8.3 Analysis Examples for a Continuous Endpoint

8.3.1 Asthma Trial with 75 Patients Per Group

Consider a phase IIb study in asthma assessing the response of a new entity in a clinical trial. The typical phase II endpoint of interest is FEV1 (forced expiratory volume in 1 second) which is a common spirometry test that is used in asthma studies. An advantage of the FEV1 endpoint is that the length of follow-up required to observe changes is much shorter than the typical phase III endpoint of exacerbations. The FEV1 endpoint is continuous and can be assumed to be normally distributed. The sponsor ran a couple of phase IIa studies for this experimental drug; the first study tested the effect of the maximum tolerated dose (MTD), the second study ...

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