specimens were obtained from the inferior meatus, bacteriologic outcome was determined by general cultures. Nasal pH value was measured by using a probe sited under the inferior turbinate before and after treatment. Efficacy was evaluated by measurement of nasal symptom scores and sign scores before and 8 weeks after treatment.. The bacterial growth was present in 37 of 42 cases (88%) before the treatment (group 1), including 53 aerobic bacteria. The bacterial growth was present in 38 of 42 cases (90.47%) 8 weeks after treatment (group 2), including 46 aerobic bacteria. There was no significant difference in the bacterial distribution between group 1 and group 2 (chi2 = 0.416, P > 0.05). Budesonide aqueous nasal spray reduced pH value from 7.90 +/- 0.39 to 7.70 +/- 0.23 (t = 2.72, P < 0.05). All the parameters of symptoms were improved after treatment, including nasal obstruction, nasal secretions, itchy feeling of the nose, closed rhinolalia and headache.. Glucocorticoid aqueous nasal spray could be used safely for eight weeks and does not increase the risk of aerobes and fungi infection and reduce the pH in chronic nonallergic rhinitis. It is effective in relieving symptoms of patients with chronic nonallergic rhinitis.

Topics: Administration, Intranasal; Adult; Aged; Budesonide; Chronic Disease; Female; Humans; Hydrogen-Ion Concentration; Male; Middle Aged; Nasal Cavity; Rhinitis

This study evaluated the efficacy and tolerability of budesonide in an aqueous nasal spray (BANS) in patients with chronic rhinosinusitis. In this double-blind, placebo-controlled, multicentre, parallel-group study, patients (n = 167) with persistent rhinosinusitis symptoms despite 2-weeks' antibiotic treatment were randomised to receive BANS 128 micrograms b.i.d. or placebo for 20 weeks. Morning combined symptom scores (CSS) in patients receiving BANS decreased by a mean of -1.85 (95% CI -2.27, -1.43), versus -1.02 (-1.43, -0.61) in the placebo group (p = 0.005); corresponding values for evening CSS were -1.78 (-2.22, -1.35) and -1.02 (-1.45, -0.60), respectively (p = 0.012). BANS produced significant reductions in nasal congestion and discharge scores, and improved patients' sense of smell (morning only), versus placebo. Peak nasal inspiratory flow (PNIF) increased significantly during BANS treatment. In allergic patients, BANS significantly (p < 0.001) reduced both morning -1.40 (-2.18, -0.62) and evening -1.37 (-2.15, -0.58) CSS from baseline versus placebo, but changes in non-allergic patients (morning: -0.04 [-0.95, 0.87]; evening: 0.14 [-0.81, 1.09]) were not significant. PNIF was significantly (p < 0.01) increased in both allergic and non-allergic patients from baseline versus placebo. BANS is an effective and well-tolerated treatment for chronic rhinosinusitis.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Double-Blind Method; Female; Humans; Male; Middle Aged; Pharmaceutical Solutions; Rhinitis; Sinusitis

This clinical trial aims to evaluate the efficacy of budesonide, a newly registered steroid with high potency and low bioavailability, for the treatment of chronic oral graft versus host disease (GVHD).. Twelve patients with chronic resistant oral GVHD were treated with 3 mg budesonide/5 ml saline 2 to 3 times a day for up to 3 months. Oral manifestations were monitored, and mucosal response scored.. All patients responded positively to the mouthwash, and 7 of the 12 patients were scored as having "good" or "complete" recovery by both examiner and subject. An early response noted within the first 2 to 3 weeks of treatment was complemented by a probable cumulative effect seen during the first months of treatment.. Budesonide is suggested as an alternative treatment for chronic oral GVHD.

Topics: Adult; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Middle Aged; Mouth Diseases; Mouth Mucosa; Mouthwashes

Whether instillation into the maxillary sinus of topical budesonide affected the immune response and improved allergic patients with chronic rhinosinusitis that had persistence of symptoms despite appropriate surgical intervention was assessed.. Double-blind placebo-controlled.. Twenty-six patients with allergy to house dust mites who had previously had surgery and who had persistent symptoms of disabling rhinorrhea or pressure-pain resistant to oral antibiotics and intranasal corticosteroids were recruited. During the double-blind study, patients instilled 256 microg budesonide daily or placebo through an intubation device (maxillary antrum sinusotomy tube) into one of the maxillary sinuses for 3 weeks before clinical assessment and a second biopsy.. We found an improvement in the symptom scores in 11 of the 13 patients who received budesonide; we also found a decrease in CD-3 (P = .02) and eosinophils (P = .002), and a decrease in the density of cells expressing interleukin4 (P = .0001) and interleukin-5 messenger RNA (P = .006) after treatment.. Topical budesonide delivered through a maxillary antrum sinusotomy tube can control chronic rhinosinusitis that persists after surgery.

Topics: Administration, Intranasal; Adult; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Double-Blind Method; Endoscopy; Female; Glucocorticoids; Humans; Intubation; Male; Maxillary Sinus; Maxillary Sinusitis; Middle Aged; Postoperative Complications; Rhinitis, Allergic, Perennial; Self Administration; Therapeutic Irrigation

Collagenous colitis (CC) is a well-described entity causing chronic diarrhea and characteristic histologic findings. Several treatment options have been suggested, but no controlled data are available. We conducted a placebo-controlled trial to show the clinical and histologic effects of budesonide in CC.. Twenty-eight patients were randomly assigned to receive placebo (n = 14) or budesonide 9 mg daily (n = 14) for 8 weeks. Patients were evaluated clinically, and blinded biopsy specimens were analyzed from fixed locations at weeks 0 and 8. Clinical response was defined as a decrease of at least 50% in the disease activity score (number of bowel movements in the last 7 days). At week 8, nonresponders received open-label budesonide for the next 8-week period; responders discontinued treatment and were followed up.. Three patients discontinued the study prematurely. Intention-to-treat analysis showed clinical response in 8 of 14 patients in the budesonide group compared with 3 of 14 responders for placebo (P = 0.05) after 8 weeks of blinded therapy, together with improved stool consistency. Histologically, there was no change in the mean thickness of the collagen band but a significant decrease of the lamina propria infiltrate in the budesonide group (P < 0.001).. Budesonide is efficacious in inducing short-term clinical response in CC with significant reduction of the histologic infiltrate in the lamina propria.

Topics: Adult; Aged; Anti-Inflammatory Agents; Biopsy; Budesonide; Chronic Disease; Colitis; Diarrhea; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prospective Studies

To compare the effects of inhaled and systemic steroids on growth in very low birthweight (VLBW) infants with chronic lung disease (CLD).. Sixteen babies with CLD randomly received inhaled budesonide (100 microg four times daily for 10 days via Aerochamber) or systemic steroids (dexamethasone 0.5 mg/kg/day, reducing over nine days). Linear growth (lower leg length, LLL) was measured by knemometry twice weekly.. The gestational age, birth weight, postnatal age, and LLL velocity (LLLvel) were similar between the two groups at the start of treatment. At the end of the treatment period, LLLvel was reduced in the dexamethasone group (mean -0.01 mm/day) but had increased in the budesonide group (mean 0.48 mm/day). Mean weight gain was non-significantly lower in the dexamethasone group (5.8 g/kg/day) compared to the budesonide group (mean 12.7 g/kg/day).. Inhaled budesonide has less short term effects on growth than systemically administered dexamethasone.

Topics: Administration, Inhalation; Bronchodilator Agents; Budesonide; Chronic Disease; Dexamethasone; Glucocorticoids; Growth Disorders; Humans; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Infant, Very Low Birth Weight; Lung Diseases; Weight Gain

High-dose inhaled corticosteroids (ICS) have been associated with the same side-effects as oral corticosteroids. Beclomethasone dipropionate (BDP) and budesonide (BUD) in doses greater than 2000 microg/day are used regularly in severe asthma, despite the fact that safety and efficacy data at such high doses are limited. Fluticasone propionate (FP) has been promoted as being twice as potent clinically as BDP or BUD at doses of 2000 microg/day or less with a similar safety profile. The aim of this study was to compare the efficacy and safety of FP with BDP and BUD in 133 symptomatic adult asthmatics requiring at least 1750 microg/day of BDP or BUD.. Patients fulfilling the entry criteria were randomized to receive either their regular ICS medication or FP at approximately half the microgram dose for 6 months in an open, parallel group study. The primary efficacy measure was based on morning peak expiratory flow measurements recorded by patients on daily record cards, while determination of safety was based on a number of endpoints including changes in bone turnover indices, the incidence of topical side-effects and assessments of quality of life.. It was shown that patients who were switched to FP, but not those continuing with BDP or BUD, had significant increases in levels of morning serum cortisol and the urine cortisol:creatinine ratio while maintaining asthma control. Serum osteocalcin and the pyridinoline:creatinine ratio, as well as the deoxypyridinoline:creatinine ratio, were also shown to increase only in the FP group. Subjective assessments such as quality of life score, the incidence and ease of bruising, and reports of hoarseness also favoured the FP group.. It is concluded that, at the doses studied and with the delivery devices used clinically, FP is at least as effective as BDP/BUD in the management of severe asthma and may offer clinical advantages with respect to steroid-related adverse effects.

Topics: Adult; Androstadienes; Asthma; Beclomethasone; Biomarkers; Budesonide; Chronic Disease; Contusions; Creatinine; Female; Fluticasone; Glucocorticoids; Hoarseness; Humans; Hydrocortisone; Male; Middle Aged; Osteocalcin; Quality of Life

A pilot study was performed to investigate a clinical algorithm using serum-eosinophil cationic protein level (S-ECP) as an objective parameter for tapering the anti-inflammatory treatment in chronic childhood asthma. We studied 21 outpatient asthmatic children (6 girls and 15 boys, mean age 9 yr, range 3-12 yr, all with initial S-ECP > or = 15 microg/l) over a period of 12 months at monthly intervals. At each visit a short history, clinical examination, blood sample for S-ECP and eosinophil count, lung function tests and drug compliance were assessed. According to the initial S-ECP, patients were allocated to two anti-inflammatory treatment groups: patients with S-ECP between 15 microg/l and 30 microg/l were treated with Budesonide 200 microg twice daily, while patients with S-ECP of 30 microg/l and above received Budesonide 400 microg twice daily. After this induction treatment the anti-inflammatory medication was tapered at monthly intervals according to actually measured S-ECP: patients with S-ECP < 15 microg/l received sodium cromoglycate (SCG) 10 mg twice daily per inhalation via spacer, patients with S-ECP > or = 15 microg/l and < 30 microg/l received Budesonide 200 microg twice daily via spacer, and patients with S-ECP > or = 30 microg/l received Budesonide 400 microg twice daily. Prior to inhalation of topical steroids or SCG all patients had to inhale 500 microg Terbutaline twice daily for optimal bronchodilatation. The use of medication was assessed by weighing the metered dose inhaler containers each month. Our results showed a decrease in symptoms (p = 0.0001) and in S-ECP (p= 0.02) and MEF50% predicted (p= 0.02) after the initial month of Budesonide treatment. During a total of 246 months of investigation there was no need for emergency room treatment or hospital admission, and no need for oral steroids. During the whole study period there was a tendency for inhaled steroids to be more effective than SCG in reduction of markers of airway inflammation, improvement of symptoms and lung function. Inadequate use of medication was related to an increase in S-ECP in all treatment groups. From this open pilot study it is concluded that a clinical algorithm including S-ECP for tapering the anti-inflammatory treatment may be helpful in childhood asthma. These first observations should be confirmed by a controlled long-term study.

Topics: Algorithms; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Biomarkers; Blood Proteins; Budesonide; Child; Child, Preschool; Chronic Disease; Cromolyn Sodium; Eosinophil Granule Proteins; Female; Humans; Male; Pilot Projects; Respiratory Function Tests; Ribonucleases; Severity of Illness Index; Treatment Outcome

We investigated the effect of an aerosolized corticosteroid (budesonide) on the oxygen requirement of infants at high risk for developing chronic lung disease (CLD) in a randomized, double-blind study. The study objective was to attain a 30% decrease in FiO2 levels in the budesonide treatment group after 14 d of therapy. Thirty very low birthweight (VLBW) infants (median (range)) gestational age 26 wk (23-29) and birthweight 805 g (525-1227) were randomized. Inclusion criteria were mechanical ventilation on day 6 of life, or if extubated on nasal continuous positive airway pressure with FiO2 > or = 0.3. The budesonide (Pulmicort) dose was 500 microg bid, or placebo. The aerosol was delivered with a dosimetric jet nebulizer, with variable inspiratory time and breath sensitivity. Inhalations were started on day 7 of life. Twenty-seven patients completed the study. A significant lowering of the FiO2 levels at 21 d of life was not detected. Infants who received budesonide were more often extubated during the study period (7/8 vs 2/9) and had a greater relative change from baseline in their oxygenation index (budesonide decreased 26% vs placebo increased 60%). Subsequent use of intravenous dexamethasone or inhaled budesonide in the treatment group was significantly less. All patients required O2 supplementation on day 28 of life. At 36 wk postconceptual age, 61% of infants in the budesonide group needed supplemental O2 as opposed to 79% in the placebo group. No side effects on growth or adrenal function were observed.. We conclude that inhaled budesonide aerosol via dosimetric jet nebulizer started on day 7 of life for infants at high risk for developing CLD decreases the need for mechanical ventilation similar to intravenous dexamethasone, but without significant side effects.

Topics: Aerosols; Birth Weight; Bronchodilator Agents; Budesonide; Chronic Disease; Double-Blind Method; Female; Gestational Age; Humans; Hydrocortisone; Infant; Infant, Newborn; Infant, Very Low Birth Weight; Lung Diseases; Male; Respiration, Artificial; Respiratory Distress Syndrome, Newborn; Weight Gain

The aim of this prospective study was to evaluate the efficacy of a combined (local and systemic) steroid therapy on the extent of chronic polypoid rhinosinusitis and patient symptoms.. Subjects of this study were 20 patients with severe chronic polypoid rhinosinusitis with total or subtotal narrowing of the all sinuses. A nasal budesonide spray (2 x 0.1 mg/day) and an oral fluocortolone medication with a daily reduction during a 12-day period (total dose: 560 mg = group 1) and a 20-day period (total dose: 715 mg = group 2), respectively, were administered. Before and after the steroid treatment we evaluated the extent of the sinusitis with MRI and patient symptoms with symptom-related questionnaires.. A significant reduction (> 30%) of the chronic polypoid rhinosinusitis was observed in 50% of MRI findings. The steroid effect on polypoid masses was heterogeneous in different anatomic areas (maxillary sinus 40%, anterior ethmoid 19%, posterior ethmoid 33%, sphenoidal sinus 61%, frontal sinus 46%). Most sinusitis-related symptoms were distinctly diminished in most patients (80%). No major side effects were observed.. A combined short-term steroid therapy is highly effective in chronic polypoid rhinosinusitis, reducing the mucosal inflammation mainly in the large sinuses and reducing the incidence of symptoms significantly. However, this therapy was insufficient in the anterior ethmoid and cannot replace the current surgical treatment concept of the osteomeatal complex in CPR. The indication for such a short-term steroid therapy is the preoperative treatment. It facilitates functional endoscopic sinus surgery by reducing the extent of surgical procedures, the time, and thereby the risks of sinus surgery.

Topics: Administration, Inhalation; Administration, Oral; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Drug Therapy, Combination; Female; Fluocortolone; Glucocorticoids; Humans; Image Processing, Computer-Assisted; Magnetic Resonance Imaging; Male; Middle Aged; Polyps; Prospective Studies; Rhinitis; Sinusitis

Collagenous colitis is a chronic watery diarrhea disorder characterized by a subepithelial collagen layer and a lymphoplasmacytic infiltration within the lamina propria. However, no standard treatment has been introduced by controlled clinical trials. Aim of the present pilot trial was to investigate the clinical effects of orally administered budesonide (3 mg t.i.d.) in 7 patients with collagenous colitis. In addition, the histomorphological changes after budesonide treatment were described in a group of 3 patients.. The study was performed as an open label pilot trial. Study end point was the clinical remission of collagenous colitis defined by stool frequency and stool consistency.. The results indicate a rapid and sustained clinical response in all patients. Stool frequency significantly decreased (p < 0.001) from 10.43 +/- 5.56 per day (4-20 per day) to 3.3 +/- 1.2 (1-5 per day) after 10 days and to 1.86 +/- 0.69 per day (1-3 per day) after 10 wk. Moreover stool consistency changed from watery (6 patients) or soft (1 patient) to soft (1 patient) or solid (6 patients). Clinical improvement was achieved within the first 10 days in all patients and maintained after dose reduction. In 3 patients no diarrhea recurred within 7, 12, or 15 months after treatment with budesonide was terminated. In these patients control biopsies were taken and showed a marked regression of both characteristics, the collagen band and the lymphoplasmacytic infiltration.. With respect to the preliminary data from this pilot trial, budesonide with its high topical and low systemic effects seems to be of therapeutic clinical benefit in collagenous colitis. A therapeutic effect could be demonstrated for both therapeutic goals, the clinical response and morphological changes. Further studies on the effects of budesonide on mucosal collagen metabolism and long-term follow-up are warranted.

