Efficacy and safety of mometasone furoate administered once-daily in the evening in patients with persistent asthma dependent on inhaled corticosteroids

BACKGROUND: Once-daily dosing with an inhaled corticosteroid (ICS) may simplify asthma management and improve patient compliance. Since asthma is frequently worse at night, evening dosing appears to be a more obvious choice to accommodate the chronobiology of asthma than morning dosing. OBJECTIVE: The primary study objective was to compare the efficacy and safety of mometasone furoate (MF) dry powder inhaler (MF-DPI) 400 microg qd PM (one 400 microg inhalation) with placebo for the treatment of asthma in patients previously dependent on twice a day (bid, bis in die) ICS therapy. We also compared different regimens of MF-DPI with each other and with placebo. METHODS: This 12-week, multicenter, double-blind, placebo-controlled study evaluated lung function and asthma symptoms in 400 subjects with persistent asthma randomized to MF-DPI 200 microg qd (once a day, quaque die) PM, 400 microg qd PM as one inhalation from a 400 microg device, 400 microg qd PM as two inhalations from a 200 microg device, 200 microg twice daily (bid), or placebo. Evening doses were to be taken in the late afternoon or early evening, preferably before dinner time. RESULTS: Mean changes from baseline at endpoint in FEV1 (forced expiratory volume in 1 s) were similar for MF-DPI 400 microg qd PM (one inhalation; 0.41 L), MF-DPI 400 microg qd PM (2 inhalations; 0.49 L), MF-DPI 200 microg qd PM (0.41 L), and MF-DPI 200 microg bid (0.51 L); and all were significantly improved compared with placebo (0.16 L; p < 0.001). Secondary efficacy variables, including nocturnal awakenings and use of rescue albuterol, were also significantly improved with MF-DPI treatment compared with placebo. All treatments were generally safe and well tolerated, with adverse events of mild to moderate severity. CONCLUSIONS: Once-daily evening dosing of MF-DPI at doses of 400 and 200 microg restored lung function and improved nocturnal and daytime symptom control in subjects with asthma previously dependent on bid ICS therapy. Comparable effectiveness of a total daily dose of 400 microg was demonstrated between once daily in the evening and twice-daily administration. The results also confirm the effectiveness of MF-DPI 200 microg qd PM, the lowest dose studied.     

Use of mometasone furoate administered via a dry powder inhaler in the treatment of asthma

Abstract

Background:

Inhaled corticosteroids (ICSs) are effective controller medications that treat the chronic inflammation of asthma. The goal of asthma treatment is to improve lung function, symptoms, and the ability to perform daily activities, while decreasing the risk of exacerbations. Mometasone furoate delivered via a dry powder inhaler (MF-DPI) is indicated for once-daily maintenance treatment of asthma in patients as young as 4 years old.     

Mometasone furoate dry powder inhaler: a once-daily inhaled corticosteroid for the treatment of persistent asthma

ABSTRACT

Background: Mometasone furoate (MF), a potent synthetic inhaled corticosteroid (ICS) with a high affinity for the glucocorticoid receptor, is approved for use in the treatment of asthma.

Scope: Publications reviewed in this article were identified via searches of MEDLINE and EMBASE databases using the terms ‘mometasone furoate AND pharmacology’ and ‘mometasone furoate AND asthma AND clinical trial’. Data from abstracts presented at respiratory society meetings, and relevant background information, are also reviewed.

Findings: In clinical studies, MF, administered by dry powder inhaler (MF-DPI), was effective in treating all severities of persistent asthma, improving pulmonary function, reducing asthma symptoms, and reducing or eliminating the need for oral corticosteroids. Once-daily dosing of MF-DPI was effective in patients with mild or moderate persistent asthma previously taking twice-daily regimens of inhaled corticosteroids (ICSs), and in patients taking only inhaled β₂?agonists for symptom relief. Once-daily dosing in the evening with MF-DPI 200?µg conferred a greater benefit than morning dosing with MF-DPI 200?µg. Patients with severe asthma who were dependent on oral corticosteroids (OCSs) and high doses of ICSs were able to achieve greater asthma control and reduce or even eliminate OCSs when switched to MF-DPI. In trials of up to 1 year in duration, MF-DPI was well tolerated, with the majority of adverse events considered mild or moderate in intensity. MF had low systemic bioavailability and no clinically significant hypothalamic–pituitary–adrenal-axis suppression at therapeutic doses. The DPI device is a multiple-dose inhaler with a counter containing agglomerates of MF and lactose. Patients of all severities of persistent asthma were able to generate and maintain airflow profiles necessary to provide a uniform and accurate dose.

