Efficacy Of Fluticasone Propionate Research Articles

Quantitative comparison of dose-effect and time-course of fluticasone furoate and fluticasone propionate in adult and adolescent patients with persistent asthma: A systematic review and meta-analysis.

This study aimed to quantitatively compare the efficacy of fluticasone furoate (FF) and fluticasone propionate (FP) in adolescents and adults with asthma. We searched the PubMed and EMBASE databases for placebo-controlled trials that met the inclusion criteria. Pharmacodynamic models were established to describe the time-course of the primary outcome (trough forced expiratory volume in the first second [FEV1 ]). Secondary outcomes (asthma symptoms, quality of life and exacerbations) were also compared via a meta-analysis. A total of 14 articles were included in the analysis, involving 6640 subjects. The efficacy plateau of the two drugs could be reached in 2 weeks. The changes from the baseline in trough FEV1 (95% CI) at week 2 of FF at 200 and 100 μg/day were 0.168 L (0.064-0.199) and 0.127 L (0.048-0.163), respectively. The changes from the baseline in trough FEV1 (95% CI) at week 2 of FP at 1000, 500, 250 and 100 μg/day were 0.133 L (0.049-0.171), 0.127 L (0.043-0.163), 0.117 L (0.039-0.150) and 0.093 L (0.032-0.129), respectively. The efficacy of FP had reached a plateau at the maximum evaluated dose (1000 μg/day), while a plateau effect was not seen at the maximum evaluated dose of FF (200 μg/day). In terms of secondary outcomes, the relative effects of the two drugs relative to the placebo were similar and did not show obvious dose-effect relationships. In this study, the time-course and dose-effect characteristics of FP, FF and placebo were quantitatively evaluated, providing necessary quantitative information for asthma-related guidelines.

Asthma control using fluticasone propionate/salmeterol in Asian and non-Asian populations: a post hoc analysis of the GOAL study

BackgroundTo analyse the efficacy of fluticasone propionate (FP) alone and combined with salmeterol (SAL) in achieving guideline-defined asthma control in Asian patients.MethodsA post hoc analysis of the GOAL study in which patients were stratified by prior-medication use into inhaled corticosteroid (ICS)-naïve (Stratum [S] 1), low-dose ICS (S2), and medium-dose ICS (S3), and randomised to receive FP/SAL or FP. Doses were stepped-up every 12 weeks until Totally Controlled asthma or maximum dose was reached (PhI) and then maintained until study end (PhII). The primary endpoint was the proportion of patients achieving Well-Controlled asthma during PhI. Additional endpoints included Total Control and adverse events. Asian and non-Asian patients were analysed separately.ResultsIn Asian patients in PhI, 74% (n = 87/118) in S1 achieved Well-Controlled asthma with FP/SAL versus 74% (n = 89/121) with FP alone (p = 0.839); corresponding values were 76% (n = 81/107) versus 60% (n = 62/104; p = 0.005) in S2, and 58% (n = 59/102) versus 43% (n = 41/95; p = 0.015) in S3. More patients in all three strata achieved Totally Controlled asthma with FP/SAL versus FP alone. Control was achieved more rapidly and with lower ICS doses with FP/SAL versus FP. A high proportion of patients who achieved control during PhI maintained control during PhII. Similar trends were found in non-Asian patients. No new safety concerns were identified.ConclusionsA greater proportion of Asian patients (S2 and S3, for Well-Controlled; all strata, for Totally Controlled) achieved guideline-defined asthma control with FP/SAL versus FP alone. High proportions of Asian patients in S1 achieved Well-Controlled asthma in both treatment groups.

