Low-dose Fluticasone Propionate Research Articles

Risk of Pneumonia with Inhaled Corticosteroid/ Long-Acting β2 Agonist Therapy in Chronic Obstructive Pulmonary Disease

Aim: To determine the pneumonia risk in COPD patients, which treatment is more effective to prevent patients to develop more complex situation. Method: This randomized study design was conducted from September 2022 to December 2022 and approval by the ethical committee of the Hospital was obtained. All the participants were 45 to 65 years old. Patients were receiving a combination of medicine whereas the first group had 51 patients receiving low-dose fluticasone propionate 250 µg and salmeterol 50 µg twice in a day. The second group was receiving high-dose treatment of fluticasone propionate 500 µg and salmeterol 100 µg twice a day. Clinical follow-up proceeded for complete assessment and for safety measures. It also includes vital sign measurements such as heart rate, pneumonia, bone fracture, and hematological measurement. In the case of suspected pneumonia, moderate to severe exacerbation event chest radiography was performed. For statistical analysis two software are used one is statistics 8.1 and the other is Pad prism version 5. One Way ANOVA is applied. Results: A total 110 number of patients aged 45-65 were recruited for this study. From the total of 110, eight persons are excluded due to cystic fibrosis, pulmonary fibrosis, and bronchiectasis. 102 patients are part of this study out of which 33(32.35%) were females and 70(67.64%) were males. Patients with smoking history were 40(39.21%), history of moderate and severe exacerbations were 20(19.60%) and 8(7.84%). Patients of group one who were receiving low doses of fluticasone propionate 250µg and salmeterol 50µg shows improvement in the patient condition and at the eight week of treatment dose the results are, moderate exacerbation was found in 12(23.52%) patients with 95% Cl=1.89-2.30, severe exacerbation in 6(11.76%) with 95% confidence intervals, and pneumonia in 6(11.76%) with 95% Cl=1.71-1.67.Group two follow-up also shows improvement in patients’ health status but it also increases the chances of pneumonia development. At eight week moderate exacerbation was found in 7(13.72%) patients with 95% Cl=3.00-0.34, severe exacerbation in 4(7.84%) with 95% confidence intervals 3.06-0.56, and pneumonia in 9(17.64%) with 95% Cl= 3.08-0.66. All the factor's p-value was statistically significant. As the number of pneumonia, patients was higher in group two patients as compared to group one. Practical implication: Pneumonia is more likely to occur in patients with chronic obstructive pulmonary disease (COPD). The frequency of acute episodes of symptom exacerbation is decreased by inhaled corticosteroids. Low dose therapy is more effective than the high doses effective in patients. This research article helps to aware the society about the risk factors and their treatment. Conclusion: we concluded that COPD patients are more vulnerable to developing pneumonia even if we used the ICS therapy in combination with long-acting β2 agonist therapy. Low dose therapy is more effective than the high doses effective in our study Keywords: chronic obstructive pulmonary disease COPD, Inhaled corticosteroids (ICS), Long-acting bronchodilators

Low-dose Fluticasone Propionate in Combination With Salmeterol in Patients With Chronic Obstructive Pulmonary Disease.

Inhaled corticosteroids are widely used in the treatment of chronic obstructive pulmonary disease (COPD). However, their use has been questioned for appropriate dose and a possible increased risk of pneumonia. Here, we reviewed patients with COPD who had received fluticasone–salmeterol combination treatment using data from a linked electronic medical record database. A total of 180 patients received salmeterol with 250 µg fluticasone propionate twice daily and 78 received salmeterol and 100 µg fluticasone propionate twice daily. In both groups, there was no difference in the improved forced expiratory volume in 1 second and COPD assessment test score and the proportion of patients with exacerbations. Although the incidence of common toxicity was approximately equal, that of pneumonia was much higher in the 250 µg group (8.9% vs 1.3%, P=.01). The beneficial effects of inhaled corticosteroids might be obtained at lower doses.

