PURPOSE: We aim to compare the effectiveness and safety of fluticasone propionate (Flt) plus tulobuterol (Hk) versus high-dose Flt alone in controlling asthma in children. METHODS: Fifty three children aged 4 to 8 years, who were diagnosed with mild persistent asthma and underwent maintenance therapy with a low dose of inhaled corticosteroid (Flt) of 50-100 microgram/day were randomized to receive Flt plus Hk (Hokunalin(R) patch 1 mg, Abbott Japan, Tokyo, Japan), or Flt alone at twice the dosage. Patients underwent new treatment for 4 weeks. Asthma symptom scores, mean changes in morning and evening peak expiratory flow (PEF), the frequency of night awakenings, the use of reliever medication, caregiver's overall satisfaction and safety were evaluated and compared in each group. And they were followed-up again 4 week after treatment course for the evaluation of treatment-emergent adverse event (TEAE). RESULTS: No significant difference was found between the groups in terms of mean changes in the morning and evening PEF, the frequency of night awakening, the use of rescue medication and caregiver's overall satisfaction (P=0.83, P=0.83, P=0.17, P=0.32 and P=0.63). Furthermore, no statistically significant difference was observed between 2 groups in the incidence of any TEAE (P=1.00). CONCLUSION: This study demonstrated that a combination of Flt and Hk was as effective as a high-dose Flt therapy in the management of mild persistent asthma in children. The results of this study suggest that tulobuterol add-on therapy can be considered as a reasonable substitute to an increase in the dosage of steroid in the patients with steroid-phobia and it might be used to reduce the risk of high dose steroid therapy.
Aged ; Androstadienes ; Asthma ; Child ; Diethylpropion ; Humans ; Incidence ; Japan ; Terbutaline ; Tokyo ; Fluticasone

BACKGROUND: The discomfort caused by chronic cough, that is persistent for more than 3 weeks, causes a number of patients to seek medical attention. However, the underlying disorder often remains undetermined despite thorough examinations, and is considered to be idiopathic. This study compared the efficacy of inhaled corticosteroid with conventional cough suppressants on chronic idiopathic cough. METHODS: Eligible patients with chronic idiopathic cough were randomly assigned to either the inhaled fluticasone group or the codeine plus levodropropizine oral administration group. The subjects in each group took their planned medication for 2 weeks. After the trial, comparative analyses of outcomes were performed in terms of the remnant cough (%) at the end of treatment, drug compliance, and adverse drug events. RESULTS: Seventy-seven patients were enrolled in this randomized trial; 38 to the inhaled fluticasone group and 39 to the codeine plus levodropropizine group. The remnant cough was 41.0+/-35.8% in the inhaled fluticasone group, and 32.4+/-32.0% in the codeine+levodropropizine group (p=0.288). Drug compliance was 95.4+/-7.4% and 81.8+/-18.6% in the inhaled fluticasone and the codeine+levodropropizine group, respectively (p<0.001). Nine patients had adverse drug events in the codeine+levodropropizine group compared to one in the inhaled fluticasone group (p<0.001). CONCLUSION: Short-term inhaled corticosteroid is not inferior to conventional antitussive agents in controlling chronic idiopathic cough without significant adverse events.
Administration, Oral ; Androstadienes ; Antitussive Agents ; Codeine ; Compliance ; Cough ; Drug Toxicity ; Humans ; Propylene Glycols ; Fluticasone

BACKGROUND: The discomfort caused by chronic cough, that is persistent for more than 3 weeks, causes a number of patients to seek medical attention. However, the underlying disorder often remains undetermined despite thorough examinations, and is considered to be idiopathic. This study compared the efficacy of inhaled corticosteroid with conventional cough suppressants on chronic idiopathic cough. METHODS: Eligible patients with chronic idiopathic cough were randomly assigned to either the inhaled fluticasone group or the codeine plus levodropropizine oral administration group. The subjects in each group took their planned medication for 2 weeks. After the trial, comparative analyses of outcomes were performed in terms of the remnant cough (%) at the end of treatment, drug compliance, and adverse drug events. RESULTS: Seventy-seven patients were enrolled in this randomized trial; 38 to the inhaled fluticasone group and 39 to the codeine plus levodropropizine group. The remnant cough was 41.0+/-35.8% in the inhaled fluticasone group, and 32.4+/-32.0% in the codeine+levodropropizine group (p=0.288). Drug compliance was 95.4+/-7.4% and 81.8+/-18.6% in the inhaled fluticasone and the codeine+levodropropizine group, respectively (p<0.001). Nine patients had adverse drug events in the codeine+levodropropizine group compared to one in the inhaled fluticasone group (p<0.001). CONCLUSION: Short-term inhaled corticosteroid is not inferior to conventional antitussive agents in controlling chronic idiopathic cough without significant adverse events.
Administration, Oral ; Androstadienes ; Antitussive Agents ; Codeine ; Compliance ; Cough ; Drug Toxicity ; Humans ; Propylene Glycols ; Fluticasone

