Blood Eosinophils to Direct Corticosteroid Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease A Randomized Placebo-Controlled Trial
Exacerbations of chronic obstructive pulmonary disease (COPD) and responses to treatment are heterogeneous. Investigate the usefulness of blood eosinophils to direct corticosteroid therapy during exacerbations. Subjects with COPD exacerbations were entered into a randomized biomarker-directed double...
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| Published in | American journal of respiratory and critical care medicine Vol. 186; no. 1; pp. 48 - 55 |
|---|---|
| Main Authors | , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
New York, NY
American Thoracic Society
01.07.2012
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| Subjects | |
| Online Access | Get full text |
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| Abstract | Exacerbations of chronic obstructive pulmonary disease (COPD) and responses to treatment are heterogeneous.
Investigate the usefulness of blood eosinophils to direct corticosteroid therapy during exacerbations.
Subjects with COPD exacerbations were entered into a randomized biomarker-directed double-blind corticosteroid versus standard therapy study. Subjects in the standard arm received prednisolone for 2 weeks, whereas in the biomarker-directed arm, prednisolone or matching placebo was given according to the blood eosinophil count biomarker. Both study groups received antibiotics. Blood eosinophils were measured in the biomarker-directed and standard therapy arms to define biomarker-positive and -negative exacerbations (blood eosinophil count > and ≤ 2%, respectively). The primary outcome was to determine noninferiority in health status using the chronic respiratory questionnaire (CRQ) and in the proportion of exacerbations associated with a treatment failure between subjects allocated to the biomarker-directed and standard therapy arms.
There were 86 and 80 exacerbations in the biomarker-directed and standard treatment groups, respectively. In the biomarker-directed group, 49% of the exacerbations were not treated with prednisolone. CRQ improvement after treatment in the standard and biomarker-directed therapy groups was similar (0.8 vs. 1.1; mean difference, 0.3; 95% confidence interval, 0.0-0.6; P = 0.05). There was a greater improvement in CRQ in biomarker-negative exacerbations given placebo compared with those given prednisolone (mean difference, 0.45; 95% confidence interval, 0.01-0.90; P = 0.04). In biomarker-negative exacerbations, treatment failures occurred in 15% given prednisolone and 2% of those given placebo (P = 0.04).
The peripheral blood eosinophil count is a promising biomarker to direct corticosteroid therapy during COPD exacerbations, but larger studies are required. |
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| AbstractList | Rationale: Exacerbations of chronic obstructive pulmonary disease (COPD) and responses to treatment are heterogeneous. Objectives: Investigate the usefulness of blood eosinophils to direct corticosteroid therapy during exacerbations. Methods: Subjects with COPD exacerbations were entered into a randomized biomarker-directed double-blind corticosteroid versus standard therapy study. Subjects in the standard arm received prednisolone for 2 weeks, whereas in the biomarker-directed arm, prednisolone or matching placebo was given according to the blood eosinophil count biomarker. Both study groups received antibiotics. Blood eosinophils were measured in the biomarker-directed and standard therapy arms to define biomarker-positive and -negative exacerbations (blood eosinophil count > and <= 2%, respectively). The primary outcome was to determine noninferiority in health status using the chronic respiratory questionnaire (CRQ) and in the proportion of exacerbations associated with a treatment failure between subjects allocated to the biomarker-directed and standard therapy arms. Measurements and Main Results: There were 86 and 80 exacerbations in the biomarker-directed and standard treatment groups, respectively. In the biomarker-directed group, 49% of the exacerbations were not treated with prednisolone. CRQ improvement after treatment in the standard and biomarker-directed therapy groups was similar (0.8 vs. 1.1; mean difference, 0.3; 95% confidence interval, 0.0-0.6; P = 0.05). There was a greater improvement in CRQ in biomarker-negative exacerbations given placebo compared with those given prednisolone (mean difference, 0.45; 95% confidence interval, 0.01-0.90; P = 0.04). In biomarker-negative exacerbations, treatment failures occurred in 15% given prednisolone and 2% of those given placebo (P = 0.04). Conclusions: The peripheral blood eosinophil count is a promising biomarker to direct corticosteroid therapy during COPD exacerbations, but