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December 26, 2001

Salmeterol and Inhaled Corticosteroids in Patients With Persistent Asthma—Reply

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorJody W.ZylkeMD, Contributing EditorIndividualAuthor

JAMA. 2001;286(24):3075-3078. doi:10.1001/jama.286.24.3075

In Reply: In response to Dr Botkin and colleagues, ethical issues related to use of placebo are complex and controversial. Although a direct comparison of triamcinolone vs salmeterol might have been accomplished by an active control equivalence or superiority trial, compelling arguments support our 3-armed design.

First, we believe that a state of clinical equipoise existed at the start of this study. Although guidelines generally do not recommend salmeterol monotherapy, this is based on opinion, not data. A recent study of steroid-naive patients suggested that salmeterol and low-dose beclomethasone are equivalent.1 The rationale for recommending that salmeterol be used with an IC is the belief that inflammation plays an important role in the susceptibility to asthma exacerbations and in airway remodeling. The placebo run-out period of our study was designed to test whether either active treatment had a disease-modifying effect that persisted after cessation of therapy.

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