Inhaled Fluticasone Propionate Research Articles

Comparative study of fluticasone propionate with budesonide and beclomethasone dipropionate in mild persistent bronchial asthma

Objective: To compare the efficacy and adverse effects of fluticasone propionate with that of budesonide and beclomethasone dipropionate in mild persistent cases of bronchial asthma. Methods: This was an open label, randomized parallel group study done in Government General and Chest Hospital, Hyderabad for a period of 12 weeks. Each group had 20 patients. The group I was given fluticasone propionate inhalation therapy 100μg twice daily. Group II was given budesonide inhalation therapy 200μg twice daily. Group III was given beclomethasone dipropionate inhalation therapy 200μg twice daily. Results: Symptomatic improvement was observed in all three groups. At end point, mean FEV1 in fluticasone propionate treatment group improved by 22.04% compared with 14.53% in budesonide and 12.02% in beclomethasone treatment groups. At end point, mean FVC value of the fluticasone propionate treatment group improved by 8.04% compared with 5.29% in budesonide and 4.27% in beclomethasone groups. Mean FEV1 / FVC also improved by 12.76% in the fluticasone propionate group compared with 8.63 % in budesonide and 7.45 % in beclomethasone groups. No adverse effects were reported in any of the treatment groups. Conclusion: This study showed that fluticasone propionate is superior to budesonide and beclomethasone in improving lung function, decreasing symptoms and need for rescue medication in mild persistent asthma

Fluticasone Furoate, a Novel Inhaled Corticosteroid, Demonstrates Prolonged Lung Absorption Kinetics in Man Compared with Inhaled Fluticasone Propionate

BackgroundFluticasone furoate (FF; GW685698) is a novel inhaled corticosteroid that is active at 24 h and under development for once-daily administration in combination with the long-acting β2-adrenoceptor agonist vilanterol (GW642444) for chronic obstructive pulmonary disease and asthma. In vitro studies examining the respiratory tissue-binding properties of corticosteroids showed FF to have the largest cellular accumulation and slowest rate of efflux compared with other clinically used inhaled corticosteroids, consistent with greater tissue retention. The enhanced affinity of the glucocorticoid receptor binding of FF, coupled with its extended tissue association, may be expected to lead to greater and more prolonged anti-inflammatory effects and should provide relevant once-daily efficacy.ObjectiveThe aim of this study was to assess the rate and extent of systemic absorption of FF from the lung following inhaled administration of FF from three exploratory dry powder formulations (via DISKHALER®) compared with inhaled fluticasone propionate (FP) [via DISKHALER®] using deconvolution analysis.MethodsThis open-label, part-randomized, six-way crossover study evaluated three early development dry powder inhaled formulations of FF administered as single doses via DISKHALER®. Healthy male subjects (n = 24) each received FF (2,000 μg; three formulations), inhaled FP (1,000 μg; via DISKHALER®) and 250 μg of each molecule by intravenous infusion. The bioavailability of both inhaled FF and FP represents absorption from the lung as the oral bioavailability from the swallowed portion of the inhaled dose is negligible (<1.5 %). To investigate the absorption kinetics from the lung, the inhaled concentration–time data were subjected to deconvolution analysis using derived pharmacokinetic parameters from fitting of the intravenous concentration–time data.ResultsThe terminal elimination half-life (t½β) for inhaled FF was considerably longer (range 17–24 h) than the t½β estimated for intravenous FF (14 h), whereas t½β for FP was similar whether inhaled or given intravenously (11 and 14 h, respectively). This would suggest that FF is exhibiting absorption rate-limited pharmacokinetics following inhaled FF dosing and that the apparent t½β is an estimate of absorption rate. The lung mean absorption time for FF was approximately 7 h irrespective of formulation, which was considerably longer than FP (2.1 h). The time for 90 % absorption from the lung was significantly longer for FF (20–30 h) than for FP (8 h), indicating a significantly longer lung retention time for FF.ConclusionIn comparison with inhaled FP, inhaled FF (independent of formulation) demonstrated prolonged absorption from the lung into the systemic circulation, indicating a longer lung retention time and suggesting the potential for maintained efficacy with once-daily administration.

