哮喘新吸入粉雾剂ProAir RespiClick获FDA扩大批准用于4岁及以上儿科哮喘患者
2016年5月1日，美国食品和药物管理局（FDA）已批准扩大其呼吸系统疾病新产品PriAir RespiClick（硫酸沙丁胺醇）吸入性粉剂的适用人群，用于患有可逆性气道阻塞性疾病的4-11岁儿童，治疗或预防支气管痉挛，以及预防运动支气管痉挛（EIB）。
此前，PriAir RespiClick已于2015年3月获FDA批准用于12岁及以上哮喘患者。截至目前，PriAir RespiClick仍然是美国市场唯一一种由呼吸驱动的多剂量短效β受体激动剂（SABA）干粉吸入器。对于急性哮喘发作的患者而言，PriAir RespiClick简直就是救命稻草。该产品另一个显著优势是用药简单，只需轻轻一吸，而不像其他产品需要双手和呼吸协调起来使用。
在美国，儿童哮喘的患病率很高，儿科哮喘患者超过600万例，而且这个数字还在不断增长。对于这类年幼的哮喘患者，学习使用吸入器可能非常具有挑战性。因此，ProAir RespiClick的儿科适应症非常重要，因为它代表着年幼患者群体中一种新的急救吸入器选择，在使用吸入器时可消除双手和呼吸协调的必要性。
ProAir RespiClick儿科适应症的获批，是基于在4岁及以上儿科哮喘患者中开展的III期临床项目。数据显示，与安慰剂治疗组相比，ProAir RespiClick治疗组用力呼气量（FEV1）实现了显著更大程度的改善。研究中，与ProAir RespiClick治疗相关的最常见不良事件包括上呼吸道感染、口腔和咽喉疼痛、呕吐。
ArmonAir RespiClick (fluticasone propionate)
ARMONAIR RESPICLICK Rx
Generic Name and Formulations:
Fluticasone propionate 55mcg, 113mcg, 232mcg; per actuation; dry pwd inhaler for oral inh with a dose counter.
Company:
Teva Pharmaceuticals
Indications for ARMONAIR RESPICLICK:
Maintenance treatment of asthma as prophylactic therapy.
Limitations Of use:
Not for the relief of acute bronchospasm.
Adult:
Administer 1 inhalation twice daily (approx. 12hrs apart) by orally inhaled route. Take at same time each day. Rinse mouth after each dose. Not previously on inhaled steroid: 1 inh of 55mcg twice daily; already on inhaled steroid: see full labeling. If insufficient response after 2 weeks, increasing the dose may provide additional asthma control. Max 1 inh of 232mcg twice daily. Titrate to lowest effective dose after stability achieved. Do not use with spacers or volume holding chambers.
Children:
<12yrs: not established.
Contraindications:
Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures. Severe milk protein hypersensitivity.
Warnings/Precautions:
Do not exceed recommended dose. Risk of local infections (eg, mouth/pharynx candidiasis). Prescribe a short-acting, inhaled β2-agonist for acute symptoms; monitor for increased need. Immunosuppression: active or quiescent tuberculosis, systemic infections, ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin or antiviral prophylactic therapies. Monitor for signs/symptoms of adrenal insufficiency when transferring from systemic corticosteroids. May need supplemental systemic corticosteroids during periods of stress or a severe asthma attack. May unmask previously suppressed allergic conditions. Reevaluate periodically. Monitor for hypercorticism and HPA axis suppression (if occurs, discontinue gradually), growth in children, any visual changes. Discontinue if paradoxical bronchospasm occurs; use alternative therapy. Eosinophilic conditions. Hepatic impairment: monitor. Assess bone mineral density if risk factors exist (eg, prolonged immobilization, osteoporosis, or chronic use of drugs that can reduce bone mass [eg, anticonvulsants, oral steroids]). Pregnancy: monitor closely. Nursing mothers.
Interactions:
Concomitant strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, atazanavir, clarithromycin, indinavir, nefazodone, nelfinavir, saquinavir, telithromycin): not recommended.
Pharmacological Class:
Steroid.
Adverse Reactions:
Nasopharyngitis, upper respiratory tract infection, oral candidiasis, headache, cough; hypersensitivity reactions, adrenal suppression, immunosuppression, Churg-Strauss syndrome, bronchospasm.
Generic Availability:
NO
How Supplied:
RespiClick (60 actuations)—1

ArmonAir™ RespiClick® Inhalation Powder is an inhaled corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.
Important Limitation of Use: ArmonAir™ RespiClick® is NOT indicated for the relief of acute bronchospasm.
INDICATION
ArmonAir™ RespiClick® is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.
Important Limitation of Use: ArmonAir™ RespiClick® is NOT indicated for the relief of acute bronchospasm.
IMPORTANT SAFETY INFORMATION
•Contraindications: ArmonAir™ RespiClick® is contraindicated in:
Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required
Patients with known severe hypersensitivity to milk proteins or known hypersensitivity to fluticasone propionate or any of the excipients
•Local Effects: Oropharyngeal candidiasis has occurred in patients treated with ArmonAir™ RespiClick®. Advise patients to rinse the mouth with water without swallowing following inhalation
•Acute Asthma Episodes: ArmonAir™ RespiClick® is not indicated for the relief of acute bronchospasm. An inhaled, short-acting beta2-agonist, not ArmonAir™ RespiClick®, should be used to relieve acute symptoms such as shortness of breath
•Immunosuppression: Patients on corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients. Use with caution, if at all, in patients with the above because of the potential for worsening of these infections
•Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. Slowly taper the dose of systemic corticosteroids if transferring patients to ArmonAir™ RespiClick®
•Hypercorticism and Adrenal Suppression: Because of the possibility of significant systemic absorption of inhaled corticosteroids, patients on ArmonAir™ RespiClick® should be observed carefully for any evidence of systemic corticosteroid effects. If such effects occur, the dosage of ArmonAir™ RespiClick® should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids, and for management of asthma symptoms
•Hypersensitivity Reactions, Including Anaphylaxis: Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of ArmonAir™ RespiClick®. Discontinue ArmonAir™ RespiClick® if such reactions occur