Limitations: Only one study evaluated both morning and evening administration of once-daily doses, and one of the comparative clinical trials was an open-label study.

Conclusion: Once-daily administration of MF-DPI 200–400?µg in patients with mild to moderate persistent asthma effectively improved lung function and asthma control. In patients with severe persistent asthma dependent on oral corticosteroids, treatment with MF-DPI 400?µg BID permitted substantial reduction of oral corticosteroid use. All MF-DPI treatments were well tolerated and had minimal systemic effects.     

孟鲁司特钠联合糠酸莫米松对变应性鼻炎患者的疗效

目的探究变应性鼻炎(AR)患者予以孟鲁司特钠与糠酸莫米松联合应用的临床效果。方法本文为前瞻性随机对照试验。选取2019年7月至2022年7月威海市中心医院收治的AR患者98例为研究对象, 采用随机数字表法将其分为两组, 各49例。对照组男27例、女22例, 年龄(35.47±7.09)岁, 予以糠酸莫米松治疗;联合组男23例、女26例, 年龄(36.85±7.37)岁, 予以糠酸莫米松与孟鲁司特钠联合治疗。对比两组临床疗效、炎症水平及用药不良反应。采用χ2检验、t检验。结果联合组总有效率为97.96%(48/49), 明显高于对照组83.67%(41/49), 差异有统计学意义(χ2=4.404, P=0.036)。治疗前, 两组患者白细胞介素-4(IL-4)、细胞间黏附分子-1(ICAM-1)、C反应蛋白(CRP)水平比较, 差异均无统计学意义(均P>0.05);治疗后, 联合组IL-4[(115.43±12.83)ng/L]、ICAM-1[(5.74±1.15)μg/L]、CRP水平[(7.36±1.46)mg/L]均明显低于对照组[(127.45±14.16)ng/L、(6...     

Efficacy,safety, and tolerability of mometasone furoate in adult Japanese patients with mild asthma: open-label clinical trial findings

Abstract

Objective:

To evaluate the clinical efficacy and safety of mometasone furoate administered via a dry powder inhaler (MF-DPI) in Japanese patients with intermittent or mild persistent asthma who were not previously receiving inhaled corticosteroids.     

青鹏软膏联合糠酸莫米松乳膏治疗老年瘙痒症的疗效

目的：观察青鹏软膏联合糠酸莫米松乳膏外用治疗老年瘙痒症的临床疗效和安全性。方法老年瘙痒症患者70例随机分为两组：试验组37例,外用青鹏软膏3周和糠酸莫米松乳膏1周;对照组33例,外用尿素乳膏3周和糠酸莫米松乳膏1周。除外用药物外,两组均予氯雷他定片口服3周。比较两组疗效和不良反应。结果治疗3周时,试验组有效率高于对照组（85.7％ vs ．63.6％）（P＜0．05）。停药2周后试验组复发率低于对照组（10.0％ vs ．33.3％）（P＜0．05）。两组均未发生严重不良反应。结论青鹏软膏联合糠酸莫米松乳膏治疗老年瘙痒症疗效好,复发率低,不良反应少。     

探讨糠酸莫米松吸入治疗过敏性鼻炎对支气管哮喘的影响

目的试验和分析糠酸莫米松吸入治疗过敏性鼻炎对支气管哮喘的影响。方法选取本院收治的过敏性鼻炎及支气管哮喘患者158例,作为研究对象。随机分为糠酸莫米松吸入治疗观察组和普通疗法对照组。比较两组患者治疗前及治疗2月后的咳嗽,鼻塞,鼻痒,喷嚏的次数。综合以上的几种临床症状判断糠酸莫米松吸入治疗过敏性鼻炎对支气管哮喘的临床疗效。记录患者的并发症并分析。结果两组患者治疗2月后,观察组的总有效率有明显具有优势,P均〈0.05,差异均具有统计学意义。观察组的总不良反应明显小于对照组,两组比较差异明显,P均〈0.05,差异均具有统计学意义。结论糠酸莫米松吸入治疗过敏性鼻炎积极有效,并对支气管哮喘有积极影响。值得临床的广泛推广与应用。     