COST-effectiveness of salmeterol/fluticasone propionate combination (Advair®) in uncontrolled asthma in Canada

To evaluate the cost-utility of the treatment with a long acting beta-agonist (LABA) and inhaled corticosteroid (ICS) combination inhaler [salmeterol xinafoate (SAL)/fluticasone propionate (FP) combination inhaler (SFC) (Advair(®))] to continuing on current ICS dose (no ICS dose change) or increased ICS dose [fluticasone propionate (FP)] in patients with uncontrolled asthma in Canada. A cost-utility analysis was conducted from a Canadian public healthcare perspective with a one year time horizon. In the no FP dose change scenarios, remaining on daily low (FP 100ugBID) or medium (FP 200-250ugBID) or high dose (FP 500ugBID) was considered. In the increased FP dose scenarios, doubling the FP dose from low to medium dose and from medium to high dose regimens were considered. A decision model was developed with two health states: "symptom free" or "with symptoms". Clinical efficacy was based on a meta-analysis of relevant randomized controlled trials. Over the one year time horizon the percentage with symptom free days (SFD) was used as the measure of differential treatment scenario effectiveness. Drug costs and non-drug costs were incorporated into the analysis. Utilities, derived from EQ5D scores and health services resource use based on patient diaries for 'symptom free' and 'with symptoms' were based on regression analyses of individual patient data from the Gaining Optimal Asthma controL (GOAL) trial. Costs were assessed by assigning unit cost for each health services resource use for each patient. The incremental cost-utility ratios (ICUR) for SFC vs no FP dose change or increased FP dose were estimated using descriptive statistics. Uncertainty was assessed by deterministic and probabilistic sensitivity analysis (PSA). Over one year, SFC resulted in an incremental cost per patient of $544-$655 compared to no FP dose change and $47-$380 per year compared to increased FP dose. SFC results in incremental QALYs per patient of 0.0100-0.0149 compared to no FP dose change and 0.0136-0.0152 compared to increased FP dose. The one year ICURs were $43,000 to $54,400 per QALY gained for SFC compared to no FP dose change and $25,000 to $3500 per QALY gained compared to increased FP dose scenarios. The probability of SFC being cost-effective at $50,000 per QALY gained was greater than 75% compared to increased FP dose scenarios and compared to no dose change for patients on low or medium dose FP. The results were robust to changes in assumptions within the model. In Canadian patients with inadequately controlled asthma on FP, it is cost-effective to use SFC for patients 12 years and over compared to doubling their FP dose. It is also cost-effective to use SFC for patients on low or medium dose FP compared to remaining on the current FP dose in patients with uncontrolled asthma.

Clinical and economic outcomes associated with low-dose fluticasone propionate versus montelukast in children with asthma aged 4 to 11 years.

Objective:Inhaled corticosteroids (ICS) are preferred first-line controller agents for adults and adolescents with asthma. There is limited effectiveness data comparing ICS to leukotriene receptor antagonists (LTRA) in children with asthma aged 4 to 11 years.Methods:A retrospective, matched cohort study was conducted using medical and pharmacy claims data. Asthma patients (ICD-9, 493.xx) naïve to any asthma controller therapy, and having ≥1 dispensing of fluticasone propionate 44 mcg (FP44), an ICS, or montelukast any dose (MON), an LTRA, were identified. Drug cohorts were matched (1:2) using propensity scores. Outcomes during follow-up included asthma-related ED visits, composite measure of asthma-related ED/hospital visit, asthma-related costs per month, and monthly rescue medication use. Statistical differences between cohorts were evaluated using multivariate regression models.Results:The final matched sample included 6,636 patients (FP44=2,212; MON=4,424). During follow-up, the FP44 cohort had a 29% significantly lower risk of an asthma-related ED visit (Hazard ratio (95% CI) =0.71 (0.52, 0.96)) compared to the MON cohort. Monthly asthma-related costs were significantly reduced on average by 36% in the FP44 compared to the MON cohort ($48 vs $75, p<0.05). Use of short-acting beta-agonists per month were similar between cohorts but monthly adjusted number of oral corticosteroid prescriptions were significantly lower in the FP44 compared to the MON cohort (0.03 vs 0.04, p<0.001).Conclusion:Initiation of FP44 versus MON in children with asthma aged 4 to 11 years is associated with a significant reduction in asthma-related ED visits, costs, and oral corticosteroid use.