larger studies are required. Exacerbations of chronic obstructive pulmonary disease (COPD) and responses to treatment are heterogeneous.RATIONALEExacerbations of chronic obstructive pulmonary disease (COPD) and responses to treatment are heterogeneous.Investigate the usefulness of blood eosinophils to direct corticosteroid therapy during exacerbations.OBJECTIVESInvestigate the usefulness of blood eosinophils to direct corticosteroid therapy during exacerbations.Subjects with COPD exacerbations were entered into a randomized biomarker-directed double-blind corticosteroid versus standard therapy study. Subjects in the standard arm received prednisolone for 2 weeks, whereas in the biomarker-directed arm, prednisolone or matching placebo was given according to the blood eosinophil count biomarker. Both study groups received antibiotics. Blood eosinophils were measured in the biomarker-directed and standard therapy arms to define biomarker-positive and -negative exacerbations (blood eosinophil count > and ≤ 2%, respectively). The primary outcome was to determine noninferiority in health status using the chronic respiratory questionnaire (CRQ) and in the proportion of exacerbations associated with a treatment failure between subjects allocated to the biomarker-directed and standard therapy arms.METHODSSubjects with COPD exacerbations were entered into a randomized biomarker-directed double-blind corticosteroid versus standard therapy study. Subjects in the standard arm received prednisolone for 2 weeks, whereas in the biomarker-directed arm, prednisolone or matching placebo was given according to the blood eosinophil count biomarker. Both study groups received antibiotics. Blood eosinophils were measured in the biomarker-directed and standard therapy arms to define biomarker-positive and -negative exacerbations (blood eosinophil count > and ≤ 2%, respectively). The primary outcome was to determine noninferiority in health status using the chronic respiratory questionnaire (CRQ) and in the proportion of exacerbations associated with a treatment failure between subjects allocated to the biomarker-directed and standard therapy arms.There were 86 and 80 exacerbations in the biomarker-directed and standard treatment groups, respectively. In the biomarker-directed group, 49% of the exacerbations were not treated with prednisolone. CRQ improvement after treatment in the standard and biomarker-directed therapy groups was similar (0.8 vs. 1.1; mean difference, 0.3; 95% confidence interval, 0.0-0.6; P = 0.05). There was a greater improvement in CRQ in biomarker-negative exacerbations given placebo compared with those given prednisolone (mean difference, 0.45; 95% confidence interval, 0.01-0.90; P = 0.04). In biomarker-negative exacerbations, treatment failures occurred in 15% given prednisolone and 2% of those given placebo (P = 0.04).MEASUREMENTS AND MAIN RESULTSThere were 86 and 80 exacerbations in the biomarker-directed and standard treatment groups, respectively. In the biomarker-directed group, 49% of the exacerbations were not treated with prednisolone. CRQ improvement after treatment in the standard and biomarker-directed therapy groups was similar (0.8 vs. 1.1; mean difference, 0.3; 95% confidence interval, 0.0-0.6; P = 0.05). There was a greater improvement in CRQ in biomarker-negative exacerbations given placebo compared with those given prednisolone (mean difference, 0.45; 95% confidence interval, 0.01-0.90; P = 0.04). In biomarker-negative exacerbations, treatment failures occurred in 15% given prednisolone and 2% of those given placebo (P = 0.04).The peripheral blood eosinophil count is a promising biomarker to direct corticosteroid therapy during COPD exacerbations, but larger studies are required.CONCLUSIONSThe peripheral blood eosinophil count is a promising biomarker to direct corticosteroid therapy during COPD exacerbations, but larger studies are required. Rationale : Exacerbations of chronic obstructive pulmonary disease (COPD) and responses to treatment are heterogeneous. Objectives : Investigate the usefulness of blood eosinophils to direct corticosteroid therapy during exacerbations. Methods : Subjects with COPD exacerbations were entered into a randomized biomarker-directed double-blind corticosteroid versus standard therapy study. Subjects in the standard arm received prednisolone for 2 weeks, whereas in the biomarker-directed arm, prednisolone or matching placebo was given according to the blood eosinophil count biomarker. Both study groups received antibiotics. Blood eosinophils were measured in the biomarker-directed and standard therapy arms to define biomarker-positive and -negative exacerbations (blood eosinophil count > and ≤ 2%, respectively). The primary outcome was to determine noninferiority in health status using the chronic respiratory questionnaire (CRQ) and