Topics: Anti-Inflammatory Agents; Biopsy; Budesonide; Chronic Disease; Colitis; Collagen; Colon; Colonoscopy; Diarrhea; Female; Humans; Immunohistochemistry; Male; Middle Aged; Pilot Projects; Prospective Studies

Airway inflammation is a hallmark of asthma, therefore current treatment recommendations include the use of inhaled glucocorticosteroids (GCS). However, there is little evidence that the effects of inhaled GCS are dose dependent.. The objective of this study was to assess the efficacy and safety of a second-generation GCS, budesonide, delivered by Turbuhaler, in adults with chronic asthma.. In a 12-week, randomized, double-blind, multicenter, parallel-group study, 473 subjects 18 to 70 years of age received either placebo or budesonide (200, 400, 800, or 1600 microg total daily dose) administered twice daily. Primary efficacy end points were mean change from baseline for FEV1 and morning peak expiratory flow. Safety was assessed by reported adverse events and by a cosyntropin-stimulation test.. The mean baseline FEV1 was 63% to 66% of predicted normal value between groups. All doses of budesonide were more effective than placebo (p < 0.001). The mean changes in morning peak expiratory flow were 12, 22, 27, and 30 L/min in the 200, 400, 800, and 1600 microg budesonide total daily dose groups, respectively, and -27 L/min for the placebo group. A statistically significant dose-response effect for the mean change from baseline over the 12-week study was seen for both morning peak expiratory flow and FEV1. Budesonide-treated subjects also demonstrated significant reduction in asthma symptoms and bronchodilator use compared with placebo. There were no clinically significant differences in treatment-related adverse experiences among groups.. Budesonide administered by Turbuhaler exhibited a dose response and was effective at low doses. It was well tolerated and significantly more effective than placebo.

Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents; Asthma; Budesonide; Chronic Disease; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Hydrocortisone; Lung; Male; Middle Aged; Nebulizers and Vaporizers

Despite the success of inhaled steroids in controlling asthma, the benefit in patients with chronic obstructive pulmonary disease (COPD) remains controversial. Five subjects with moderate to severe emphysema due to alpha 1-antitrypsin deficiency (phenotype PiZ) were followed with daily home spirometry in a 2 x 8 weeks, randomized double-blind, placebo-controlled, crossover study of inhaled budesonide 0.8 mg b.i.d. In three of the five patients, there was a statistically significant increase in the mean forced expiratory volume in 1 s (FEV1), and in two of these patients, there was also a statistically significant increase in the mean forced vital capacity (FVC) during budesonide treatment. A significant diurnal variation in FEV1 and FVC was found in three and two patients, respectively, but did not change significantly during treatment. These findings emphasize the need for renewed evaluation of inhaled steroids in the treatment of patients with emphysema, and indicate that individual patients may have significant clinical improvement.

Topics: Administration, Inhalation; alpha 1-Antitrypsin Deficiency; Bronchodilator Agents; Budesonide; Chronic Disease; Cross-Over Studies; Double-Blind Method; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Lung; Male; Middle Aged; Phenotype; Pregnenediones; Pulmonary Emphysema; Vital Capacity

Tenascin and fibronectin are extracellular matrix glycoproteins expressed during morphogenesis and tissue repair. In the present study bronchial biopsies were studied by the morphometric method of immunocytochemistry to reveal the distribution of different tenascin and fibronectin isoforms as well as the presence of inflammatory cells in the airway mucosa of patients with chronic asthma (n = 32) and those with seasonal birch-pollen-sensitive asthma out of season (n = 17), both in comparison with healthy control subjects (n = 12). The results showed an increase in tenascin immunoreactivity in the bronchial subepithelial reticular basement membrane layer in patients with chronic asthma (p < 0.0001) and in those with seasonal asthma (p < 0.01) compared with control subjects. The tenascin immunoreactivity, appearing as an intense wide subepithelial band in asthma, was seen only occasionally in the basement membrane of control specimens. Instead, a diffuse immunoreaction against both total fibronectin and locally produced extradomain A fibronectin was similarly visible in the airway mucosa of both patients and control subjects. Despite the significant increase in the airway mucosa of eosinophils and lymphocytes in patients with chronic asthma (p < 0.0001 and p < 0.0001, respectively) and of eosinophils in patients with seasonal asthma (p < 0.001), there was no correlation between the number of these cell types and level of tenascin expression. In patients with birch-pollen-sensitive asthma during the birch-pollen season, inhaled corticosteroid treatment, budesonide 400 micrograms twice daily, decreased tenascin immunoreactivity, in comparison with effects of placebo (p = 0.01). Our results suggest that the higher amount of tenascin reflects disease activity in asthma and may be an indicator of a remodeling process rather than of injury itself.

Topics: Adult; Anti-Inflammatory Agents; Asthma; Basement Membrane; Biopsy; Bronchi; Budesonide; Case-Control Studies; Chronic Disease; Female; Fibronectins; Humans; Immunohistochemistry; Male; Middle Aged; Seasons; Tenascin

The efficacy and safety of anti-inflammatory treatment with inhaled glucocorticosteroids in patients with cystic fibrosis (CF) and complicating chronic Pseudomonas aeruginosa (P.a.) lung infection was studied in a placebo-controlled, parallel, double-blind single center trial. Active treatment consisted of budesonide dry powder, 800 microg twice daily, delivered from a Turbuhaler. The study period covered two successive 3-mo intervals between elective courses of intravenous anti-Pseudomonas antibiotics. Fifty-five patients entered the study, with a mean age of 20 yr and a mean FEV1 of 63% of predicted. Analysis of all patients entered, irrespective of trial adherence ("intention to treat"), showed a decrease in FEV1 in the first period of -0.032 L in patients on budesonide versus -0.187 L in patients on placebo (p = 0.08). The corresponding figures for the patients adhering to the protocol during the first period were -0.017 L versus -0.198 L (p < 0.05, confidence interval of the difference: -0.035 to +0.327 L). For all patients entered, as well as for patients adhering to the trial, there was always a trend in favor of budesonide, as judged by changes in FEV1 and FVC in both 3-mo periods. None of the patients had asthma, but the patients on budesonide had a mean improvement in histamine reactivity of +1.15 dose steps over the entire 6-mo period, as opposed to +0.017 dose steps in patients on placebo (p < 0.05). There was also a significant (p = 0.01) correlation between pre-trial histamine reactivity and the change in FEV1 in the first period in patients on budesonide. We conclude that inhaled glucocorticosteroids can be of short-term benefit in patients with CF and chronic P.a. infection and that those patients most likely to benefit from this treatment are patients with hyperreactive airways. Prolonged studies in larger number of patients are necessary to determine the long-term efficacy of this treatment.

Topics: Administration, Inhalation; Anti-Bacterial Agents; Anti-Inflammatory Agents; Biomarkers; Bronchial Hyperreactivity; Bronchial Provocation Tests; Bronchopneumonia; Budesonide; Child; Chronic Disease; Cystic Fibrosis; Double-Blind Method; Follow-Up Studies; Forced Expiratory Flow Rates; Histamine; Humans; Pseudomonas aeruginosa; Pseudomonas Infections; Sputum; Treatment Outcome

Budesonide, a corticosteroid with high topical anti-inflammatory activity and low systemic activity, has been shown to prolong time to relapse in Crohn's disease. In the present study, the efficacy of budesonide in an oral pH-modified-release formulation was evaluated for maintenance treatment in patients with steroid-dependent ulcerative colitis.. Fourteen patients with steroid-dependent ulcerative colitis in the reduction phase of conventional glucocorticosteroids (c-GCS) following a severe attack, were treated with budesonide 3 mg t.d.s. for 6 months. The primary investigation parameters were changes in the clinical activity index (CAI) and in the daily dose of c-GCS.. In 11 cases the CAI improved significantly and treatment with c-GCS could be terminated. Three patients experienced relapse and needed further c-GCS treatment. The average daily dose of c-GCS and the average value of the CAI before treatment with budesonide were significantly higher in the relapse group than in the remission group.. In patients with c-GCS-dependent ulcerative colitis, a dose of 9 mg budesonide daily in an oral pH-modified-release formulation was well tolerated, significantly decreased the CAI, and rendered c-GCS unnecessary in the majority of cases.

Topics: Administration, Oral; Administration, Topical; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Colitis, Ulcerative; Female; Glucocorticoids; Humans; Hydrogen-Ion Concentration; Male; Middle Aged; Pilot Projects; Steroids; Substance-Related Disorders

Two hundred and forty one children with chronic perennial asthma, who had been treated with budesonide via a metered dose inhaler with a spacer device (Nebuhaler), had their normal dose of budesonide reduced by 50% to determine if they had been overtreated. Within three weeks, asthma control deteriorated in 126 patients to such an extent that budesonide had to be increased to the normal dose. After stabilising their asthma, these children were enrolled in a randomised, double blind, double dummy, parallel study, performed to compare the effect of budesonide via Nebuhaler with that of half the dose of budesonide via Turbuhaler. The study started with a two week run-in during which patients were treated with their normal dose of budesonide via Nebuhaler. After run-in, 64 children were randomised to treatment with their normal budesonide treatment and the remaining 62 children to treatment with half their normal dose via Turbuhaler for nine weeks. Throughout the study, patients recorded asthma symptoms, peak flow measurements, and beta 2 agonist use in a diary. Pulmonary function tests, exercise tests, and 24 hour urine sample collections were performed at hospital visits during run-in and the study period. Apart from beta 2 agonist use, which was significantly lower for patients on Turbuhaler treatment than on Nebuhaler treatment, there were no differences between the groups in any of the parameters studied during run-in or during the study period. Furthermore, there was no trend of deterioration in asthma control when the dose of budesonide was reduced by 50% when Turbuhaler was the inhalation device. It is concluded that budesonide via Turbuhaler is more effective than via Nebuhaler in the treatment of asthma. Based on this finding, attempts should be made to reduce the dose of budesonide when patients are switched from Nebuhaler to Turbuhaler treatment.

Topics: Administration, Inhalation; Adolescent; Asthma; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Chronic Disease; Double-Blind Method; Equipment Design; Female; Humans; Male; Nebulizers and Vaporizers; Pregnenediones; Respiratory Mechanics; Treatment Outcome

A placebo-controlled, double blind, cross-over study of inhaled budesonide was carried out to examine its effectiveness in the treatment of chronic airflow limitation (CAL). Fourteen patients (11 males, mean age 66 years) with stable CAL received placebo treatment for four weeks followed by inhaled budesonide 400 micrograms BD for eight weeks. Response was assessed by measuring forced expiratory volume in one second (FEV1). There was no significant improvement in the overall spirometric measurements and symptom scores except a reduction in daily peak expiratory flow rate fluctuation (p < 0.05). However, individual patients showed significant increase in FEV1. Two patients (14%) had greater than 30% increase in FEV1 in response to inhaled corticosteroids. This response could not be predicted from history of allergy, skin test, bronchial challenge test, peripheral blood or sputum eosinophilia. We conclude that only a minority of patients with stable CAL may respond to inhaled budesonide. Nonetheless, patients who are symptomatic despite treatment with maximum doses of bronchodilators may have a trial of inhaled corticosteroids in order to demonstrate any additional benefit.

Topics: Administration, Inhalation; Administration, Topical; Aerosols; Aged; Anti-Inflammatory Agents; Bronchial Provocation Tests; Bronchitis; Bronchodilator Agents; Budesonide; Chronic Disease; Double-Blind Method; Emphysema; Glucocorticoids; Humans; Male; Middle Aged; Pregnenediones; Respiratory Mechanics

The prevalence of posterior subcapsular cataracts in young patients receiving inhaled glucocorticoids for treatment of chronic asthma is unknown. In a cross-sectional study, slit-lamp examinations were done on 95 consecutive young patients who were taking inhaled beclomethasone or budesonide. No posterior subcapsular cataracts were found. The median age of the patients was 13.8 (range 5.8-24.8). The median dose of inhaled beclomethasone or budesonide was 750 micrograms/day (range 300-2000), or 12.9 micrograms/kg per day (range 7.5-34.2). The median duration of treatment was 5 years (range 1-15). 77% of the patients had not used oral glucocorticoids in the year preceding the examination. This study suggests that routine screening for posterior subcapsular cataracts in this patient population is not warranted.

Topics: Administration, Inhalation; Adolescent; Adult; Aerosols; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Cataract; Child; Child, Preschool; Chronic Disease; Cross-Sectional Studies; Female; Humans; Male; Manitoba; Patient Compliance; Pregnenediones

The clinical efficacy and adverse effects of budesonide administered as a nasal aerosol in addition to sinus washings and erythromycin therapy was assessed by comparison with placebo in a randomized, double-blind study of 40 patients with chronic or recurrent maxillary sinusitis. Most of the patients had been referred for operative treatment. Corticosteroid therapy, 400 micrograms daily, or placebo was continued for 3 months. Budesonide and antral irrigations reduced nasal symptoms more effectively than placebo, and there was a significantly greater reduction in facial pain and sensitivity in the budesonide group than in the placebo group. During the treatment period, mucosal thickening as evaluated by radiology decreased more clearly in the budesonide group than in the placebo group, but the difference did not reach statistical significance. The most frequently isolated bacteria were Staphylococcus aureus, Staphylococcus epidermidis and Haemophilus influenzae. Only 2 of 20 Haemophilus strains were beta-lactamase producers. The cellular picture was dominated by neutrophils in all secretions. There was no significant difference in clinical outcome between the two groups. Topical steroid therapy did not cause any adverse effects.

Topics: Administration, Topical; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Double-Blind Method; Erythromycin; Female; Glucocorticoids; Haemophilus Infections; Haemophilus influenzae; Humans; Male; Maxillary Sinusitis; Middle Aged; Pregnenediones; Staphylococcal Infections

In 30 stable asthmatics, a comparison was made between the changes in pulmonary function (FEV1, FVC, PEF, MEF75, MEF50 and MEF25) hourly for 9 h after a single dose of inhaled budesonide 1,600 micrograms, and placebo. All subjects used inhaled steroids daily; this medication was, however, withheld 8 days prior to the study. For all parameters of pulmonary function, a significant difference in favour of budesonide was demonstrated. The effect tended to decrease after 9 h, and had abated within 24 h. FEV1 age, sex, smoking habits, or results of an inhaled beta 2-agonist reversibility test could not be demonstrated as predictors of those subjects to react with the most pronounced responses to budesonide. In conclusion, our results demonstrate an effect 3 h after administration of an inhaled glucocorticosteroid in adult outpatients with chronic asthma. These results parallel previous findings in highly selected asthmatics and after systemic administration of glucocorticosteroids. Single-dose administration and subsequent monitoring for 8-9 h may therefore prove valuable in evaluating new prophylactic agents for the treatment of asthma.

Topics: Administration, Inhalation; Adult; Asthma; Bronchodilator Agents; Budesonide; Chronic Disease; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Pregnenediones

In a short-term, open cross-over clinical efficacy study, inhalation of budesonide 800 micrograms once daily was compared to inhalation of budesonide 400 micrograms twice daily and beclomethasone dipropionate 200 micrograms four times daily in 20 patients with stable steroid-dependent chronic asthma. Budesonide was inhaled through a spacer tube. The drugs were given in 3-week periods. Clinical symptoms, consumption of beta 2-agonists and peak flow were measured. In all but one patient, the reduced frequency of budesonide inhalations to only once daily has not given significantly different results compared with more frequent inhalations.

Topics: Administration, Intranasal; Asthma; Beclomethasone; Budesonide; Chronic Disease; Clinical Trials as Topic; Drug Administration Schedule; Female; Glucocorticoids; Humans; Male; Middle Aged; Pregnenediones; Random Allocation

Topics: Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Budesonide; Chronic Disease; Clinical Trials as Topic; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Middle Aged; Pregnenediones

The efficacy and side-effects of a new corticosteroid, budesonide, was assessed by comparison with beclomethasone dipropionate in double-blind, cross-over study of 30 patients with chronic asthma. The treatment regimens were budesonide 200 micrograms twice daily by conventional pressurized aerosol with a tube spacer attached and beclomethasone 100 micrograms four times daily via a conventional inhaler. Each treatment was given for four weeks. Results were analyzed using Student's t-test for paired comparisons. No significant differences were found for morning and evening peak flow rates, symptom scores, bronchodilator inhaler usage or forced vital capacity. Forced expiratory volume in one second after 4 weeks on each treatment was significantly higher following budesonide therapy (p less than 0.05), but the absolute changes were small and unlikely to be of clinical relevance. There were no major side-effects during either treatment period, but compared with pre-treatment levels serum creatinine and lactic dehydrogenase levels rose significantly during treatment with budesonide (p less than 0.01 and p less than 0.05 respectively). None of these results reflected clinically important biochemical or haematological changes. There was a significant reduction in neutrophil counts following treatment with beclomethasone (p less than 0.05). In the short term treatment of chronic asthma, budesonide administered twice daily is as effective as four times daily beclomethasone. A twice daily dosage regimen should improve patient compliance with therapy.

Topics: Adolescent; Adult; Aerosols; Aged; Asthma; Budesonide; Chronic Disease; Female; Humans; Male; Middle Aged; Pregnenediones; Respiratory Function Tests

The influence of various dosing regimens on the response of asthmatic patients to aerosol steroid was investigated. Budesonide, a topically active corticosteroid like beclomethasone dipropionate, was given q.i.d. or b.i.d., in the morning or A.M./P.M., at doses of 400, 800, and 1600 micrograms/day. Each patient (n = 34) took every treatment combination for 2 wk. The antiasthmatic and systemic effects, measured by changes in peak expiratory flow rate (PEFR), blood eosinophils, and serum cortisol levels increased approximately linearly on log dose budesonide (p less than 0.0005). Systemic effects of the drug were nonsignificant at low dosage. At high dosage, morning dosing conserved hypothalamic-pituitary-adrenal function, but at the cost of a marginal reduction in efficacy (delta PEFR, p = 0.12). Having the dose frequency reduced the antiasthmatic potency of the drug, i.e., PEFR fell by an amount equivalent to approximately eightfold reduction in daily dosage (p = 0.002). This effect was not evident when asthma was in remission but became so with asthma in relapse. Overall, the q.i.d. A.M./P.M. regimen showed the best risk-benefit relationships. The data indicate (1) that reductions in dose frequency made with the hope of improving patient compliance and thus conserving the drug's long-term efficacy are likely to lead to the reverse effect, (2) that the clinician can conserve a better balance of risk vs benefit by titrating dosage in terms of puffs per dose rather than doses per day, and (3) that patients can increase the antiasthmatic efficacy of this aerosol steroid without any increase in drug costs (or apparent risk) by simply increasing dosing frequency. These therapeutic considerations probably apply to some or all of the other topically active steroids currently used to treat asthma.

