慢性阻塞性肺疾病（Chronic Obstructive Pulmonary Disease）是一种常见但严重的肺部疾病，被认为影响全球3.84亿人。对于COPD患者来说，无法正常呼吸消耗着他们的生命，而进行简单的活动，如走楼梯，更是带来很大的困扰。长期暴露在肺部和气道上的吸入刺激物通常是COPD的原因，同时吸烟、呼吸二手烟、空气污染，化学烟雾或来自环境或工作场所的灰尘都可能导致COPD。大多数COPD患者在症状开始时至少40岁。葛兰素史克公司认为，患有COPD的每个人是不同的，具有不同的需求，不同的挑战和不同的目标。
  2017年9月21日，美国食品和药品管理局（FDA）已批准葛兰素史克用于治疗慢性阻塞性肺疾病的药物，商品名为Trelegy Ellipta。
  该药物为糠酸氟替卡松／芜地溴铵／维兰特罗（FF/UMEC/VI）三联吸入性药物，通常用于已服用固定剂量的糠酸氟替卡松和维兰特罗的患者，并进一步缓解气道阻塞和防止病情进一步恶化。
  Trelegy Ellipta并不适用于缓解急性支气管痉挛和哮喘。
  Trelegy Ellipta是一种吸入性皮质类固醇（ICS），长效毒蕈碱拮抗剂（LAMA）和长效β2-肾上腺素能激动剂（LABA）的组合，使用葛兰素史克的Ellipta干粉吸入器中每日一次，这是美国第一个每日一次的三联吸入药物，它将三个活性分子结合在一个单一的吸入器中，用于对适当的COPD患者进行维护治疗。
  是药三分毒，服用Trelegy Ellipta也存在风险。
  对于对乳蛋白或任何成分具有严重超敏反应的患者，Ellipta被禁用。慢性阻塞性肺疾病的患者出现急性、恶化性症状，不要使用Trelegy Ellipta。同时该药物不应与含有LABA的其他药物组合使用，因为可能存在服用过量的风险。
  Trelegy Ellipta其中一个组分氟替卡松糠酸盐可导致患者口腔和咽部感染白念珠菌，需要定期监测，并建议病人用水冲洗口腔，不要在吸入后吞咽，这样有助于降低风险。患有COPD患者服用Trelegy Ellipta后，患肺炎风险增加，应该定期监测患者肺炎的症状和体征。
  与葛兰素史克共同研发该药物的Innoviva公司表示，对于接受Breo Ellipta治疗并存在持续性进展性支气管扩张的慢性阻塞性肺病患者，Trelegy Ellipta提供了更优化的治疗方案，会将继续在开发治疗呼吸系统疾病的药物方面与葛兰素史克进一步加强合作。
  Trelegy Ellipta将在美国即将推出，澳大利亚和加拿大在内的其他一些国家已经向药品监督机构提交了监管申请并开始进行评估。2017年9月15日，欧洲药品管理局（EMA）人类药用产品委员会（CHMP）发布了积极意见，建议FF/UMEC/VI的营销授权作为中度至重度COPD成人患者的维持治疗，通过吸入皮质类固醇和长效β2-激动剂的组合治疗。不过，好消息是欧盟委员会批准Trelegy Ellipta营销授权已经走到最后一步，但是拟议的商品名称Trelegy Ellipta仍需经欧洲监管部门批准方可使用。截止目前，FF/UMEC/VI三联吸入性药物在美国境外的任何地方仍未获得治疗许可。

Trelegy Ellipta(Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate)
TRELEGY ELLIPTA Rx
Generic Name and Formulations:
Fluticasone furoate, umeclidinium, vilanterol 100mcg/62.5mcg/25mcg; per inh; dry pwd for oral inhalation.
Company:
GlaxoSmithKline
Indications for TRELEGY ELLIPTA:
Long-term maintenance treatment of airflow obstruction in patients with 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 inh once daily (max). Rinse mouth after use.
Children:
Not established.
Contraindications:
Severe hypersensitivity to milk proteins.
Warnings/Precautions:
Increased risk of asthma-related events (death, hospitalizations, intubations) with LABA as monotherapy (without ICS). Do not initiate in rapidly or acutely deteriorating COPD. 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 prophylaxis or antiviral ­treatment. Monitor for adrenal insufficiency when transferring from systemic steroids. May need supplemental systemic corticosteroids during periods of stress or a severe COPD exacerbation. May unmask previously suppressed allergic conditions.
Reevaluate 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); discontinue if significant effects occur. Convulsive disorders.
Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Hypokalemia. Hyperglycemia.
Urinary retention. Prostatic hyperplasia. Bladder-neck obstruction.
Assess bone mineral density if risk factors exist (eg, prolonged immobilization, osteoporosis, postmenopausal, advanced age, others). Fluticasone furoate: moderate or severe hepatic impairment (monitor). Labor & delivery. Pregnancy. Nursing mothers.
Pharmacological Class:
Corticosteroid+anticholinergic+long-acting beta-2 agonist (LABA).
Interactions:
Caution with concomitant strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole), MAOIs, tricyclic antidepressants, 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; if needed, consider cardioselective agents. Additive effects with concomitant other anticholinergic-containing drugs; avoid.
Adverse Reactions:
Upper RTI, pneumonia, bronchitis, oral candidiasis, headache, back pain, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, dysgeusia, constipation, UTI, diarrhea, gastroenteritis, oropharyngeal pain, cough, dysphonia; hypersensitivity reactions.
Generic Availability:
NO
How Supplied:
Dry pwd inhaler—30 doses
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