Is low dose inhaled corticosteroid therapy as effective for inflammation and remodeling in asthma? A randomized, parallel group study

BackgroundWhile most of the clinical benefits of inhaled corticosteroid (ICS) therapy may occur at low doses, results of dose-ranging studies are inconsistent. Although symptom/lung function response to low and high dose ICS medication is comparable, it is uncertain whether low dose ICSs are as effective as high dose in the treatment of inflammation and remodeling.Methods22 mild or moderate asthmatic adult subjects (corticosteroid free for > 2 months) participated in a randomized, parallel group study to compare effects of fluticasone propionate (FP) 200 mcg/day and 1000 mcg/day. Alveolar macrophage (AM)-derived cytokines and basement membrane thickness (BMT) were measured at baseline and after 7 weeks treatment while symptoms, spirometry, exhaled nitric oxide (eNO) and airway hyperresponsiveness (AHR) to mannitol at baseline and 6 weeks.ResultsFP improved spirometry, eNO, symptoms and AHR with no difference between low and high dose FP. Both high and low dose FP reduced GM-CSF, TNF-alpha and IL-1ra, with no change in BMT and with no differences between low and high dose FP.Conclusions200 μg/day of FP was as effective as 1000 μg/day in improving asthma control, airway inflammation, lung function and AHR in adults in the short term. Future studies should examine potential differential effects between low and high dose combination therapy (ICS/long acting beta agonist) on inflammation and airway remodeling over longer treatment periods.

Montelukast added to fluticasone propionate does not alter inflammation or outcomes

Airway inflammation is a key pathological feature of asthma which underlies its clinical presentation. To examine whether adding a leukotriene modifier to an inhaled corticosteroid produces further clinical and/or anti-inflammatory benefits in patients symptomatic on short-acting beta(2)-agonists. Patients uncontrolled on short-acting beta(2)-agonists were treated for 12 weeks with either fluticasone propionate (100mcg BD) or fluticasone propionate (100mcg BD) and montelukast (10mg QD) in a randomized, double-blind, parallel group study. Bronchoscopy with endobronchial biopsy and bronchoalveolar lavage (BAL) was performed before and after treatment to compare effects on airway inflammation. Of 103 subjects enrolled, 89 subjects completed treatment and 82 subjects had matched pair biopsy samples. Submucosal eosinophil counts, the primary endpoint, and asthma control improved to similar extents after both treatments (p<or=0.008). Both treatments significantly reduced submucosal mast cell, CD3+, CD4+, CD8+ and CD25+ cell counts. Submucosal mast cell reduction was greater in the fluticasone propionate plus montelukast group. There were no differences between treatments in BAL markers of inflammation or thickness of sub-epithelial collagen. Low-dose fluticasone propionate significantly improves clinical disease control and reduces airway inflammation in asthma patients uncontrolled with short-acting beta(2)-agonists without further improvement when montelukast is added to low-dose fluticasone propionate.

Low-dose fluticasone propionate with and without salmeterol in steroid-naïve patients with mild, uncontrolled asthma

The role of combination ICS/LABA as initial controller therapy in mild, persistent asthma is uncertain. Therefore, the objective of this study was to compare the efficacy of initial controller therapy with fluticasone propionate (FP) 100 microg twice daily to the efficacy of fluticasone propionate/salmeterol xinafoate (FSC) 100/50 microg twice daily in patients with persistent asthma symptoms while using as-needed SABA alone. This randomized, double-blind, parallel-group study was conducted at 45 general practice and 15 specialist centers. A total of 526 adult patients were randomized to receive FP or FSC for 24 weeks. The primary efficacy endpoint was change in morning peak expiratory flow (PEF) from baseline. Secondary efficacy endpoints included symptom- and rescue-free days; asthma exacerbation rate; asthma-related health-care utilization; and the onset of effect. Safety was assessed by monitoring adverse events. Mean morning PEF was significantly greater in the FSC versus the FP group (P<0.001); this greater effect was evident as early as the first week of treatment (P<0.001). The percentages of symptom-free days and rescue-free days in the FSC group were 7.7% (P=0.009) and 8.4% (P=0.001) higher than the FP group, respectively. Trends toward lower exacerbation-related health care-utilization for FSC versus FP were not statistically significant and exacerbation rates were not significantly different. The incidence of adverse events was low with both treatments. :Treatment with FSC was a more effective initial controller therapy than FP monotherapy in ICS-naïve patients who had uncontrolled asthma while using as-needed SABA alone.

