Cystic Fibrosis Withdrawal of Inhaled Steroids Evaluation Study (CF WISE Study)
Status:
Completed
Trial end date:
2005-02-01
Target enrollment:
Participant gender:
Summary
The overall aim of this study is to find out whether taking regular inhaled steroids (eg
Pulmicort, Flixotide, Becotide, Becloforte) is good for the lungs of children and adults with
cystic fibrosis (CF).
Some patients are put on inhaled steroids because they are wheezy despite taking regular
bronchodilators (inhaled medicines that help open up the airways eg Ventolin, Bricanyl).
Occasionally young children are put on them when they wheeze with colds, and have simply
remained on them ever since. However many CF patients have been put onto inhaled steroids
because their doctors thought it might reduce the inflammation in the lungs and help improve
lung function. This inflammation (which is swelling of the lining of the airways) is known to
be important in CF and results from recurrent chest infections.
Although it is believed, in theory, that inhaled steroids should be useful for most CF
patients, we are not sure how well they work in CF and it has not yet been possible to prove
this with standard studies. This would normally involve starting inhaled steroids in patients
who have not been taking them. We have therefore taken a different approach, namely to
withdraw them from some patients who have been on them for a long time, to see if there is
any effect of stopping them.
It is important that we answer this question, as we do not want CF patients taking medicines
that may be unnecessary. CF patients already have to take many oral and inhaled medicines and
if we can cut down this burden, it would be helpful for everyone. Of course, we may find that
patients do need these medicines but at least we will then be certain that it is for a good
reason.
The main hypothesis is that withdrawing inhaled steroids is not associated with an earlier
onset of acute chest exacerbations.