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Only randomised double blind studies controlled trials were included. Patients with radiographic evidence of bronchiectasis were included, but patients with cystic fibrosis were excluded.
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Eight RCTs were identified, two had insufficient data for any analysis. There were 338 patients in the four usable trials of oral steroids, and 66 patients in two trials of inhaled steroids. The oral steroid dose was equivalent to prednisolone 15-40 mg/day. The inhaled steroid was budesonide 0.8 - 1.2 mg/day. Outcomes were symptoms, chest X-ray (CXR) changes, lung function and global scores (a combination of all three outcomes). Oral steroids improved the CXR over 6-24 months. One study showed no improvement in lung function, in another there was an improvement in diffusing capacity in the treated group. Global scores improved in patients with stage 2 and 3 disease but not with stage 1 disease. There were no data on side-effects. Inhaled steroids had no effect on CXR. In one study diffusing capacity improved. In another, symptoms improved at the end of six months of treatment.
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Double-blind, placebo-controlled, 8-month study with three treatment periods (1-month acute period followed with 1-month maintenance period and 6-month follow-up period) was carried out. Group 1 received FPANS 200 microg bd, during acute, maintenance and follow-up periods, Group 2 received FPANS 200 microg bd during acute period and FPANS 200 microg od during maintenance and follow-up periods, and Group 3 received placebo during acute and maintenance periods and FPANS 200 microg bd during follow-up period. Endpoints were change from baseline in clinic peak nasal inspiratory flow (PNIF), domiciliary evening PNIF, intensity of symptoms and polyposis grade.
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The searches identified 34 citations, of which 26 (representing 13 trials) were eligible for inclusion. These 13 trials reported the use of inhaled corticosteroids in 506 people with cystic fibrosis aged between six and 55 years. One was a withdrawal trial in individuals who were already taking inhaled corticosteroids. Methodological quality and risk of bias were difficult to assess from published information. Many of the risk of bias judgements were unclear due to a lack of available information. Only two trials specified how participants were randomised and less than half of the included trials gave details on how allocation was concealed. Trials were generally judged to have a low risk of bias from blinding, except for two which were open label or did not use a placebo. There were some concerns that a number of trials had not been published in peer-reviewed journals, but the risk of bias from this was unclear. Inclusion criteria varied between trials, as did type and duration of treatment and timing of outcome assessments. Objective measures of airway function were reported in most trials but were often incomplete. Significant benefit has not been conclusively demonstrated. Four trials systematically documented adverse effects and growth was significantly affected in one study using high doses.
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Thirty-five patients (.7-18.7 years old; median: 9.3 years) with AD requiring topical GCs from infancy underwent a low-dose adrenocorticotrophin hormone (ACTH; Synacthen) test (LDST) (500 ng/1.73 m(2) ACTH). Groups 1 (7 patients), 2 (17 patients), and 3 (4 patients) used mild, moderate, or potent/very potent topical preparations, respectively. Group 4 (7 boys with severe, treatment-resistant disease) had received GC in at least 1 form (inhaled +/- intranasal +/- oral) in addition to varying potencies of topical GC. Fourteen healthy subjects (3.8-17.3 years old) served as control subjects. Group 4 patients had a daytime plasma cortisol profile and 08.00 hours measurement of plasma ACTH and its precursors.
