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Azithromycin or montelukast as inhaled corticosteroid–sparing agents in moderate-to- severe childhood asthma study  Robert C. Strunk, MD, Leonard B. Bacharier,

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Presentation on theme: "Azithromycin or montelukast as inhaled corticosteroid–sparing agents in moderate-to- severe childhood asthma study  Robert C. Strunk, MD, Leonard B. Bacharier,"— Presentation transcript:

1 Azithromycin or montelukast as inhaled corticosteroid–sparing agents in moderate-to- severe childhood asthma study  Robert C. Strunk, MD, Leonard B. Bacharier, MD, Brenda R. Phillips, MS, Stanley J. Szefler, MD, Robert S. Zeiger, MD, PhD, Vernon M. Chinchilli, PhD, Fernando D. Martinez, MD, Robert F. Lemanske, MD, Lynn M. Taussig, MD, David T. Mauger, PhD, Wayne J. Morgan, MD, Christine A. Sorkness, PharmD, Ian M. Paul, MD, Theresa Guilbert, MD, Marzena Krawiec, MD, Ronina Covar, MD, Gary Larsen, MD  Journal of Allergy and Clinical Immunology  Volume 122, Issue 6, Pages e4 (December 2008) DOI: /j.jaci Copyright © 2008 American Academy of Allergy, Asthma & Immunology Terms and Conditions

2 Fig 1 Cascade of enrollment. OCS, Oral corticosteroid.
Journal of Allergy and Clinical Immunology  , e4DOI: ( /j.jaci ) Copyright © 2008 American Academy of Allergy, Asthma & Immunology Terms and Conditions

3 Fig 2 The conditional power in MARS calculated as the probability of rejecting the null hypothesis of no active treatment effect if the trial had reached the target enrollment (210 randomized children), given that the active treatment and placebo groups displayed approximately 0.5 failure rates at the interim stage (55 randomized children). Journal of Allergy and Clinical Immunology  , e4DOI: ( /j.jaci ) Copyright © 2008 American Academy of Allergy, Asthma & Immunology Terms and Conditions

4 Fig 3 Product-limit survival function estimates for time to return of inadequate control for children assigned to the azithromycin (n = 17), montelukast (n = 19), and placebo (n = 19) groups. Journal of Allergy and Clinical Immunology  , e4DOI: ( /j.jaci ) Copyright © 2008 American Academy of Allergy, Asthma & Immunology Terms and Conditions

5 Study schematic. Journal of Allergy and Clinical Immunology  , e4DOI: ( /j.jaci ) Copyright © 2008 American Academy of Allergy, Asthma & Immunology Terms and Conditions

6 Design of the run-in period to determine inadequate control status and ability to regain control with a step-up of ICS dose. BUD, Budesonide. Journal of Allergy and Clinical Immunology  , e4DOI: ( /j.jaci ) Copyright © 2008 American Academy of Allergy, Asthma & Immunology Terms and Conditions

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