NL-OMON45213撤回不适用
A better understanding of molecular mechanisms leading to asthma and its remission. - Asthma origins and remission study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria for all subjects:
- •Age between 40 and 65 years old.
- •Smoking history <= 10 packyears.;Inclusion criterium for asthma remission subjects:
- •Onset of asthma symptoms <=21 years.;Specific inclusion criteria for the 4 different groups:
- •o Group 1. Subjects with clinical asthma remission:
- •Documented history of asthma diagnosed according to latest GINA guidelines, i.e. respiratory symptoms and either bronchodilator reversibility (improvement in FEV1 of more than 12% of baseline (and at least 200 mL) after inhalation of 800 µg salbutamol.
- •No use of asthma medications such as inhaled or oral corticosteroids, β2-agonists or anticholinergics for 3 years.
- •No symptoms of wheeze or asthma attacks during the last 3 years.
- •o Group 2. Subjects with complete asthma remission
- •Documented history of asthma diagnosed according to latest GINA guidelines, i.e. respiratory symptoms and either bronchodilator reversibility (improvement in FEV1 of more than 12% of baseline (and at least 200 mL) after inhalation of 800 µg salbutamol.
- •No use of asthma medications such as inhaled or oral corticosteroids, β2-agonists or anticholinergics for 3 years.
- •No symptoms of wheeze or asthma attacks during the last 3 years.
- •FEV1 > 90% predicted.
- •Absence of bronchial hyperresponsiveness, i.e. both PC20 methacholine > 8 mg/ml and PC20 AMP > 320 mg/ml.;o Group 3. Patients with ongoing asthma
- •Documented history of asthma diagnosed according to latest GINA guidelines, i.e. respiratory symptoms and either bronchodilator reversibility (improvement in FEV1 of more than 12% of baseline (and at least 200 mL) after inhalation of 800 µg salbutamol.
- •Use of inhaled corticosteroids
- •Either persistent symptoms of wheeze, cough, or dyspnea or regular use of β2 agonists at least once a week during the last 2 months.
- •PC20 methacholine < 8 mg/ml.
- •o Group 4. Non-asthmatic controls
- •No history of asthma.
- •No use of inhaled corticosteroids or β2-agonists for a period longer than 1 month.
- •No symptoms of wheeze, nocturnal dyspnea, or bronchial hyperresponsiveness.
- •PC20 methacholine > 8 mg/ml, FEV1/FVC > 70% and FEV1 > 80% predicted.
排除标准
- •FEV1 <1.2 L,
- •Upper respiratory tract infection (e.g. colds), within 6 weeks.
- •Signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
- •Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
- •Known recent substance abuse (drug or alcohol).
- •Females of childbearing potential without an efficient contraception
研究者
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