S89 Epithelial Mesenchymal Transition (EMT) in Chronic Obstructive Pulmonary Disease (COPD) Airways is Attenuated by Inhaled Corticosteroids (ICS)

Introduction and ObjectivesWe recently reported1, 2 that EMT is active in the airways of COPD patients; in this process epithelial cells change shape and become motile, then digest through the...

Osteocalcin, Cortisol Levels, and Bone Mineral Density in Prepubertal Children with Asthma Treated with Long-Term Fluticasone Propionate

Aims: The objective of this study is to determine the effects of the long-term treatment with inhaled fluticasone propionate on osteocalcin, cortisol levels, and bone mineral status in children with asthma. Methods: This cross-sectional study examined 230 prepubertal children with asthma (aged 6–11) who had intermittently used inhaled fluticasone propionate for at least 5 years at a mean daily dose of 200 µg (range: 200–350 µg). Serum osteocalcin, cortisol, and bone mineral density (BMD) of the lumbar spine were obtained from each participant. The control group consisted of gender- and age-matched children (n = 170) who were newly diagnosed with asthma and who were not being treated with corticosteroid. Results: The average age (±SEM) was 8.9 ± 0.7 years, their mean (±SEM) daily steroid dose was 180.3 ± 55.0 µg, with 236.5 ± 17.2 g total steroid use during treatment. Between the study and the control groups, no significant differences were observed in cortisol, osteocalcin levels, and BMD (p > 0.05). Conclusion: Long-term treatment with inhaled fluticasone propionate (100 µg twice daily) revealed no negative effects on serum osteocalcin, cortisol levels, and BMD in children with asthma.

Endocrine effects of inhaled budesonide compared with inhaled fluticasone propionate and oral prednisolone in healthy Beagle dogs

Orally administered corticosteroids are commonly used to treat chronic respiratory disease, but adverse effects suggest that the inhalation route may be safer. To compare the systemic effects of inhaled and oral corticosteroids, a prospective, randomised, placebo-controlled cross-over study was conducted. Six healthy neutered female Beagle dogs were randomly allocated to four treatment groups: (1) budesonide inhalation (200 μg twice daily); (2) fluticasone inhalation (250 μg twice daily); (3) oral prednisolone (1mg/kg once daily); and (4) placebo inhalation (room air twice daily). Each treatment and wash-out period lasted 4 weeks. The endocrine status of each dog was assessed on days 0, 28 and 35 using the adrenocorticotropic hormone (ACTH) stimulation test. The effects of treatments were assessed using a linear mixed effects model. After the 4 week treatment period, a significant decrease was observed in the basal serum cortisol level of the prednisolone group (P<0.03), and a decrease was also seen in the ACTH-stimulated peak cortisol levels of both the prednisolone and fluticasone groups (P<0.001), compared with the budesonide group in which no suppression was detected. The results showed that cortisol production in dogs was strongly suppressed by oral prednisolone and by inhaled fluticasone.

Association between WDR21A polymorphisms and airway responsiveness to inhaled corticosteroids in asthmatic patients

Genetic polymorphism is partially responsible for the wide variation in the response of moderate-to-severe asthmatic patients to inhaled corticosteroids. The goal of the study was to examine polymorphisms in WDR21A, which encodes a putative glucocorticoid receptor (GR)-interacting protein, for their possible association with corticosteroid responsiveness. The change in forced expiratory volume in 1 s [FEV(1) (ΔFEV(1))] induced by 4 weeks of inhaled treatment with fluticasone propionate (1000 µg daily) was measured in 230 asthmatic patients. Fifteen single nucleotide polymorphisms (SNPs) of WDR21A were genotyped using a TaqMan assay, and 11 SNPs were used for further analysis. WDR21A transcripts were analyzed for variant splicing using reverse transcriptase-PCR. The WDR21A protein structure was predicted using a template-based modeling method and docked to a GR using Zdock. Of the 11 SNPs and three haplotypes of WDR21A analyzed, only the intronic SNP -10073G>C appeared to affect ΔFEV(1). The ΔFEV(1) of the -10073C/C homozygous genotype was twice that of the -10073G/G and -10073C/G genotypes (P(corr)=0.04 in recessive model). No splicing variant of WDR21A was observed, regardless of genotype. The predicted WDR21A protein structure was similar to the Gβ(1) protein structure (template modeling-score=0.93). The minor allele -10073C of WDR21A may induce a good response to inhaled corticosteroids possibly through competition with the Gβ(1) proteins for binding to GRs.