卡泊三醇搽剂联合糠酸莫米松乳膏序惯疗法治疗头皮银屑病临床疗效观察

目的观察卡泊三醇搽剂联合糠酸莫米松乳膏序惯疗法治疗头皮银屑病的疗效及安全性。方法 62例头皮银屑病患者,采用随机对照的方法分为治疗组和对照组,每组31例。治疗组采用卡泊三醇搽剂联合糠酸莫米松乳膏序贯疗法治疗,对照组采用卡泊三醇搽剂治疗。比较两组患者临床疗效、皮损面积评分,并分析其不良反应发生情况。结果治疗2周后,治疗组有效率为45.16%,对照组有效率为32.26%,两组比较差异无统计学意义(χ2=1.09, P>0.05)。治疗4周后,治疗组有效率为67.74%,高于对照组的41.94%,差异有统计学意义(χ2=4.17, P<0.05)。治疗6周后,治疗组有效率87.10%显著高于对照组的64.52%,差异有统计学意义(χ2=4.31, P<0.05)。两组患者治疗前及治疗2周后皮损面积评分比较差异无统计学意义(P>0.05);治疗4、6周后,治疗组患者的皮损面积评分均低于对照组,差异具有统计学意义(P<0.05)。两组患者在治疗过程中均未见严重不良反应,治疗组中2例(6.45%)患者出现局部皮肤轻微烧灼感和疼痛,对照组中2例患者(6.45%)自觉局部轻微灼热不适和疼痛,均未影响治疗,未予处理。结论卡泊三醇搽剂联合糠酸莫米松乳膏序惯疗法治疗头皮银屑病疗效好,安全性高。     

糠酸氟替卡松/维兰特罗复方剂治疗哮喘疗效与耐受性的Meta分析

目的 比较糠酸氟替卡松/维兰特罗复方剂（FF/VI）与吸入型糖皮质激素单药或联合长效β₂受体激动剂治疗哮喘患者的疗效与耐受性差异。方法 计算机检索CNKI、PubMed、Embase、Cochrane Library等数据库,纳入随机对照试验,采用Cochrane系统评价方法进行评价。结果 共纳入10个研究,共9 811例患者。在疗效上,FF/VI组与对照组相比,提高患者的1秒用力呼气量谷值[WMD=0.09,95% CI（0.05,0.13）,P=0.000]和哮喘控制测试评分[WMD=0.63,95% CI（0.24,1.03）,P=0.002]。在耐受性方面,FF/VI组与对照组相比不增加患者发生与治疗相关不良反应事件风险[RR=1.15,95% CI（0.98,1.36）,P=0.000]。结论 用FF/VI治疗哮喘在疗效方面具有优势,且具有良好的耐受性。其每日1次的用药频次可提高患者依从性,值得推荐使用。     

糠酸莫米松鼻喷雾剂联合孟鲁斯特钠咀嚼片治疗儿童中重度过敏性鼻炎的疗效及安全性

目的 研究糠酸莫米松鼻喷雾剂联合孟鲁斯特钠咀嚼片治疗儿童中重度过敏性鼻炎的疗效及安全性.方法 研究对象选自2011年9月至2012年3月在同济医学院附属同济医院门诊就诊的6～12岁中重度过敏性鼻炎患儿.将患儿按就诊时间的先后顺序用随机数字法分为2组:联合用药组和单独用药组.联合用药组采用糠酸莫米松鼻喷雾剂100 μg/d联合孟鲁斯特钠咀嚼片5 mg/d,单独用药组单用糠酸莫米松鼻喷雾剂100 μg/d治疗,疗程均为2周.治疗第7、14天采用0～10 cm视觉模拟量表进行过敏性鼻炎总体症状和喷嚏、流涕、鼻痒、鼻塞症状评分,记录不良反应.结果 共入选患儿252例.联合用药组127例,男54例,女73例,平均年龄(8.1±2.6)岁;单独用药组125例,男58例,女67例,平均年龄(8.7±3.0)岁.2组患儿性别、年龄分布、病程、鼻炎总体症状及单个症状评分比较差异均无统计学意义(均P>0.05).联合用药组有2例患儿因用药后出现关节疼痛、腹痛和睡眠障碍而退出研究.与治疗前相比,治疗第7、14天鼻炎总体症状评分联合用药组分别下降(4.7±1.9)和(5.5±2.2)分[(2.6±1.7)、(1.8±1.7)分比(7.3±1.3)分],单独用药组下降(3.9±2.2)和4.9±1.7分[(3.2±2.0)、(2.3±2.1)分比(7.2±1.5)分],差异均有统计学意义(均P<0.05),联合用药组改善程度优于单独用药组(P<0.05).单项症状评分中,治疗第7、14天联合用药组对流涕和鼻塞症状的疗效均优于单独用药组(均P<0.05).联合用药组有5例发生不良反应(3.9%),其中与糠酸莫米松鼻喷雾剂相关的不良反应为鼻出血(2例)和鼻腔干燥(1例),与孟鲁斯特钠咀嚼片相关的不良反应为关节疼痛、腹痛(1例)和睡眠障碍(1例);单独用药组有4例发生不良反应(3.2%),鼻腔干燥和鼻出血各2例.2组间不良反应发生率差异无统计学意义(P>0.05).2组患儿不良反应均较轻微,停药后很快自行缓解.2组均无严重不良反应发生.结论 糠酸莫米松鼻喷雾剂联合孟鲁斯特钠咀嚼片治疗儿童中重度过敏性鼻炎疗效优于单用糠酸莫米松鼻喷雾剂,且安全性良好.     

