Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220259
Status:
COMPLETED
Last Update Posted:
2005-11-08
First Post:
2005-09-20
Brief Title:
Cystic Fibrosis Withdrawal of Inhaled Steroids Evaluation Study CF WISE Study
Sponsor:
Royal Brompton Harefield NHS Foundation Trust
Organization:
Royal Brompton Harefield NHS Foundation Trust
Study Overview
Official Title:
Cystic Fibrosis Withdrawal of Inhaled Steroids Evaluation Study CF WISE Study
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Background Long term and often high dose inhaled corticosteroids ICS are being increasingly prescribed to patients with CF to combat lung inflammation Despite five published studies a Cochrane systematic review has concluded that there is not enough evidence of either benefit or harm The number of CF patients already taking ICS in the UK means recruitment into conventional studies has proved difficult
Aims to test the feasibility and safety of withdrawal of ICS in CF by performing a study of randomised placebo-controlled withdrawal of ICS in children and adults already taking them The results will be used to determine the feasibility of a future prospective study to prove whether starting ICS in CF patients not already on them and those successfully withdrawn leads to benefit in lung function and chest exacerbations andor harm compared to placebo
Methods We will study 240 children and adults in 12 centres We have matching placebo and Flixotide metered dose inhalers to be used through a Volumatic so any subjects currently on Pulmicort or Becotide will switch to Flixotide 2 months during the run-in phase and all subjects will use their ICS through a spacer device Patients will be randomised to continue on ICS or take placebo for 6 months in a double-blind fashion Primary outcome is time to 1st exacerbation secondary ones are decline in lung function new courses of antibiotics and rescue bronchodilator usage
Aims to test the feasibility and safety of withdrawal of ICS in CF by performing a study of randomised placebo-controlled withdrawal of ICS in children and adults already taking them The results will be used to determine the feasibility of a future prospective study to prove whether starting ICS in CF patients not already on them and those successfully withdrawn leads to benefit in lung function and chest exacerbations andor harm compared to placebo
Methods We will study 240 children and adults in 12 centres We have matching placebo and Flixotide metered dose inhalers to be used through a Volumatic so any subjects currently on Pulmicort or Becotide will switch to Flixotide 2 months during the run-in phase and all subjects will use their ICS through a spacer device Patients will be randomised to continue on ICS or take placebo for 6 months in a double-blind fashion Primary outcome is time to 1st exacerbation secondary ones are decline in lung function new courses of antibiotics and rescue bronchodilator usage
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PJ498 | None | None | None |
| Cystic Fibrosis Trust | None | None | None |