Bone mineral density and associated parameters in pre-pubertal children with asthma treated with long-term fluticasone propionate

AimsThe primary aim of the objective of the study was to determine the effects of long-term treatment with the recommended dose of inhaled fluticasone propionate spray usage on bone mineral status in children with asthma. MethodsThis cross-sectional, case–control study was of 270 pre-pubertal children with asthma, who had used inhaled fluticasone propionate at a mean daily dose of 200μg (range: 200–350μg) for at least 5 years. The bone mineral density (BMD) of the lumbar spine was measured by dual-energy X-ray absorptiometry (DEXA). The results were compared to untreated controls (n=200), who were newly diagnosed children with asthma without any corticosteroid treatment. ResultsThe 270 study patients (175 males) were aged between 6 and 13 years. The average age (±SEM) was 9.2±0.6 years, and the mean (±SEM) steroid dosage used was 183.3±57.0μg daily, with 236.5±17.2g total steroid use during treatment. Between the study and the control groups, no significant difference was observed in BMD (p>0.05). ConclusionThe findings suggest that long-term periodical treatment for 5 years with inhaled fluticasone propionate, 100μg twice daily, in children with asthma revealed no negative effect on bone mineral density by using DEXA.

The clinical observation of fluticasone salmeterol inhaler combined with salbutamol inhalation of oxygen-driven treatment of chronic obstructive pulmonary disease with acute exacerbation

Objective To observe the clinical efficacy of fluticasone salmeterol inhaler combined with salbutamol inhalation of oxygen-driven treatment of chronic obstructive pulmonary disease with acute exacerbation. Methods 60 patients of chronic obstructive pulmonary disease with acute exacerbation ,randomly divided into observation and control groups of 30 patients each. The control group on the basis of conventional treatment with salmeterol plus flutica sone inhalation powder compound and the oxygen-driven albuterol inhalation aerosol liquid, the other group by conventional therapy based on the use of oxygen-driven albuterol inhalation aerosol solution, then compare the clinical curative effects. Results There were 18 examples excellencely, i0 examples improve, 2 examples ineffective of observation group with total effective rate 93.3% ;9 examples excellencely, 11 examples improve, 10 examples ineffective of control group with total effective rate 66.7%. The contrast of total effective power with the two groups exists the staffstical significance （ X2 = 4.60,P 〈 0.05 ） o In the observation group, FEV1 and FVC of post-treatment, were better than pretherapy and post-treatment of control group （ t = 2. 629,2. 649,2.064,2.051, P 〈 0. 05 ）. Conclusion Salmeterol and fluticasone propionate inhalation powder hybrid atomizing inhalation of salbutamol effective than salbutamol alone. Key words: Pulmonary disease, chronic obstructive ; Administration, inhalation; Salmeterol, fluticasone ; Salbutamol

Understanding risk in asymptomatic carotid stenosis

Drug delivery by inhalation is used to maximize the therapeutic effect in the lung while minimizing systemic exposure. However, to achieve the best possible treatment we need to understand where a targets is expressed in the lung and assure retention of drugs at the relevant location. Currently, our models regard the lung as a uniform unit and do not distinguish between different tissue structures and hence we need to increase our understanding of what structures are targeted by inhalation and if all benefit from inhaled delivery equally. In the present study, we used RNAscope in-situ hybridization to systemically examine how the administration route influences which part of the lung respond to fluticasone propionate (FP). Together with an automated image analysis, developed specifically to adress the different sub-compartments of the lung, we were able to measure mRNA expression of Zbtb16 in epithelium, sub-epithelium, alveolar bed and blood vessels. Spleenic Zbtb16 expression, measured by qPCR, was used to assess systemic responses. The results show that inhaled and i.v. administration give different distinct spatial responses. Inhalation of FP provides superior targeting of the airway epithelium and sub-epithelium regions but not alveolar space or vasculature compared to systemic administration. Finally, the analysis shows that exclusive targeting of lung epithelium by inhalation can be achieved with very low doses of FP.

