nbiased BIOmarkers for the Prediction of REspiratory Disease Outcomes : understanding severe asthma.
- Conditions
- Severe asthma10038716
- Registration Number
- NL-OMON37938
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 46
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
study.
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The study will assess and integrate multiple parameters in terms of clinical,<br /><br>functional, cellular, molecular and patient reported outcomes for developing<br /><br>phenotype *handprints* of severe asthma. For each parameter a number of<br /><br>endpoints have been selected which<br /><br>will be used for the following goals:<br /><br>* The characterization into phenotypic handprints of patients with severe<br /><br>asthma and the comparison of these characteristics with those of mild to<br /><br>moderate asthmatics and healthy controls<br /><br>* To enable the linking of molecular targets for drug intervention with the<br /><br>pathophysiology of severe asthma<br /><br>* Based upon the integration of data collected from severe asthma patients,<br /><br>classifiers and predictors will be developed. This will form the basis of the<br /><br>initial phenotype handprint.</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>