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Aims of this study were: to evaluate changes in lung function in wheezing children with detected MP and CP infection according to treatment; to measure the response to inhaled corticosteroids in children with significant wheezing who were selected as having a high risk of progressing into childhood asthma. 54 children were randomly assigned 2:1 into 2 groups-the main group (36 patients), in which inhaled corticosteroids were administered, and the control group (18 patients), without inhaled corticosteroids. Serum IgE levels were determined using the ELISA (reagents: IBL-Hamburg). Serologic studies were performed by the ELISA for IgM and IgG antibodies to MP and for IgG and IgA antibodies to CP (reagents: ImmunoLISA, Orgenics, Israel) on the Hiperion MRIII (USA). Pulmonary function testing was done with SpiroLab II (DEGO GmbH, Medizin-Elektronik, Germany). The patients of both groups were administered macrolides: azitromycin during five days. Patients of the first group received inhaled fluticasone propionate 125 mg twice daily. The parents were asked to record symptoms. Each symptom (wheezing, cough, and shortness of breath) were scored on a scale of 0 to 3--daily symptom score (DSS). Scores were calculated every 4 weeks for a total treatment period 16 weeks. The days within each period on which the DSS equalled zero were pointed as symptom free days (SFD). It had been shown an significant improvement in DSS, an increase in SFD and significant improvement of the lung functions following the treatment with inhaled fluticasone and macrolide in children with wheezing and documented MP or CP infection, compared to control group treated only with antibiotics. In conclusion, the use of ICS should be seriously considered in children with wheezing and the risk of persisting symptoms.
With repeated dosing across a dose range of 250-1000 micrograms twice daily, fluticasone propionate produced significantly greater adrenal suppression than budesonide for both plasma and urinary cortisol. It was therefore possible to demonstrate differences between fluticasone and budesonide at lower doses with chronic dosing from those previously found with single dosing when given on a microgram equivalent basis in asthmatic patients. Factors contributing to the systemic adverse activity profile of fluticasone comprise enhanced receptor potency, prolonged receptor residency time, greater tissue retention, and a longer elimination half life.
The aims were to determine the effect of an oral inhibitor of the signaling mediator p38 mitogen-activated protein kinase (GW856553, losmapimod) on sputum neutrophils, pulmonary function, and blood biomarkers of inflammation in chronic obstructive pulmonary disease (COPD). Three hundred and two individuals with GOLD stage II COPD were randomized to oral losmapimod 7.5 mg twice daily, inhaled salmeterol/fluticasone propionate 50 µg/500 µg combination (SFC), or placebo in a 12-week, randomized, double-blind, double-dummy study (MKI102428/NCT00642148). Neither losmapimod nor SFC had an effect on the primary end point of sputum neutrophils. Losmapimod was well tolerated and reduced plasma fibrinogen by 11% (-0.4 g/L, ratio of effect of losmapimod/placebo 0.89; 95% confidence interval, 0.83-0.96; P = .002) with nonsignificant reductions in interleukin-6, interleukin-8, and C-reactive protein. There was evidence of improvement in hyperinflation with losmapimod compared with placebo (overall P = .02). Inhaled SFC significantly improved lung function and reduced serum CC-16 (ratio of effect of SFC/placebo 0.87; 95% confidence interval, 0.82-0.93; P < .001). It was concluded that oral losmapimod significantly reduced plasma fibrinogen in patients with COPD.
To test the hypothesis that once-daily treatment with fluticasone propionate is as effective as twice-daily treatment in children with well controlled asthma.
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After searching Medline, Cochrane, EMBASE, and Google Scholar, we identified ten articles that described randomized controlled trials of ICS versus placebo or oral SC for treating children with asthma attacks in the ED. Primary outcome was the hospital admission rate as defined as inpatient admission or admission into intensive care unit.
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We conducted a network meta-analysis using Markov chain Monte Carlo methods for two efficacy outcomes: St George's Respiratory Questionnaire (SGRQ) total score and trough forced expiratory volume in one second (FEV1). We modelled the relative effectiveness of any two treatments as a function of each treatment relative to the reference treatment (placebo). We assumed that treatment effects were similar within treatment classes (LAMA, LABA, ICS, LABA/ICS). We present estimates of class effects, variability between treatments within each class and individual treatment effects compared with every other.To justify the analyses, we assessed the trials for clinical and methodological transitivity across comparisons. We tested the robustness of our analyses by performing sensitivity analyses for lack of blinding and by considering six- and 12-month data separately.