PURPOSE: To compare the effect of loteprednol etabonate (LE) with prednisolone acetate (PDA) drops on the proliferation of human Tenon's capsule fibroblasts (HTFBs). METHODS: Primarily cultured HTFBs were treated with serially diluted PDA and LE for 3 days. Cellular survival was determined by a rapid colorimetric assay using MTT. RT-PCR was performed to determine the relative expression of TGF-beta mRNA in response to LE and PDA. RESULTS: PDA inhibited proliferation of HTCF in a dose-dependent manner and LE inhibited significantly the proliferation of HTCF at the higher concentration of 50 microg/ml (p < 0.05). Compared to LE, PDA inhibited proliferation of HTCF significantly at each diluted concentration (p < 0.05). Expressions of TGF-beta were decreased as the concentration of both PDA and LE increased. PDA decreased expression of TGF-beta more significantly compared to LE at each concentration (p < 0.05). CONCLUSIONS: Although LE has offered promising anti-inflammatory efficacy with decreased impact on intraocular pressure, LE may be less effective than PDA in inhibiting fibroblast proliferation and may be not comparable to PDA in preventing excessive scarring after glaucoma filtering surgery.
Androstadienes ; Cicatrix ; Fibroblasts ; Filtering Surgery ; Glaucoma ; Humans ; Intraocular Pressure ; Ophthalmic Solutions ; Prednisolone ; RNA, Messenger ; Tenon Capsule ; Transforming Growth Factor beta ; Loteprednol Etabonate

BACKGROUND: To compare the profiles of the bronchodilator response (BDR) among children with asthma and/or allergic rhinitis (AR) and to determine whether BDR in these children is reduced by treatment with inhaled and/or nasal corticosteroid. METHODS: Sixty-eight children with asthma (mean age, 10.9 years), 45 children with comorbid asthma and AR (mean age, 10.5 years), and 44 children with AR alone (mean age, 10.2 years) were investigated. After a 2-week baseline period, all children were treated with inhaled fluticasone propionate (either 100 or 250 microg b.i.d., tailored to asthma severity) or nasal fluticasone propionate (one spray b.i.d. in each nostril) or both, according to the condition. Before and 2 weeks after starting treatment, all children were evaluated with spirometry and bronchodilator testing. BDR was calculated as a percent change from the forced expiratory volume in 1 second (FEV1) at baseline. RESULTS: The mean BDR was 10.3% [95% confidence interval (CI) 8.3-12.4%] in children with asthma, 9.0% (95% CI 7.3-10.9%) in subjects with asthma and AR, and 5.0% (95% CI 4.1-5.9%) in children with AR alone (P<0.001). After treatment, the mean BDR was reduced to 5.2% (95% CI 4.2-6.3%) (P<0.001) in children with asthma and to 4.5% (95% CI 3.5-5.5%) (P<0.001) in children with asthma and AR. However, children with rhinitis showed no significant change in BDR after treatment, with the mean value being 4.7% (95% CI 3.7-5.8%) (P=0.597). CONCLUSION: The findings of this study imply that an elevated BDR in children with AR cannot be attributed to nasal inflammation alone and highlights the close relationship between the upper and lower airways.
Adrenal Cortex Hormones ; Androstadienes ; Asthma ; Child ; Diethylpropion ; Forced Expiratory Volume ; Humans ; Inflammation ; Rhinitis ; Rhinitis, Allergic, Perennial ; Spirometry ; Fluticasone

