NL-OMON23727招募中不适用
Temporal fluctuations of biomarkers in patients with asthma and controls: Proof of concept for predicting loss of control - BIOFLUC
Academic Medical Centre, Amsterdam0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
研究概览
简要总结
Muskulus M, Slats AM, Sterk PJ, Verduyn-Lunel S. Fluctuations and determinism of respiratory impedance in asthma and chronic obstructive pulmonary disease. J Appl Physiol (1985) 2010; 109:1582-91.
Frey U, Brodbeck T, Majumdar A, Taylor DR, Town GI, Silverman M, et al. Risk of severe asthma episodes predicted from fluctuation analysis of airway function. Nature 2005; 438:667-70.
Sinha A, Yadav AK, Chakraborty S, Kabra SK, Lodha R, Kumar M, et al. Exosome-enclosed microRNAs in exhaled breath hold potential for biomarker discovery in patients with pulmonary diseases. J Allergy Clin Immunol 2013; 132:219-22.
研究设计
- 研究类型
- Interventional
入排标准
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
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 Rhinovirus inoculation visit
- •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 Rhinovirus inoculation day
研究者
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