COMPARATIVE STUDY ON THE EFFICACY OF MOMETASONE AND FLUTICASONE NASAL SPRAYS FOR TREATMENT OF ALLERGIC RHINITIS

Objective: Allergic rhinitis is the most prevalent of allergic diseases in the world. Nasal corticosteroids are the most applicable drugs for the treatment of allergic rhinitis. In this study, we compared the efficacy of fluticasone propionate (FP) and mometasone furoate (MF) nasal sprays in the treatment of allergic rhinitis based on total nasal symptom score (TNSS) questionnaire.Methods: For this study, 75 allergic rhinitis patients based on skin prick test and inclusion criteria were randomly assigned to two groups: FP and MF groups. FP group received 200 µg dose of FP nasal spray (1 spray/nostril) daily and the MF group received 100 mg dose of MF nasal spray (1 spray/nostril) daily for 8 w. The effects of the two agents were compared based on TNSS questionnaire in 0, 4 and 8 w after the beginning of the treatment.Results: Results showed that patients in both groups exhibited significant improvement in their TNSS (P Value<0.001). A detailed TNSS analysis showed MF to be more effective for relieving all symptoms than FP. The most difference is in decreasing postnasal discharge (PND) symptom. However, the difference for relieving all symptoms is not significant (P value>0.05).Conclusion: In conclusion, FP and MF are significantly effective in relieving of allergic rhinitis symptoms. Even though, the difference between the two is not significant for 8 w therapy.

Glucocorticosteroids in the treatment of inflammatory bowel disease and approaches to minimizing systemic activity

Inflammatory bowel diseases (IBDs) are a group of inflammatory conditions characterized by chronic, uncontrolled inflammation of the gastrointestinal tract. Reported prevalence is high in the United States and northern Europe, while the incidence varies greatly across the rest of Europe. Glucocorticosteroids are the standard treatment for IBD, but due to adverse events their use can be limited. However, new formulations of glucocorticosteroids have been developed to reduce systemic activation. The aim of this review was to assess and summarize the efficacy and safety of new formulations of glucocorticosteroids. A MEDLINE search identified publications focused on new formulations of nonsystemic steroid-based drugs for IBD and benefits and limitations of each of the new glucocorticosteroid formulations were identified. Budesonide has good efficacy and is an established treatment for Crohn's disease; it has been shown to be beneficial for the induction of remission in these patients, although it is not recommended for the maintenance of induced remission. Glucocorticosteroids are not recommended for the maintenance of remission in patients with IBD. However, a recent study suggested that beclomethasone dipropionate may be effective for prolonged treatment in patients in the postacute phase of Crohn's disease who were treated with a short course of systemic steroids. The efficacy of fluticasone propionate and prednisolone metasulphobenzoate in IBD is not well established given the small number of patients enrolled in the few published clinical trials. While the tolerability of these glucocorticosteroids is favourable, more research comparing these new agents with traditional systemic glucocorticosteroids is warranted.

Safety and efficacy of long-term treatment with fluticasone propionate and salmeterol via DISKUS versus fluticasone propionate alone

This 52 week study (ADA109057; ClinicalTrials.gov identifier: NCT00452348) was designed to assess the safety and efficacy of fluticasone propionate (FP)/salmeterol 250/50 mcg via DISKUS (FSC) vs FP 250 mcg in subjects with persistent asthma symptomatic on FP 100 mcg. The objective was to demonstrate superiority in lung function (FEV1) of FSC 250/50 mcg vs FP 250 mcg. Secondary objectives included AM PEF, percentage of symptom-free days, and rate of asthma attacks. Three hundred and ten subjects received FSC 250/50 mcg and 318 subjects received FP 250 mcg, both administered twice daily following a 14–21 days of open-label FP 100 mcg. Treatment with FSC 250/50 mcg resulted in an improvement in lung function vs FP 250 mcg (p = 0.09). Additionally, treatment with FSC 250/50 mcg improved AM PEF and increased the percentage of symptom-free days. The asthma attack rate was similar between treatments, as was the safety profile. FSC 250/50 mcg demonstrated improvements in lung function and asthma control vs FP 250...