Topics: Adrenal Cortex Hormones; Aerosols; Analysis of Variance; Asthma; Budesonide; Chronic Disease; Dose-Response Relationship, Drug; Female; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Middle Aged; Peak Expiratory Flow Rate; Pituitary-Adrenal System; Prednisone; Pregnenediones

Asthma is the most frequent chronic airway illness in preschool children and is difficult to diagnose due to the disease's heterogeneity. This study aimed to investigate different machine learning models and suggested the most effective one to classify two forms of asthma in preschool children (predominantly allergic asthma and non-allergic asthma) using a minimum number of features.. After pre-processing, 127 patients (70 with non-allergic asthma and 57 with predominantly allergic asthma) were chosen for final analysis from the Frankfurt dataset, which had asthma-related information on 205 patients. The Random Forest algorithm and Chi-square were used to select the key features from a total of 63 features. Six machine learning models: random forest, extreme gradient boosting, support vector machines, adaptive boosting, extra tree classifier, and logistic regression were then trained and tested using 10-fold stratified cross-validation.. Among all features, age, weight, C-reactive protein, eosinophilic granulocytes, oxygen saturation, pre-medication inhaled corticosteroid + long-acting beta2-agonist (PM-ICS + LABA), PM-other (other pre-medication), H-Pulmicort/celestamine (Pulmicort/celestamine during hospitalization), and H-azithromycin (azithromycin during hospitalization) were found to be highly important. The support vector machine approach with a linear kernel was able to diffrentiate between predominantly allergic asthma and non-allergic asthma with higher accuracy (77.8%), precision (0.81), with a true positive rate of 0.73 and a true negative rate of 0.81, a F1 score of 0.81, and a ROC-AUC score of 0.79. Logistic regression was found to be the second-best classifier with an overall accuracy of 76.2%.. Predominantly allergic and non-allergic asthma can be classified using machine learning approaches based on nine features.. Supplemental data for this article is available online at at www.tandfonline.com/ijas .

Topics: Asthma; Azithromycin; Budesonide; Child, Preschool; Chronic Disease; Hospitalization; Humans; Machine Learning

Chronic rhinosinusitis (CRS) is a chronic inflammatory condition affecting the nasal and paranasal sinuses of approximately 11.5% of the United States adult population. Oral corticosteroids are effective in controlling sinonasal inflammation in CRS, but the associated adverse effects limit their clinical use. Topical budesonide has demonstrated clinical efficacy in patients with CRS. Herein, we investigated the systemic delivery of liposomes tethered with poly(ethylene glycol) (PEG) and loaded with budesonide in a murine model of CRS. PEGylated liposomes encapsulated with budesonide phosphate (L-BudP) were administered via tail vein injection, and the feasibility of L-BudP to reduce sinonasal inflammation was compared to that of free budesonide phosphate (F-BudP) and topical budesonide phosphate (T-BudP) treatment over a 14-day study period. Compared to a single injection of F-BudP and repeat T-BudP administration, a single injection of L-BudP demonstrated increased and prolonged efficacy, resulting in the significant improvement of sinonasal tissue histopathological scores (p < 0.05) with decreased immune cell infiltration (p < 0.05). Toxicities associated with L-BudP and T-BudP treatment, assessed via body and organ weight, as well as peripheral blood liver enzyme and differential white blood cell analyses, were transient and comparable. These data suggest that systemic liposomal budesonide treatment results in improved efficacy over topical treatment.

Topics: Adult; Animals; Budesonide; Chronic Disease; Humans; Inflammation; Liposomes; Mice; Polyethylene Glycols; Rhinitis; Sinusitis

Pathophysiology-targeting treatments exist for aspirin-exacerbated respiratory disease (AERD) through aspirin desensitization and biologics, such as dupilumab. With increasing attention paid to these treatments, which may be associated with significant side effects and/or cost, there is little description of chronic rhinosinusitis with nasal polyps (CRSwNP) response to treatment with intranasal corticosteroids and saline irrigations in AERD.. To determine the effect of intranasal budesonide irrigations for the treatment of CRSwNP in AERD.. This is an observational study of 14 AERD patients presenting to a rhinology clinic for CRS who were treated with twice daily high volume, low pressure irrigations with 240 mL of saline to which a 0.5 mg/2 mL respule of budesonide was added. All participants completed a 22-item Sinonasal Outcome Test (SNOT-22) at enrollment and at follow up 1 to 6 months later. Polyp scores were also calculated at each time point.. SNOT-22 scores ranged from 26 to 98 (median: 40.5) at enrollment and 3 to 85 (median: 38.5) at follow-up. Polyp scores ranged from 2 to 6 (median: 4) at enrollment at 0 to 6 (median: 2) at follow-up. Over the treatment period, change in SNOT-22 score ranged from -38 to 16 (median: -18) and change in polyp score ranged from -2 to 0 (median: -0.5). Approximately 57% of participants experienced at least 1 minimal clinically important difference in SNOT-22 score and 21% of participants had a SNOT-22 score <20 at follow-up.. Medical management with intranasal corticosteroids and saline irrigations alone leads to significant improvement in sinonasal symptomatology in a subset of AERD.

Topics: Adrenal Cortex Hormones; Aspirin; Asthma, Aspirin-Induced; Budesonide; Chronic Disease; Humans; Nasal Polyps; Rhinitis; Sinusitis

In this article, we have explored the effects of endoscopic sinus surgery together with budesonide treatment on nasal function and serum inflammatory factors on patients with chronic sinusitis. We retrospectively analyzed 120 patients with chronic sinusitis who were admitted to our hospital from March 2018 to March 2021 and were eligible for this study. They were separated into 2 groups according to different treatments, that is, the control group (treated with endoscopic surgery alone) of 58 cases and observation group (treated with endoscopic sinus surgery combined with budesonide) with 62 cases. Treatment efficacy, surgical status, overall symptom score before and after treatment, nasal mucociliary clearance function, serum eosinophils (EOS), serum immunoglobulin E (IgE), serum inflammatory factors, and occurrence of adverse reactions of both groups were recorded and compared. Total effective rate in the observation group presented strikingly more positive compared with that among patients in control group (P<0.05), as well as the data recorded in terms of operation time, blood loss during surgery and postoperative improvement time of patients (P<0.05). Overall symptom score, nasal mucociliary clearance, EOS, IgE and serum inflammatory factors in both groups were improved notably after treatment, while the observation group held a more obvious improvement. And it also had a markedly lower incidence of adverse reaction (P<0.05). Endoscopic sinus surgery combined with budesonide in the treatment of chronic sinusitis could effectively improve the clinical symptoms of patients, reestablish the function of the nasal cavity and improve their inflammation level. Meanwhile, it was of high safety and is worthy of clinical promotion.

Topics: Budesonide; Chronic Disease; Endoscopy; Humans; Immunoglobulin E; Inflammation; Nasal Cavity; Retrospective Studies; Sinusitis

This study discusses the effect of Biyanning Granules on local symptoms and systemic immune function of patients with chronic rhinosinusitis with nasal polyps(CRSwNP) within the 6 months of treatment by glucocorticoid nasal spray after surgical treatment. To be specific, a total of 237 CRSwNP patients, treated in Otorhinolaryngology Head and Neck Surgery in Shanxi Bethune Hospital, were enrolled. All patients were treated by nasal endoscopy and classified into hormone group(Budesonide Nasal Spray after surgery), Chinese medicine group(Biyanning Granules after surgery), and combination group(Budesonide Nasal Spray+Biyanning Granules after surgery) with random number table method, 79 cases in each group, and the treatment lasted 3 months. The follow-up was performed from the day of discharge to 12 months after the surgery. The clinical effect was observed. The visual analogue scale(VAS) scores and sino-nasal outcome test-20(SNOT-20) scale scores were used to assess patient's subjective symptoms and quality of life. Lund-Kennedy endoscopic score(LKES), Japanese T&T olfactometry, and standard olfactory test were used to evaluate the objective curative effect on patients. The levels of interleukin(IL)-21, CD4~+CD25~+Foxp3~+Treg, and CD4~+Th17 in peripheral blood were analyzed. The incidence of complications, recurrence rate, and adverse reactions during treatment were also recorded. The total effective rate after treatment in the combination group was higher than that in the hormone group and Chinese medicine group(P<0.05). VAS scores and SNOT-20 scale scores were lower in the three groups after treatment than before treatment and lower in the combination group than in the other two groups(P<0.05). The improvement in LKES and T&T standard olfactometry test was better in the combination group than in the other two groups(P<0.05). Serum levels of IL-21 and CD4~+Th17 in the three groups were lower than before treatment. The levels in the combination group were lower than those in the other two groups and lower in the hormone group than in the Chinese medicine group(P<0.05). Serum CD4~+CD25~+Foxp3~+Treg level was higher in the three groups after treatment than before, higher in the combination group than in the other two groups, and higher in the Chinese medicine group than in the hormone group(P<0.05). During the treatment, no serious adverse reactions were observed. After treatment, the combination group showed no significant difference in

Topics: Budesonide; Chronic Disease; Forkhead Transcription Factors; Glucocorticoids; Humans; Immunity; Medicine, Chinese Traditional; Nasal Sprays; Quality of Life; Rhinitis; Sinusitis

Intranasal corticosteroid drugs are widely used in chronic rhinosinusitis with nasal polyps (CRSwNP). In contrast to classical delivery with nasal pump sprays, pulsating aerosols can deliver significant doses into superior and posterior sinonasal spaces. A case-control study was designed to assess the efficacy of corticosteroid transnasal nebulization on short-term mucosal recovery and quality of life (QoL) following endoscopic sinus surgery in CRSwNP. Thirty patients were prospectively enrolled to receive either 1-month budesonide nasal pump spray or 1-month budesonide 100-Hz acoustic pulsating nebulization at the first postoperative visit (day 8). Patients were evaluated with Lund-Kennedy endoscopic score at day 8 (D8) and 1 month later (M1). CRS-related QoL questionnaires (SNOT22 and RhinoQOL) were fulfilled at M1. The Lund-Kennedy endoscopic scores compared between D8 and M1 were suggestively improved in the group treated with budesonide nebulization (mean difference between groups, - 18.28 units; 95%CI, - 31.29 to - 5.28 units, p = 0.014). QoL measurements were comparable at M1 between the groups of patients. No unexpected adverse event was described with both budesonide delivery protocols. In the early postoperative period, patients with CRswNP may benefit from pulsating nebulization. Large studies should be conducted to confirm the results. Safety profile related to systemic steroid absorption and bioavailability in chronic respiratory diseases also need to be addressed for further use.

Topics: Adrenal Cortex Hormones; Budesonide; Case-Control Studies; Chronic Disease; Humans; Nasal Polyps; Nasal Sprays; Quality of Life; Rhinitis; Sinusitis; Steroids

Studies on eosinophilic gastroenteritis have identified broad spectrums of disease. We aimed to characterize subtypes of disease and ascertain outcomes of each group.. This is a retrospective cohort study from a large tertiary medical center including 35 patients diagnosed with eosinophilic gastroenteritis from 2007 to 2018. We defined 2 groups of patients based on clinical and laboratory findings at presentation. Severe disease was defined as having weight loss at time of presentation, hypoalbuminemia at presentation, serosal disease involvement, or anemia at diagnosis. The remaining patients were labeled as mild disease group. We collected and compared demographic data, clinical features, laboratory findings, an allergy history, and disease course of both cohorts.. Among 35 patients with eosinophilic gastroenteritis, 18 patients met the criteria for severe disease and 17 patients for mild disease. Of the patients with severe eosinophilic gastroenteritis, 6 (38%) had remission without chronic symptoms, whereas 10 (63%) had chronic symptoms requiring chronic medical therapy. Of the mild group, 12 patients (80%) had disease remission without chronic medications. An allergy history was more common in the severe disease group (83%) compared with the mild disease group (45%). Prednisone and open capsule budesonide were the most commonly used treatment medications in both groups.. Patients with eosinophilic gastroenteritis may be characterized into 2 forms. Patients with weight loss at time of presentation, hypoalbuminemia at presentation, serosal disease involvement, or anemia at diagnosis were associated with a chronic disease course requiring chronic medications.

Topics: Adult; Anemia; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Enteritis; Eosinophilia; Female; Gastritis; Humans; Hypoalbuminemia; Male; Prednisone; Retrospective Studies; Serous Membrane; Severity of Illness Index; Weight Loss

Eosinophilic chronic rhinosinusitis (eCRS), contemporarily classified as diffuse type 2 dominant chronic rhinosinusitis (CRS), is characterized by eosinophil-dominant mucosal inflammation. Contemporary management of eCRS as an inflammatory airway condition is multimodal with corticosteroid irrigations after the surgical creation of a neosinus cavity.. To assess long-term treatment outcomes in patients with primary diffuse type 2 CRS or eCRS receiving multimodal treatment.. A prospective cohort study of patients seen in a tertiary rhinology practice recruited from May 2010 to November 2018 was conducted. Follow-up duration was 12 months or more following endoscopic sinus surgery (ESS) with a neosinus cavity formed. Data analysis was performed from August to November 2020. Consecutive adult (≥18 years) patients diagnosed with primary diffuse type 2 dominant CRS or eCRS based on the European Position Paper on Rhinosinusitis and Nasal Polyps 2020 criteria were included. Type 2 inflammation was defined as more than 10 eosinophils per high-power field obtained from sinus mucosal biopsy and managed with neosinus cavity ESS and ongoing corticosteroid irrigations. Exclusion criteria were less than 12 months of follow-up and secondary CRS.. Endoscopic sinus surgery with complete removal of intersinus bony partitions to create a neosinus cavity. Nasal irrigation (240 mL) with betamethasone, 1 mg, or budesonide, 1 mg, daily for 3 to 6 months after ESS and tapered to an as-needed basis (minimum, 2-3 per week).. Poor control was defined as polyp recurrence (polyp growth in >1 sinus area on a single side), use of long-term systemic therapy (biologic therapy or ≥3 consecutive months of oral corticosteroids), and revision surgery involving polypectomy. The disease in patients with no poor control criteria was defined as well controlled, and the disease in those with 1 or more criteria was considered poorly controlled. Maintenance medical therapy use and patient-reported outcomes based on the 22-item Sinonasal Outcomes Test for preoperative and last follow-up were collected.. Of the 222 participants recruited with primary diffuse type 2 dominant CRS or eCRS and minimum of year of follow-up, 126 were men (56.8%). Mean (SD) age was 54.8 (13.6) years, and median (SD) follow-up was 2.2 (2.2) years. Of the 222 patients, 195 (87.8%) had well-controlled disease, 16 (7.2%) had polyp recurrence, 7 (3.2%) continued to receive long-term oral corticosteroid therapy, 5 (2.3%) received biologic therapy, and 8 (3.6%) underwent a revision polypectomy. Clinically meaningful change on the 22-item Sinonasal Outcomes Test and the nasal subdomain score was maintained at the last follow-up in 134 patients (67.0%). Poor disease control was not associated with poor adherence to irrigation use.. The findings of this cohort study suggest that long-term disease control and reduction in symptom burden in patients with primary diffuse type 2 CRS or eCRS might be achieved when managed as an inflammatory disorder. Maintenance corticosteroid irrigations in the population examined appeared to be successfully self-tapered to disease activity.

Topics: Betamethasone; Budesonide; Chronic Disease; Cohort Studies; Endoscopy; Eosinophilia; Female; Follow-Up Studies; Glucocorticoids; Humans; Male; Middle Aged; Nasal Lavage; Nasal Mucosa; Nasal Polyps; Paranasal Sinuses; Postoperative Complications; Rhinitis; Sinusitis

Cough variant asthma (CVA) is classified as a distinct form of asthma. As the primary or only symptom, cough is the leading cause for the most prevalent chronic cough among kids. The American College of Clinical Pharmacy, British Thoracic Society, and Chinese guidelines established for diagnosing and treating chronic cough in kids recommend inhaled corticosteroids, combined with leukotriene receptor antagonists when necessary.. We will conduct a comprehensive search in major databases using keywords to find studies related to the analysis of montelukast sodium and budesonide for treating CVA in kids. Two reviewers will independently assess the quality of the selected research articles and perform data extraction. Next, we will use the RevMan software (version: 5.3) to conduct the statistical analysis of the present study.. This study will assess the efficacy and safeness of using montelukast sodium and budesonide to treat kids with CVA by pooling the results of individual studies.. Our findings will provide vigorous evidence to judge whether montelukast sodium and budesonide therapy is an efficient form of therapy for CVA patients.. Ethics approval is not needed for the present meta-analysis.. May 17, 2021.osf.io/cuvjz (https://osf.io/cuvjz/).

Topics: Acetates; Administration, Inhalation; Asthma; Budesonide; Child; Chronic Disease; Cough; Cyclopropanes; Drug Therapy, Combination; Glucocorticoids; Humans; Leukotriene Antagonists; Meta-Analysis as Topic; Quinolines; Randomized Controlled Trials as Topic; Sulfides; Systematic Reviews as Topic; Treatment Outcome

Chronic rhinosinusitis and nasal polyps (CRNP) is a common public health concern for general population, and is thought to negatively impact their quality of life. Although previous studies have reported that nasal nebulization inhalation of budesonide (NNIB) can benefit patients with such condition, its conclusions are still inconsistent. Thus, this study will assess the efficacy and safety of NNIB for the treatment of CRNP.. To identify any associated studies, we will comprehensively and systematically search Cochrane Library, PubMed, EMBASE, Web of Science, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure. We will search all electronic databases from inception to the present with no limitations of language and publication status. Two independent reviewers will undertake selection of study, data collection, and study quality evaluation, respectively. Another reviewer will help to settle down any different opinions between both of them. Study quality will be checked using Cochrane risk of bias tool, and statistical analysis will be performed using RevMan 5.3 software.. This study will assess the efficacy and safety of NNIB for the treatment of CRNP through assessing primary outcomes of nasal symptoms and polyp sizes, and secondary outcomes of serum cortisol levels, health-related quality of life, and any expected and unexpected adverse events.. The results of this study will summarize the up-to-date evidence on assessing the efficacy and safety of NNIB for the treatment of CRNP.. INPLASY202040108.

