nbiased BIOmarkers for the Prediction of REspiratory Disease Outcomes : understanding severe asthma. - UBIOPRED: understanding severe asthma

Academisch Medisch Centrum0 个研究点目标入组 46 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•1. Able to give written informed consent prior to participation in the study, which includes ability
•to comply with the requirements and restrictions listed in the consent form. Informed consent
•must be obtained prior to undertaking any study procedures.
•2. Male or female subject aged 18 years or older at screening.
•3. Able to complete the study and all measurements.
•4. Able to read, comprehend, and write at a sufficient level to complete study related materials.;The additional in- and exclusion criteria for all cohorts are mentioned on page 28-34 of the protocol.

•1. As a result of medical interview, physical examination or screening investigation the physician responsible considers the subject unfit for the study either because of the risk to the patient due to the study or the influence this may have on the study results.
•2. The subject has a history of drug or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation.
•3. Subject is female who is pregnant or lactating or up to 6 weeks post partum or 6 weeks cessation of breast feeding.
•4. The subject has participated within 3 months of the first dose in a study using a new molecular
•entity, or the first dose in any other study investigating drugs or having participated within three
•months in a study with invasive procedures. Any U-BIOPRED assessments should be deferred
•until 3 months after the first dose or invasive procedure. Permission from the Scientific Board must be obtained to enroll or allow the continued participation of a subject enrolled in another
•5. Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
•6. The subject has a recent history of incapacitating psychiatric disorders
•7. History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments (assessments should be deferred).;The additional in- and exclusion criteria for all cohorts are mentioned on page 28-34 of the protocol.

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