OBJECTIVE: To study the clinical effect of different combinations of fluticasone propionate (Flu), montelukast sodium (Mon) and ketotifen (Ket) in the treatment of children with cough variant asthma (CVA). METHODS: A total of 280 children with CVA who were admitted to the department of respiratory medicine from June 2015 to January 2018 were randomly divided into Flu+Mon+Ket, Flu+Mon, Flu+Ket, Mon+Ket, Flu, Mon and Ket groups, with 40 children in each group. The children in each group were given corresponding drug(s), and the course of treatment was 3 months for all groups. The condition of cough, cough symptom score, pulmonary function and adverse drug reactions were evaluated after 2 and 3 months of treatment. The children were followed up to observe recurrence. RESULTS: After treatment, cough symptom score tended to decrease in all 7 groups, with increases in percentage of forced expiratory volume in 1 second (FEV1%) and percentage of predicted peak expiratory flow (PEF%). After 2 months of treatment, the Flu+Mon+Ket group had a significantly lower cough symptom score and significantly higher FEV1% and PEF% than the other groups (P<0.05). After 2 and 3 months of treatment, the Ket group had a significantly higher cough symptom score and significantly lower FEV1% and PEF% than the other groups (P<0.05). After 3 months of treatment, there were no significant differences in cough symptom score, FEV1% and PEF% among the other groups (P>0.05). There was a low incidence rate of adverse events in all 7 groups, and there was no significant difference among the 7 groups (P>0.05). The Ket group had a significantly higher recurrence rate of cough than the other groups (P<0.001), while there was no significant difference in this rate among the other groups (P>0.0024). CONCLUSIONS For children with CVA, a combination of Flu, Mon and Ket has a better clinical effect than a combination of two drugs and a single drug at 2 months of treatment and is safe. After 3 months of treatment, Flu or Mon alone has a similar effect to drug combination. Ket alone has a poor clinical effect and a high recurrence rate after drug withdrawal.
Acetates ; Androstadienes ; Anti-Asthmatic Agents ; Asthma ; drug therapy ; Child ; Cough ; drug therapy ; Drug Combinations ; Fluticasone ; Humans ; Ketotifen ; Quinolines

PURPOSE: Smoking elicits airway inflammation and airflow obstruction in patients with asthma, even after smoking cessation. The aim of this study was to examine the effects of smoking cessation on lung function and quality of life (QOL) in asthmatic patients. METHODS: Thirty-two patients with asthma who were active smokers were recruited. After education on the effects of smoking on asthma, 22 patients continued to smoke, and 10 quit smoking. All patients were treated with inhaled fluticasone propionate (1 mg/day) for 3 months. We compared forced expiratory volume in 1 s (FEV1), FEV1/forced vital capacity (FVC), forced expiratory flow between 25 and 75% FVC (FEF(25-75%)), and scores on a QOL questionnaire at baseline, 1, 2, and 3 months. RESULTS: Quitters showed a greater percent change in FEV1 (19.1+/-6.3 vs. 7.9+/-2.4%, P=0.024) and FEV1/FVC (6.5+/-4.14 vs. 3.5+/-1.5%, P=0.05) than smokers. Both quitters and smokers showed improved QOL scores after 1, 2, and 3 months of fluticasone treatment. CONCLUSIONS: Patients with asthma who quit smoking showed less airway obstruction, suggesting that smoking cessation is crucial in the management of asthma.
Airway Obstruction ; Androstadienes ; Asthma ; Diethylpropion ; Forced Expiratory Volume ; Humans ; Inflammation ; Lung ; Quality of Life ; Smoke ; Smoking ; Smoking Cessation ; Vital Capacity ; Fluticasone ; Surveys and Questionnaires

