RCT Induced Sputum Sample Processing Methodology Study
Research type
Research Study
Full title
A methodology study to compare two induced sputum sample processing techniques and assess their effect on the measurement of inflammatory biomarker levels, cell viability and cell differential counts in COPD subjects.
IRAS ID
148699
Contact name
Brian Leaker
Contact email
Sponsor organisation
Queen Anne Street Medical Centre
Research summary
This is a methodology study to compare two induced sputum sample processing techniques and assess their effect on the measurement of inflammatory biomarker levels, cell viability and cell differential counts in COPD subjects.
The main aims of the study are to compare inflammatory biomarker levels including but not limited to IL-1β, IL-4, IL-5, IL-8 and MCP-1 in induced sputum samples processed using two contrasting methods. It also aims to compare cell viability and differential cell counts of inflammatory cells in induced sputum samples processed using two contrasting methods and to assess the effect of DTT on soluble biomarker analysis matrices (ELISA/Luminex standards and capture antibodies).
The study will comprise 16 evaluable COPD GOLD Stage I-III subjects who are current or ex-smokers with at least a 10 pack year smoking history.
The study comprises 1-2 visits (the subject will be required to attend an additional visit if unable to produce a sufficient sputum sample at Visit 1).
Visit 1 will also be the Screening Visit. Providing all inclusion/exclusion criteria are satisfied (except laboratory test values which will be reviewed as soon as they are available), the subject will undergo a sputum induction.
If all entry criteria, including sputum induction and laboratory test value criteria are met, the subject will be considered as a completed subject.
If a subject is unable to produce an evaluable sample at visit 1 they may undergo a single additional visit (at least 4 days following the previous induction).
A post study telephone contact will be made to the subjects.An evaluable subject is defined as a subject who meets all of the inclusion and exclusion criteria, and produces at least one sufficient sputum sample.
REC name
London - Brent Research Ethics Committee
REC reference
14/LO/0276
Date of REC Opinion
28 Feb 2014
REC opinion
Favourable Opinion