Effects of inhaled fluticasone on intraocular pressure and central corneal thickness in asthmatic children without a family history of glaucoma

Purpose:The aim of this study is to report the effects of fluticasone-inhaled corticosteroid on intraocular pressure (IOP) and central corneal thickness (CCT) of asthmatic children without a family history of glaucoma.Materials and Methods:In this prospective study, 93 children were divided into two groups: 69 asthmatic children with no family history of glaucoma who were taking inhaled fluticasone propionate 250 μg daily for at least 6 months (Group 1) and 24 age-matched control subjects without asthma (Group 2). Three measurements each, of IOP and CCT, were performed with a hand-held noncontact tonometer and a noncontact specular microscope, respectively, over a 12-week period. The order of IOP and CCT measured were randomized at each visit. Between-group comparison and the relationship between CCT and IOP measurements were investigated. P < 0.05 was statistically significant.Results:The mean age was 8 ± 2.4 years (range, 5–15 years) and 9 ± 2.9 years (range, 5–15 years) for Groups 1 and 2, respectively (P = 0.1337). The mean IOP was 14 ± 3.3 mmHg (range, 10–24 mmHg) and 14 ± 2.9 mmHg (range, 11–22 mmHg) for Groups 1 and 2, respectively (P = 0.3626). The mean CCT was 531 ± 30.1 μm (range, 467–601 μm) and 519 ± 47.0 μm (range, 415589 μm) for Groups 1 and 2, respectively (P = 0.1625). There was a weak but statistically significant correlation between IOP and CCT in Group 1 (Pearson's R = 0.3580, P = 0.0025).Conclusions:Inhaled fluticasone at the regular dose used in this study over a short period (6–24 months) was not associated with a significant effect on CCT and IOP measured with noncontact devices in asthmatic children between 5 and 15 years, without a family history of glaucoma. A weak correlation between IOP and CCT values in asthmatic children did exist.

Increased risk of nontuberculous mycobacterial infection in asthmatic patients using long‐term inhaled corticosteroid therapy

The risk of pneumonia is increased among COPD patients using inhaled corticosteroids (ICS). However, there is uncertainty regarding the association between long-term use of ICS and exacerbations of respiratory tract infections among asthmatic patients. A case-control nested cohort study was performed to assess the association of asthma with nontuberculous mycobacterium (NTM) infection. Among this cohort of 464 asthmatic patients, 14 experienced complications due to NTM infections, of which eight were caused by Mycobacterium avium-intracellulare complex, three by M. kansasii, one by M.terrae and the remaining two by unclassifiable scotochromogens. Asthmatic patients with NTM infections were older (67.1 ± 8.6 vs 58.8 ± 12.3 years, P < 0.01) and had more severe airflow limitation (FEV(1) %, 60.6 ± 10.3 vs 72.3 ± 18.3, P < 0.03) than those without NTM infections. All except one had received ICS treatment for more than 5 years, and 12 of the 14 patients used inhaled fluticasone propionate daily (four patients at a dose of 400 µg/day and eight patients at a dose >800 µg/day). These findings suggest that the risk of NTM infection may be greater in asthmatic patients who are older, have more severe airflow limitation and receive higher doses of ICS therapy.

Bioavailability of inhaled fluticasone propionateviachambers/masks in young children

