If a patient has a cough that the PI believes is IPF related, but also has a history of reflux and some cough associated with it (which partially responds to a PPI) is the patient still eligible if their cough scores are at least 5?

Yes, patients with this sort of history are eligible. Reflux is a common comorbidity in patients with IPF and some will have cough that is also associated with the reflux. In this case the PI attributes at least some of the cough to IPF, they are on an appropriate treatment for reflux, and still have […]

Does the exclusion criteria refer to oxygen at rest or exertion? What about nocturnal oxygen? There is also the concomitant medication criteria that specifies supplemental oxygen is permitted for use if at least 2 weeks prior to screening and can be continued throughout the study.

The only requirement is stability in use of oxygen. If a patient has been using oxygen intermittently at rest for more than 2 weeks then that’s fine, and if another patient has been using it on exertion for more than 2 weeks then that is also fine. What would not be permitted is for a […]

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 […]