Pharmaceutical制药公司宣布美国FDA批准Aridol检测盒(甘露醇吸入粉末)上市,用于哮喘检查。当怀疑患者有哮喘病时,用该试剂盒可进行支气管激发试验,增加正确诊断率,评估哮喘症状。FDA批准该试剂盒用于6岁以上临床无明显哮喘症状的患者进行支气管高反应性测试,操作时患者逐渐. 市场上销售： pharmaxis公司（位于宾夕法尼亚州Exton） 适应症： FDA批准Aridol（甘露醇吸入粉末）在6岁或以上的患者没有临床上明显的哮喘支气管高反应性的评估。在Aridol试验中，患者吸入增加剂量的甘露醇透气粉末状。当吸入，甘露醇引起呼吸道渗透压增加其他的支气管动机测试类似。气道收缩1秒呼出的空气量的测量。 aridol应作为医生的整体评估哮喘的一部分。 如何提供： 每个测试套件包含干粉甘露醇胶囊毕业剂量0，5，10，20和40毫克和1个病人使用吸入装置。   WARNING: RISK OF SEVERE BRONCHOSPASM See full prescribing information for complete boxed warning.Mannitol, the active ingredient in ARIDOL, acts as abronchoconstrictorandmaycauseseverebronchospasm.Bronchial challenge testing with ARIDOL is for diagnosticpurposes only. Only trained professionals under the supervision ofa physician who are familiar with the management of acutebronchospasm should perform bronchial challenge testing withARIDOL. Medications (such as short acting inhaled beta-agonist)and equipment to treat severe bronchospasm must be present inthe testing area. Because of thepotentialforseverebronchoconstriction, bronchial challenge testing with ARIDOLshould not be performed in any patient with clinically apparentasthma or very low baseline pulmonary function tests (e.g.,FEV1<1-1.5 liters or <70% of the predicted values) (5.1) Aridol®(mannitol inhalation powder) Bronchial Challenge Test Kit Welcome to the U.S. Homepage for Aridol®(mannitol inhalation powder) Bronchial Challenge Test Kit ARIDOL®was approved by the U.S. Food and Drug Administration on October 5, 2010 and is now commercially available. ARIDOL® is used for the assessment of bronchial hyperresponsivesness in patients six years of age or older who do not have clinically apparent asthma.  ARIDOL® is not a stand alone test or a screening test for asthma.  Bronchial challenge testing with ARIDOL® should be used only as part of a physician’s overall assessment of asthma. ARIDOL® is a single-use, indirect test that is easy-to-administer, accurate and reproducible and requires minimal preparation and administration time. The ARIDOL® test requires patients to inhale increasing doses of dry powder mannitol from a hand-held device, which causes airways to narrow and contract when airway inflammation is present.  The doses are contained in capsules that are administered at one-minute intervals until a positive response is achieve or until all the capsules have been inhaled, indicating a negative result.  A positive response is indicated when there is a 15% reduction in FEV1 from baseline or a 10% incremental reduction in FEV1 between doses.   ARIDOL® is manufactured by Pharmaxis Ltd (Frenchs Forest, Sydney Australia) and marketed by Pharmaxis, Inc. (Exton, PA).  ARIDOL® is approved for use in 19 countries, including Australia, major European countries and Korea, and has been used by more than 96,000 patients worldwide.  ARIDOL® is included in official international guidelines for the clinical assessment of asthma including the International Olympic Committee Medical Commission’s Independent Panel on Asthma, the US Asthma Management Guidelines, the Global Initiative for Asthma (GINA) Report on Global Strategy for Asthma Management and Prevention and the Australian Asthma Management Handbook.  For more detailed product information please refer to the Product Information and United States (PI & Test Kit Instructions) pages. ABOUT ARIDOL® Indication Mannitol, the active ingredient in ARIDOL®, is a sugar alcohol indicated for the assessment of bronchial hyperresponsiveness in patients 6 years of age or older who do not have clinically apparent asthma.  ARIDOL® is not a stand alone test or a screening test for asthma.  Bronchial challenge testing with ARIDOL® should be used only as part of a physician’s overall assessment of asthma. ARIDOL® is contraindicated in patients with known hypersensitivity to mannitol, the active ingredient in ARIDOL, or to the gelatin used to make the capsules.  The product is also contraindicated for patients with medical conditions that may be compromised by induced bronchospasm or repeated spirometry maneuvers. Bronchial challenge testing with ARIDOL® should not be performed in children less than 6 years of age due to their inability to provide reliable spirometric measurements. Use with caution in patients with conditions that may increase sensitivity to the bronchoconstricting or other potential effects of ARIDOL®     such as: severe cough, ventilatory impairment, unstable angina, or active upper or low  er respiratory tract infection that may worsen with use of a bronchial irritant. The most common adverse reactions (rate ≥1%) were headache, pharyngolaryngeal pain, throat irritation, nausea, cough, rhinorrhea, dyspnea, chest discomfort, wheezing, retching and dizziness.  No formal drug-drug interaction studies have been conducted with ARIDOL®.