U-BIOPRED clinical

First Name
Neil
Last Name
Fitch
Affiliation
BioSci Consulting
Email
neilfitch@biosciconsulting.com
Business Phone Number
+3289254009
Business Fax Number
-
Business Address
-
Project Website
www.ubiopred.eu
Data Standards Implemented
-
Therapeutic Area Standards (Disease Area)
-
Study Protocal Description
A observational study of people with mild, moderate and severe asthma including both smokers and non-smokers and a control group of healthy volunteers. An extensive range of clinical parameters and omics from blood, urine, sputum and bronchial brushings and biopsy and nasal brushings.
Multi-center Study
True
Description of Cohorts
Cohort A adult: Severe asthma non-smoking (under 5 pack years) Cohort B Adult: Severe asthma smoking (5+ pack years) Cohort C Adult: Mild-moderate asthma Cohort D adult: Healthy volunteers Cohort A Paediatric: Severe school aged asthma Cohort B Paediatric: Mild-moderate school aged asthma Cohort C Paediatric: Severe pre-school aged asthma/wheeze Cohort D Paediatric: Mild-moderate pre-school aged asthma/wheeze
Study Type
-
Study Type Comment
-
Primary Purpose
Phenotype severe asthma
Study Phase
Yes
Intervention Model
-
Study Classification
-
Indication
-
Age Range (Low Limit) of Study
1
Age Range (Upper Limit) of Study
79
Age Unit (of the above ranges)
Year
BMI Range
-
BMI Range (lower limit)
17.77
BMI Range (upper limit)
53.63
Informed Consent
True
Planned Arm (Description of Sub-cohorts)
-
Name of Treatment
-
Standardized Name of Treatment
-
Category
-
Dose Description
-
Organism
Yes
Body System or Organ Class
lung
Total Number of (Human) Subjects
-
Total Number of (Non-Human) Subjects
-
Number of Subjects in Each Cohorts (if multi-cohorts)
Adult: Cohort A: 367 Cohort B: 121 Cohort C: 130 Cohort D: 112 Paediatric Cohort A: 102 Cohort B: 58 Cohort C: 83 Cohort D: 56
Detail Subject Composition
-
Type of Samples Collected
No
Number of Samples Collected
~20,000
Samples Details
Number = total subject numbers (multiple samples per subject) 532 Adult Blood plasma 543 Adult Urine 24 Serum for protemomics 24 Nasal Lavage Supernatant Paediatric A B C D Total Blood 85 43 72 45 245 Sputum 14 6 0 0 20 Urine 92 43 64 45 244 Enose 50 56 106 GWAS 93 43 70 45 251
Secondary Analysis
No