If a patient has recently discontinued use of either pirfenidone or nintedanib, how long must they have been off treatment before the screening visit?
The protocol does not specifically address this scenario so each subject should be considered on a case by case basis, taking into account the reason for discontinuation. The most likely reason for discontinuation is intolerability in which case the screening visit can be scheduled once the drug is fully washed out (only ~2 days for […]
If a patient cannot meet ATS standards when performing pulmonary function tests due to excessive coughing, can they qualify for the study?
The reference to ATS standards in the protocol is intended to refer more to the technical aspects of spirometry (for example daily calibration). We fully expect some subjects to find it difficult to perform spirometry because of coughing and so failing to meet all of the exact requirements of the ATS guidelines is NOT a […]
Yes, patients who vape are eligible for the study.
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 […]
Can previous CT scans/imaging (if required), lung function tests, and DLCO be used for screening/baseline requirements? If so, what is the time window from when they can be used?
Lung function tests are necessary at screening and must meet Inclusion Criteria #4 for the subject to qualify for the study. Previous lung function tests cannot be used. DLCO tests done within 12 months can be used, but the assessment can be waived if a subject is unable to complete it, for example due to […]
Is additional imaging needed for this study for proof of diagnosis or otherwise? Will there be additional radiation exposure to the patients?
The study does not require additional radiological confirmation of IPF diagnosis or for any other reason. There is no additional radiation exposure for patients.
Many IPF cough patients will experience a worse cough in the morning and a less troublesome cough through the rest of the day. Would these patients be excluded based on this criteria despite meeting all other definitions/measures of the chronic IPF cough?
The cough in the morning can be worse than during the rest of the day provided the rest of the day cough is still troublesome.
Inclusion criterion 8 requires the cough to be attributed to IPF – is this based on PI’s evaluation/determination?
Yes, PI determination after considering the features of the cough and consideration/exclusion of other likely causes of chronic cough (asthma, GERD, UACS). Note that this does not mean that other possible causes have to be extensively investigated or treated empirically – they just need to have been considered in the context of the patients medical […]
If a subject is on a registry, is that considered a not interventional study for the purposes of exclusion criterion 13?
Being on a registry is permitted (and many patients will be). A registry is not considered another trial for the purposes of this study.
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 […]