Eosinophilic otitis media (EOM) shows a very high rate of association with asthma, and intractable otitis media involves marked eosinophil infiltration into the middle ear. The middle ear space is connected to the nasopharynx by the Eustachian tube, and it is considered a part of the upper respiratory tract. Allergic rhinitis and asthma often coexist as chronic inflammatory diseases of the upper and lower airways, respectively, and have an impact on each other. In fact, inhaled corticosteroids reduce seasonal eosinophilia systemically in the circulation and locally in the nasal mucosa, as well as attenuate seasonal nasal symptoms. We report a case of EOM associated with adult-onset asthma that improved following optimal asthma therapy after changing the treatment from inhaled fluticasone propionate (FP) (200 microg b.i.d.) to a combination of FP/salmeterol (250/50 microg b.i.d.). This result supports the hypothesis that EOM and asthma are closely linked, presenting as different manifestations of a similar disease syndrome.
Adrenal Cortex Hormones ; Androstadienes ; Asthma ; Diethylpropion ; Ear, Middle ; Eosinophilia ; Eosinophils ; Eustachian Tube ; Nasal Mucosa ; Nasopharynx ; Otitis ; Otitis Media ; Respiratory System ; Respiratory Therapy ; Rhinitis ; Rhinitis, Allergic, Perennial ; Seasons ; Fluticasone

BACKGROUND: Local adverse events associated with inhaled corticosteroid use, including dysphonia, pharyngitis and oral candidiasis, can affect adherence for treatment. 'Mouth rinsing method' has been used for reducing local adverse events, but it cannot ensure complete prevention. The goal of this pilot study was to identify whether the 'immediate diet method' can reduce local adverse events in a limited number of patients. METHODS: The study was conducted in a total of 98 patients, who had been prescribed a medium-dose fluticasone propionate for the first time, from January to October in 2010. One training nurse had performed the education on how to use the inhaler, including the mouth rinsing method. And with follow-ups at one month intervals, any patient who experienced such adverse events were educated on the immediate diet method, having a meal within 5 minutes after using an inhaler and they were checked on any incurrence of adverse events with one month intervals for 2 months. RESULTS: The mean age of patients was 65.9 years old. The local adverse events had incurred from 18.4% of the study subjects. When performed the follow-up observation in 18 patients with local adverse events after education on the immediate diet method, 14 patients (77.8%) had shown symptomatic improvements. Three of 4 patients did not show any improvement, in spite of implementing the immediate diet method. The other 1 patient did not practice the immediate diet method properly. CONCLUSION: The immediate diet method may be useful in reducing the local adverse events, caused by the use of inhaled corticosteroid.
Androstadienes ; Candidiasis, Oral ; Diet ; Dietary Sucrose ; Diethylpropion ; Drug Toxicity ; Dysphonia ; Follow-Up Studies ; Humans ; Meals ; Mouth ; Nebulizers and Vaporizers ; Pharyngitis ; Pilot Projects ; Steroids ; Fluticasone

BACKGROUND: A combination of salmeterol and fluticasone propionate (SFC) and tiotropium bromide (TIO) is commonly prescribed for COPD patients but there is little data on their effectiveness, particularly in COPD patients with bronchial hyperresponsiveness. This study compared the spirometric improvement based on the change in FEV1, FEV1/FVC, and IC as well as the clinical outcomes of the therapeutic strategies with SFC and TIO versus the individual components in patients with severe COPD and bronchial hyperresponsiveness. METHODS: This study examined the spirometric data and clinical outcomes of 214 patients with COPD and hyperresponsiveness, who were divided into three groups according to the therapeutic regimen (TIO only, SFC only, and a triple therapy regimen). RESULTS: All regimen groups showed early improvement in the FEV1 and IC (at 3- and 6 months after treatment). However, long-term beneficial effects were observed only in the SFC group (at 24 months after treatment). However, these beneficial effects decreased after a 36-month follow up. In all spirometric results, the 12-, 24-, and 36-months data showed a similar degree of improvement in the three groups. The triple therapy group showed higher St. George's Respiratory Questionnaire scores and lower acute exacerbations and hospitalization. CONCLUSION: SFC can be a more important component in the pharmacological treatment of severe COPD patients with hyperresponsiveness than TIO, particularly in the spirometric and clinical outcomes.
Albuterol ; Androstadienes ; Diethylpropion ; Drug Therapy, Combination ; Follow-Up Studies ; Hospitalization ; Humans ; Pulmonary Disease, Chronic Obstructive ; Surveys and Questionnaires ; Scopolamine Derivatives ; Treatment Outcome ; Fluticasone ; Tiotropium Bromide ; Salmeterol Xinafoate