in the proportion of exacerbations associated with a treatment failure between subjects allocated to the biomarker-directed and standard therapy arms. Measurements and Main Results : There were 86 and 80 exacerbations in the biomarker-directed and standard treatment groups, respectively. In the biomarker-directed group, 49% of the exacerbations were not treated with prednisolone. CRQ improvement after treatment in the standard and biomarker-directed therapy groups was similar (0.8 vs. 1.1; mean difference, 0.3; 95% confidence interval, 0.0–0.6; P = 0.05). There was a greater improvement in CRQ in biomarker-negative exacerbations given placebo compared with those given prednisolone (mean difference, 0.45; 95% confidence interval, 0.01–0.90; P = 0.04). In biomarker-negative exacerbations, treatment failures occurred in 15% given prednisolone and 2% of those given placebo ( P = 0.04). Conclusions : The peripheral blood eosinophil count is a promising biomarker to direct corticosteroid therapy during COPD exacerbations, but larger studies are required. Clinical trial registered with www.controlled-trials.com (ISRCTN92422949). Exacerbations of chronic obstructive pulmonary disease (COPD) and responses to treatment are heterogeneous. Investigate the usefulness of blood eosinophils to direct corticosteroid therapy during exacerbations. Subjects with COPD exacerbations were entered into a randomized biomarker-directed double-blind corticosteroid versus standard therapy study. Subjects in the standard arm received prednisolone for 2 weeks, whereas in the biomarker-directed arm, prednisolone or matching placebo was given according to the blood eosinophil count biomarker. Both study groups received antibiotics. Blood eosinophils were measured in the biomarker-directed and standard therapy arms to define biomarker-positive and -negative exacerbations (blood eosinophil count > and ≤ 2%, respectively). The primary outcome was to determine noninferiority in health status using the chronic respiratory questionnaire (CRQ) and in the proportion of exacerbations associated with a treatment failure between subjects allocated to the biomarker-directed and standard therapy arms. There were 86 and 80 exacerbations in the biomarker-directed and standard treatment groups, respectively. In the biomarker-directed group, 49% of the exacerbations were not treated with prednisolone. CRQ improvement after treatment in the standard and biomarker-directed therapy groups was similar (0.8 vs. 1.1; mean difference, 0.3; 95% confidence interval, 0.0-0.6; P = 0.05). There was a greater improvement in CRQ in biomarker-negative exacerbations given placebo compared with those given prednisolone (mean difference, 0.45; 95% confidence interval, 0.01-0.90; P = 0.04). In biomarker-negative exacerbations, treatment failures occurred in 15% given prednisolone and 2% of those given placebo (P = 0.04). The peripheral blood eosinophil count is a promising biomarker to direct corticosteroid therapy during COPD exacerbations, but larger studies are required. Exacerbations of chronic obstructive pulmonary disease (COPD) and responses to treatment are heterogeneous. Investigate the usefulness of blood eosinophils to direct corticosteroid therapy during exacerbations. Subjects with COPD exacerbations were entered into a randomized biomarker-directed double-blind corticosteroid versus standard therapy study. Subjects in the standard arm received prednisolone for 2 weeks, whereas in the biomarker-directed arm, prednisolone or matching placebo was given according to the blood eosinophil count biomarker. Both study groups received antibiotics. Blood eosinophils were measured in the biomarker-directed and standard therapy arms to define biomarker-positive and -negative exacerbations (blood eosinophil count > and ≤ 2%, respectively). The primary outcome was to determine noninferiority in health status using the chronic respiratory questionnaire (CRQ) and in the proportion of exacerbations associated with a treatment failure between subjects allocated to the biomarker-directed and standard therapy arms. There were 86 and 80 exacerbations in the biomarker-directed and standard treatment groups, respectively. In the biomarker-directed group, 49% of the exacerbations were not treated with prednisolone. CRQ improvement after treatment in the standard and biomarker-directed therapy groups was similar (0.8 vs. 1.1; mean difference, 0.3; 95% confidence interval, 0.0-0.6; P = 0.05). There was a greater improvement in CRQ in biomarker-negative exacerbations given placebo compared with those given prednisolone (mean difference, 0.45; 95% confidence interval, 0.01-0.90; P = 0.04). In biomarker-negative exacerbations, treatment failures occurred in 15% given prednisolone and 2% of those given placebo (P = 0.04). The peripheral blood eosinophil count is a promising biomarker to direct corticosteroid therapy during COPD exacerbations, but larger studies are required. |