Fluticasone versus placebo for chronic asthma in adults and children

Inhaled fluticasone propionate (FP) is a relatively new inhaled corticosteroid for the treatment of asthma. To assess efficacy and safety outcomes in studies that compared FP to placebo for treatment of chronic asthma. We searched the Cochrane Airways Group Specialised Register (January 2008), reference lists of articles, contacted trialists and searched abstracts of major respiratory society meetings (1997-2006). Randomised trials in children and adults comparing FP to placebo in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and risk of bias. Two review authors extracted data. Quantitative analyses were undertaken using Review Manager software. Eighty-six studies met the inclusion criteria, recruiting 16,160 participants. In non-oral steroid treated asthmatics with mild and moderate disease FP resulted in improvements from baseline compared with placebo across all dose ranges (100 to 1000 mcg/d) in FEV1 (between 0.1 to 0.43 litres); morning PEF (between 23 and 46 L/min); symptom scores (based on a standardised scale, between 0.44 and 0.7); reduction in rescue beta-2 agonist use (between 1 and 1.4 puffs/day). High dose FP increased the number of patients who could withdraw from prednisolone: FP 1000-1500 mcg/day Peto Odds Ratio 14.07 (95% CI 7.17 to 27.57). FP at all doses led to a greater likelihood of sore throat, hoarseness and oral Candidiasis. Doses of FP in the range 100-1000 mcg/day are effective. In most patients with mild-moderate asthma improvements with low dose FP are only a little less than those associated with high doses when compared with placebo. High dose FP appears to have worthwhile oral-corticosteroid reducing properties. FP use is accompanied by an increased likelihood of oropharyngeal side effects.

Comparative Efficacy and Safety of Low-Dose Fluticasone Propionate and Montelukast in Children With Persistent Asthma

Purpose of the Study. To evaluate efficacy, safety, health outcomes, and cost-effectiveness of fluticasone propionate (FP) versus montelukast in children with asthma Study Population. Children aged 6 to 12 years with persistent asthma. Methods. Multicenter, randomized, double-blind, double-dummy, parallel-group study of 342 children with persistent asthma. Children received either FP 50 μg twice daily via Diskus or montelukast 5 mg once daily for 12 weeks. The primary efficacy variable was percent change in morning predose forced expiratory volume in 1 second at the end point. Results. Compared with montelukast, children treated with FP experienced a significantly greater increase in mean percent forced expiratory volume in 1 second, mean morning peak expiratory flow rate, and mean evening peak expiratory flow rate. Children treated with FP also experienced significantly greater reductions in total supplemental albuterol use, mean nighttime albuterol use, and mean nighttime symptom scores compared with children treated with montelukast. There were no significant differences between the groups for daytime asthma symptom scores, daytime albuterol use, percent symptom-free days, or adverse events. Parent and physician satisfaction ratings were significantly higher for FP treatment. The daily total asthma-related cost per patient in the FP group was approximately one third of the cost in the montelukast group. Conclusions. FP was significantly more effective than montelukast in improving pulmonary function, asthma symptoms, and rescue albuterol use. Both therapies had similar safety profiles. Reviewer Comments. Comparative studies in adults and adolescents have previously shown greater efficacy with inhaled corticosteroids versus leukotriene receptor antagonists. This 12-week study reports similar findings for children 6 to 12 years of age with persistent asthma. Based on efficacy, cost, and safety profiles, low-dose inhaled corticosteroids should be considered first-line therapy in this age group.

Comparative Efficacy and Safety of Low-dose Fluticasone Propionate and Montelukast in Children with Persistent Asthma

