opc,
FUSE was an observational study, meaning no new treatment was being introduced. Subjects included in this study are past participants in previous Exubera treatment studies - both patients that received Exubera and patients that were treated with a comparator drug. In those past studies, for both groups of patients: following initial use of randomized treatment, physicians and subjects were free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).
What this means is that those original Exubera studies, subjects were randomized to Exubera or another treatment for an initial period of time. After that time, the subjects and their physicians could change regimens or dosing if the subject was not showing adequate response.
This is just going back and following up on old study subjects. They did exclude anyone who subsequently participated in an investigational study of an unapproved drug since completing the Exubera trial or who ever used an other (non-Exubera) inhaled insulin.
http://clinicaltrials.gov/ct2/show/NCT00734591?term=nct00734591&rank=1
