Breo Ellipta(糠酸氟替卡松/维兰特罗吸入性粉剂)为每日一次的吸入性疗法  
Generic Name and Formulations:
Fluticasone furoate 100mcg, vilanterol 25mcg; per inhalation; dry pwd for oral inhalation.

Company:
GlaxoSmithKline

Indications for BREO ELLIPTA:
Long term maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and/or emphysema. To reduce exacerbations of COPD in patients with a history of exacerbations. Limitations of use: not indicated for relief of acute bronchospasm or for treatment of asthma.

Adult:
1 inhalation once daily. Rinse mouth after use.

Children:
Not established.

Pharmacological Class:
Corticosteroid + long-acting beta2-agonist.

Contraindications:
Severe hypersensitivity to milk proteins.

Warnings/Precautions:
Increased risk of asthma-related deaths. Do not initiate in rapidly or acutely deteriorating COPD. Not for relief of acute bronchospasm. Not for use with other long-acting β2-agonists. Do not exceed recommended dose. Prescribe a short-acting, inhaled β2-agonist for acute symptoms; monitor for increased need. Monitor for signs/symptoms of pneumonia. Immunosuppressed. Tuberculosis. Systemic infections. Ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin or antiviral ­prophylactic therapies. Monitor for adrenal insufficiency when transferring from systemic steroids. Reeva luate periodically. Monitor for hypercorticism and HPA axis suppression (if occurs, discontinue gradually), intraocular pressure, glaucoma, or cataracts. Discontinue if paradoxical bronchospasm occurs; use alternative therapy. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension). Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Hypokalemia. Hyperglycemia. Moderate or severe hepatic impairment; monitor. Assess bone mineral density if risk factors exist (eg, osteoporosis, postmenopausal). Labor and delivery. Pregnancy (Cat. C). Nursing mothers.

Interactions:
Caution with concomitant strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole). Caution with concomitant MAOIs, tricyclic antidepressants, or drugs known to prolong the QT interval or within 2 weeks of discontinuing such agents (increased cardiac effects), K+-depleting diuretics. Antagonized by β-blockers.

Adverse Reactions:
Nasopharyngitis, upper respiratory tract infection, headache, oral candidiasis; risk of asthma-related death.

How Supplied:
Dry pwd inhaler—30 doses
美国FDA批准Breo Ellipta用于慢性阻塞性肺疾病新的治疗选择
5月10日，美国食品药品管理局（FDA）批准Breo Ellipta用于包括慢性支气管炎和/或肺气肿在内的慢性阻塞性肺病（COPD）患者气流阻塞的长期维持治疗，该药物为糠酸氟替卡松和维兰特罗的吸入型复方药物粉末，可每日吸入一次。Breo Ellipta还被批准用于减少患者的慢性阻塞性肺病发作。
慢性阻塞性肺病是一种严重的肺疾病，可随时间的推移而恶化。症状有胸闷、久咳和过度痰液。根据美国国家心脏、肺和血液研究所提供的信息，吸烟是慢性阻塞性肺病的主要因素，而慢性阻塞性肺病在美国是第三大主要死亡原因。Breo Ellipta可通过减轻慢性阻塞性肺病患者肺部的炎症，以及松弛肺气道周围的肌肉来增加气流及减少疾病的发作。
FDA药品评价与研究中心药物评价II办公室的主任Curtis Rosebraugh医学博士说：“慢性阻塞性肺病是一种造成呼吸困难的严重疾病，新型的长期维持药物的应用为美国数百万遭受该病困扰的患者提供了一种新的治疗选择。”
Breo Ellipta中的糠酸氟替卡松是一种吸入型糖皮质激素，维兰特罗是一种长效β2肾上腺素受体激动剂(LABA)。该药物的安全性和有效性通过一项7700名慢性阻塞性肺病患者参与的临床试验进行了评价。用药组患者相比安慰剂组患者其肺部功能得到了改善，疾病发作次数减少。
Breo Ellipta在获批时其标签内容中有一项黑框警告，提示长效β2肾上腺素受体激动剂能增加哮喘有关的死亡风险。这款药物对哮喘患者的安全性和有效性还没得到确认，所以没被批准用于哮喘的治疗。
FDA在批准Breo Ellipta时附带一患者用药指南，内容包含该药物的使用说明和用药后的潜在风险信息。Breo Ellipta不能作为一种急救措施用于治疗突然的呼吸困难（急性支气管痉挛），也不建议用于18岁以下患者。
Breo Ellipta可能会引起严重的副作用，包括肺炎和骨折的风险增加。Breo Ellipta用药患者报道的最常见副作用有鼻腔炎症（鼻咽炎）、上呼吸道感染、头痛及口腔念珠菌病(鹅口疮)。
Breo Ellipta由葛兰素史克与总部位于旧金山的治疗先锋公司联合开发。