Topics: Administration, Intranasal; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Humans; Meta-Analysis as Topic; Nasal Polyps; Nebulizers and Vaporizers; Rhinitis; Sinusitis; Systematic Review as Topic

Topics: Adult; Aged; Anti-Inflammatory Agents; Betacoronavirus; Budesonide; Chronic Disease; Coronavirus Infections; COVID-19; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Lavage; Pandemics; Pilot Projects; Pneumonia, Viral; Pregnanes; Retrospective Studies; Rhinitis; SARS-CoV-2; Sinusitis; Treatment Outcome

Pouchitis treatment is a complex entity that requires a close medical and surgical relationship. The elective treatment for acute pouchitis is antibiotics. After a first episode of pouchitis it is recommended prophylaxis therapy with a probiotic mix, nevertheless it is not clear the use of this formulation for preventing a first episode of pouchitis after surgery. First-line treatment for chronic pouchitis is an antibiotic combination. The next step in treatment should be oral budesonide. Selected cases of severe, chronic refractory pouchitis may benefit from biologic agents, and anti-TNF α should be recommended as the first option, leaving the new biologicals for multi-refractory patients. Permanent ileostomy may be an option in severe refractory cases to medical treatment.

Topics: Acute Disease; Advisory Committees; Algorithms; Anti-Bacterial Agents; Biological Products; Budesonide; Chronic Disease; Ciprofloxacin; Colitis, Ulcerative; Crohn Disease; Drug Resistance; Enema; Humans; Ileostomy; Immunosuppressive Agents; Metronidazole; Postoperative Complications; Pouchitis; Probiotics; Randomized Controlled Trials as Topic; Secondary Prevention; Spain

Topics: Budesonide; CD8-Positive T-Lymphocytes; Chronic Disease; Forkhead Transcription Factors; Humans; Nasal Mucosa; Nasal Polyps; Rhinitis; T-Lymphocytes, Regulatory

A short-course oral corticosteroid taper and topical intranasal corticosteroids may be used to maximize the success of medical management for chronic rhinosinusitis with nasal polyps (CRSwNP). In this study, we sought to identify characteristics that would be predictive of efficacy for this combination regimen.. Sixty-four patients with CRS, bilateral polyps, a polyp score of at least 3, and a 22-item Sino-Nasal Outcome Test (SNOT-22) score ≥20 were prospectively enrolled and uniformly treated with a 15-day prednisone taper and twice daily dilute budesonide irrigations. Participants were assessed at enrollment and at follow up, 2 to 5 months later. Clinical and demographic characteristics were assessed at enrollment. At both time points, CRS symptoms were assessed with SNOT-22, and polyp score (range, 0 to 6) was assessed endoscopically. Associations were determined with regression.. Pretreatment SNOT-22 score (adjusted β = -0.83; 95% CI, -1.08 to -0.58; p < 0.001) and comorbid asthma (adjusted β = 15.75; 95% CI, 4.74 to 26.75; p = 0.007) were associated with a change in SNOT-22 experienced over the study period. Achieving a greater-than-1 minimal clinically important difference (MCID) improvement in SNOT-22 score was also associated with pretreatment SNOT-22 score (adjusted OR = 1.09; 95% CI, 1.04 to 1.14; p < 0.001) and comorbid asthma (adjusted OR = 0.13; 95% CI, 0.03 to 0.72; p = 0.019). SNOT-22 score ≥47 had 81.5% sensitivity and 78.4% specificity to detect patients experiencing 1 MCID improvement. Pretreatment polyp score was not associated with any outcome metric.. In treatment of CRSwNP with prednisone and budesonide irrigations, pretreatment endoscopy was not informative of treatment response. Pretreatment SNOT-22 and comorbid asthma may be more predictive.

Topics: Administration, Intranasal; Administration, Oral; Adrenal Cortex Hormones; Adult; Aged; Budesonide; Chronic Disease; Female; Humans; Male; Middle Aged; Nasal Polyps; Prednisone; Rhinitis; Sino-Nasal Outcome Test; Sinusitis; Treatment Outcome

Inhaled corticosteroids (ICS) are a treatment of choice for eosinophilic airway diseases, but their efficacy for other causes of chronic cough is controversial.. We conducted a prospective observational study to determine the ICS efficacy and clinical predictors of response to ICS in patients with upper airway cough syndrome (UACS) or unexplained chronic cough (UCC). Sixty-eight patients with UACS and 33 patients with UCC (duration of cough ≥ 8 weeks) were treated with ICS: 250 µg of fluticasone propionate or 400 µg of budesonide twice a day at physician's discretion. They were followed after 2 weeks to assess persistent cough which was measured as 0% to 100% compared with baseline cough frequency.. The median grade of persistent cough after 2-week ICS treatment was 40% (interquartile range [IQR], 10 to 70) in UACS and was 50% (IQR, 20 to 70) in UCC. The only adverse event was infrequent, mild hoarse voice (five UACS and one UCC). Long duration of cough (≥ 52 weeks) and cough not aggravated by cold air exposure were predictors of a poorer response to short course ICS treatment (logistic regression analysis, p = 0.018 and p = 0.031, respectively). However, prolonged treatment with ICS more than 2 weeks was more effective in patients with long cough duration (≥ 52 weeks).. Short course ICS treatment has modest efficacy on UACS and UCC without significant adverse events. Duration of cough and cough triggered by cold air exposure were the clinical factors associated with ICS response. Extended treatment with ICS may be beneficial in patients with long duration of cough.

Topics: Administration, Inhalation; Adult; Bronchodilator Agents; Budesonide; Chronic Disease; Cough; Female; Fluticasone; Glucocorticoids; Humans; Male; Middle Aged; Republic of Korea; Treatment Outcome

Budesonide improves the prognosis of chronic rhinosinusitis (CRS). However, few reports have examined whether its use for nasal irrigation, compared to normal saline, improves the prognosis of patients after endoscopic sinus surgery (ESS). We compared the effects of nasal irrigation with budesonide and normal saline in CRS patients after ESS.. Sixty CRS patients who had undergone ESS were randomly divided into an experimental group (30 patients), which used budesonide nasal irrigation, and a control group (30 patients), which used normal saline nasal irrigation. All patients received regular follow-up evaluations and were assessed via questionnaires, including the Lund-Kennedy endoscopic score (LKES), the symptom visual analog scale (VAS), the 22-item Sino-Nasal Outcome Test (SNOT-22), the Short-Form 36-Item Questionnaire (SF-36), the Self-Rating Anxiety Scale (SAS), the Self-Rating Depression Scale (SDS) and a side effects scale.. Scores of polyposis, mucosal edema, secretions and total score of LKES; VAS scores of nasal blockage, hyposmia and rhinorrhea; and SNOT-22 results in both groups were significantly improved 3 months after ESS. Scores of polyposis, mucosal edema, secretions and scarring and total score of LKES in experimental group were significantly better than in control group 3 months after ESS. No significant differences were observed in SF-36, SAS or SDS before or 3 months after ESS within or between the two groups. The side effects of the two groups were not significantly different.. Nasal irrigation improved the prognosis of CRS patients after ESS. Budesonide nasal irrigation had a better effect than normal saline nasal irrigation.

Topics: Adult; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Endoscopy; Female; Humans; Male; Middle Aged; Nasal Lavage; Nasal Obstruction; Paranasal Sinuses; Postoperative Complications; Prognosis; Rhinitis; Sinusitis; Treatment Outcome

Several topical treatments are used in the management of Chronic Rhinosinusitis (CRS), some of which the safety and efficacy has yet to be determined. The purpose of this study was to investigate the effect of commonly used topical treatments on the sinonasal epithelial barrier.. Normal saline (0.9% Sodium Chloride), hypertonic saline (3% Sodium Chloride), FESS Sinu-Cleanse Hypertonic, FLO Sinus Care and Budesonide 1 mg/ 2 ml were applied to the apical side of air-liquid interface (ALI) cultures of primary human nasal epithelial cells (HNECs) from CRS patients (n=3) and non-CRS controls (n=3) for 24 hours. Epithelial barrier structure and function was assessed using trans-epithelial electrical resistance (TEER), measuring the passage of Fluorescein Isothiocyanate labelled Dextrans (FITC-Dextrans) and assessing the expression of the tight junction protein Zona Occludens-1 (ZO-1) using immunofluorescence. Toxicity was assessed using a Lactate Dehydrogenase (LDH) assay. Data was analysed using ANOVA, followed by Tukey HSD post hoc test.. Hypertonic solution and budesonide significantly increased TEER values in CRS derived HNECs. In contrast, FESS Sinu-Cleanse Hypertonic significantly reduced TEER 5 minutes after application of the solution followed by an increase in paracellular permeability of FITC-Dextrans (30 minutes) and increased LDH levels 6 hours after application of the solution.. Our findings confirm that isotonic and hypertonic saline solutions do not compromise epithelial barrier function in vitro but underscore the importance of examining safety and efficacy of over-the-counter wash solutions.

Topics: Administration, Intranasal; Administration, Topical; Budesonide; Cells, Cultured; Chronic Disease; Epithelial Cells; Glucocorticoids; Humans; Isotonic Solutions; Microscopy, Fluorescence; Rhinitis; Saline Solution, Hypertonic; Sinusitis; Sodium Chloride; Tight Junctions

Although short-term use (≤2 months) of atomized topical nasal steroids has been shown to be safe and effective, the long-term safety has yet to be demonstrated. The aim of this study was to determine the impact of long-term topical budesonide treatment via the mucosal atomization device (MAD) on the hypothalamic-pituitary-adrenal axis (HPAA) and intraocular pressure (IOP).. A cross-sectional study of patients with chronic rhinosinusitis (CRS), with or without nasal polyposis, managed with daily nasal budesonide via MAD was conducted at a tertiary rhinology center. Patients using systemic steroids within 3 months of assessment were excluded. HPAA impact was assessed using the cosyntropin stimulation test for adrenal function and a survey of relevant symptomatology. Patients also underwent tonometry to assess for elevated IOP potentially related to corticosteroid use.. A total of 100 CRS patients were recruited with a mean budesonide treatment duration of 23.5 months (range, 6-37 months). Stimulated cortisol response was diminished in 3 patients (3%). No patients with adrenal suppression had relevant symptomatology. IOP was elevated in 6 patients (6%).. These findings suggest that there is a risk of adrenal suppression and raised IOP associated with the long-term use of topical nasal budesonide via MAD. Otolaryngologists should consider periodic surveillance for these adverse events in this patient cohort.

Topics: Administration, Intranasal; Aged; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Female; Glucocorticoids; Humans; Hypothalamo-Hypophyseal System; Intraocular Pressure; Male; Middle Aged; Nasal Polyps; Nebulizers and Vaporizers; Pituitary-Adrenal System; Rhinitis; Sinusitis

Chronic ozone exposure leads to a model of mice with lung inflammation, emphysema and oxidative stress. Progesterone plays an important role in attenuating the neuroinflammation. We assume that progesterone will reduce the chronic airway inflammation exposed to ozone and evaluate whether combination of progesterone with glucocorticoids results in synergistic effects. C57/BL6 mice were exposed to ozone (2.5ppm, 3h) 12 times over 6 weeks, and were administered with progesterone (0.03 or 0.3mg/L; inhaled) alone or combined with budesonide (BUD) (0.2g/L) after each exposure until the tenth week. Mice were studied 24h after final exposure, cells and inflammatory mediators were assessed in bronchoalveolar lavage fluid (BALF) and lungs used for evaluation of glucocorticoids receptors (GR), p38 mitogen-activated protein kinase (MAPK) phosphorylation and nuclear transcription factor κB (NF-κB) activation. Exposure to ozone resulted in a marked lung neutrophilia. Moreover, in ozone-exposed group, the levels of oxidative stress-related interleukin (IL)-1β, IL-6, IL-8, IL-17A, activated NF-κB and p38MAPK, airway inflammatory cells infiltration density, mean linear intercept (Lm) were greatly increased, FEV

Topics: Administration, Inhalation; Animals; Blotting, Western; Budesonide; Chronic Disease; Disease Models, Animal; Glucocorticoids; Immunohistochemistry; Male; Mice; Mice, Inbred C57BL; Oxidative Stress; Ozone; Pneumonia; Progesterone; Pulmonary Disease, Chronic Obstructive

Off-label high-volume sinonasal budesonide irrigations are commonly used during the management of chronic rhinosinusitis (CRS). Although short-term use (4 to 8 weeks) has been demonstrated to be safe, the long-term effects on the hypothalamic-pituitary-adrenal (HPA) axis remain unclear. The objective of this study is to determine whether CRS patients using long-term (minimum greater than 12 months) budesonide sinonasal irrigations have evidence of HPA axis suppression.. Patients with CRS being managed with high-volume sinonasal budesonide irrigations were recruited from 2 tertiary level rhinology clinics between March 2014 and July 2015. Inclusion criteria were as follows: (1) adult (age greater than 18 years); (2) guideline-based diagnosis of CRS; (3) previous endoscopic sinus surgery; (4) minimum of twice daily high-volume sinonasal budesonide irrigation (concentration of 1 mg per irrigation; total daily dose of 2 mg); and (5) a minimum of 12-month duration. Exclusion criteria included systemic corticosteroid use within 3 months of HPA axis testing. The primary outcomes were morning (am) serum cortisol levels and, when indicated, cosyntropin stimulation levels.. A total of 35 patients fulfilled eligibility criteria and underwent HPA axis testing. Mean duration of budesonide sinonasal irrigation therapy use was 38.2 months (2.9 years). The mean ± standard deviation (SD) am serum cortisol was 431.2 ± 146.9 nmol/L (normal, 200 to 650 nmol/L). Subsequent cosyntropin stimulation tests, in indicated patients (n = 19), demonstrated no evidence of HPA axis suppression.. Outcomes from this study suggest that daily high-volume sinonasal budesonide irrigations fail to produce evidence of HPA axis suppression with prolonged courses lasting longer than 2 years.

Topics: Adult; Aged; Budesonide; Chronic Disease; Cohort Studies; Cross-Sectional Studies; Female; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Middle Aged; Nasal Lavage; Off-Label Use; Pituitary-Adrenal System; Rhinitis; Sinusitis; Time Factors; Treatment Outcome; Young Adult

Although the safety of topical nasal steroids is well established for nasal spray forms, data regarding the safety of steroid irrigations is limited. We studied the effect of long-term budesonide nasal irrigations (>6 months) on hypothalamic-pituitary-adrenal axis (HPAA) function and intraocular pressure (IOP) in patients post-endoscopic sinus surgery.. This was retrospective case series. Adrenal function was assessed by using the high-dose cosyntropin stimulation test.. A total of 48 patients were assessed, with a mean duration of budesonide irrigations of 22 months. Stimulated cortisol levels were abnormally low in 11 patients (23%). None reported to have symptoms of adrenal suppression. Three of 4 patients who repeated the study being off budesonide for at least 1 month returned to near normal levels. Logistic regression analysis revealed that concomitant use of both nasal steroid sprays and pulmonary steroid inhalers was significantly associated with HPAA suppression (p = 0.024). Patients with low stimulated cortisol levels were able to continue budesonide irrigations under the supervision of an endocrinologist without frank clinical manifestations of adrenal insufficiency. IOP was within normal limits in all patients.. Long-term use of budesonide nasal irrigations is generally safe, but asymptomatic HPAA suppression may occur in selected patients. Concomitant use of both nasal steroid sprays and pulmonary steroid inhalers while using daily budesonide nasal irrigations is associated with an increased risk. Rhinologists should be alerted to the potential risks of long-term use of budesonide nasal irrigations, and monitoring for HPAA suppression may be warranted in patients receiving long-term budesonide irrigation therapy.

Topics: Adult; Aged; Budesonide; Chronic Disease; Cosyntropin; Female; Glucocorticoids; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Intraocular Pressure; Male; Middle Aged; Nasal Lavage; Pituitary-Adrenal System; Rhinitis; Serum Albumin; Sinusitis

Inflammation drives asthma and atherosclerosis. Clinical studies suggest that asthmatic patients have a high risk of atherosclerosis. Yet this hypothesis remains uncertain, given that Th2 imbalance causes asthma whereas Th1 immunity promotes atherosclerosis. In this study, chronic allergic lung inflammation (ALI) was induced in mice by ovalbumin sensitization and challenge. Acute ALI was induced in mice by ovalbumin and aluminum sensitization and ovalbumin challenge. Atherosclerosis was produced in apolipoprotein E-deficient (Apoe(-/-)) mice with a Western diet. When chronic ALI and atherosclerosis were produced simultaneously, ALI increased atherosclerotic lesion size, lesion inflammatory cell content, elastin fragmentation, smooth muscle cell (SMC) loss, lesion cell proliferation, and apoptosis. Production of acute ALI before atherogenesis did not affect lesion size, but increased atherosclerotic lesion CD4(+) T cells, lesion SMC loss, angiogenesis, and apoptosis. Production of acute ALI after atherogenesis also did not change atherosclerotic lesion area, but increased lesion elastin fragmentation, cell proliferation, and apoptosis. In mice with chronic ALI and diet-induced atherosclerosis, daily inhalation of a mast cell inhibitor or corticosteroid significantly reduced atherosclerotic lesion T-cell and mast cell contents, SMC loss, angiogenesis, and cell proliferation and apoptosis, although these drugs did not affect lesion area, compared with those that received vehicle treatment. In conclusion, both chronic and acute ALI promote atherogenesis or aortic lesion pathology, regardless whether ALI occurred before, after, or at the same time as atherogenesis. Antiasthmatic medication can efficiently mitigate atherosclerotic lesion pathology.