To evaluate efficacy, safety, health outcomes, and cost-effectiveness of fluticasone propionate (FP) versus montelukast (MON) in 342 children (6 to 12 years of age) with persistent asthma. Randomized, double-blind, 12-week study of treatment with FP inhalation powder 50 mug twice daily or MON chewable 5 mg once daily for 12 weeks. Compared with MON, FP significantly increased mean percent change from baseline FEV1 (forced expiratory volume in 1 second) (P=.002), morning PEF (peak expiratory flow) (P=.004), evening PEF (P=.020), and percent rescue-free days (P=.002) at end point, and it significantly reduced nighttime symptom scores (P <.001) and mean total (P=.018), and nighttime (P <.001) albuterol use. Withdrawals from the study were more frequent with MON (21%) than with FP (13%). Adverse events (69% vs 71%) and mean end point to baseline 12-hour urinary cortisol excretion ratios were similar. Parents and physicians were more satisfied with FP treatment than with MON (P=.006 and P=.016, respectively, at Week 12). Mean total daily asthma-related cost per patient in the FP group was approximately one-third of that in the MON group ($1.25 vs $3.49). FP was significantly more effective than MON in improving pulmonary function, asthma symptoms, and rescue albuterol use. Both therapies had similar safety profiles. Parent- and physician-reported satisfaction ratings were higher with FP treatment, and asthma-related costs were lower.

Asthma hospitalization risk and costs for patients treated with fluticasone propionate vs montelukast

Inhaled corticosteroids have been shown to reduce rates of hospitalization and emergency department use compared with leukotriene receptor antagonists. To examine differences in the probability of asthma-related hospitalizations, probability of switching or augmentin, with another therapy, and costs for patients treated with fluticasone propionate vs montelukast. The study involved a 24-month retrospective analysis of patients with claims for asthma treatment (primary diagnosis International Classification of Disease, Ninth Revision code of 493.xx) between January 1, 1997, and June 30, 2000, and at least I outpatient pharmaceutical claim for fluticasone propionate (44 microg) or montelukast (5 or 10 mg). Univariate and multivariate analyses were used to determine the probability of asthma-related hospitalizations and switching or augmenting to another therapy, asthma costs, and total health care costs. Sensitivity analyses were conducted by replicating all of the analyses by age strata (ages 4-17 years and > or = 18 years) and varying lengths of follow-up. Patients receiving fluticasone propionate had a 62% lower risk of experiencing an asthma-related hospitalization within 1 year and a 44% lower risk of switching or augmenting to another asthma controller medication compared with montelukast. Asthma-related health care expenditures for montelukast patients were dollar 339 higher than for fluticasone propionate users (P < .001). Overall health care expenditures (asthma and nonasthma) were also dollar 1,197 higher in the montelukast group. Compared with montelukast-treated patients, patients treated with low-dose fluticasone propionate had a significantly lower risk of experiencing an asthma-related hospitalization, a lower risk of switching or augmenting with another controller, and significantly lower asthma and total health care costs.

Low-dose fluticasone propionate may be associated with adrenal dysfunction in children,

Low-dose fluticasone propionate may be associated with adrenal dysfunction in children,

Fluticasone propionate increases suppression of allergen-driven T cell proliferation by CD4+CD25+ T cells

Rationale Corticosteroids are the main anti-inflammatory treatment for asthma and allergic diseases, and have been reported to increase the suppressive cytokine IL-10. We have previously reported less suppression by CD4+CD25+ regulatory T cells from atopics compared to non-atopics. We asked whether the steroid fluticasone propionate (FP) could increase activity of naturally occurring CD4+CD25+ regulatory T cells. Methods CD4+CD25+ and CD4+CD25- T cells were isolated by immunomagnetic columns from atopic and non-atopic donors. The effects of different concentrations of FP on CD4+CD25- T cells, co-cultures of CD25+ and CD25- T cells, and the effect of pre-incubation of CD4+CD25+ T cells with FP on subsequent suppression of allergen-stimulated CD4+CD25- T cells were examined. Results FP suppressed allergen stimulated proliferation CD4+CD25- in a dose dependent fashion with an IC50 of 10 -9M. Addition of low dose FP to mixed cultures did not affect suppression of allergen induced proliferation by CD4+CD25+, which was significantly less in atopic than in non-atopic donors. However, pre-incubation of CD4+CD25+ T cells in 10 -7M FP for 24 hours significantly increased their suppressive ability in allergen cultures, (p<0.01 for atopics and 0.05 for non-atopics). This increase in suppression was associated with an increase in allergen-stimulated IL-10 production by CD4+CD25+ that were pre-incubated in FP. Conclusions Fluticasone propionate increases the suppressive activity of CD4+CD25+ regulatory T cells for allergen-stimulation of CD4+CD25- T cells, and this may be by increasing their production of IL-10.