Comparative Safety and Efficacy of Fluticasone Propionate plus Salmeterol via Diskus® Versus Fluticasone Propionate in Subjects with Asthma Greater than or Equal to 55 and 65 Years of Age

Comparative Safety and Efficacy of Fluticasone Propionate plus Salmeterol via Diskus® Versus Fluticasone Propionate in Subjects with Asthma Greater than or Equal to 55 and 65 Years of Age

SAFETY AND EFFICACY OF FLUTICASONE PROPIONATE PLUS SALMETEROL VIA A SINGLE DEVICE COMPARED WITH FLUTICASONE PROPIONATE ALONE IN SUBJECTS WITH ASTHMA GREATER THAN OR EQUAL TO 50 YEARS OF AGE

PURPOSE: Most clinical studies evaluating asthma are conducted in young adults and there is limited clinical data in an older population. Therefore, the purpose of this analysis is to examine the safety and efficacy of fluticasone propionate plus salmeterol (FSC) or fluticasone propionate (FP) alone in asthmatics ≥ 50 years of age.

Propionate de fluticasone dans l'asthme de l'enfant et du nourrisson

The known efficacy of fluticasone propionate in adults, comparable at half-dosage of corticosteroids has been validated by the market autorization (MA) and by the national and international guidelines for beclomethasone. This could be partly explained by its pharmacological properties, affinity for glucorticosteroid receptors, lung deposition and lipophilicity. The limited systemic adverse events is due to its low bioavailability, optimal hepatic clearance, high plasma protein binding. The efficacy in asthmatic children has been confirmed in clinical studies showing a “plateau” efficacy between 100 and 200 μg/d for the majority of children. Most children are controlled by such dosages: the added value of increasing posology on asthma control exists but is small. A high off-label posology does not allow more quickly asthma control and therefore is not justified. A twice daily dosing is more efficient, particularly for initiation of maintenance therapy, than a once daily dosing. A literature survey confirms that, at MA recommended daily doses in children (100–200 μg), fluticasone propionate has no clinically significant effect either on hypothalamic-pituitary-adrenal (HPA) axis (basal function or stimulation tests), bone or growth velocity. However, high daily doses (higher to 500 μg/day) for long periods expose to systemic adverse effects with measurable consequences on growth rate, bone density (decreasing biochemical makers of bone formation) and HPA function. Several cases of adrenal insufficiency that may have led to acute adrenal crisis have been reported in 4- to 10-year-old children receiving fluticasone propionate in doses between 500 to 2000 μg daily. In case of surgery or infection, a preventive treatment of adrenal insufficiency with hydrocortisone should be proposed for children treated for more than 6 months with such high daily doses. Such children need definitely an advice from paediatricians specialized in chest diseases as well as in endocrinology. It is important to recall that the clinical benefit of daily doses of inhaled corticosteroids higher than recommended is low and that the good use of inhaled corticosteroids particularly in children lays on the careful search of the minimal efficient daily doses.

Comparing outcomes in patients with persistent asthma: a registry of two therapeutic alternatives

ABSTRACTObjective: Clinical trials have demonstrated improved efficacy of fluticasone propionate/ salmeterol (100/50 mcg) in a single device (FSC) compared with montelukast (10 mg) (MON). This study was designed to assess asthma control, asthma-related quality of life, asthma-related emergency department (ED) visit/hospitalization, treatment-related satisfaction, and productivity losses in patients newly started on FSC or MON.Research design and methods: Patients who were newly prescribed FSC or MON during a regularly scheduled office visit were enrolled in a prospective observational study by nearly 500 physicians from eight managed care plans. Patient survey data were collected at baseline and at months 1, 3, 6, and 12, to measure study outcomes. ED visits/inpatient stays were reported from commercial claims data. Multivariate analyses assessed 12‐month outcomes, controlling for several baseline patient characteristics.Results: A total of 1414 patients ≥ 15 years old were enrolled in the registry (FSC, n = 1061; MON, n = 353), 90% of which completed a 12‐month survey. FSC patients had significantly greater improvement in both asthma control and quality of life, and reported significantly higher satisfaction with their medication ( p = 0.003) and fewer days at work/school with asthma symptoms ( p = 0.04) than MON. Other parameters of productivity losses such as missed work/school days due to asthma were not significantly different between the two groups. FSC use was also significantly associated with a lower risk of an asthma-related ED visit/hospitalization compared with MON (odds ratio = 0.35, 95% confidence interval: 0.15–0.92).Conclusion: In a 12‐month office-based observational study, patients age 15 and older with persistent asthma, newly started on FSC, improved in symptom, quality of life, treatment, and utilization-related outcomes compared with patients newly started on MON. These results should be interpreted in light of the inherent limitations of non-randomized, uncontrolled studies.

