Is local read of the HRCT to exclude emphysema etc. acceptable?
Yes, local read is fine as this is not a disease modification study. Also note that it should be based on the most recent CT scan available (i.e., a new CT scan is not required). There is no limit on how recent it needs to be. If there is no high res CT then the […]
FEV1/FVC ratio of >0.65: Most IPF studies have inclusion of >0.70. Why are we going with 0.65? Might get some emphysema patients with 0.65 (though there is an exclusion criteria for emphysema).
Bear in mind this is not a typical IPF study as we are focused on one of the key symptoms (cough) rather than disease progression. We recognise that a ratio of 0.65 may result in some emphysema slipping through, but provided it is not dominant and they have also have clearly established IPF and are […]
Incl. Criteria 8 (Cough that is attributed to IPF, which has not responded to anti-tussive treatment, and which has been present for at least 8 weeks prior to Screening) – does this rule out patients that have not had anti-tussive treatment at all?
No, there is no requirement for prior anti-tussive therapy although most patients will probably have tried something. The wording “which has not responded to anti-tussive treatment” is intended to make sure that patients who have easily controlled cough don’t stop taking effective meds just so they can be enrolled.