| Author | Pancholi, Mitesh Barer, Michael R. Terry, Sarah Pavord, Ian D. Lomas, David A. Venge, Per Johnston, Sebastian L. Bafadhel, Mona McKenna, Susan Mistry, Vijay Brightling, Christopher E. |
| Author_xml | – sequence: 1 givenname: Mona surname: Bafadhel fullname: Bafadhel, Mona organization: Institute for Lung Health, University of Leicester, Leicester, United Kingdom – sequence: 2 givenname: Susan surname: McKenna fullname: McKenna, Susan organization: Institute for Lung Health, University of Leicester, Leicester, United Kingdom – sequence: 3 givenname: Sarah surname: Terry fullname: Terry, Sarah organization: Institute for Lung Health, University of Leicester, Leicester, United Kingdom – sequence: 4 givenname: Vijay surname: Mistry fullname: Mistry, Vijay organization: Institute for Lung Health, University of Leicester, Leicester, United Kingdom – sequence: 5 givenname: Mitesh surname: Pancholi fullname: Pancholi, Mitesh organization: Institute for Lung Health, University of Leicester, Leicester, United Kingdom – sequence: 6 givenname: Per surname: Venge fullname: Venge, Per organization: Department of Medical Sciences, Clinical Chemistry, University of Uppsala, Uppsala, Sweden – sequence: 7 givenname: David A. surname: Lomas fullname: Lomas, David A. organization: Cambridge Institute for Medical Research, University of Cambridge, Cambridge, United Kingdom; and – sequence: 8 givenname: Michael R. surname: Barer fullname: Barer, Michael R. organization: Institute for Lung Health, University of Leicester, Leicester, United Kingdom – sequence: 9 givenname: Sebastian L. surname: Johnston fullname: Johnston, Sebastian L. organization: Department of Respiratory Medicine, National Heart and Lung Institute, Centre for Respiratory Infections, Imperial College London, London, United Kingdom – sequence: 10 givenname: Ian D. surname: Pavord fullname: Pavord, Ian D. organization: Institute for Lung Health, University of Leicester, Leicester, United Kingdom – sequence: 11 givenname: Christopher E. surname: Brightling fullname: Brightling, Christopher E. organization: Institute for Lung Health, University of Leicester, Leicester, United Kingdom |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26029603$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/22447964$$D View this record in MEDLINE/PubMed https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-177560$$DView record from Swedish Publication Index |
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| Snippet | Exacerbations of chronic obstructive pulmonary disease (COPD) and responses to treatment are heterogeneous.
Investigate the usefulness of blood eosinophils to... Exacerbations of chronic obstructive pulmonary disease (COPD) and responses to treatment are heterogeneous. Investigate the usefulness of blood eosinophils to... Exacerbations of chronic obstructive pulmonary disease (COPD) and responses to treatment are heterogeneous.RATIONALEExacerbations of chronic obstructive... Rationale : Exacerbations of chronic obstructive pulmonary disease (COPD) and responses to treatment are heterogeneous. Objectives : Investigate the usefulness... Rationale: Exacerbations of chronic obstructive pulmonary disease (COPD) and responses to treatment are heterogeneous. Objectives: Investigate the usefulness... |
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| SubjectTerms | Aged Aged, 80 and over Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy Biological and medical sciences Biomarkers Biomarkers - analysis Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis Chronic obstructive pulmonary disease Confidence intervals Disease Progression eosinophils Eosinophils - metabolism exacerbations Failure Female Glucocorticoids - administration & dosage Humans infection Inflammation Intensive care medicine Male Medical sciences Middle Aged Mortality prednisolone Prednisolone - administration & dosage Pulmonary Disease, Chronic Obstructive - blood Pulmonary Disease, Chronic Obstructive - diagnosis Pulmonary Disease, Chronic Obstructive - drug therapy Pulmonary Disease, Chronic Obstructive - physiopathology Questionnaires Respiratory Function Tests Statistical analysis Steroids Transfusions. Complications. Transfusion reactions. Cell and gene therapy |
| Subtitle | A Randomized Placebo-Controlled Trial |
| Title | Blood Eosinophils to Direct Corticosteroid Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease |
| URI | https://www.ncbi.nlm.nih.gov/pubmed/22447964 https://www.proquest.com/docview/1026851113 https://www.proquest.com/docview/1023299415 https://pubmed.ncbi.nlm.nih.gov/PMC3400995 https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-177560 |
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