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Chronic rhinosinusitis (CRS) is a recalcitrant inflammatory process which has a marked detrimental impact on quality of life. At the present there is no cure for this condition, measures are taken to stop progression, and provide symptomatic relief. Topical corticosteroids are commonly prescribed in the management of CRS, but few trials show effectiveness in clinical settings. We set up a randomized, double-blind, placebo-controlled trial to study the effectiveness of a topical corticosteroid agent--fluticasone propionate aqueous nasal spray (FPANS) in patients with CRS. We measured symptoms, diary card, and rigid endoscopy scores, acoustic rhinometry, middle meatal swabs, blood tests--CRP, ESR, WBC, and eosinophil count. Measurements were done at the start of the trial, at 8 weeks, and 16 weeks where possible. Twenty-two patients completed the trial, 9 received FPANS, and 13 had placebo. There was no difference between the 2 groups on all counts. When patients were considered as one group, there was an improvement in the diary card scores (p = 0.054), comparing baseline to 8 or 16 weeks. There was no evidence that the regular use of topical corticosteroid increased the risk of developing an infection. An important observation was that the topical corticosteroid did not precipitate acute sinusitis. There is compelling evidence that topical corticosteroids down-regulate cytokine expression, and it is likely that a larger, and longer multi-centre trial may prove their efficacy in CRS.
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Fifty patients with well-controlled mild to moderate persistent asthma using FP for more than 6 months were randomly assigned to FP and HFA-BDP groups, and the treatment regimens of the two groups were switched twice between FP and HFA-BDP in a double cross-over manner at 3-month intervals after 2-week washout periods. Evidence of eosinophilic inflammation in blood and induced sputum samples was assessed, together with pulmonary function testing and an Asthma-related Quality of Life Questionnaire (AQLQ) survey after each treatment period.
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A patient-level simulation was developed to compare the costs and outcomes of IND/GLY versus SFC based on data from the LANTERN trial (NCT01709903). Monte-Carlo simulation methods were employed to follow individual patients over various time horizons. Population and efficacy inputs were derived from the LANTERN trial. Considering the payers' perspective, only direct costs were included. Costs and health outcomes were discounted annually at 3.0 % for all countries. Unit costs were taken from publically available sources with all costs converted to euros (€). The cost base year was 2015. Deterministic and probabilistic sensitivity analyses were undertaken to test the robustness of the model results.
We conducted a cross-sectional survey of 500 American Academy of Pediatrics members between November 2005 and May 2006. Standardized vignettes were used to test how different indicators of a patient's asthma status affect pediatrician asthma assessments and recommendations. Linear and logistic regression models were used to examine the association of pediatrician assessments and treatment recommendations for these vignettes, respectively, with the proportion of reported African-American and Latino children seen in their practice.
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A 6-month follow-up of 277 patients with mild, moderate, and severe persistent asthma was randomized to receive fluticasone propionate (FP), BUD, or beclomethasone dipropionate (BDP) in equipotent doses according to their global initiative on asthma (GINA) severity.
Inhaled corticosteroids remain the most important therapy for chronic asthma in both adults and children. As all inhaled corticosteroids act by binding to a common glucocorticoid receptor there is little evidence of any real difference in clinical efficacy between the different inhaled corticosteroids. The main potential differences are in their propensity to cause side effects. Local side effects such as a hoarse voice do occur in a proportion of adults and there is some limited evidence that ciclesonide may cause less local side effects. In adults there is little evidence for clinically important systemic side effects from doses of inhaled steroids below 800 mcg/day (beclomethasone equivalent). Above this dose a proportion of patients may show some adrenocortical suppression, though it is unlikely to be of clinical importance. Data on bone mineral density and fracture rates is discrepant, but an overview would suggest that below 800 mcg/day there is no increase in fracture risk whereas above this dose there might be an increased fracture risk. The properties of ciclesonide would suggest that it has less propensity for systemic side effects, but large long term studies are needed to confirm this. In children using inhaled steroids at above-licensed doses reductions in short-term growth can occur, but there is little evidence for reductions in long-term growth at normal doses. At above-licensed doses, biochemical adrenocortical suppression can occur with some unusual but documented cases of clinical Addisonian crisis. Limited evidence in paediatric age groups would suggest that ciclesonide may have some advantage although it is not as yet licensed in all countries for paediatric use. Data on differences in side effects between normal and asthmatic patients, and between asthmatic patients with near-normal lung function compared to those with impaired lung function, indicate that inhaled corticosteroids (particularly fluticasone) are absorbed more in those with normal lung function; this strongly supports stepping down the inhaled steroid dose when asthma is controlled - as is recommended in asthma guidelines.