A Comparison of Short-Term Treatment with Inhaled Fluticasone Propionate and Zafirlukast for Patients with Persistent Asthma

Purpose of the Study. To compare the short-term efficacy and safety of low-dose fluticasone propionate with that of oral zafirlukast therapy for patients previously treated with β2-agonists alone, and to evaluate the potential therapeutic benefit of switching from zafirlukast to a low-dose inhaled corticosteroid. Subjects and Methods. This study consisted of a 4-week randomized, double-blind treatment period followed by a 4-week open-label period. Two hundred …

Efficacy and safety of low-dose fluticasone propionate compared with zafirlukast in patients with persistent asthma

Purpose To compare the efficacy and safety of fluticasone propionate and zafirlukast in patients with relatively stable persistent asthma who were previously treated with inhaled corticosteroids and short-acting β 2-agonists. Subjects and methods A total of 440 patients (≥12 years of age) previously treated with inhaled corticosteroids (beclomethasone dipropionate or triamcinolone acetonide) and short-acting β 2-agonists were included in this randomized double-blind study. After an 8-day run-in period, patients were treated with fluticasone (88 μg) or zafirlukast (20 mg) twice daily for 6 weeks. Outcome measures included pulmonary function (forced expiratory volume in 1 second [FEV 1], peak expiratory flow [peak flow]), albuterol use, asthma symptoms, withdrawals due to lack of efficacy, and asthma exacerbations. Results Patients treated with fluticasone (n = 224) experienced greater mean increases in FEV 1 (0.24 L vs. 0.08 L, P <0.001), morning peak flow (30 L/min vs. 6 L/min, P <0.001), and evening peak flow (23 L/min vs. 5 L/min, P <0.001) during the study than did those treated with zafirlukast (n = 216). Fluticasone-treated patients had significantly greater increases in the mean percentages of symptom-free days (22% vs. 8%, P <0.001), rescue-free days (23% vs. 10%, P = 0.002), nights with uninterrupted sleep (<1% vs. –5%, P = 0.006), and fewer asthma exacerbations (1% vs. 6%, P = 0.005). Fewer fluticasone-treated patients were withdrawn due to lack of efficacy (2% vs. 13%, P <0.001). Conclusion Inhaled fluticasone was more effective than zafirlukast in maintaining or improving asthma control in patients with relatively stable asthma who were switched from low-dose inhaled corticosteroids.

Efficacy and Safety of Low-Dose Fluticasone Propionate Compared With Montelukast for Maintenance Treatment of Persistent Asthma