Efficacy of Fluticasone Propionate on Lung Function and Symptoms in Wheezy Infants

Efficacy of Fluticasone Propionate on Lung Function and Symptoms in Wheezy Infants

Influence of nasal corticosteroid therapy duration on its efficiency at nasal polyposis

Efficacy of fluticasone propionate (FP) – Flixonase, GSK, in 76 patients with nasal polyposis (NP) was studied. After the first 3-month trial phase (FP 400 mcg / day), 46 patients (the 1 st group) have continued the 12-month treatment with FP 200 mcg / day, and 23 patients (the 2-nd group) have stopped the therapy with nasal steroids. Intensity of nasal symptoms using a 4-point scale, need for topical vasoconstrictors, rhinometric ventilation parameters (nasal inspiratory flow, NIF, nasal resistance, NR) and endoscopic symptoms were evaluated every 3 months. Trial results showed various shifts in clinical and functional parameters in the compared groups. The intensity of NP symptoms in the 1-st group decreased and reached the minimal level in 6 to 12 months, NIF rate reduced and NR decreased while reaching the normal values after 12 months of the FP therapy. The 2-nd patient group had a considerable worsening of the NP symptoms and in the functional parameters of the nasal breath within 3 months after FP cancellation. After 6 month follow up these indices did not differ essentially from those at the baseline condition. Thus, the early FP cancellation can cause instability of clinical effect and fast recurrence to the initial status. Long-term (for several months) therapy of NP with decrease in the FP dose in 3 months not only can keep the achieved results, but also allows to improve them considerably.

Efficacy of Fluticasone Propionate on Lung Function and Symptoms in Wheezy Infants

The role of inhaled corticosteroids in the treatment of recurrent or persistent wheeze in infancy remains unclear. We evaluated the effect of 3 months of treatment with inhaled fluticasone propionate, 200 microg daily (FP200), on lung function and symptom scores in wheezy infants. Moreover, we evaluated whether infants with atopy and/or eczema respond better to FP200 as compared with non-atopic infants. Forced expiratory flow (Vmax(FRC)) was measured at baseline and after treatment. Sixty-five infants were randomized to receive FP200 or placebo, and 62 infants (mean age, 11.3 months) completed the study. Mean Vmax(FRC), expressed as a Z score, was significantly below normal at baseline and after treatment in both groups. The change from baseline of Vmax(FRC) was not different between the two treatment arms. After 6 weeks of treatment, and not after 13 weeks, the FP200 group had a significantly higher percentage of symptom-free days and a significant reduction in mean daily cough score compared with placebo. Separate analysis of treatment effect in infants with atopy or eczema showed no effect modification. We conclude that in wheezy infants, after 3 months of treatment with fluticasone, there was no improvement in lung function and no reduction in respiratory symptoms compared with placebo.

Utility and Efficacy of Fluticasone Propionate and Salmeterol Inhaled from a Single Inhaler for Persistent Asthma

The utility of a new therapy, in this instance fluticasone and salmeterol combination (FSC), is determined by multiple uncontrollable factors in individual patients and can be measured by continued use and efficacy over time. Over one year from April 2001, 186 patients with persistent asthma were switched from controller pharmacotherapy to FSC at equidose to prior inhaled corticosteroid. Follow-up data on 171 (92%) indicated 129 (75%) had continued FSC for one year. Compared to the 42 who discontinued FSC, those who continued had significant reduction of asthmatic exacerbations, improved spirometry, and reduced usage of inhaled reliever and systemic corticosteroid.