Topics: Animals; Apolipoproteins E; Atherosclerosis; Budesonide; Chronic Disease; Disease Progression; Glucocorticoids; Hypersensitivity; Inflammation; Ketotifen; Male; Mast Cells; Mice, Inbred C57BL; Mice, Knockout; Ovalbumin; Pneumonia

Topics: Budesonide; Chronic Disease; Endoscopy; Humans; Olfaction Disorders; Postoperative Complications; Rhinitis; Rhinoplasty; Sinusitis; Surveys and Questionnaires

Oral chronic graft versus host disease (cGVHD) is often refractory to systemic therapies. Additional topical treatment is commonly required. The potency of the agent, the vehicle and formulation in which it is delivered are all critical factors in determining the effectiveness of topical therapies. High potency of budesonide, combined with its very low bioavailability when absorbed through mucosal surfaces, increased the potential role in topical application for oral cGVHD. Viscous formulation increases mucosal contact time resulting in a greater decrease in mucosal inflammation. This short communication suggests that oral viscous budesonide should be considered as a potential new therapy in the management of oral cGVHD.

Topics: Administration, Topical; Budesonide; Child; Chronic Disease; Female; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Mouth Diseases; Mouth Mucosa; Oral Ulcer

Asthma and chronic obstructive pulmonary disease (COPD) are common chronic inflammatory respiratory diseases, which impose a substantial burden on healthcare systems and society. Fixed-dose combinations (FDCs) of inhaled corticosteroids (ICS) and long-acting β2 agonists (LABA), often administered using dry powder inhalers (DPIs), are frequently prescribed to control persistent asthma and COPD. Use of DPIs has been associated with poor inhalation technique, which can lead to increased healthcare resource use and costs.. A model was developed to estimate the healthcare resource use and costs associated with asthma and COPD management in people using commonly prescribed DPIs (budesonide + formoterol Turbuhaler(®) or fluticasone + salmeterol Accuhaler(®)) over 1 year in Spain, Sweden and the United Kingdom (UK). The model considered direct costs (inhaler acquisition costs and scheduled and unscheduled healthcare costs), indirect costs (productive days lost), and estimated the contribution of poor inhalation technique to the burden of illness.. The direct cost burden of managing asthma and COPD for people using budesonide + formoterol Turbuhaler(®) or fluticasone + salmeterol Accuhaler(®) in 2015 was estimated at €813 million, €560 million, and €774 million for Spain, Sweden and the UK, respectively. Poor inhalation technique comprised 2.2-7.7 % of direct costs, totalling €105 million across the three countries. When lost productivity costs were included, total expenditure increased to €1.4 billion, €1.7 billion and €3.3 billion in Spain, Sweden and the UK, respectively, with €782 million attributable to poor inhalation technique across the three countries. Sensitivity analyses showed that the model results were most sensitive to changes in the proportion of patients prescribed ICS and LABA FDCs, and least sensitive to differences in the number of antimicrobials and oral corticosteroids prescribed.. The cost of managing asthma and COPD using commonly prescribed DPIs is considerable. A substantial, and avoidable, contributor to this burden is poor inhalation technique. Measures that can improve inhalation technique with current DPIs, such as easier-to-use inhalers or better patient training, could offer benefits to patients and healthcare providers through improving disease outcomes and lowering costs.

Topics: Administration, Inhalation; Adrenal Cortex Hormones; Asthma; Bronchodilator Agents; Budesonide; Chronic Disease; Drug Combinations; Dry Powder Inhalers; Ethanolamines; Europe; Female; Formoterol Fumarate; Health Care Costs; Humans; Models, Economic; Pulmonary Disease, Chronic Obstructive; Receptors, Glucocorticoid

To investigate the effect of oral plus intranasal corticosteroid (CS) treatment on nasal polyp (NP) mucosa remodeling from patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP).. Case series, retrospective study.. Patients (n = 18) with severe CRSwNP were treated with oral prednisone for 2 weeks and intranasal budesonide for 12 weeks. NP biopsies were obtained from patients biopsies before (w0) and after 2 weeks (w2) and 12 weeks (w12) of CS treatment. Matrix metalloprotease 1 (MMP-1), MMP-2, MMP-7, MMP-9, and tissue inhibitor of metalloprotease type 1 (TIMP-1) expression was evaluated by immunohistochemistry in cell and tissue structures. Epithelial damage, eosinophil infiltration, and collagen content were also examined in NP tissues before and after CS treatment.. Compared to w0: 1) oral plus intranasal CS significantly (P < .01) increased presence of submucosal glands at w2, decreased epithelial cell hyperplasia at w12, and decreased tissue eosinophilia at w2 and w12; 2) CS treatment significantly (P < .05) increased immunoreactivity for MMP-1 and MMP-2 in the epithelium at w2, but decreased immunoreactivity for MMP-9 in the epithelium at w2 and w12; 3) at w12, CS significantly (P < .05) reduced MMP-9 immunoreactive positivity and intensity in the extracellular matrix, while increasing total collagen amount in the extracellular matrix; and 4) CS treatment significantly (P < .01) reduced the number of eosinophils and their MMP and TIMP-1 immunoreactive expression.. CS treatment modulates NP mucosa remodeling, particularly by promoting epithelial repair, regulating tissue remodeling markers, increasing total collagen content, and reducing tissue eosinophil infiltration.. 4

Topics: Administration, Intranasal; Administration, Oral; Biopsy; Budesonide; Chronic Disease; Collagenases; Drug Therapy, Combination; Eosinophils; Female; Glucocorticoids; Humans; Immunohistochemistry; Male; Middle Aged; Nasal Mucosa; Nasal Polyps; Prednisone; Retrospective Studies; Rhinitis; Sinusitis; Tissue Inhibitor of Metalloproteinases

Inhaled steroids are widely used for persistent cough treatment. Although the side effects of long-term inhaled steroids have been well described in the literature, their laryngeal side effects after short-term use have not yet been defined. The aim of this study was to evaluate the effect of 1 month application of inhaled steroid treatment on voice parameters in patients with subacute or chronic cough. Furthermore, the efficacy of inhaled steroids on cough was investigated, as well.. This study included 46 patients (27 females and 19 males) with a persistent cough lasting at least 3 weeks and treated with inhaled steroids. All patients were examined by a pulmonologist and lung auscultation where a posteroanterior chest X-ray and spirometry were performed. The patients were also examined by an otolaryngologist. Anterior rhinoscopy, flexible fiberoptic nasopharyngoscopy, and laryngostroboscopy were performed. Also, the patients' acoustic voice analyses were performed and recorded using a multidimensional voice program. Cough symptom index (CSI) scores were used to evaluate the response to treatment. Patients with an underlying disease that was unresponsive to inhaled steroids were excluded from study. The 46 patients were administered inhaled budesonide 400 mcg twice a day, for 1 month, and their acoustic voice analyses were performed again at the end of the treatment. In addition, CSI scores were determined after stopping medication.. When pretreatment and posttreatment acoustic voice analysis parameters (Fo, Jita, Jitt, Shim, APQ, vAm, and NHR) were compared, statistically significant differences were detected for vAm (P = 0.001) and F0 (P0.003). After treatment with inhaled steroids, the CSI score reduced from 3 to 1 (median), and the difference was statistically significant.. Inhaled budesonide treatment in the proper dose seems to be an effective treatment for persistent cough, in the selected patient group. In addition, short-term budesonide application did not cause any negative effects on the voice parameters in these patients. These findings may be related to the steroid formulation used, the application method, and the duration of treatment. Further studies are needed on a larger group of patients with different formulations of inhaled steroids to clarify aforementioned issues.

Topics: Administration, Inhalation; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Cough; Female; Humans; Male; Middle Aged; Prospective Studies; Voice; Young Adult

Topics: Adult; Budesonide; Chronic Disease; Cross Reactions; Dermatitis, Allergic Contact; Female; Glucocorticoids; Hand Dermatoses; Humans; Hydrocortisone; Patch Tests; Prednisolone

This study observed children with chronic nonspecific isolated cough (NIC) to investigate clinical differences between children whose symptoms resolved spontaneously and those who eventually developed asthma and then explored the differences among the children who eventually developed asthma in terms of their time of response to a trial of inhaled corticosteroid (ICS).. Children with chronic NIC were managed either with a wait-and-review approach or with a 2-week trial with 400 μg/d inhaled budesonide according to the preference of their parents. Responses were monitored with a validated cough score. Treatment was prolonged to 8 weeks in the case of partial responders. All children were followed up at 3-month intervals.. A total of 109 children (median [interquartile range] age, 5 [3.5-9] years; cough duration, [8-16] weeks]) were followed for a mean (± SD) time of 21(± 5) months. Cough did not recur in 71% (spontaneous resolution) but relapsed in 28% of the children who later responded to ICS treatment again (asthma). Aeroallergen sensitization (relative risk, 2.86; 95% CI, 1.17-6.99) and previous history of chronic cough (relative risk, 2.68; 95% CI, 1.10-6.49) increased the risk of asthma. Cough duration, the cough score, the family history of asthma, and serum eosinophilia were not found discriminative for the final diagnosis. There were no differences among children who eventually developed asthma and responded to either the 2-week or 8-week trial in terms of the study parameters.. Chronic NIC does not recur in the majority of children. Initial response to the ICS trial may be misleading but the trial may be preferred for children who have atopic sensitization, a previous history of chronic cough, or both .

Topics: Administration, Inhalation; Adrenal Cortex Hormones; Asthma; Budesonide; Child; Child, Preschool; Chronic Disease; Cough; Disease Progression; Female; Follow-Up Studies; Humans; Incidence; Male; Recurrence; Remission, Spontaneous; Risk Factors; Treatment Outcome; Watchful Waiting

Asthma is estimated to affect as many as 300 million people worldwide and its incidence and prevalence are rapidly increasing throughout the world, especially in children and within developing countries. Recently, there has been a growing interest in the use of potentially beneficial bacteria for allergic diseases. This study is aimed at exploring the therapeutic effects of long-term treatment with two different beneficial bacterial strains (Bifidobacterium breve M-16 V and Lactobacillus rhamnosus NutRes1) and a glucocorticoid (budesonide), as a reference treatment, on inflammatory response in a murine model for chronic allergic asthma.. To mimic the chronic disease in asthmatic patients, we used the murine ovalbumin-induced asthma model combined with prolonged allergen exposure. Airway function; pulmonary airway inflammation; airway remodelling, mRNA expression of pattern recognition receptors, Th-specific cytokines and transcription factors in lung tissue; mast cell degranulation; in vitro T cell activation; and expression of Foxp3 in blood Th cells were examined.. Lactobacillus rhamnosus reduced lung resistance to a similar extent as budesonide treatment in chronically asthmatic mice. Pulmonary airway inflammation, mast cell degranulation, T cell activation and airway remodelling were suppressed by all treatments. Beneficial bacteria and budesonide differentially modulated the expression of toll-like receptors (TLRs), nod-like receptors (NLRs), cytokines and T cell transcription factors. Bifidobacterium breve induced regulatory T cell responses in the airways by increasing Il10 and Foxp3 transcription in lung tissue as well as systemic by augmenting the mean fluorescence intensity of Foxp3 in blood CD4+ T cells.. These findings show that Bifidobacterium breve M-16 V and Lactobacillus rhamnosus NutRes1 have strong anti-inflammatory properties that are comparable to budesonide and therefore may be beneficial in the treatment of chronic asthma.

Topics: Animals; Anti-Inflammatory Agents; Asthma; Bifidobacterium; Budesonide; Chronic Disease; Disease Models, Animal; Lacticaseibacillus rhamnosus; Male; Mice; Mice, Inbred BALB C; Pneumonia; Treatment Outcome

Asthma is the most common chronic childhood illness today. However, little attention is paid for the impacts of chronic asthma-induced hypoxia on cognitive function in children. The present study used immature mice to establish ovalbumin-induced chronic asthma model, and found that chronic asthma impaired learning and memory ability in Morris Water Maze test. Further study revealed that chronic asthma destroyed synaptic structure, impaired long-term potentiation (LTP) maintaining in the CA1 region of mouse hippocampal slices. We found that intermittent hypoxia during chronic asthma resulted in down-regulation of c-fos, Arc and neurogenesis, which was responsible for the impairment of learning and memory in immature mice. Moreover, our results showed that budesonide treatment alone was inadequate for attenuating chronic asthma-induced cognitive impairment. Therefore, our findings indicate that chronic asthma might result in cognitive dysfunction in children, and more attention should be paid for chronic asthma-induced brain damage in the clinical therapy.

Topics: Animals; Animals, Newborn; Asthma; Bronchodilator Agents; Budesonide; Chronic Disease; Cognition Disorders; Cytoskeletal Proteins; Developmental Disabilities; Disease Models, Animal; Female; Gene Expression Regulation, Developmental; Hippocampus; In Vitro Techniques; Ki-67 Antigen; Lung; Maze Learning; Mice; Mice, Inbred BALB C; Nerve Tissue Proteins; Ovalbumin; Pneumonia; Time Factors; Vascular Endothelial Growth Factor A

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.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Female; Follow-Up Studies; Glaucoma; Humans; Male; Middle Aged; Nasal Polyps; Ocular Hypertension; Prospective Studies; Rhinitis; Sinusitis; Therapeutic Irrigation; Young Adult

Nasal steroids play an important role in the postoperative management of patients with chronic rhinosinusitis (CRS). However, commercially available nasal steroid sprays may not deliver adequate amounts of medication to the entire postoperative sinus cavity. The off-label use of budesonide nasal irrigation (BNI) theoretically solves this problem by delivering concentrated steroid solution through a high-pressure, high-volume system. Several studies have attested to the safety of BNI, but there are very few reports of its efficacy.. This is a retrospective review of prospectively-collected data. We identified 60 patients who were prescribed BNI postoperatively, but had a lapse in therapy for 1 month or longer. The 20-item Sinonasal Outcomes Test (SNOT-20) and Lund-Kennedy endoscopy scores while the patients were using BNI were compared with scores from the same patients while they were not using BNI. Student paired t test was used for statistical analysis.. Thirty patients had eosinophilic chronic rhinosinusitis (eCRS) with polyps (eCRSwNP), 13 had allergic fungal sinusitis (AFS), 13 had Samter's triad (ST), and 4 had eosinophilic chronic rhinosinusitis without polyps (eCRSsNP). Mean follow-up time was 25 months (range, 2-89 months). Overall, SNOT-20 scores were significantly lower with BNI (p < 0.05). On subgroup analysis, SNOT-20 scores were significantly improved with BNI for patients with eCRS and Samter's triad (p = 0.04, 0.03). Endoscopy scores were significantly improved only in the eCRS group (p = 0.02).. The addition of BNI is beneficial in the postoperative management of patients with CRS.

Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Drug Dosage Calculations; Endoscopy; Female; Follow-Up Studies; Humans; Male; Middle Aged; Postoperative Care; Prospective Studies; Rhinitis; Sinusitis; Therapeutic Irrigation; Young Adult

Bronchiolar Clara cells play a critical role in lung homoeostasis. The main goal of this study was to evaluate the effects of chronic allergy on these cells and the efficacy of budesonide (BUD) and montelukast (MK) in restoring their typical phenotypes after ovalbumin-induced chronic allergy in mice. Chronic allergy induced extensive bronchiolar Alcian blue-periodic acid-Schiff (AB/PAS)-positive metaplasia. In addition, cells accumulated numerous big electron-lucent granules negative for Clara cell main secretory protein (CC16), and consequently, CC16 was significantly reduced in bronchoalveolar lavage. A concomitant reduction in SP-D and CYP2E1 content was observed. The phenotypic changes induced by allergy were pharmacologically reversed by both treatments; MK was more efficient than BUD in doing so. MK decreased AB/PAS reactivity to control levels whereas they remained persistently elevated after BUD. Moreover, most non-ciliated cells recovered their normal morphology after MK, whereas for BUD normal cells coexisted with 'transitional' cells that contained remnant mucous granules and stained strongly for CC16 and SP-D. Glucocorticoids were also less able to reduce inflammatory infiltration and maintained higher percentage of neutrophils, which may have contributed to prolonged mucin expression. These results show that chronic allergy-induced mucous metaplasia of Clara cells affects their defensive mechanisms. However, anti-inflammatory treatments were able to re-establish the normal phenotype of Clara cell, with MK being more efficient at restoring a normal profile than BUD. This study highlights the role of epithelial cells in lung injuries and their contribution to anti-inflammatory therapies.

Topics: Acetates; Animals; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Bronchi; Budesonide; Chronic Disease; Cyclopropanes; Cytochrome P-450 CYP2E1; Disease Models, Animal; Epithelium; Female; Mice; Mice, Inbred BALB C; Ovalbumin; Phenotype; Pulmonary Surfactant-Associated Protein D; Quinolines; Sulfides; Uteroglobin

To describe the long term use of inhaled budesonide in cats with naturally occurring asthma and chronic bronchitis and to measure its effects.. Owners of 43 cats diagnosed with asthma or chronic bronchitis, which had been prescribed 400 µg of inhaled budesonide twice daily, were contacted and information was retrieved by a questionnaire. Nineteen cats still receiving inhaled budesonide after more than 2 months were re-evaluated clinically and underwent barometric whole body plethysmography and adrenocorticotropic hormone-stimulation testing.. In 20 of the cats, therapy had been withdrawn by the owners. Cats (n=23) still receiving inhaled budesonide improved clinically and 19 cats that were reevaluated had significantly lower basal PENH (P=0·048) and higher PCPenh300 (P=0·049) values than before treatment. Corticosteroid-induced side effects were not observed in any cats but hypothalamic-pituitary-adrenal axis suppression was detected in 3 of 15 cases.. Treatment with inhaled budesonide was well tolerated, resulting in improvement of clinical signs and barometric whole body plethysmography parameters. Although inhaled budesonide therapy was found to cause suppression of the hypothalamic-pituitary-adrenal axis in some cats, no cats showed clinical signs attributable to corticosteroid side effects.

