Is concomitant use of salbutamol (albuterol) permitted?
Yes, there are no restrictions on the use of salbutamol. We have occasionally seen it indicated as a treatment for either cough or IPF but in practice it is being used to manage co-existing bronchoconstriction rather than either cough or the underlying disease.
Is there a wash-out period for the use of Halls Soothers (no active ingredients and is essentially glucose)?
No, this doesn’t require a wash-out. The reference to over-the-counter products refers to things with active ingredients such as codeine or dextromethorphan.
Corticosteriods – most studies provide guidance on maximum daily dose. Any guidance for this study? Or is the only requirement is that it is stable for 2 weeks prior and patients remain on same dose?
The guidance on corticosteroids in other studies was something of a hang-over from the days before the disease modifying therapies became available and steroids were used in combination therapy to try to control the disease in the absence of any other options. As they are no longer recommended and less widely used there is no […]
Any issues with angiotension receptor blockers (ARBs) as these may have the same effects as ACE inhibitors? Are calcium channel blockers allowed?
These are both allowed. ACE also breaks down Substance P (SP) which is the endogenous ligand of the NK1 receptor and it is the accumulation of SP that is believed to cause ACE inhibitor induced coughing. This consideration isn’t relevant to other anti-hypertensives which do not block the breakdown of SP.
ACE inhibitors within 3 months of screening are prohibited: is this any use within 3 months or is this for starting new ACE inhibitors within 3 months?
Any use within 3 months because of the very specific nature of ACE inhibitor induced cough (see below).