We determined lung bioavailability of a fluticasone propionate (FP) pressurised metred-dose inhaler (Flovent HFA; GlaxoSmithKline, Research Triangle Park, NC, USA) administered via AeroChamber Plus (Monaghan Medical, Plattsburgh, NY, USA) with Facemask and Babyhaler (GlaxoSmithKline) valved holding chambers (VHCs) using a population pharmacokinetic approach. Children from 1 to <4 yrs of age with stable asthma but a clinical need for inhaled corticosteroid therapy were administered 88 μg FP hydrofluoroalkane (2 × 44 μg) twice daily delivered through the two devices in an open-label, randomised crossover manner for 8 days each. Patients were randomised to one of three sparse sampling schedules for blood collection throughout the 12-h dosing interval on the 8th day of each treatment for pharmacokinetic analysis. The area under the FP plasma concentration-time curve (AUC) was determined for each regimen. 17 children completed the study. The population mean AUC following FP with AeroChamber Plus with Facemask was 97.45 pg·h·mL(-1) (95% CI 85.49-113.32 pg·h·mL(-1)) and with Babyhaler was 51.55 pg·h·mL(-1) (95% CI 34.45-64.46 pg·h·mL(-1)). The relative bioavailability (Babyhaler/AeroChamber Plus) was 0.53 (95% CI 0.30-0.75). Clinically significant differences in lung bioavailability were observed between the devices. VHCs are not interchangeable, as differences in drug delivery to the lung may occur. A population pharmacokinetic approach can be used to determine lung bioavailability of FP.

Effect of adjunct fluticasone propionate on airway physiology during rest and exercise in COPD

Combination therapy with corticosteroid and long-acting β(2)-agonists (LABA) in a single inhaler is associated with superior effects on airway function and exercise performance in COPD compared with LABA monotherapy. The physiological effects of adding inhaled corticosteroid monotherapy to maintenance bronchodilator therapy (long-acting anticholinergics and LABA singly or in combination) in COPD are unknown. This was a randomized, double-blind, placebo-controlled, crossover study (NCT00387036) to compare the effects of inhaled fluticasone propionate 500 μg (FP500) twice-daily and placebo (PLA) on airway function during rest and exercise, measured during constant work rate cycle exercise at 75% of maximum incremental cycle work rate, in 17 patients with COPD (FEV(1) ≤ 70% predicted). After treatment with FP500 compared to PLA, there were significant increases in post-dose measurements of FEV(1) (+115 mL, P = 0.006) and the FEV(1)/FVC ratio (+2.5%, P = 0.017), along with decreases in plethysmographic residual volume (-0.32L; P = 0.031), functional residual capacity (-0.30L, P = 0.033), and total lung capacity (-0.30L, P = 0.027) but no changes in vital capacity or inspiratory capacity (IC). Post-treatment comparisons demonstrated a significant improvement in endurance time by 188 ± 362 s with FP500 (P = 0.047) with no concomitant increase in dyspnea intensity. End-inspiratory and end-expiratory lung volumes were reduced at rest and throughout exercise with FP500 compared with PLA (P < 0.05). Inhaled FP500 monotherapy was associated with consistent and clinically important improvements in FEV(1), static lung volumes, dynamic operating lung volumes, and exercise endurance when added to established maintenance long-acting bronchodilator therapy in patients with moderate to severe COPD.

A case of peripheral and eosphagatic hypereosinophilia and food wllergy after liver’s transplantation in adult

From one year of liver's transplantation and cyclosporin (CSA) maintenance treatment(100 mg a day), a 43 years old women presented with abdominal pain and diarrhea immediately after eating milk and egg. She underwent the transplantation after an acute liver toxicity caused by isoniazid during tuberculosis treatment. Increasing hyperosinophilia (40%) and eosinophilic oesophagitis (EE) presented with food allergy. Total IgE were low (45UI). Commercial skin prick test and prick by prick as specific IgEs detection (IMMUNOCAP) were positive for milk's proteins, egg, rice and wheat flour. Hypereosinophilia persisted inspite of an elimination diet for the culprit allergens while the clinical symptoms of food allergy improved. Other causes of hypereosinophilia were excluded. Interestingly only an inhaled fluticasone propionate treatment (FP,250 mcg bid) for three months was followed by an outstanding reduction of EE and hypereosinophilia (less than 1000/mm3 and <25%) without changing CSA dosage. Food allergy and hypereosinophilia has been increasingly reported in children in the setting of liver transplantation during tacrolimus treatment.On the contrast reports in adults are very rare expecially during CSA treatment. In our patient elimination diet wasn't followed by a reduction of hypereosinofilia as generally occurs in pediatric cases. Our patient didn't present any allergy before the transpantation.No information was available on donor's known allergy. Different meccanisms are supposed underlying the new onset of food allergy and hypereosinophilia in liver's transplantation: • An imbalance between Th1/Th2 cells or an increased enteric permeability. • Immune effects of viral infections associated with the immunosoppressive state. • Acquired food allergy and hypereosinophilia due to a transfer of hepatic hematopoietic stam cells or active IGE from the donor's liver. More studied are needed in a controlled setting to identify similar findings among liver transplants.Moreover in the pretransplant investigation should be inlcluded the allergic status both of the donor as the recipient.

