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Review
. 2020 Sep 1;202(5):660-671.
doi: 10.1164/rccm.201912-2384PP.

Blood Eosinophil Counts in Clinical Trials for Chronic Obstructive Pulmonary Disease

Dave Singh  1 , Mona Bafadhel  2 , Christopher E Brightling  3 , Frank C Sciurba  4 , Jeffrey L Curtis  5   6 , Fernando J Martinez  7 , Cara B Pasquale  8 , Debora D Merrill  9 , Norbert Metzdorf  10 , Stefano Petruzzelli  11 , Ruth Tal-Singer  9 , Christopher Compton  12 , Stephen Rennard  13   14 , Ubaldo J Martin  15
Affiliations
Review

Blood Eosinophil Counts in Clinical Trials for Chronic Obstructive Pulmonary Disease

Dave Singh et al. Am J Respir Crit Care Med. .
No abstract available

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Figures

Figure 1.
Figure 1.
Post hoc analysis of (A) annual exacerbation rate and (B) exacerbation rate reduction by baseline blood eosinophil counts for patients with chronic obstructive pulmonary disease treated with budesonide–formoterol or formoterol. Shaded areas represent 95% confidence interval. Budesonide–formoterol 160–4.5 μg was administered by pressurized metered-dose inhaler (two inhalations). Formoterol 4.5 μg was administered by dry powder inhaler (two inhalations). Reprinted by permission from Reference .
Figure 2.
Figure 2.
Prespecified analysis of between treatment ratios for rates of moderate or severe exacerbations by baseline blood eosinophil counts for patients with chronic obstructive pulmonary disease treated with (A) triple or dual therapy containing inhaled corticosteroids compared with dual therapy, and (B) triple therapy containing inhaled corticosteroids compared with dual therapy in smokers and former smokers. CI = confidence interval; FF = fluticasone furoate; UMEC = umeclidinium; VI = vilanterol. Reprinted by permission from Reference .
See this image and copyright information in PMC

Comment in

References

    1. Singh D, Martin M. Biologics for chronic obstructive pulmonary disease: present and future. BRN Reviews. 2018;4:34–52.
    1. Sidhaye VK, Nishida K, Martinez FJ. Precision medicine in COPD: where are we and where do we need to go? Eur Respir Rev. 2018;27:180022. - PMC - PubMed
    1. FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) resource. Silver Spring, MD: Food and Drug Administration (US); 2016. - PubMed
    1. European Medicines Agency. Amsterdam, the Netherlands: European Medicines Agency; 2014. Qualification of novel methodologies for medicine development: guidance to applicants.
    1. Food and Drug Administration. Silver Spring, MD: Food and Drug Administration (US); 2018. Biomarker qualification: evidentiary framework: guidance for industry and FDA staff.

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