Objective To compare the long-term effects of an inhaled corticosteroid with those of a leukotriene modifier on measures of clinical efficacy, subject preference, and safety in patients with persistent asthma. Patients and Methods Between November 17, 1998, and May 26, 2000, we conducted a multicenter, randomized, double-blind, double-dummy, parallel-group study of patients aged 15 years or older with persistent asthma. The patients were symptomatic while taking short-acting β2-agonists alone and were treated with fluticasone propionate (88 μg [2 puffs of 44 μg] twice daily) or montelukast (10 mg/d) for 24 weeks. Measures of pulmonary function, asthma symptoms, albuterol use, nighttime awakenings, physician assessments of efficacy, patient satisfaction, asthma-related quality of life, and safety were evaluated. Results A total of 522 patients were randomized to receive fluticasone or montelukast, and 395 patients completed the study. At end point, treatment with fluticasone significantly improved pulmonary function, asthma symptom scores, the percentage of symptom-free days, rescue albuterol use, and the number of nighttime awakenings due to asthma when compared with montelukast (P=.002, each comparison). Significantly more patients were satisfied with fluticasone therapy (83%) compared with montelukast therapy (66%) (P<.001), and fluticasone therapy was rated as effective by a significantly greater portion of physicians (67%) than was montelukast therapy (54%) (P<.001). Treatment with fluticasone significantly improved asthma-related quality-of-life measures compared with montelukast (P=.01). The incidence of asthma exacerbations was similar in the fluticasone (19 patients, 7%) and montelukast (21 patients, 8%) treatment groups, although slightly more patients in the montelukast group were withdrawn from the study because of asthma exacerbations (6% vs 4%, respectively). Conclusion Long-term treatment with a low dose of inhaled fluticasone is more effective than oral montelukast as first-line maintenance therapy for the treatment of persistent asthma. To compare the long-term effects of an inhaled corticosteroid with those of a leukotriene modifier on measures of clinical efficacy, subject preference, and safety in patients with persistent asthma. Between November 17, 1998, and May 26, 2000, we conducted a multicenter, randomized, double-blind, double-dummy, parallel-group study of patients aged 15 years or older with persistent asthma. The patients were symptomatic while taking short-acting β2-agonists alone and were treated with fluticasone propionate (88 μg [2 puffs of 44 μg] twice daily) or montelukast (10 mg/d) for 24 weeks. Measures of pulmonary function, asthma symptoms, albuterol use, nighttime awakenings, physician assessments of efficacy, patient satisfaction, asthma-related quality of life, and safety were evaluated. A total of 522 patients were randomized to receive fluticasone or montelukast, and 395 patients completed the study. At end point, treatment with fluticasone significantly improved pulmonary function, asthma symptom scores, the percentage of symptom-free days, rescue albuterol use, and the number of nighttime awakenings due to asthma when compared with montelukast (P=.002, each comparison). Significantly more patients were satisfied with fluticasone therapy (83%) compared with montelukast therapy (66%) (P<.001), and fluticasone therapy was rated as effective by a significantly greater portion of physicians (67%) than was montelukast therapy (54%) (P<.001). Treatment with fluticasone significantly improved asthma-related quality-of-life measures compared with montelukast (P=.01). The incidence of asthma exacerbations was similar in the fluticasone (19 patients, 7%) and montelukast (21 patients, 8%) treatment groups, although slightly more patients in the montelukast group were withdrawn from the study because of asthma exacerbations (6% vs 4%, respectively). Long-term treatment with a low dose of inhaled fluticasone is more effective than oral montelukast as first-line maintenance therapy for the treatment of persistent asthma.

Efficacy and Safety of Low-Dose Fluticasone Propionate Compared With Montelukast for Maintenance Treatment of Persistent Asthma

To compare the long-term effects of an inhaled corticosteroid with those of a leukotriene modifier on measures of clinical efficacy, subject preference, and safety in patients with persistent asthma. Between November 17, 1998, and May 26, 2000, we conducted a multicenter, randomized, double-blind, double-dummy, parallel-group study of patients aged 15 years or older with persistent asthma. The patients were symptomatic while taking short-acting beta2-agonists alone and were treated with fluticasone propionate (88 microg [2 puffs of 44 microg] twice daily) or montelukast (10 mg/d) for 24 weeks. Measures of pulmonary function, asthma symptoms, albuterol use, nighttime awakenings, physician assessments of efficacy, patient satisfaction, asthma-related quality of life, and safety were evaluated. A total of 522 patients were randomized to receive fluticasone or montelukast, and 395 patients completed the study. At end point, treatment with fluticasone significantly improved pulmonary function, asthma symptom scores, the percentage of symptom-free days, rescue albuterol use, and the number of nighttime awakenings due to asthma when compared with montelukast (P< or = .002, each comparison). Significantly more patients were satisfied with fluticasone therapy (83%) compared with montelukast therapy (66%) (P<.001), and fluticasone therapy was rated as effective by a significantly greater portion of physicians (67%) than was montelukast therapy (54%) (P<.001). Treatment with fluticasone significantly improved asthma-related quality-of-life measures compared with montelukast (P< or =.01). The incidence of asthma exacerbations was similar in the fluticasone (19 patients, 7%) and montelukast (21 patients, 8%) treatment groups, although slightly more patients in the montelukast group were withdrawn from the study because of asthma exacerbations (6% vs 4%, respectively). Long-term treatment with a low dose of inhaled fluticasone is more effective than oral montelukast as first-line maintenance therapy for the treatment of persistent asthma.