Systemic exposure to fluticasone MDI delivered through antistatic chambers

We performed this study to evaluate how age and device affect the systemic exposure of inhaled fluticasone propionate (FP) in children. The findings indicate an anti-static valved holding chamber significantly increases systemic exposure of FP.

Selective cyclooxygenase-2 inhibitor cross-reactivity in aspirin-exacerbated respiratory disease

Aspirin-induced asthma (AIA) is a severe and difficult-to-treat allergic disease in which acute asthma attacks are induced by nonsteroidal anti-inflammatory drugs. Patients with AIA rarely experience asthma attacks when taking celecoxib, a specific inhibitor of cyclooxygenase (COX) 2. A 33-year-old woman had a severe asthma attack with hypoxia and lost consciousness after oral provocation testing with 15 mg of aspirin and also with 50 mg of celecoxib. After 2 months of treatment with 10 mg/day of oral prednisolone, 1600 μg/day of inhaled fluticasone propionate, montelukast as a leukotriene receptor antagonist (LTRA), and long-term beta-agonist, we again challenged her with a provocation test with up to 200 mg of celecoxib; this time there were neither allergic symptoms nor decrease in forced expiratory volume in 1 second. Patients with severe or poorly controlled asthma may experience asthma attacks even if using selective COX-2 inhibitors. However, treatment with steroids and an LTRAs may inhibit asthma attacks induced by celecoxib.

The ‘stage-by-stage’ deposition of drugs from commercial single-active and combination dry powder inhaler formulations

Inhalation of salmeterol xinafoate (SX) and fluticasone propionate (FP) from a combination product is reported to produce superior clinical outcomes in comparison to the concurrent administration of ‘similar’ doses via separate single-active inhalers. For bioequivalence determination across different products, emphasis is currently placed on the assessment of drug deposition within inertial impactors on a ‘stage-by-stage’ basis as stipulated in a recent European Medicines Agency guidance. The aim of this study was to compare the stage-by-stage deposition of drugs aerosolised from the single-active Accuhaler® products Serevent® (SX) and Flixotide® (FP) with the SX–FP combination product Seretide® Accuhaler® in vitro. Drug deposition on a stage-by-stage basis was assessed using the next generation impactor (NGI). Significant differences in drug deposition profiles were obtained following aerosolisation from the single-active versus combination products. The concurrent administration of the two single-active products: Serevent® and Flixotide® Accuhaler® may not be bioequivalent to inhalation of the combination product Seretide® Accuhaler®. The observed differences may have resulted from different characteristics of the active pharmaceutical ingredient (APIs) and the carrier alpha-lactose monohydrate between the single-active and combination inhalers and/or a change in the drug-carrier inter-particulate interaction as a consequence of the presence of a second active.

Effect of short-term oral and inhaled corticosteroids on airway inflammation and responsiveness in a feline acute asthma model

