Comparison of adjustable- and fixed-dose budesonide/formoterol pressurized metered- dose inhaler and fixed-dose fluticasone propionate/salmeterol dry powder.

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Comparison of adjustable- and fixed-dose budesonide/formoterol pressurized metered- dose inhaler and fixed-dose fluticasone propionate/salmeterol dry powder inhaler in asthma patients William W. Busse, FAAAAI, MD, Shailen R. Shah, MD, Laura Somerville, MD, PhD, Bhash Parasuraman, PhD, Paula Martin, MS, Mitchell Goldman, MD, PhD Journal of Allergy and Clinical Immunology Volume 121, Issue 6, Pages 1407-1414.e6 (June 2008) DOI: 10.1016/j.jaci.2008.03.019 Copyright © 2008 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Study design and patient disposition. AD, Adjustable dose; BUD, budesonide; FD, fixed dose; FM, formoterol; FP, fluticasone propionate; SM, salmeterol. Journal of Allergy and Clinical Immunology 2008 121, 1407-1414.e6DOI: (10.1016/j.jaci.2008.03.019) Copyright © 2008 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 Criteria for dose adjustments in patients receiving adjustable-dose budesonide/formoterol. ∗Initial step ups and step downs were evaluated by the investigator. During the periods between visits, step ups and step downs to previous therapy were evaluated by the patient, with input from the investigator if needed. BUD, Budesonide; FM, formoterol; bid, twice daily; qd, once daily. Journal of Allergy and Clinical Immunology 2008 121, 1407-1414.e6DOI: (10.1016/j.jaci.2008.03.019) Copyright © 2008 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 Kaplan-Meier curve for the time to first asthma exacerbation during the overall randomized treatment period. The estimated probability of having an asthma exacerbation at each time point is shown. Data symbols represent the days on which censored observations occurred. Hazard ratios (95% CIs) for treatment comparisons are as follows: adjustable-dose budesonide/formoterol pMDI versus fixed-dose fluticasone propionate/salmeterol DPI (0.847 [95% CI, 0.526–1.366; P = .496]), fixed-dose budesonide/formoterol pMDI versus adjustable-dose budesonide/formoterol (1.163 [95% CI, 0.722–1.875; P = .535]), and fixed-dose budesonide/formoterol pMDI versus fixed-dose fluticasone propionate/salmeterol (0.994 [95% CI, 0.791–1.248; P = .958]). AD, Adjustable dose; BUD, budesonide; FM, formoterol; FD, fixed dose; FP, fluticasone propionate; SM, salmeterol. Journal of Allergy and Clinical Immunology 2008 121, 1407-1414.e6DOI: (10.1016/j.jaci.2008.03.019) Copyright © 2008 American Academy of Allergy, Asthma & Immunology Terms and Conditions