研究疾病:
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过敏性哮喘
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研究疾病代码:
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Target disease:
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Allergic asthma
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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II期临床试验
Phase II clinical trial
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研究目的:
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通过临床试验研究,初步探索脱敏定喘汤治疗轻度过敏性哮喘的临床疗效及安全性,在减少激素用量、控制急性发作及对过敏症状和生活质量改善等方面起到的作用,发挥中医药治疗过敏性哮喘的优势,为过敏性哮喘患者提供福音。
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Objectives of Study:
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Through clinical trial study, to explore the clinical efficacy and safety of Tuo-Min-Ding-Chuan Decoction in the treatment of mild allergic asthma, and its role in reducing hormone dosage, controlling acute attack and improving allergic symptoms and quality of life, etc. give full play to the advantages of traditional Chinese medicine in the treatment of allergic asthma and provide good news for patients with allergic asthma.
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药物成份或治疗方案详述:
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治疗方法
试验组:予脱敏定喘汤治疗,组成如下:乌梅15g,蝉衣9g,灵芝9g,防风10g,炙麻黄6g,杏仁9g,石膏20g,生甘草6g,厚朴6g,石韦10g。原料药材的质量标准均符合中国《药典》(2015版)的规定,并通过重金属、微生物污染、农药残留的检测。由北京康仁堂药业制作为全成分配方颗粒。热水冲服,1袋/次,2次/天,治疗3个月。
对照组:予脱敏定喘汤安慰剂(含5%试验药),由水、淀粉、糊精和苦味剂等制成,其剂型、色泽、气味、口感与脱敏定喘汤一致,由北京康仁堂药业制作。热水冲服,1袋/次,2次/天,治疗3个月。
为保障受试者利益,在整个治疗及随访期间,试验组与对照组受试者均可按需使用布地奈德/福莫特罗粉吸入剂(160ug/4.5ug×60吸,瑞典阿斯利康公司生产)吸入,以缓解急性发作时症状,每次使用后予以记录。对于过敏症状严重者,可按需使用盐酸西替利嗪片(10mg/片,扬子江药业集团有限公司),每次使用后予以记录。注:布地奈德/福莫特罗粉吸入剂按需使用标准为:患者若出现喘息、气急、胸闷及咳嗽等哮喘症状中的任一症状时,即可吸入,吸入次数按患者自身的需求而定,以当时症状缓解为标准;盐酸西替利嗪片应在符合说明书规定剂量的前提下按需使用。
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Description for medicine or protocol of treatment in detail:
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The intervention group will be given TMDCD granules (one bag twice a day), and the control group will be given placebo granules. Treatment will continue for 12 weeks. During the treatment and follow-up period, all the participants will be allowed to use budesonide-formoterol (160μg of budesonide and 4.5μg of formoterol, produced by AstraZeneca, Sweden) and cetirizine hydrochloride tablets (10mg/ tablets, Yangzijiang Pharmaceutical Group Co., Ltd.) as needed. The subjects will be required to record the time, frequency, and dose of medication. If subjects inhale budesonide-formoterol more than 8 actuations over 24 hours, they still cannot escape from asthma symptoms. The subject will be terminated from the trial and receive emergency treatment.
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纳入标准:
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研究参与者必须符合过敏性哮喘的诊断(1)典型症状、诱因和病程;对类固醇治疗的典型反应。(2)肺功能试验(人体容积描记或肺活量测定):至少部分可逆的气道阻塞和/或支气管高反应性的证据。(3)过敏相关调查:特异性过敏相关病史和皮肤点刺试验或特异性血清IgE测定;血清总IgE;过敏原激发试验(如适用)。(4)生物标志物测量:血液和/或FeNO中嗜酸性粒细胞增加的证据:I:嗜酸性粒细胞增加(≥150cell/μL血液或痰中≥2%);II:一氧化氮呼出增加:呼出的NO,FeNO增加,单位为百万分之(≥20 ppb)。2.参与者必须患有轻度过敏性哮喘:通过第一步或第二步治疗得到良好控制(全球哮喘倡议,2020)。(1)第一步建议是:i:对每月症状少于两次且没有恶化危险因素的患者进行初步哮喘治疗;ii:对哮喘在第二步治疗中得到很好控制的患者进行逐步停止治疗。(2)第二步建议:对有症状的患者进行哮喘治疗,每月两次或两次以上,但不超过每天。3.参赛者年龄必须在18岁至75岁之间。4.参加者必须签署知情同意书。
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Inclusion criteria
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1.Study participants must meet the diagnostic criteria of AA (Lommatzsch et al., 2020).
(1)Typical symptoms, triggers, and disease course; typical response to steroid therapy.
(2)Lung function test (bodyplethysmography or spirometry): Evidence of at least partially reversible airway obstruction and/or bronchial hyperresponsiveness.
(3)Allergy-related investigation: Specific allergy-related history and skin prick test or measurement of specific serum IgE; total serum IgE; allergen provocation test if appropriate.
(4)Biomarker measurement: Evidence of increased eosinophils in blood and/or raised FeNO:
i: Increase in eosinophils (≥150 cell/μL blood or ≥2% in sputum) ;
ii: Increased exhalation of nitric oxide: increased fraction of exhaled NO, FeNO, measured in parts per billion (≥ 20 ppb).
2. The participants must be in mild allergic asthma: controlled well by the Step 1 or 2 treatment (Global Initiative for Asthma, 2020).
(1)The Step 1 recommendations are for:
i: Initial asthma treatment in patients with symptoms less than twice a month and no exacerbation risk factors;
ii: Step-down treatment for patients whose asthma is well-controlled on Step 2 treatment.
(2)The step 2 recommendations are for: asthma treatment in patients with symptoms twice a month or more, but less than daily.
3. The participants must be between 18 and 75 years old.
4. The participant must sign informed consent forms.
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排除标准:
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符合以下任意一项标准者予以排除。
(1)合并有慢性阻塞性肺疾病(COPD)、支气管扩张及变应性支气管肺曲菌病(ABPA)患者;
(2)对本试验中药组成成分或布地奈德/福莫特罗药物成分过敏者;
(3)入组前1年内接受过系统的变应原特异性免疫治疗者;
(4)合并有恶性肿瘤、血液系统疾病、精神病或严重肝肾功能不全者;
(5)妊娠或哺乳期患者;
(6)无法完成肺功能测试、FeNO及抽血检测等辅助检查者;
(7)同期参与其他药物临床试验者。
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Exclusion criteria:
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1.Patients with chronic obstructive pulmonary disease (COPD), bronchiectasis and allergic bronchopulmonary aspergillosis (ABPA).
2. With a history of the ingredients of TMDCD allergies or being allergic to the budesonide-formoterol.
3. Patients had received systematic allergen-specific immunotherapy within one year before enrollment.
4. Patients with a malignant tumor, hematological disease, mental illness, or severe hepatorenal insufficiency.
5. Pregnancy, ready to be pregnant or lactating patients.
6. Unable to complete the tests, such as lung function, FeNO, blood routine, etc.
7. Participate in other clinical studies at the same time.
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研究实施时间:
Study execute time:
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从From
2022-01-31
至To
2024-06-06
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征募观察对象时间:
Recruiting time:
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从From
2022-01-31
至To
2022-09-30
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