Topics: Administration, Inhalation; Animals; Asthma; Bronchitis; Bronchodilator Agents; Budesonide; Cat Diseases; Cats; Chronic Disease; Female; Male; Plethysmography, Whole Body; Treatment Outcome

Chronic respiratory disease and inhaled corticosteroid (ICS) therapy for chronic obstructive pulmonary disease (COPD) increase the risk of pneumonia. Few data are available on the association of these risk factors with non-tuberculous mycobacterial (NTM) pulmonary disease.. This study examined chronic respiratory diseases and ICS use as risk factors in a population-based case-control study encompassing all adults in Denmark with microbiologically confirmed NTM pulmonary disease between 1997 and 2008. The study included 10 matched population controls per case. Conditional logistic regression was used to compute adjusted ORs for NTM pulmonary disease with regard to chronic respiratory disease history.. Overall, chronic respiratory disease was associated with a 16.5-fold (95% CI 12.2 to 22.2) increased risk of NTM pulmonary disease. The adjusted OR for NTM disease was 15.7 (95% CI 11.4 to 21.5) for COPD, 7.8 (95% CI 5.2 to 11.6) for asthma, 9.8 (95% CI 2.03 to 52.8) for pneumoconiosis, 187.5 (95% CI 24.8 to 1417.4) for bronchiectasis, and 178.3 (95% CI 55.4 to 574.3) for tuberculosis history. ORs were 29.1 (95% CI 13.3 to 63.8) for patients with COPD on current ICS therapy and 7.6 (95% CI 3.4 to 16.8) for patients with COPD who had never received ICS therapy. Among patients with COPD, ORs increased according to ICS dose, from 28.1 for low-dose intake to 47.5 for high-dose intake (more than 800 μg/day). The OR was higher for fluticasone than for budesonide.. Chronic respiratory disease, particularly COPD treated with ICS therapy, is a strong risk factor for NTM pulmonary disease.

Topics: Administration, Inhalation; Aged; Androstadienes; Anti-Inflammatory Agents; Asthma; Bronchiectasis; Budesonide; Case-Control Studies; Chronic Disease; Confidence Intervals; Denmark; Female; Fluticasone; Humans; Male; Middle Aged; Mycobacterium Infections, Nontuberculous; Odds Ratio; Pneumoconiosis; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases; Risk Factors; Tuberculosis, Pulmonary

Phosphoinositide 3-kinase (PI3K) plays an important role in tissue inflammatory reactions and fibrotic processes. The objective of this study was to evaluate the potential mechanism and therapeutic effects of PI3K inhibitor on pancreatic elastase (PE)-induced acute and chronic lung inflammation, edema, and injury.. Rats were terminated at 7 or 28 days after an intratracheal challenge with PE and intranasal instillation with a PI3K inhibitor, SHBM1009. Alterations of airway epithelial cells and myofibroblasts were studied in vitro.. Lung inflammation, edema, and injury; emphysema; and tissue remodeling were measured after PE instillation with or without treatment with PI3K inhibitor and budesonide. Cellular biologic functions were monitored.. SHBM1009 could prevent PE-induced acute lung inflammation, edema, and injury, and chronic lung inflammation, remodeling, and emphysema. Different patterns of inhibitory effects of SHBM1009 and BEZ235, a dual PI3K/mechanistic target of rapamycin inhibitor, on PE-challenged epithelial cells were observed. PE per se reduced epithelial cell proliferation and stability through the inhibition of cell division rather than promoting cell death, in dose- and time-dependent patterns. Effects of PI3K inhibitors on cells were associated with the severity of PE challenges.. PI3K plays a critical role in the development of acute and chronic lung injury, including the process of tissue remodeling and emphysema. PI3K inhibitors could be new therapeutic alternatives for chronic lung diseases.

Topics: Acute Disease; Airway Remodeling; Animals; Anti-Inflammatory Agents; Budesonide; Cell Proliferation; Chronic Disease; Disease Models, Animal; Dose-Response Relationship, Drug; Emphysema; Enzyme Inhibitors; Imidazoles; Male; Pancreatic Elastase; Phosphatidylinositol 3-Kinases; Phosphoinositide-3 Kinase Inhibitors; Pneumonia; Quinolines; Rats; Rats, Wistar; Time Factors

To evaluate the outcomes of corticosteroid-treated microscopic colitis (MC) in a population-based cohort, and to compare these outcomes in patients treated with prednisone or budesonide.. A historical cohort study of Olmsted County, Minnesota residents diagnosed with collagenous or lymphocytic colitis (LC) between 1986 and 2010 was performed using the Rochester Epidemiology Project.. Of 315 patients with MC, 80 (25.4%) were treated with corticosteroids. The median age at colitis diagnosis was 66.5 years (range: 16-95) and 78.7% were female. Forty patients (50%) had LC and 40 (50%) had collagenous colitis. Prednisone was used in 17 patients (21.2%) and budesonide in 63 (78.8%); 56 (75.6%) had complete response and 15 (20.3%) had partial response. Patients treated with budesonide had a higher rate of complete response than those treated with prednisone (82.5 vs. 52.9%; odds ratio, 4.18; 95% CI, 1.3-13.5). Six patients were lost to follow-up. The remaining 74 had a median follow-up of 4 years (range 0.2-14). Fifty patients out of the 71 who responded (70.4%) had a recurrence after corticosteroid discontinuation. Patients treated with budesonide were less likely to recur than those treated with prednisone (hazard ratio, 0.38; 95% CI, 0.18-0.85; P=0.02). After 397 person years of follow-up in the 73 patients with long-term data, 47 (64.4%) required maintenance with corticosteroids.. Patients with MC often respond to corticosteroid therapy, but with a high relapse rate. Budesonide had a higher response rate and a lower risk of recurrence than prednisone.

Topics: Adolescent; Adrenal Cortex Hormones; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Cohort Studies; Colitis, Microscopic; Disease-Free Survival; Female; Follow-Up Studies; Gastrointestinal Agents; Humans; Male; Medical Records; Middle Aged; Minnesota; Odds Ratio; Prednisone; Proportional Hazards Models; Retrospective Studies; Secondary Prevention; Time Factors; Treatment Outcome

The recurrent TNBS-colitis model in BALB/c mice has been proposed as a model of Inflammatory Bowel Disease with a shifting pattern of local cytokines with the expression of Th1 cytokines during the early phase, Th17 cytokines during the intermediate phase and Th2 cytokines during late fibrotic stages. In this study, we evaluated the development of pathology in time-in conjunction with genome-wide gene expression in the colons-in response to three weekly intrarectal instillations of TNBS. During this time-frame mice develop colitis with extensive cellular infiltration of (sub)mucosa and mildly to moderately affected crypt architecture. These pathological processes were sensitive to local treatment with budesonide. Gene expression profiling confirmed an acute phase response after each intrarectal TNBS-challenge. In addition, a chronic inflammatory process developed over time particularly evident from a gradual increase in expression of mast cell related genes. The changes in pathological hallmarks were consistent with a temporal expression of mRNA encoding a selection of chemokines. In conclusion, the early stages of the recurrent TNBS-colitis model reflect several aspects of inflammatory bowel disease which are sensitive to immunomodulation.

Topics: Administration, Rectal; Animals; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Colitis; Colon; Cytokines; Disease Models, Animal; Female; Gene Expression Profiling; Gene Expression Regulation; Immunomodulation; Inflammation; Mice; Mice, Inbred BALB C; Oligonucleotide Array Sequence Analysis; Signal Transduction; Th1-Th2 Balance; Time Factors; Transcriptome; Trinitrobenzenesulfonic Acid

Topics: Anti-Inflammatory Agents; Budesonide; Chronic Disease; Eosinophilic Esophagitis; Humans; Secondary Prevention

Corticosteroids are used to treat dermatoses, including allergic contact dermatitis, but can also cause contact allergy. The frequency of corticosteroid allergy varies between studies and is influenced by treatment traditions and availability.. To estimate the prevalence of tixocortol-21-pivalate, budesonide and hydrocortisone-17-butyrate allergy in a Danish patch test population and characterize individuals with corticosteroid allergy.. Three thousand five hundred and ninety-four patients were patch tested with tixocortol-21-pivalate, budesonide, and hydrocortisone-17-butyrate. Characterization was performed according to the MOAHLFA index and duration of disease.. Two per cent had a steroid allergy: 0.8% had a tixocortol-21-pivalate allergy, 1% a budesonide allergy, and 1% a hydrocortisone-17-butyrate allergy. Tixocortol-21-pivalate and budesonide allergy were associated with atopic dermatitis in crude analyses, but only tixocortol-21-pivalate allergy and atopic dermatitis remained associated in adjusted analyses. Leg dermatitis was uniquely associated with tixocortol-21-pivalate allergy. Hydrocortisone-17-butyrate allergy was associated with duration of disease in both crude and adjusted analyses.. Chronic dermatoses (atopic dermatitis and leg dermatitis) were identified as risk factors for group A corticosteroid allergy, probably because of more pronounced exposure to group A steroids resulting from ease of access that is exploited by patients with a chronic dermatosis. The duration of disease rather than the dermatosis itself seemed to be important for group B and D2 corticosteroid allergy.

Topics: Adult; Budesonide; Chronic Disease; Denmark; Dermatitis, Allergic Contact; Dermatitis, Atopic; Dermatitis, Occupational; Dermatologic Agents; Facial Dermatoses; Female; Hand Dermatoses; Humans; Hydrocortisone; Leg Dermatoses; Male; Middle Aged; Patch Tests; Prevalence; Risk Factors

Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adult; Anti-Inflammatory Agents; Asthma; Body Height; Budesonide; Child; Chronic Disease; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug-Related Side Effects and Adverse Reactions; Humans; Long-Term Care

Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Asthma; Body Height; Budesonide; Child; Chronic Disease; Controlled Clinical Trials as Topic; Drug Administration Schedule; Drug Therapy, Combination; Humans; Long-Term Care

Topics: Aged; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Colitis, Microscopic; Diarrhea; Humans; Male

Studies of the genetics of chronic rhinosinusitis offer potential insights into the pathophysiology of this poorly understood condition. However, genetic studies are both expensive and time consuming-hence the importance of establishing beforehand the proper population and target genes. We wished to identify patient factors associated with a proposed definition of severe chronic rhinosinusitis to minimize heterogeneity and maximize the impact of genetic contributions. We therefore wanted to determine if the response to a standardized therapy following endoscopic sinus surgery could be used as a viable phenotypic criterion for subsequent genetic studies.. Retrospective chart review.. Tertiary sinus centre.. Seventy-one cases of chronic rhinosinusitis refractory to medical and surgical treatment were studied. They formed two groups according to their response to a standardized treatment protocol. We collected information concerning patients' characteristics and bacteriology on endoscopic culture.. 60.5% patients were managed successfully with budesonide irrigations. Atopy was present in 33.8%, asthma in 69.0%, and aspirin sensitivity in 33.3%. The rate of asthma was higher in nonresponders. Bacterial colonization rates showed the presence of Staphylococcus aureus (36.4%), gram-negative rods (29.1%), and Pseudomonas aeruginosa (32.7%).. Patients with refractory chronic rhinosinusitis represent a severely diseased, more homogeneous population in which the genetic contribution(s) to disease may be maximal. Strong associations with asthma, aspirin intolerance, and atopy suggest links between these disorders. Irrigation with budesonide solution appears to be effective in management. Studies of the genetics of chronic rhinosinusitis will include genes known to be involved with both asthma and innate immunity.

Topics: Administration, Intranasal; Anti-Inflammatory Agents; Bacterial Infections; Budesonide; Chronic Disease; Dermatitis, Atopic; Female; Genetic Techniques; Humans; Male; Middle Aged; Phenotype; Retrospective Studies; Rhinitis; Sinusitis; Therapeutic Irrigation

Topics: Aged; Biomarkers; Budesonide; Celiac Disease; Chronic Disease; Diagnosis, Differential; Diagnostic Errors; Diarrhea; Diet, Gluten-Free; Duodenum; Endoscopy, Gastrointestinal; Female; Genetic Testing; GTP-Binding Proteins; Haplotypes; HLA-DQ Antigens; Humans; Immunoglobulin A; Immunoglobulin G; Immunosuppressive Agents; Malabsorption Syndromes; Predictive Value of Tests; Protein Glutamine gamma Glutamyltransferase 2; Transglutaminases; Treatment Failure

To analyses the clinical characteristics of 28 chronic rhino-sinusitis patients only characterized olfactory disorders.. Twenty-eight patients who have only olfactory disorder were diagnosed chronic rhino-sinusitis, among which 16 patients accepted intranasal budesonide for 15 days. All patients accepted CT scan, T&T test and olfactory event-related potentials test before and after treatment.. (1) No difference was found between 21 patients ( < or = 12 months) and 7 patients (>12 months) (P > 0.05), significant difference was found between maxillary sinus,ethmoid sinus and frontal sinus, sphenoid sinus in CT scan (P < 0.01). (2) Olfactory function improves after treatment (P < 0.01). Significant difference is found between 12 patients ( < or =12 months) and 4 patients (P < 0.01).. (1) Chronic rhino-sinusitis patients who have only olfactory disorder were found; (2) Intranasal budesonide treatment could improve olfactory functions of chronic rhino-sinusitis' patients.

Topics: Adult; Aged; Budesonide; Chronic Disease; Female; Humans; Male; Middle Aged; Olfaction Disorders; Olfactory Mucosa; Sinusitis

Common variable immunodeficiency disorder (CVID), the commonest symptomatic primary antibody deficiency syndrome, is characterised by recurrent bacterial infections, particularly of the upper and lower airways; it is also associated with an increased incidence of autoimmune and neoplastic disorders.CVID has a high prevalence of infectious, inflammatory and neoplastic gastrointestinal diseases. Up to 60% of the patients with non-treated CVID develop diarrhea and 10% associated idiopathic malabsorption with weight loss.The case of a 50-year-old woman with CVID-associated diarrhea, abdominal pain and bloating of one year s duration is reported. An exhaustive evaluation made for secondary causes of her symptoms was unrevealing; she was treated with loperamide and diet, without improvement. She later followed a course of oral budesonide for 3 months; her clinical symptoms disappeared and her quality of life improved.In conclusion, we report the case of a patient with CVID-related chronic diarrhea who responded well to oral budesonide treatment. This outcome provides the gastroenterologist with a new therapeutic option in this difficult group of patients.

Topics: Budesonide; Chronic Disease; Common Variable Immunodeficiency; Diarrhea; Female; Humans; Middle Aged; Remission Induction

Topics: Administration, Inhalation; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Eosinophilia; Eosinophils; Humans; Pilot Projects; Sinusitis

Nebulized budesonide (Pulmicort Respules, AstraZeneca, Wilmington, DE) provides control of respiratory tract inflammation in asthmatic patients. The Mucosal Atomization Device (MAD; Wolfe-Tory Medical, Salt Lake City, UT) is a novel sinonasal atomization device.. Uncontrolled case series of postoperative patients with chronic rhinosinusitis (CRS) who received budesonide via MAD was performed.. A total of 44 patients with a mean age of 53.5 years met inclusion criteria. The average follow-up was 31.5 weeks (SD 17.55; range, 8 to 80 weeks). Overall, patient and physician global assessments demonstrated moderate to significant improvement. Average daily oral prednisone usage among patients who took systemic steroids (n = 27) was reduced from 7.96 to 1.94 mg/day without relapse of polyps, mucosal edema, and nasal discharge. Prednisone use was reduced to zero in 16 patients and reduced or stabilized in 10 other patients.. Topical budesonide via MAD may reduce the need for systemic prednisone and improve both physician and patient global assessment scores in postoperative CRS patients. Additional investigation is warranted to exclude placebo effect, spontaneous resolution, and regression to the mean as responsible factors for the reported findings.

Topics: Administration, Topical; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Female; Glucocorticoids; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Postoperative Complications; Prednisone; Sinusitis

Budesonide (BUD) is a steroid with a low bioavailability, which has been used for the treatment of oral manifestations of chronic GVHD (cGVHD). We retrospectively evaluated the efficacy of BUD in the treatment of gastrointestinal cGVHD. Thirteen patients (median age 47 years) receiving BUD for the treatment of cGVHD after allogeneic hematopoietic SCT for hematological malignancies were evaluated for response. Five patients had isolated gastrointestinal cGVHD and 8 patients had mild multiorgan involvement including gastrointestinal manifestations. Six patients received CYA at the time of onset of cGVHD, which was continued during treatment with BUD. Treatment consisted of BUD, with an initial daily dose of 3 x 3 mg orally. Complete resolution of cGVHD was achieved in seven patients, and one patient achieved partial remission of cGVHD. One patient achieved complete resolution of gastrointestinal cGVHD, while systemic manifestations of cGVHD remained stable. Four patients progressed on BUD. Owing to the predominantly local effect, relapse of symptoms of cGVHD after withdrawal of immunosuppression (n=3) as well as progression of GVHD at other sites (n=3) has been observed. BUD represents a treatment option in mild-to-moderate cGVHD, which is well tolerated and associated with a high response rate in gastrointestinal cGVHD.

Topics: Administration, Oral; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Cyclosporine; Female; Gastrointestinal Diseases; Graft vs Host Disease; Hematologic Neoplasms; Hematopoietic Stem Cell Transplantation; Humans; Immunosuppressive Agents; Male; Middle Aged; Remission Induction; Transplantation, Homologous

Pouchitis is the most frequent complication following total proctocolectomy with ileal pouch-anal anastomosis for ulcerative colitis. Up to 15% of patients with pouchitis experience a chronic course, which can be resistant to antibiotic therapy and may lead to surgical excision of the pouch. Further therapeutic options are therefore needed. Oral budesonide, a corticosteroid with topical activity in the terminal ileum (controlled ileal release [CIR] capsules), may be an alternative.. We performed a prospective, open study of five patients with chronic refractory pouchitis. Patients were treated with 9 mg of budesonide capsules after other causes of the lack of treatment response were excluded. Assessments included clinical, endoscopic and histological evaluation at baseline and after 8 weeks of treatment. Efficacy was evaluated using the pouchitis disease activity index (PDAI) global scores as well as the clinical, endoscopic and histological subscores at baseline and 8 weeks. Remission was defined as a global score < 7. Variations in laboratory parameters and tolerance were also assessed.. Four out of five patients went into remission at 8 weeks and a significant decrease was observed in the median total PDAI score from 14 (range, 12-15) to 4 (range, 4-11) (p = 0.0422) and in the three subscores: clinical from 4 (range, 4-5) to 1 (range, 0-4) (p = 0.0394), endoscopic from 5 (range, 4-6) to 2 (range, 1-5) (p = 0.0394), and histologic from 4 (range, 4-5) to 2 (range, 2-2) (p = 0.0339). No significant adverse effects were reported.. Oral budesonide CIR capsules may be an option to induce remission in active chronic refractory pouchitis. Because tolerance is good, the use of enemas may be avoided.