The objective of this study was to investigate whether high-dose inhaled fluticasone propionate (FP), alone or in combination with salmeterol (SAL), is as effective as oral prednisolone in reducing airway inflammation and obstruction in cats with experimentally-induced acute asthma. Six cats sensitised to Ascaris suum (AS) were enrolled in a prospective controlled therapeutic trial and underwent four aerosol challenges, at 1-month intervals with AS allergen. The allergen - stimulated animals received four consecutive days treatment with either oral prednisolone at 1mg/kg twice daily, 500 μg of FP inhaled twice daily, or a combination of FP/SAL at 500 μg/50 μg inhaled twice daily, respectively, according to a randomised cross-over design. Treatment-related changes in lung function, airway responsiveness (AR) and bronchoalveolar lavage fluid (BALF) cytology were assessed. Barometric whole-body plethysmography (BWBP) was used for the assessment of respiratory variables and AR. No significant differences in respiratory rate or Penh (an estimate of airflow limitation measured by BWBP) were detected among treatment groups. Allergen-induced airway hyper-responsiveness was significantly inhibited by all three steroid treatments (P<0.05). The mean BALF eosinophil percentage (±SEM) was lower after oral and inhaled corticosteroid treatment and these changes were significant for groups receiving prednisolone and the FP/SAL combination. Findings suggest high-dose FP, particularly in combination with SAL, is effective in ameliorating airway inflammation and hyper-responsiveness in this model of acute feline asthma, and highlight the potential use of these drugs in cats experiencing acute exacerbations of the naturally occurring disease.

Evaluation impact of long-term usage of inhaled Fluticasone propionate on ocular functions in children with asthma

Objective Although systemic, topical, and periocular corticosteroid administration have long been associated with ocular side effects, there has been little evidence to suggest that long-term inhaled corticosteroids can cause ocular side effects. The aim of this study was to evaluate the effects of long term treatment inhaled fluticasone propionate spray usage the recommended dose on some ocular functions in pediatric patients with asthma. Methods The study group consisted of 266 prepubertal children with asthma who had used inhaled fluticasone propionate spray at 3–6 years intermittently. One hundred and sixty children who were newly diagnosed with asthma without any treatment made up the control group. Schirmer test results, central corneal thickness, visual acuity, intraocular pressure, cataract formation, keratometry and tear break-up time compared between study and control groups. Results The ages of the 266 study patients (150 male) were between 7 and 11 years. The average age (±SEM) was 8.2 ± 1.7 years, and the mean (±SEM) a daily dose of 323 μg (range 250–450 μg) inhaled fluticasone propionate spray, with 865.2 ± 215 g total steroid use during treatment. Eye functions including cataract formation, corneal ectasia, ocular hypertension or glaucoma, and dry eye were not observed in any of the patients in the study group and were not correlated with total steroid dosage ( t = 0.150, p = 0.384). Conclusion Our findings suggest that long-term intermittent treatment for 3–6 years with inhaled fluticasone propionate spray, as much as average 320 μg daily, in children with asthma seems to be safe for some eye functions.

Evaluation of adrenocortical function in 3-7 aged asthmatic children treated with moderate doses of fluticasone propionate: reliability of dehydroepiandrosterone sulphate (dhea-s) as a screening test

Background Inhaled corticosteroids (ICS) are the first-line therapy in the treatment of persistent asthma. At medium to high doses and prolonged usage, ICS can supresss the hypothalamic-pituitary-adrenal axis. Dehydroepiandrosterone sulphate (DHEA-S) is a corticotropin-dependent adrenal androgen precursor that is supressible in patients treated with ICS. Objectives To evaluate the adrenal axis in asthmatic children treated with moderate doses of fluticasone propionate and to evaluate the DHEA-S as a possible marker for adrenal axis ın preadrenarchal children. Methods Twenty-eight children with persistent asthma with a mean age of 4.4 years (median 4.2; range 2.5-7.1) on long term treatment (mean 6.16; median 6; range 4.5-9 months) with moderate doses (mean 250; median 253; range 158-347 (g/m 2/day) of inhaled fluticasone propionate were evaluated with low-dose ACTH stimulation test to assess adrenal function, and DHEA-S levels were compared with the results. Results One out of 28 patients (3.57%) demonstrated an abnormal cortisol response to low-dose ACTH test. There was no correlation between DHEA-S and peak cortisol, morning cortisol and fasting blood glucose levels. However, mean inhaled corticosteroid dosages were inversely correlated with the DHEA-S. Conclusıons In most of the children with persistent asthma, mild to moderate fluticazone propionate doses supress the hypothalamic-pituitary-adrenal axis rarely. Chronic moderate doses of ICS may suppress adrenal androgen levels without supression of cortisol production. DHEA-S levels may be used as a practical method to follow adrenal functions and may be an earlier indicator of adrenal dysfunction in children.