Sputum induction for assessment of biomarkers in early respiratory drug development
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Objective: To study the success rate and reproducibility of sputum induction (SI) in healthy subjects (HS) and asthma patients (AP).
Materials and Methods: 130 HSs/APs were recruited for early-phase studies to evaluate sputum biomarkers. SI and sample processing were performed according to standard protocols.
Results: Adequate samples were obtained from 46% of HSs and 80% of APs. There was no difference between the groups with adequate and nonadequate samples. Differences between HS and AP groups were minor. Reproducibility was 56.0% in HSs and 90.6% in APs.
Conclusion: Sputum induction for biomarker assessment in early drug development is feasible in HSs and APs, but only modestly reproducible in HSs. The technique is complex and time consuming.
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