鼻炎宁胶囊联合糠酸莫米松治疗慢性鼻炎的临床研究

目的探讨鼻炎宁胶囊联合糠酸莫米松治疗慢性鼻炎的有效性和安全性。方法选取2016年5月—2017年5月在太和县人民医院进行治疗的慢性鼻炎患者174例,根据用药方案不同分成对照组和治疗组,每组各87例。对照组患者给予糠酸莫米松鼻喷雾剂,4揿/次,1次/d,症状明显缓解后每鼻孔1揿;治疗组患者在对照组的基础上口服鼻炎宁胶囊,5粒/次,3次/d。两组患者均治疗4周。观察两组患者临床疗效,比较治疗前后两组患者鼻阻力、临床症状评分、生活质量评分、IL-17和Ig E水平及不良反应。结果治疗后,对照组临床总有效率为87.36%,显著低于治疗组的97.70%,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者鼻阻力、临床症状评分和生活质量评分均较治疗前显著降低(P0.05);且治疗组患者这些指标较对照组降低得更显著(P0.05)。治疗后,两组患者IL-17、Ig E水平均显著下降(P0.05);且治疗组IL-17和Ig E水平显著低于对照组(P0.05)。治疗期间,治疗组患者不良反应发生率为3.45%,显著低于对照组的12.64%,两组比较差异具有统计学意义(P0.05)。结论鼻炎宁胶囊联合糠酸莫米松鼻喷剂治疗慢性鼻炎具有较好的临床疗效,改善炎症反应水平,具有一定的临床推广应用价值。     

Efficacy and long-term safety of mometasone furoate nasal spray in children with perennial allergic rhinitis

Abstract

Background:

Allergic rhinitis (AR) affects up to 40% of children by age 6 years. Perennial AR (PAR) causes sleep disturbance, diminishes concentration in school, impairs psychosocial functioning, and reduces quality of life. This study evaluated efficacy and long-term safety of the intranasal corticosteroid mometasone furoate nasal spray (MFNS) in children with PAR.     

An update on the safety of long-acting β-agonists in asthma patients using inhaled corticosteroids

Importance of the field: Pooled trial data have shown that long-acting β-agonists increase the risk for asthma hospitalizations and deaths by two to fourfold compared with placebo. Until recently, it was unclear whether concomitant inhaled corticosteroids (ICSs) could eliminate this risk.

Areas covered in this review: This review summarizes the available data on the safety of long-acting β-agonist use in asthma, with and without concomitant ICSs. The results from an updated meta-analysis are presented, with data through December 2008.

What the reader will gain: In pooled trial data, catastrophic asthma events (defined as asthma-related intubation or death) were increased fourfold for concomitant treatment with long-acting β-agonists and ICSs compared with corticosteroids alone (odds ratio 3.7; 95% CI 1.4 – 9.6). It is estimated that the addition of long-acting β-agonists to ICS therapy is associated with an absolute increase of one catastrophic event per 1500 patient-years.

Take home message: When the available trial data are pooled together, it is clear that long-acting β-agonists significantly increase the risk for asthma-related intubations and deaths, even when used in a controlled fashion with concomitant ICSs. Clinical guidelines should readdress the role long-acting β-agonists have in the management of asthma.     