Topics: Administration, Oral; Adult; Budesonide; Chronic Disease; Female; Glucocorticoids; Humans; Male; Middle Aged; Pouchitis; Prospective Studies

To evaluate the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression by budesonide nasal irrigations in the treatment of refractory chronic rhinosinusitis with polyposis (CRSwP).. Retrospective, descriptive review of patient charts.. Tertiary care rhinology practice in an academic teaching hospital.. Eighteen adult subjects with CRSwP refractory to conservative medical therapy.. The charts of consecutive patients identified as being treated with topical budesonide in saline for nasal irrigation from January to October 2006 were reviewed. In all cases, pre- and posttreatment morning cortisol levels had been measured following at least 8 weeks of uninterrupted therapy. In addition, a subset of patients who continued therapy longer than 8 weeks had undergone the more sensitive adrenocorticotropic hormone (ACTH) stimulation test.. All pre- and posttreatment morning cortisol levels were within the normal range. For an 8-week treatment period, there was no evidence of HPA axis suppression (p=.4171). For patients who continued treatment beyond 8 weeks, ACTH stimulation did not detect HPA axis suppression. Furthermore, there were no issues with compliance or acceptability, nor were any adverse side effects reported.. Budesonide in saline sinonasal irrigation for the treatment of refractory CRSwP does not cause HPA axis suppression. The efficacy of this higher dose of steroid delivered locally would benefit from further study.

Topics: Adult; Budesonide; Chronic Disease; Cohort Studies; Glucocorticoids; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Nasal Lavage; Nasal Polyps; Pituitary-Adrenal System; Retrospective Studies; Rhinitis; Sinusitis; Sodium Chloride; Treatment Outcome

Oral chronic graft versus host disease (cGVHD) is common and a major cause of morbidity and loss of quality of life in long term survivors. Cyclosporine with prednisone remains the first line therapy for oral manifestations of cGVHD. However, even with routine administration of systemic agents, many patients with oral manifestations of cGVHD do not have resolution of their disease and may benefit from incorporation of local therapy. Budesonide is a highly potent steroid which has minimal systemic side effects and being used for oral cGVHD. We designed a retrospective study to compare treatment results of patients with oral cGVHD who received topical budesonide in addition to systemic therapy that consists of combined prednisone and cyclosporine (Group A, n = 12), with the treatment results of patients who were administered the same systemic therapy alone (Group B, n = 11) to determine whether budesonide mouthwash had any advantage on response rates. Three mg topical budesonide/10 ml saline was used 3-4 times a day for up to 6 months in group A. Diagnosis, clinical staging, and treatment response scoring for cGVHD were performed according to National Institutes of Health (NIH) consensus criteria. At the baseline examination, there were no statistically significant differences in terms of median oral cGVHD examination scores between two groups. After treatment, there was statistically significant decrease in median oral cGVHD examination scores compared to baseline (P < 0.001 and 0.021), and significant differences were found between two groups (P < 0.032). Overall response rate was 83% and 36% for group A and B, respectively (P = 0.036). However, no statistically significant differences were found between median pain scores of two groups before and after treatment (P = 0.740 and P = 0.091). No major systemic side effects and oral candidiasis were observed in two groups of patients. We concluded that topical budesonide might be added to systemic therapy to obtain better response rates in patients with oral cGHVD.

Topics: Adult; Budesonide; Candidiasis, Oral; Chronic Disease; Cohort Studies; Cyclosporine; Drug Evaluation; Drug Therapy, Combination; Female; Graft vs Host Disease; Hematologic Neoplasms; Humans; Immunosuppressive Agents; Male; Middle Aged; Mouthwashes; Pain Measurement; Peripheral Blood Stem Cell Transplantation; Prednisone; Retrospective Studies; Sodium Chloride; Stomatitis; Transplantation Conditioning; Treatment Outcome

Common variable immunodeficiency disorder (CVID) is an immunological disease that can present with gastrointestinal (GI) symptoms including chronic diarrhea and abdominal pain. We report a patient with CVID and chronic diarrhea who significantly improved with budesonide.. A 47-yr-old woman with CVID-associated diarrhea, steatorrhea, abdominal pain, and bloating for several years had an exhaustive evaluation for secondary causes of her symptoms, which was unrevealing. At the advice of her immunologist, she attempted a course with budesonide that significantly improved her GI symptoms. Given the absence of literature on this treatment in CVID, we attempted to systematically evaluate the clinical benefits after withdrawal of and retreatment with budesonide.. Diarrhea, steatorrhea, abdominal pain, and bloating recurred within 2 days of discontinuing budesonide. All parameters assessed improved upon reinitiating budesonide. Further, serum immunoglobulin G (IgG) levels significantly increased with treatment. No significant side effects were observed with budesonide.. This is the first report of a patient with CVID-related chronic diarrhea to be successfully treated with oral budesonide. This observation provides clinicians with an effective and safe treatment option in this difficult group of patients.

Topics: Administration, Oral; Budesonide; Chronic Disease; Common Variable Immunodeficiency; Diarrhea; Female; Glucocorticoids; Humans; Immunoglobulin G; Middle Aged

Topics: Administration, Oral; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Diarrhea; Eosinophilia; Humans; Ileitis; Male; Mastocytosis; Middle Aged

Effects of respiratory viral infection on airway epithelium include airway hyper-responsiveness and inflammation. Both features may contribute to the development of asthma. Excessive damage and loss of epithelial cells are characteristic in asthma and may result from viral infection.. To investigate apoptosis in Adenoviral-infected Guinea pigs and determine the role of death receptor and ligand expression in the airway epithelial response to limit viral infection.. Animal models included both an Acute and a Chronic Adeno-infection with ovalbumin-induced airway inflammation with/without corticosteroid treatment. Isolated airway epithelial cells were cultured to study viral production after infection under similar conditions. Immunohistochemistry, western blots and viral DNA detection were used to assess apoptosis, death receptor and TRAIL expression and viral release.. In vivo and in vitro Adeno-infection demonstrated different apoptotic and death receptors (DR) 4 and 5 expression in response to corticosteroid exposure. In the Acute Adeno-infection model, apoptosis and DR4/5 expression was coordinated and were time-dependent. However, in vitro Acute viral infection in the presence of corticosteroids demonstrated delayed apoptosis and prolonged viral particle production. This reduction in apoptosis in Adeno-infected epithelial cells by corticosteroids exposure induced a prolonged virus production via both DR4 and TRAIL protein suppression. In the Chronic model where animals were ovalbumin-sensitized/challenged and were treated with corticosteroids, apoptosis was reduced relative to adenovirus-infected or corticosteroid alone.. Our data suggests that apoptosis of infected cells limits viral production and may be mediated by DR4/5 and TRAIL expression. In the Acute model of Adeno-infection, corticosteroid exposure may prolong viral particle production by altering this apoptotic response of the infected cells. This results from decreased DR4 and TRAIL expression. In the Chronic model treated with corticosteroids, a similar decreased apoptosis was observed. This data suggests that DR and TRAIL modulation by corticosteroids may be important in viral infection of airway epithelium. The prolonged virus release in the setting of corticosteroids may result from reduced apoptosis and suppressed DR4/TRAIL expression by the infected cells.

Topics: Acute Disease; Adenoviridae; Adenoviridae Infections; Animals; Anti-Inflammatory Agents; Apoptosis; Budesonide; Cells, Cultured; Chronic Disease; Epithelial Cells; Female; Guinea Pigs; Ovalbumin; Pneumonia; Receptors, TNF-Related Apoptosis-Inducing Ligand; Receptors, Tumor Necrosis Factor; Trachea; Virion

In general, the colonic mucosa is macroscopically normal in collagenous colitis, although minor, non-specific abnormalities may be found. Significant endoscopic abnormalities, "mucosal tears" representing longitudinal mucosal lacerations, have been reported in a few patients with collagenous colitis. We report the cases of three women with collagenous colitis and mucosal tears detected at the index colonoscopy in order to illustrate the endoscopic characteristics and review the literature. Including the present cases, a total of 12 patients with mucosal tears and collagenous colitis have been reported. In 10 patients, the mucosal lacerations involved the ascending or the transverse colon. Three of the 12 patients had a colonic perforation immediately after the colonoscopy. The colonoscopist should be aware that the risk of perforation is likely to be increased when mucosal tears are present.

Topics: Anti-Inflammatory Agents; Budesonide; Chronic Disease; Colitis, Collagenous; Colon; Colonoscopy; Female; Follow-Up Studies; Humans; Intestinal Mucosa; Intestinal Perforation; Time Factors; Treatment Outcome

This case report describes a rare situation in which a superinfected cyst of the urachus complicated initially unknown and inactive Crohn's disease.. A 21-year-old man presented a chronic fever finally attributed to a superinfected urachal cyst. Six months after ablation of the cyst, progressive Crohn's disease was diagnosed.. The association of Crohn's disease and a superinfected urachal cyst is extremely rare. The case reported here is original in two aspects: the slowly progressive Crohn's disease was diagnosed after its complication; the superinfection developed through local bacterial translocation (ileal loop adjacent to the urachal cyst).

Topics: Adult; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Crohn Disease; Disease Progression; Fever; Humans; Male; Time Factors; Tomography, X-Ray Computed; Urachal Cyst

A case is discussed of eosinophilic bronchial inflammation without asthma due to chloramine T (CLT) exposure in a nurse. She reported a non-productive chronic cough on contact with CLT during workshifts. She had negative results of skin prick testing to CLT. However, sensitisation to CLT was confirmed by the presence of specific anti-chloramine IgE. Airway responsiveness to histamine was normal before and after CLT challenge. Eosinophil proportion in sputum was increased at 6 and 24 h after CLT challenge.

Topics: Anti-Inflammatory Agents; Bronchitis; Budesonide; Chloramines; Chronic Disease; Cough; Disinfectants; Eosinophilia; Female; Humans; Middle Aged; Occupational Exposure; Tosyl Compounds

To explore the follow-up time and the effect of intranasal glucocorticoid for chronic sinusitis and nasal polyps after endoscopic sinus surgery.. After the endoscopic sinus surgery, 30 cases of sinusitis and nasal polyps accepted the postsurgical care for the cavity, sinus washing, and intranasal local glucocorticoid rhinocort, then the clinical effects was follow-up surveyed.. Intranasal local glucocorticoid could evidently reduce the courses of dry and the epithelial metaplasia of nasal cavity and sinus.. After the endoscopic sinus surgery, follow-up of endoscopic sinus, postsurgical care for the cavity and intranasal local glucocorticoid played equally important roles in treating sinusitis and nasal polyps.

Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Endoscopy; Female; Follow-Up Studies; Humans; Male; Middle Aged; Nasal Polyps; Postoperative Care; Sinusitis

Histologic and immunohistologic features of nasal polyps (NP) are similar to those observed in asthma, thus suggesting a similar immunopathology.. The primary objective of this study was to further understand the anti-inflammatory and immunoregulatory effects of locally delivered corticosteroids. To this end, the effect of intranasal budesonide on the expression of specific cytokines, lymphocyte subsets, and epithelial remodeling in this model of airway tissue inflammation were studied.. We used immunohistochemical techniques to examine nasal mucosae (NM) from healthy individuals and nasal polyp (NP) tissues from patients with nasal polyposis obtained before and after intranasal budesonide treatment.. First, the density of CD8(+) cells was markedly increased in NP tissues after intranasal budesonide treatment from 16.1 +/- 8.4 (M +/- SEM) per mm(2) to 39.9 +/- 24.1. Second, the density of cells immunoreactive for IL-4, IL-5, IFN-gamma, IL-12, and TGF-beta in NP was significantly greater than in control NM tissues. The density of IL-4(+) and IL-5(+) cells in NP tissues significantly decreased after budesonide treatment from 40 +/- 12 to 17.8 +/- 8 and from 19.3 +/- 11 to 10.4 +/- 7, respectively. In contrast, the density of IFN-gamma(+) and IL-12(+) cells remained unchanged. In addition, we found that the density of TGF-beta(+) cells significantly increased after intranasal budesonide from 18 +/- 5 to 41 +/- 9. Third, damage to the entire length of the NP epithelium was quantified using a grading system. The epithelium of untreated NP was substantially damaged; remarkable epithelial restitution with no apparent changes in stromal collagen deposition was observed after intranasal budesonide treatment.. These findings demonstrate that intranasal budesonide induced an increase in CD8 population and a selective regulatory effect on tissue cytokine expression. Furthermore, intranasal budesonide promoted epithelial remodeling. We hypothesize that these immunoregulatory and remodeling effects elicited by steroids might be, at least in part, mediated by the induction of TGF-beta.

Topics: Administration, Intranasal; Adult; Budesonide; Chronic Disease; Cytokines; Eosinophils; Female; Humans; Immunohistochemistry; Male; Middle Aged; Nasal Mucosa; Nasal Polyps; T-Lymphocyte Subsets; Transforming Growth Factor beta

Topics: Acetates; Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adult; Aged; Asthma; Bronchodilator Agents; Budesonide; Chronic Disease; Cyclopropanes; Drug Therapy, Combination; Humans; Leukotriene Antagonists; Middle Aged; Quinolines; Sulfides

Eosinophilic inflammation of the airway is usually associated with airway hyper-responsiveness in bronchial asthma. However, there is a small group of patients which has the eosinophilic inflammation in the bronchial tree with normal spirometry and no evidence of airway hyper-responsiveness, which was named eosinophilic bronchitis. The objectives of this study are 1) to investigate the incidence of eosinophilic bronchitis in the chronic cough syndrome and 2) to evaluate the clinical features and course of eosinophilic bronchitis.. We evaluated 92 patients who had persistent cough for 3 weeks or longer. In addition to routine diagnostic protocol, we performed differential cell count of sputum. Eosinophilic bronchitis was diagnosed when the patient had normal spirometric values, normal peak expiratory flow variability, no airway hyper-responsiveness and sputum eosinophilia (> 3%).. The causes of chronic cough were post-nasal drip in 33%, cough variant asthma in 16%, chronic bronchitis in 15% and eosinophilic bronchitis in 12% of the study subjects. Initial eosinophil percentage in the sputum of patients with eosinophilic bronchitis was 26.8 +/- 6.1% (3.8-63.7%). Treatment with inhaled steroid is related with a subjective improvement of cough severity and a significant decrease of sputum eosinophil percentage (from 29.1 +/- 8.3% to 7.4 +/- 3.3%). During the follow-up period, increase in sputum eosinophil percentage with aggravation of symptoms were found.. Eosinophilic bronchitis is one of the important cause of chronic cough. Assessment of airway inflammation by sputum examination is important in investigating the cause of chronic cough. Cough in eosinophilic bronchitis is effectively controlled by inhaled corticosteroid, but may follow a chronic course.

Topics: Adult; Aged; Anti-Inflammatory Agents; Asthma; Bronchitis; Budesonide; Chronic Disease; Cough; Eosinophilia; Female; Gastroesophageal Reflux; Humans; Male; Middle Aged; Respiratory Function Tests; Severity of Illness Index; Sputum

In non-smokers the underlying causes for chronic persistent cough (CPC) e.g. chronic cough without diagnostic chest X-ray or pulmonary function test--are usually as follows: several common upper airways diseases, bronchial (cough type) asthma, gastrooesophageal reflux or treatment with an ACE (angiotensin converting enzyme)--inhibitor. In 10% of CPC however the cause remains uncertain. We report a 30 year old non-smoker with severe coughing and repeated vomiting for two months. No laboratory or technical data could be collected suggestive of a common cause of CPC: Upper airways disease, bronchial flow limitation or hyperresponsiveness, ACE inhibitor medication, B. pertussis infection, gastrooesophageal reflux disease (by 24 hours pH-probe) were ruled out. Fiberbronchoscopic findings remained unremarkable, except for the bronchial biopsy specimen, which showed moderate eosinophilic inflammation of the mucosa and marked thickening of the subepithelial layer. Since the cough was non-productive, sputum induction with 3 ml nebulised 3% NaCl solution was performed. 28% of the granulocytes were eosinophil stained. A low quality morning sputum (< 1 ml) showed 21% eosinophilia. Thus, the diagnosis of eosinophilic bronchitis was established. 400 micrograms budesonide dry powder inhalations b.i.d. for one week resolved the cough, treatment was stopped after three weeks. No recurrence was seen two months later. Both the cough type asthma and the eosinophilic bronchitis could represent a form fruste of classical bronchial asthma beyond wheezing or dyspnoea, but with the common main symptom: cough. Since hyperresponsiveness and cough are phenotypic hallmarks of cough variant asthma, in eosinophilic bronchitis--beside cough--another two features of asthma are present: eosinophilic inflammation of the mucosa along with sputum eosinophilia and subepithelial layer thickening. Not surprisingly, eosinophilic bronchial inflammation could be shown in patients with cough variant asthma as well, who--up to 56% during a four year-period--develop classic asthma. The long-term outcome of eosinophilic bronchitis is not known, however. Thus, asthma, cough variant asthma and cough due to eosinophilic bronchitis can mirror different phenotypes or phases of the same entity. CPC due to either the cough type asthma or the eosinophilic bronchitis is like asthma fast responding to inhalative steroids. (Induced) sputum staining should be added to the diagnostic armamentarium of CPC.