Once-daily low dose fluticasone propionate in the treatment of adult and adolescent subjects with persistent asthma currently using low doses of inhaled corticosteroids

Once-daily low dose fluticasone propionate in the treatment of adult and adolescent subjects with persistent asthma currently using low doses of inhaled corticosteroids

The effect of low-dose inhaled fluticasone propionate on exhaled nitric oxide in asthmatic patients and comparison with oral zafirlukast

Exhaled nitric oxide (ENO) is a noninvasive marker of ongoing inflammation in asthmatic patients. Comparison between inhaled and oral anti-inflammatory medications in reduction of ENO in asthmatic patients has not been performed. We measured changes in ENO, spirometry, need for rescue medication, quality of life (QOL), and diary scores (DS) after inhaled and oral anti-inflammatory therapy in adults with moderate asthma. A randomized, double-blind, placebo-controlled, crossover design with 4-week washout periods was used. A plateau level of ENO, measured in parts per billion (ppb), was obtained by chemiluminescence with a Sievers 280NOA as per American Thoracic Society recommendations. Eighteen asthmatic adults (15 Hispanic, with a percentage predicted forced expiratory volume in 1 second (FEV1%) of 50% to 85%) on bronchodilators (beta2) only were studied. Subjects used fluticasone propionate (FP) metered-does inhaler (44 microg), two puffs twice daily, and matching placebo (PB) for 4 weeks. Eight of the asthmatic patients (7 Hispanic, FEV1% 50% to 85%) on bronchodilators only then received blinded zafirlukast (ZK) 20 mg and matching PB twice daily for 4 weeks. Low-dose inhaled FP resulted in significant improvements in ENO, spirometry, QOL, DS, and beta2 use. A significant difference in mean ENO was found (P < 0.01) before and after FP from 34+/-7 ppb to 13+/-3 ppb. A significant improvement was found (P < 0.05) with FEV1% from 75+/-3 to 85+/-3 with FP treatment. The other measured parameters, percentage predicted of peak expiratory flow rate, beta2 need, DS, and QOL measurements, were improved with low-dose FP treatment. No significant reduction was found in ENO with oral ZK for 4 weeks. After oral ZK washout and the second extension arm of placebo, ENO significantly increased back to 47+/-14 ppb (P < 0.05), but spirometry measures did not worsen. Significant improvements were found with DS and beta2 use with oral ZK therapy. These results reveal ENO is reduced with only low-dose inhaled FP in asthmatic patients not on anti-inflammatory medication. In the smaller extension study, ENO was reduced with FP and not with oral ZK treatment, and ENO levels increased back to near prestudy levels after ZK washout and the second extension arm of placebo. As a marker of inflammation, ENO levels reveal an improvement with anti-inflammatory medication and worsening when it is discontinued.

A comparison of short-term treatment with inhaled fluticasone propionate and zafirlukast for patients with persistent asthma

PurposeTo compare the short-term efficacy and safety of low-dose fluticasone propionate with that of oral zafirlukast therapy for patients previously treated with beta-2-agonists alone, and to evaluate the potential therapeutic benefit of switching from zafirlukast to a low-dose inhaled corticosteroid. Subjects and methodsThis study consisted of a 4-week randomized, double-blind treatment period followed by a 4-week open-label period. Two hundred ninety-four patients ≥12 years old with asthma previously uncontrolled with beta-2-agonists alone were randomly assigned to treatment with low-dose inhaled fluticasone (88 μg twice daily) or oral zafirlukast (20 mg twice daily). After 4 weeks, all patients discontinued their double-blind therapy and received open-label fluticasone (88 μg twice daily). Outcomes included pulmonary function, asthma symptoms, albuterol use, asthma exacerbations, and adverse events. ResultsDuring the double-blind treatment period, fluticasone patients had significantly greater improvements in morning peak flow (29.3 L/min vs. 18.3 L/min), percentage of symptom-free days (19.8% vs. 11.6%), and daily albuterol use (−1.8 puffs per day vs. −1.1 puffs per day) compared with zafirlukast patients (P ≤0.025, each comparison). During the open-label treatment period, patients switched from zafirlukast to fluticasone experienced additional improvements in morning peak flow (17.2 L/min), evening peak flow (13.6 L/min), and FEV1 (0.11 liter) and daily albuterol use (−0.9 puffs daily) compared with values obtained at the end of the double-blind treatment period (P ≤0.001, each comparison). ConclusionLow-dose fluticasone was more effective than zafirlukast in improving pulmonary function and symptoms in patients with persistent asthma. In addition, switching patients from zafirlukast to fluticasone further improved clinical outcomes.