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The study had three parts. Firstly, sphingosine 1-phosphate receptor expression on the eosinophils of allergic rhinitis patients and control patients was determined. Secondly, sphingosine 1-phosphate receptor expression was quantified pre- and post-allergen challenge, before and after a short course of fluticasone propionate; all patients underwent symptom scoring and peak nasal inspiratory flow measurement pre- and post-allergen challenge, both before and after steroid or saline treatment. Thirdly, the effect of sphingosine 1-phosphate on eosinophil migration was examined.
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A single-centre, double-blind nasal biopsy study in 22 patients with perennial allergic rhinitis, receiving fluticasone propionate aqueous nasal spray (FPANS) containing BKC, BKC plus placebo or placebo alone for 6 weeks. Before, at two weekly intervals during treatment and 2 weeks after treatment ceased an indigocarmine saccharine transport time (ICST) was performed.
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Combination inhalers improve pulmonary function without potentiating anti-inflammatory effects on exhaled NO and serum ECP as compared with ICS alone, but delay acute salbutamol recovery after bronchoconstriction.
These data suggest that beta2-agonists in combination with low doses of steroids can suppress T-cell proliferation and TH1 cytokine production from healthy individuals, but suppression of T cells with a combination of FP and salmeterol in asthmatic patients requires inhibition of phosphodiesterases.
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The fluticasone group had a significantly increased histamine sensitivity after treatment, unlike the placebo group who had an unchanged or slightly decreased histamine sensitivity after treatment.
This study investigated the structural relaxation of micronized fluticasone propionate (FP) under different lagering conditions and its influence on aerodynamic particle size distribution (APSD) of binary and tertiary carrier-based dry powder inhaler (DPI) formulations. Micronized FP was lagered under low humidity (LH 25 C, 33% RH [relative humidity]), high humidity (HH 25°C, 75% RH) for 30, 60, and 90 days, respectively, and high temperature (HT 60°C, 44% RH) for 14 days. Physicochemical, surface interfacial properties via cohesive-adhesive balance (CAB) measurements and amorphous disorder levels of the FP samples were characterized. Particle size, surface area, and rugosity suggested minimal morphological changes of the lagered FP samples, with the exception of the 90-day HH (HH90) sample. HH90 FP samples appeared to undergo surface reconstruction with a reduction in surface rugosity. LH and HH lagering reduced the levels of amorphous content over 90-day exposure, which influenced the CAB measurements with lactose monohydrate and salmeterol xinafoate (SX). CAB analysis suggested that LH and HH lagering led to different interfacial interactions with lactose monohydrate but an increasing adhesive affinity with SX. HT lagering led to no detectable levels of the amorphous disorder, resulting in an increase in the adhesive interaction with lactose monohydrate. APSD analysis suggested that the fine particle mass of FP and SX was affected by the lagering of the FP. In conclusion, environmental conditions during the lagering of FP may have a profound effect on physicochemical and interfacial properties as well as product performance of binary and tertiary carrier-based DPI formulations.
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FP extensively inhibited inflammatory recruiters, at both protein and RNA levels, confirming the ability of glucocorticoids to modulate the inflammatory process in nasal polyps. This inhibition was associated to decreased NF-kappaB nuclear translocation, demonstrating that this is an important mechanism of glucocorticoids action for nasal polyps.