Airway inflammation in patients with asthma with high-fixed or low-fixed plus as-needed budesonide/formoterol Ian D. Pavord, DM, FRCP, Peter K. Jeffery,

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Airway inflammation in patients with asthma with high-fixed or low-fixed plus as-needed budesonide/formoterol Ian D. Pavord, DM, FRCP, Peter K. Jeffery, DSc (Med), Yusheng Qiu, PhD, Jie Zhu, PhD, Debbie Parker, BSc, Åsa Carlsheimer, BSc, Ian Naya, BSc, Neil C. Barnes, FRCP Journal of Allergy and Clinical Immunology Volume 123, Issue 5, Pages 1083-1089.e7 (May 2009) DOI: 10.1016/j.jaci.2009.02.034 Copyright © 2009 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Consort diagram shows flow of subjects through the study. All doses are expressed as metered doses. bid, Twice daily. Journal of Allergy and Clinical Immunology 2009 123, 1083-1089.e7DOI: (10.1016/j.jaci.2009.02.034) Copyright © 2009 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 Effect of treatment on airway inflammation and reticular basement membrane (RBM) thickness. Geometric mean plus 95% CIs over the run-in and treatment periods for sputum differential eosinophil counts (A) and Feno(C) are shown. Individual profiles for biopsy eosinophil counts (B) and RBM thickness (D) are also shown. Horizontal bars, Geometric means at baseline and week 52. BUD/FORM, Budesonide/formoterol; FENO, fraction of exhaled nitric oxide. Journal of Allergy and Clinical Immunology 2009 123, 1083-1089.e7DOI: (10.1016/j.jaci.2009.02.034) Copyright © 2009 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 Clinical outcomes on treatment. Cumulative rate of exacerbations over time (A), mean (95% CI) FEV1(B), mean (95% CI) reliever use (C), and mean inhaled corticosteroid (ICS) load in budesonide-equivalent doses during the run-in and treatment periods plus cumulative exposure to different levels of low- to high-dose budesonide in the budesonide/formoterol (BUD/FORM) maintenance and reliever group (reliever-free days = 400 μg/d [57% days] to ≥1,600 μg/d with 6 or more inhalations of reliever [<1% days]; D). Journal of Allergy and Clinical Immunology 2009 123, 1083-1089.e7DOI: (10.1016/j.jaci.2009.02.034) Copyright © 2009 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Dot plot showing individual sputum eosinophil counts (in percentages) with geometric mean (solid line) at baseline and again at 12 months. BUD/FORM, Budesonide/formoterol. Journal of Allergy and Clinical Immunology 2009 123, 1083-1089.e7DOI: (10.1016/j.jaci.2009.02.034) Copyright © 2009 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Line plot of differential eosinophil counts in sputum, showing individual profiles and time trends. ∗The shaded area represents a sputum differential eosinophil count of less than 3%. BUD/FORM, Budesonide/formoterol. Journal of Allergy and Clinical Immunology 2009 123, 1083-1089.e7DOI: (10.1016/j.jaci.2009.02.034) Copyright © 2009 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Box plots showing the effect of treatment on eosinophil counts in sputum (in percentages; A) and biopsy specimens (cells per cubic millimeter; B) and Feno values (C) in patients with low (≤3%) and high (>3%) sputum eosinophil baseline counts. BUD/FORM, Budesonide/formoterol. Journal of Allergy and Clinical Immunology 2009 123, 1083-1089.e7DOI: (10.1016/j.jaci.2009.02.034) Copyright © 2009 American Academy of Allergy, Asthma & Immunology Terms and Conditions