Efficacy of Fluticasone Propionate on Lung Function and Symptoms in Wheezy Infants

The role of inhaled corticosteroids in the treatment of recurrent or persistent wheeze in infancy remains unclear. We evaluated the effect of 3 months of treatment with inhaled fluticasone propionate, 200 μg daily (FP200), on lung function and symptom scores in wheezy infants. Moreover, we evaluated whether infants with atopy and/or eczema respond better to FP200 as compared with non-atopic infants. Forced expiratory flow (VmaxFRC) was measured at baseline and after treatment. Sixty-five infants were randomized to receive FP200 or placebo, and 62 infants (mean age, 11.3 months) completed the study. Mean VmaxFRC, expressed as a Z score, was significantly below normal at baseline and after treatment in both groups. The change from baseline of VmaxFRC was not different between the two treatment arms. After 6 weeks of treatment, and not after 13 weeks, the FP200 group had a significantly higher percentage of symptom-free days and a significant reduction in mean daily cough score compared with placebo. Sepa...

Efficacy of fluticasone propionate in 0.05% cream for the treatment of neurodermatitis and eczema

目的 评价0.05%丙酸氟替卡松乳膏治疗皮炎湿疹的疗效及安全性.方法对73例神经性皮炎和湿疹患者分别外用0.05%丙酸氟替卡松乳膏和0.1%糠酸莫米松乳膏进行治疗,观察记录患者的临床表现和治疗效果.结果治疗2周后0.05%丙酸氟替卡松乳膏的有效率为89.5%,0.1%糠酸莫米松乳膏的有效率为68.6%,两组相比差异有显著意义(P＜0.05);两组不良反应均少.结论 0.05%丙酸氟替卡松乳膏治疗神经性皮炎和湿疹疗效显著,安全性好。

Abstracts

Abstracts

Intranasal fluticasone propionate is effective for perennial nonallergic rhinitis with or without eosinophilia

Although response to intranasal corticosteroid therapy has been reported in patients with nonallergic rhinitis with eosinophilic syndrome (NARES), efficacy specifically in non-NARES patients has not been fully characterized. To evaluate the efficacy of intranasal fluticasone propionate (FP) in the treatment of patients with perennial nonallergic rhinitis, with and without nasal eosinophilia. Data from 983 patients in three randomized, double-blind, placebo-controlled PNAR trials were integrated. Patients received a total daily dose of FP 200 microg (n = 332), FP 400 microg (n = 325), or placebo (n = 326) for 28 days. Patients were > or =12 years of age with perennial rhinitis and negative skin tests to all allergens relevant to the geographic region. Nasal eosinophils were evaluated using a five-point scale. Patients were classified as non-NARES with a point score of 0 (n = 674; 69%); patients with a point score between I and 4 were classified as NARES (n = 309; 31%). Efficacy of FP was evaluated by the mean change in total nasal symptom score (TNSS), a sum of patient ratings of nasal obstruction, postnasal drip, and rhinorrhea. Patients with either NARES or non-NARES had similar statistically significant improvement with FP 200 microg or 400 microg compared with placebo; thus, the total group comprising both varieties of rhinitis responded to FP. In the total population, both FP treatment groups showed significantly greater improvement in TNSS compared with placebo during each week of treatment (P < or = 0.002), with mean changes in TNSS for day 22 to day 28 ranging from -84 and -85 in the FP 200 microg and FP 400 microg groups, respectively, to -64 in the placebo group. The three study treatment groups had similar proportions of non-NARES (68 to 69%) and NARES (31 to 32%) patients at baseline. In the non-NARES subgroup, mean changes in TNSS for each treatment group were similar to changes seen in the total population. In the NARES subgroup, mean changes in TNSS for the FP 200 microg and placebo groups were similar to changes seen in the total population; mean change in TNSS for the FP 400 microg group was somewhat greater than changes seen in the total population. Intranasal FP is an effective treatment for perennial nonallergic rhinitis with or without nasal eosinophilia (NARES or non-NARES).