Letters1 January 1998Zafirlukast in AsthmaSamy Suissa, PhD, Pierre Ernst, MD, and Rodolfo Dennis, MDSamy Suissa, PhDMcGill University; Montreal, Quebec H3A 1A3, CanadaUniversidad Javeriana; Bogota, ColombiaSearch for more papers by this author, Pierre Ernst, MDMcGill University; Montreal, Quebec H3A 1A3, CanadaUniversidad Javeriana; Bogota, ColombiaSearch for more papers by this author, and Rodolfo Dennis, MDMcGill University; Montreal, Quebec H3A 1A3, CanadaUniversidad Javeriana; Bogota, ColombiaSearch for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-128-1-199801010-00015 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:Honig and colleagues note that our study protocol was considered “exploratory” when submitted to the FDA because, at the time, it did not have a statistical plan of analysis. Indeed, the larger study (study 0029), based on 762 patients in whom efficacy and safety outcomes were of primary interest, was the study submitted for approval. It contained all elements required by the FDA, including an a priori plan of data analysis. On the other hand, the subprotocol used for our study, applied to 150 of the 762 patients, intended rather to address outcomes of clinical and economic effectiveness. ... Author, Article, and Disclosure InformationAuthors: Samy Suissa, PhD; Pierre Ernst, MD; Rodolfo Dennis, MDAffiliations: McGill University; Montreal, Quebec H3A 1A3, CanadaUniversidad Javeriana; Bogota, Colombia PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics 1 January 1998Volume 128, Issue 1 Page: 71 Keywords Asthma Corticosteroid therapy Evidence based medicine Food and Drug Administration Leukotriene Peer review Prophylaxis Safety Safety studies ePublished: 15 August 2000 Issue Published: 1 January 1998 Copyright & PermissionsCopyright © 1998 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...