The effect of ketoconazole on the pharmacokinetics and pharmacodynamics of inhaled fluticasone furoate and vilanterol trifenatate in healthy subjects

Aim

To investigate the effects of the cytochrome P450 3A4 (CYP3A4) inhibitor ketoconazole on the pharmacokinetics (PK) and pharmacodynamics of fluticasone furoate (FF) and vilanterol trifenatate (VI).

Methods

Two double-blind, randomized, placebo-controlled, two-way crossover studies in healthy subjects. In study 1, subjects received single doses of ketoconazole (400 mg) or placebo on days 1–6, with a single dose of inhaled VI (25 μg) on day 5. Pharmacodynamic and PK data were obtained up to 48 h following the VI dose. In study 2, subjects received once daily ketoconazole (400 mg) or placebo for 11 days, with FF/VI (200/25 μg) for the final 7 days. Pharmacodynamic and PK data were obtained up to 48 h following the day 11 dose.

Results

In study 1, there was no effect of co-administration of ketoconazole and VI on pharmacodynamic or PK parameters. In study 2, co-administration of ketoconazole and FF/VI had no effect on 0–4 h maximal heart rate or minimal blood potassium {treatment difference [90% confidence interval (CI)] –0.6 beats min^–1 (−5.8, 4.5) and 0.04 mmol l⁻¹ (−0.03, 0.11), respectively}, whilst there was a 27% decrease in 24 h weighted mean serum cortisol [treatment ratio (90% CI) 0.73 (0.62, 0.86)]. Co-administration of ketoconazole increased [percentage change (90% CI)] FF area under the curve (0-24) and maximal plasma concentration by 36% (16, 59) and 33% (12, 58), respectively, and VI area under the curve (0–t′) and maximal plasma concentration by 65% (38, 97) and 22% (8, 38), respectively.

Conclusion

Co-administration of FF/VI or VI with ketoconazole resulted in a less than twofold increase in systemic exposure to FF and VI. There was no increase in β-agonist systemic pharmacodynamic effects, while serum cortisol was decreased by 27%. Co-administration of FF/VI with strong CYP3A4 inhibitors has the potential to increase systemic exposure to both fluticasone furoate and vilanterol, which could lead to an increase in the potential for adverse reactions.     

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

ABSTRACT

Objective: 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.     

哮喘维持治疗中的可调节剂量与固定剂量疗法的研究进展

可调节维持剂量方案是近几年提出用于哮喘维持治疗的一种新的措施,与传统的固定剂量的治疗方案有很大的不同,也由此引发了很多争议。本文就这2种治疗方案比较的临床试验进行综述。     

Improvement in quality of life with omalizumab in patients with severe allergic asthma

ABSTRACT

Background: Patients with severe persistent asthma experience daily symptoms and frequent serious exacerbations that contribute to a significant impairment of health-related quality of life (QoL).

Methods: A pooled analysis was completed of six controlled clinical trials that evaluated the effect of add-on omalizumab on asthma-related QoL in patients with severe persistent allergic (IgE-mediated) asthma. Asthma-related QoL was assessed at baseline and treatment endpoint using the well-validated Juniper Asthma Quality of Life Questionnaire (AQLQ). Change from baseline in AQLQ total score was compared between treatments using analysis of covariance methods. The percentage of patients who achieved a clinically meaningful (≥ 0.5-point) improvement in AQLQ total score was compared using the Mantel–Haenszel Chi-square test.

Results: The pooled patient population comprised 2548 patients (omalizumab, n = 1342; control, n = 1206), of whom 96% had severe persistent asthma according to the GINA 2002 classification. Omalizumab produced significantly greater improvements in AQLQ total score vs the control group (mean increases of 1.01 and 0.61 points, respectively; p < 0.001). In addition, significantly more omalizumab-treated patients achieved a clinically meaningful improvement in AQLQ total score than patients in the control group (66.3% vs 52.4%; p < 0.001).

Conclusions: Add-on therapy with omalizumab improves QoL to a significant and clinically meaningful level in patients with severe persistent allergic asthma.     

