NL-OMON44025已完成不适用
Temporal fluctuations of biomarkers in patients with asthma and controls: Proof of concept for predicting loss of control. - BIOFLUC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Asthma patients will be selected using the following inclusion criteria:
- •Age 18-50 years
- •History of episodic chest tightness and wheezing
- •Intermittent or mild to moderate persistent asthma according to the criteria by the Global
- •Initiative for Asthma (Global Initiative of Asthma. www.ginasthma.org)
- •Non-smoking or stopped smoking more than 12 months ago and 5 pack years or less
- •Clinically stable, no exacerbations within last six weeks prior to study
- •Steroid-naïve or those participants who are currently not on corticosteroids and have not taken any corticosteroids by any dosing-routes within 6 weeks prior to the study or only using on-demand reliever therapy
- •Baseline pre-bronchodilator FEV1 >= 70% of predicted
- •Airway hyperresponsiveness, indicated by a positive methacholine bromide (MeBr) challenge test with PC20<= 9.8 mg/ml
- •Positive skin prick test (SPT) to one or more of the 12 common aeroallergen extracts, defined as a wheal with an average diameter of => 3 mm
- •No other clinically significant abnormality on history and clinical examination
- •Able to give written and dated informed consent prior to any study-specific procedures;Healthy subjects will be selected using the following inclusion criteria
- •Age 18-50 years
- •Non-smoking or stopped smoking more than 12 months ago and 5 pack years or less
- •Steroid-naïve, non-atopic participants who are currently not on any maintenance (subjects using oral contraceptives can be accepted)
- •No maintenance medication
- •Baseline FEV1 >= 80% of predicted
- •Negative methacholine bromide (MeBr) challenge or PC20 >= 19.6 mg/ml
- •Negative skin prick test (SPT) to all of the 12 common aeroallergen extracts
- •Negative history of pulmonary and any other relevant disease
- •Able to give written and dated informed consent prior to any study-specific procedure
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participation in the study:
- •Women who are pregnant, lactating or have a positive urine pregnancy test at baseline visit
- •Participation in any clinical investigational drug treatment protocol within the preceding 5 half-lives of the drug (or 12 weeks if the half life is unknown) before the screening visit
- •Concomitant disease or condition which could interfere with the conduct of the study, or for which the treatment might interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the patient;Furthermore the following additional exclusion criteria will be used in part 2 of the study:
- •RV16 titre > 1:8 in serum, measured at screening (visit 1) and also at visit 24
- •History of clinical significant hypotensive episodes or symptoms of fainting, dizziness, or light-headedness
- •History of an asthma exacerbation within the last 6 weeks prior to the study
- •Has had any acute illness, including a common cold, within 4 weeks prior to visit 1
- •Close contact with young children or with any immunosuppressed patients
- •Has donated blood or has had a blood loss of more than 450 mL within 60 days prior to screening visit 1 or plans to donate blood during the study.
- •Positive for any virus in nasal lavage at visit 24
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