Topics: Adult; Asthma; Bronchial Hyperreactivity; Bronchitis; Bronchodilator Agents; Budesonide; Chronic Disease; Cough; Diagnosis, Differential; Eosinophilia; Humans; Male

Damage to the airway epithelium is one prominent feature of chronic asthma. Corticosteroids induce apoptosis in inflammatory cells, which in part explains their ability to suppress airway inflammation. However, corticosteroid therapy does not necessarily reverse epithelial damage. We hypothesized that corticosteroids may induce airway epithelial cell apoptosis as one potential explanation for persistent damage. We tested this hypothesis in cultured primary central airway epithelial cells and in the cell line 1HAEo(-). Treatment with dexamethasone, beclomethasone, budesonide, or triamcinolone each elicited a time-dependent and concentration-dependent cell death. This cell death was associated with cleavage of nuclear chromatin, mitochondrial depolarization, cytochrome c extrusion, activation of caspase-9, and expression of phosphatidylserine on the outer cell membrane. Inhibitors of caspase activity blocked apoptotic cell death, as did overexpression of the apoptosis regulators Bcl-2 or Bcl-x(L). We demonstrated that CD95 ligation is not essential for the corticosteroid-induced apoptosis in airway epithelial cells. These data demonstrate that corticosteroids induce apoptotic cell death of airway epithelium. This raises the possibility that at least one of the major components of chronic airway damage in asthma, epithelial shedding and denudation, may in part result from a major therapy for the disease.

Topics: Anti-Asthmatic Agents; Anti-Inflammatory Agents; Apoptosis; Asthma; bcl-X Protein; Beclomethasone; Bronchodilator Agents; Budesonide; Caspase 9; Caspases; Cells, Cultured; Chronic Disease; Cytochrome c Group; Dexamethasone; Dose-Response Relationship, Drug; Drug Evaluation, Preclinical; fas Receptor; Genes, bcl-2; Humans; Inflammation; Proto-Oncogene Proteins c-bcl-2; Receptors, Interleukin-2; Respiratory Mucosa; Time Factors; Triamcinolone

Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Anti-Inflammatory Agents; Asthma; Budesonide; Chronic Disease; Double-Blind Method; Humans; Prospective Studies; Randomized Controlled Trials as Topic; Reproducibility of Results; Respiratory Function Tests; Treatment Outcome

Topics: Acute Disease; Anti-Inflammatory Agents; Antibodies, Monoclonal; Azathioprine; Budesonide; Chronic Disease; Colectomy; Colitis, Ulcerative; Crohn Disease; Cyclosporine; Drug Combinations; Gastrointestinal Agents; Glucosamine; Humans; Immunosuppressive Agents; Infliximab; Sulfasalazine

Eosinophilic bronchitis presents with chronic cough and sputum eosinophilia, but without the abnormalities of airway function seen in asthma. It is important to know how commonly eosinophilic bronchitis causes cough, since in contrast to cough in patients without sputum eosinophilia, the cough responds to inhaled corticosteroids. We investigated patients referred over a 2-yr period with chronic cough, using a well-established protocol with the addition of induced sputum in selected cases. Eosinophilic bronchitis was diagnosed if patients had no symptoms suggesting variable airflow obstruction, and had normal spirometric values, normal peak expiratory flow variability, no airway hyperresponsiveness (provocative concentration of methacholine producing a 20% decrease in FEV(1) ([PC(20)] > 8 mg/ml), and sputum eosinophilia (> 3%). Ninety-one patients with chronic cough were identified among 856 referrals. The primary diagnosis was eosinophilic bronchitis in 12 patients, rhinitis in 20, asthma in 16, post-viral-infection status in 12, and gastroesophageal reflux in seven. In a further 18 patients a diagnosis was established. The cause of chronic cough remained unexplained in six patients. In all 12 patients with eosinophilic bronchitis, the cough improved after treatment with inhaled budesonide 400 micrograms twice daily, and in eight of these patients who had a follow-up sputum analysis, the eosinophil count decreased significantly, from 16.8% to 1.6%. We conclude that eosinophilic bronchitis is a common cause of chronic cough, and that sputum induction is important in the investigation of cough.

Topics: Administration, Inhalation; Adult; Aged; Algorithms; Anti-Inflammatory Agents; Bronchitis; Bronchodilator Agents; Budesonide; Chronic Disease; Cough; Dose-Response Relationship, Drug; Drug Administration Schedule; Eosinophilia; Female; Humans; Male; Middle Aged; Sputum

Interleukin (IL)-12 is a relatively new and structurally distinct TH1-associated cytokine produced by B cells and macrophages, which may play a suppressive role in the development of allergic sinonasal mucosal responses.. We investigated the expression of IL-12 (inducible p40 subunit) and its receptor (IL-12R beta2 subunit) in tissue biopsies of naturally exposed patients with allergy-associated (ACS) and nonallergy-associated chronic sinusitis (NCS) and compared it with controls. We also examined IL-12 and IL-12R expression in biopsies from a ragweed allergen challenge model. In the allergen challenge model, the effect of pretreatment with topical corticosteroids on IL-12 and IL-12R expression was assessed.. To detect IL-12 and IL-12R mRNA, we employed the technique of in situ hybridization using digoxigenin-labelled riboprobes.. In both ACS and NCS subjects there was decreased expression of IL-12 as compared with control (P < 0.05). IL-12R (beta2) expression was decreased in ACS subjects as compared with control (P < 0.05), however, there was no significant difference found between NCS subjects and control. In the allergen challenge subjects, there was a significant decrease in IL-12 expression following challenge (P < 0.05). This effect was abrogated by pretreatment of the subjects with topical corticosteroids. However, IL-12R (beta2) expression showed no change following allergen challenge while pretreatment with topical corticosteroids resulted in increased expression of the (beta2) receptor after allergen challenge (P < 0.05).. Our data suggest that IL-12 plays a role in the in vivo suppression of the allergic inflammatory response and that the control of this suppression may be exerted largely via the IL-12 (beta2) receptor.

Topics: Adult; Allergens; Antigens, Plant; Budesonide; Chronic Disease; Female; Humans; Interleukin-12; Male; Middle Aged; Nasal Mucosa; Paranasal Sinuses; Plant Proteins; Pollen; Protein Isoforms; Receptors, Interleukin; Receptors, Interleukin-12; Rhinitis, Allergic, Perennial; Sinusitis

The expression of the glucocorticoid receptor (GR) in untreated or in steroid-dependent asthmatic patients is poorly understood. We therefore studied GR mRNA and protein levels in bronchial biopsies obtained from seven untreated asthmatic patients, seven control volunteers, and seven patients with chronic bronchitis. We also studied in bronchial epithelial cells obtained by brushing from 13 untreated asthmatics, 18 steroid-dependent asthmatics, 11 control volunteers, and 12 patients with chronic bronchitis, GR and heat shock protein 90 kD (hsp90) mRNA as well as the immunoreactivity of GR, intercellular adhesion molecule (ICAM-1), and granulocyte macrophage-colony-stimulating factor (GM-CSF). GR mRNA and protein level was similar in all subject groups in both biopsies and bronchial epithelial cells. Hsp90 mRNA level was also similar in all subject groups. ICAM-1 expression was significantly increased in bronchial epithelial cells from untreated asthmatics, but ICAM-1 was not expressed in those from steroid-dependent asthmatic patients. GM-CSF expression was significantly increased in bronchial epithelial cells from untreated and steroid-dependent asthmatic patients. GR expression within the airways is unaltered by oral long-term steroid treatment in asthma, but the expression of some but not all specific markers for asthma is modified by oral steroid.

Topics: Administration, Oral; Adult; Aged; Albuterol; Anti-Inflammatory Agents; Asthma; Biopsy; Bronchi; Bronchitis; Bronchodilator Agents; Budesonide; Chronic Disease; Epithelial Cells; Gene Expression Regulation; Glucocorticoids; Granulocyte-Macrophage Colony-Stimulating Factor; HSP90 Heat-Shock Proteins; Humans; Intercellular Adhesion Molecule-1; Middle Aged; Prednisone; Proteins; Receptors, Glucocorticoid; RNA, Messenger; Salmeterol Xinafoate; Theophylline

Topics: Anti-Inflammatory Agents; Budesonide; Chronic Disease; Colitis, Ulcerative; Crohn Disease; Humans; Inflammatory Bowel Diseases

Preliminary observations of the clinical efficacy of intravenous immunoglobulin in two patients with severe corticosteroid insensitive asthma are reported. In both patients treatment with intravenous immunoglobulin resulted in clinical improvement and enabled a significant reduction in the dose of prednisolone. In one of the patients fibreoptic bronchoscopy with endobronchial biopsies was performed and peripheral blood was analysed by flow cytometry before and after treatment. Immunohistological analysis of the biopsy samples after treatment showed a decrease in the number of all cell types, especially CD3+ T cells, CD4+ T cells, and activated CD25+ T lymphocytes, which was associated with a reduction in peripheral blood T cell activation. Intravenous immunoglobulin may be a valid option for the treatment of corticosteroid insensitive asthma. To elucidate the role and mode of action of intravenous immunoglobulin further studies in larger groups of patients are needed.

Topics: Adolescent; Asthma; B-Lymphocytes; Biomarkers; Blood Proteins; Budesonide; Chronic Disease; Combined Modality Therapy; Eosinophil Granule Proteins; Female; Glucocorticoids; Humans; Immunoglobulin E; Immunoglobulin G; Immunoglobulins, Intravenous; Inflammation Mediators; Interleukin-8; Lymphocyte Count; Prednisolone; Pregnenediones; Ribonucleases; T-Lymphocytes

We report a case of typical chronic eosinophilic pneumonia (CEP), in a female of 27 years-old suffering bronchial asthma light. Although the initial answer to the treatment with steroids was satisfactory, the patient develop difficult to control asthma (DCA). DCA is a clinical situation which requires careful investigation of several potential factors which can be solved. We suggest a protocol of treatment for patients affected with DCA.

Topics: Administration, Topical; Adult; Aerosols; Anti-Inflammatory Agents; Asthma; Bronchodilator Agents; Budesonide; Chronic Disease; Female; Glucocorticoids; Humans; Pregnenediones; Pulmonary Eosinophilia; Radiography, Thoracic

Serum eosinophilic cationic protein (ECP) and soluble low affinity receptor for IgE (Fc epsilon RII/sCD23) concentrations were measured in relation to symptom-medication scores, pulmonary function, and total IgE levels in 27 chronic allergic asthmatic children (17 boys, 10 girls), mean age 10.8 years, before and at the end of a three month inhaled corticosteroid (budesonide) treatment period. Serum ECP and sCD23 concentrations were also measured in age matched non-asthmatic controls with allergic rhinitis. All asthma patients had significantly higher serum ECP and sCD23 than the controls, whereas the mean serum IgE was not different. No correlation between total IgE concentrations and serum sCD23 could be detected in either group. At the end of the treatment period, symptom-medication scores and pulmonary function improved. Serum ECP and sCD23 concentrations were reduced; however, total IgE values did not change significantly. A significant relation was found between the improvement of symptom-medication scores and fall in both sCD23 and ECP concentrations. Although there was a significant correlation of pulmonary function values with serum ECP, no such relation was observed for sCD23. It appears that serum sCD23 and ECP concentrations could be good disease markers, particularly in asthma. Monitoring of serum inflammation markers, especially ECP, may be useful in the follow up of asthmatic children on anti-inflammatory treatment.

Topics: Adolescent; Anti-Inflammatory Agents; Asthma; Blood Proteins; Budesonide; Child; Chronic Disease; Eosinophil Granule Proteins; Female; Humans; Inflammation Mediators; Lung; Male; Pregnenediones; Receptors, IgE; Respiratory Function Tests; Rhinitis, Allergic, Perennial; Ribonucleases

The transcription factor Fos is involved in cell proliferation and differentiation. Its expression in normal and pathological adult human tissues and cells has rarely been studied. We therefore studied bronchial biopsies obtained from 14 normal subjects (NS), 18 non-steroid-treated asthmatics, 10 corticosteroid-treated asthmatics and 10 patients with chronic bronchitis (CB), in addition to 34 patients with lung cancer (LC), by immunofluorescence for Fos immunoreactivity, using a highly specific polyclonal antibody. Bronchial tissue of 0/10 NS, 11/18 non-steroid-treated asthmatics, 1/10 steroid-treated asthmatics, 0/10 CB and 1/34 LC expressed Fos. In asthmatic patients, the expression was heterogeneous, localized to epithelial cells and correlated with the epithelium shedding (tau = 0.45, P = 0.0001). Corticosteroid-treated patients rarely expressed Fos, suggesting a role for this proto-oncogene in asthmatic bronchial inflammation. Fos was rarely expressed in the normal and pathological (CB, LC) proliferative compartment of the human bronchi, suggesting its low role in cell proliferation of the large airways.

Topics: Adenocarcinoma; Adolescent; Adult; Aged; Aged, 80 and over; Asthma; Beclomethasone; Bronchi; Bronchitis; Budesonide; Carcinoma, Small Cell; Carcinoma, Squamous Cell; Chronic Disease; Female; Fluorescent Antibody Technique; Humans; Lung Neoplasms; Male; Middle Aged; Pregnenediones; Proto-Oncogene Mas; Proto-Oncogene Proteins c-fos

Despite the dramatic success of inhaled steroids in controlling asthma symptoms there remains a small number of patients in whom asthma can only be treated with continuous oral steroids. Eighteen such patients, aged 19-62 years (seven males, 11 females) were followed in an open trial of nebulized budesonide over 12-18 months. All had required at least 7.5 mg or more daily prednisolone to control their symptoms over the preceeding 2 or more years and were taking 1200 micrograms beclomethasone dipropionate or 1600 micrograms budesonide daily. With a daily dose ranging between 4 and 8 mg nebulized budesonide, 14 patients successfully stopped oral steroids while in three the dose was reduced; only one patient failed to benefit. There was an increase in the mean FEV1 from 1.9 (+/- 0.9) to 2.2 (+/- 0.9) l, and in the mean morning PEFR, from 238 (+/- 119) to 286 (+/- 130) l min-1. There was also a significant decrease in the mean number of hospital admissions for acute severe asthma, from 1.5 (+/- 1.8) to 0.9 (+/- 1.1) per year. These findings should encourage a careful and controlled evaluation of nebulized steroids as a substitute for oral steroids in this difficult group of asthmatics.

Topics: Adult; Asthma; Budesonide; Chronic Disease; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Peak Expiratory Flow Rate; Prednisolone; Pregnenediones; Vital Capacity

We studied 22 Asian patients with steroid dependent asthma. Using a clinical approach to the addition of high dose inhaled budesonide and tapering of systematic steroid, we were able to substitute 5 to 20 mg prednisolone with 800 micrograms per day of inhaled budesonide in all patients. There was also a greater reduction in nocturnal symptoms and awakenings and a smaller overnight fall in PEFR during treatment with budesonide than with prednisolone. Inhaled budesonide was an effective long term substitute for prednisolone in chronic asthma.

Topics: Administration, Inhalation; Adult; Asian People; Asthma; Budesonide; Chronic Disease; Clinical Protocols; Dose-Response Relationship, Drug; Female; Humans; Male; Middle Aged; Prednisolone; Pregnenediones; Prospective Studies; Time Factors

Twenty-six children with chronic bronchial asthma, 19 boys and 7 girls, aged between 6 and 16 years with duration of asthma ranging from 1-12 years, were studied by a control, oral prednisolone 5 mg twice a day and inhaled budesonide 200 micrograms twice daily, each for 3 weeks. The clinical efficacy assessed daily by day and night symptom scores of cough, wheeze, sleep disturbance, limitation of activity, symptomatic inhaled terbutaline usage, daily morning and afternoon Peak Expiratory Flow Rate (PEFR), and weekly PEFR and Forced Expiratory Volume in 1 second (FEV1) in percent of predict, showed statistically significant improvement during the inhaled budesonide aerosol and oral prednisolone treatment periods in comparison with the control. No side effect was observed during any study periods.

Topics: Administration, Topical; Adolescent; Aerosols; Anti-Inflammatory Agents; Asthma; Budesonide; Child; Chronic Disease; Female; Glucocorticoids; Humans; Male; Medical Records; Peak Expiratory Flow Rate; Prednisolone; Pregnenediones; Thailand

Topics: Administration, Intranasal; Administration, Oral; Adolescent; Adult; Aerosols; Aged; Asthma; Budesonide; Child; Chronic Disease; Female; Humans; Male; Middle Aged; Prednisolone; Pregnenediones; Respiratory Function Tests

Topics: Administration, Topical; Adult; Aged; Anti-Inflammatory Agents; Bronchitis; Budesonide; Chronic Disease; Erythrocyte Count; Hematocrit; Hemoglobinometry; Humans; Hydrocortisone; Male; Middle Aged; Pregnenediones; Respiratory Therapy

Corticosteroid inhalants, beclomethasone dipropionate (BDP) and budesonide, were compared with each other and with oral prednisolone in patients with steroid dependent chronic bronchial asthma. In a first study in 23 patients the PEF values during 2 weeks' therapy with a supplementary dose of 200 or 800 micrograms of budesonide or 400 micrograms of BDP were found to be better than those noted during a preceding week with a supplementary dose of 30 mg prednisolone. In a following open study 31 patients on an initial maintenance therapy consisting of a standard dose of BDP and a mean daily dose of 9 mg prednisolone were treated with increasing (when necessary) doses of budesonide instead of BDP and decreasing (if possible) dose of prednisolone. After one year's treatment 21 patients were well controlled without oral prednisolone, and the mean prednisolone dose for the entire group was 2.5 mg a day. During the study lung function significantly improved in the subgroup of patients who were initially on the highest dose of oral prednisolone. In a third study in 17 patients the effects on lung function and on symptom scores were compared after a supplementary therapy with 10 or 20 mg oral prednisolone, or 400 or 800 micrograms budesonide. During such treatment the effect of 400 micrograms budesonide on PEF was the same as that of 10 mg prednisolone, and 800 micrograms budesonide and 20 mg prednisolone seemed to be equipotent. For corticosteroid dependent patients with severe asthma the introduction of budesonide seems to offer an improvement, allowing substantial reduction or withdrawal of oral prednisolone. This had not been possible earlier in such patients without deterioration of lung function and their clinical state. During treatment with budesonide lung function remained unchanged or improved.

Topics: Administration, Oral; Adrenal Cortex Hormones; Adult; Aerosols; Aged; Asthma; Beclomethasone; Budesonide; Chronic Disease; Female; Humans; Male; Middle Aged; Prednisolone; Pregnenediones