辛芩雾化剂对支气管哮喘患者肺功能及其生命质量的影响

目的 探讨辛芩雾化剂对支气管哮喘患者肺功能及其生命质量的影响.方法 124例支气管哮喘患者按随机数字表随机分为对照组(60例)和观察组(64例).2组均予同时配合抗炎、抗过敏、止咳、化痰等对症治疗.在此基础上,观察组加用辛芩雾化剂(3级:辛芩雾化剂30 ml;2级:辛芩雾化剂15 ml;1级:辛芩雾化剂15 ml)超声雾化吸入,对照组加用丙酸倍氯米松气雾剂(3级:200～300 μg;2级:100～200μg;1级:100～200 μg)吸入,2组中2、3级患者均加用β2受体激动剂吸入,于治疗3个月后评估临床症状、征候积分、疗效及生命质量评分.结果 观察组和对照组总有效率比较,差异无统计学意义[96.9％ (62/64)比100.0％ (60/60)] (P ＞0.05);观察组和对照组治疗后3个月测得的第1秒用力呼气容积占预计值百分比(FEV1％)、最大呼气流量(PEF)、最大呼气流速(PEFR)值均较治疗前明显改善[观察组:FEV1％为(87±4)％比(70±4)％,PEF为(350±40) L/min比(316±35) L/min,PEFR为(13.4±2.4)％比(18.3±3.0)％;对照组:FEV1％为(86±4)％比(71±4)％,PEF为(346±37) L/min比(326±37) L/min,PEFR为(14.3±2.1)％比(19.7±2.9)％](均P＜0.05).但2组治疗后3个月测得的FEV1％、PEF、PEFR值比较差异无统计学意义(P＞0.05).观察组生命质量评分总分[(62±6)分]明显优于对照组[(82±7)分](P＜0.05).结论 辛芩雾化剂吸入替代激素治疗能改善支气管哮喘患者肺功能及其生命质量,其治疗成人支气管哮喘安全、有效.     

Clinical study of the effects on asthma-related QOL and asthma management of a medical food in adult asthma patients

Abstract

Background:

Asthma can have a negative impact on quality of life although this is not well correlated with objective evaluations of pulmonary function. A medical food, EFF1009, containing the fatty acids gamma-linolenic acid (GLA) and eicosapentaenoic acid (EPA) decreases leukotriene B₄ synthesis in patients with asthma. Two previous clinical studies with EFF1009 provided preliminary evidence that the medical food improves asthma-related quality of life (ARQOL) and asthma management.     

The impact of a medical food containing gammalinolenic and eicosapentaenoic acids on asthma management and the quality of life of adult asthma patients

ABSTRACT

Background: Leukotriene synthesis inhibitors and receptor antagonists are efficacious for the treatment of asthma. Diets containing the fatty acids gammalinolenic acid (GLA) and eicosapentaenoic acid (EPA) decrease leukotriene synthesis; however, their impact on asthma management and quality of life (QOL) has not been evaluated in asthmatic subjects.

Objective: To evaluate asthma management and the QOL of asthmatic adult subjects consuming a medical food emulsion containing GLA and EPA.

Research design and methods: Trial 1 was a random­ized, prospective, double-blind, placebo-controlled, parallel group trial in atopic subjects with mild-to-moderate asthma (n = 35 evaluable) consuming a low dose (0.75?g GLA + 0.5?g EPA), high dose (1.13?g GLA + 0.75?g EPA) or placebo emulsion daily. Subjects were questioned about their asthma management using a non-validated questionnaire after 2 and 4 weeks. Blood leuko­trienes were measured at baseline and after 4 weeks. Trial 2 was an open-label study (n = 65 evaluable) where subjects consumed the low-dose medical food emulsion, EFF1009, daily. QOL and asthma management were measured using the validated Mini Asthma Quality of Life (MiniAQLQ) and the Asthma Control (ACQ) questionnaires, respectively, administered at baseline and after 4 weeks.

Results: In Trial 1, leukotriene biosynthesis decreased (?p < 0.05). Self-reported asthma status and broncho­dilator use improved in subjects consuming low- and high-dose emulsion between week 2 and week 4 (?p < 0.01), but not compared to placebo (?p > 0.1). In Trial 2, mean ± standard error total MiniAQLQ and ACQ scores improved by 1.5 ± 0.2 and 1.0 ± 0.1, respectively (?p < 0.001). Subdomain scores from MiniAQLQ improved and rescue bronchodilator use decreased (?p < 0.001).

Conclusion: The inclusion of the medical food EFF1009 in asthma management regimens can improve patient quality of life and decrease reliance on rescue medication.