Status:
COMPLETED
Cystic Fibrosis Withdrawal of Inhaled Steroids Evaluation Study (CF WISE Study)
Lead Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Collaborating Sponsors:
Cystic Fibrosis Trust
GlaxoSmithKline
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6+ years
Phase:
NA
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 (...
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 ...
Eligibility Criteria
Inclusion
- .Diagnosis of CF (positive sweat test or DNA analysis). .Age over 6.0 years (no upper limit). .FEV1 \> 40% predicted for gender, height and age. .Already taking ICS for at least 3 months. .Patients who are able to perform spirometry and can correctly use their prescribed inhaler.
- .Patients whose parents or legal guardians are willing to give written informed consent for their child to participate in the study. The investigators will also obtain consent from the child whenever possible.
- .Patients who are likely to cooperate with taking the study medication and attend the clinic at appointed times.
Exclusion
- Taking oral corticosteroids, usually for allergic bronchopulmonary aspergillosis (ABPA), currently or within the previous month.
- Cases in which the clinician feels unhappy about stopping ICS due to severe lung disease or concomitant "asthma" (see below).
- Course of intravenous antibiotics (IVABs) within last month.
- Taking part in another drug trial within last 2 months. .Use of high doses of inhaled corticosteroids (greater than or equal to 2000mcg/d fluticasone for 17 years or over and greater than or equal to 1000mcg/d fluticasone if less than 17 years.
- Patients with any medical or psychological condition, which in the opinion of the investigators precludes their entry into the study.
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00220259
Start Date
May 1 2001
End Date
February 1 2005
Last Update
November 8 2005
Active Locations (1)
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1
Royal Brompton Hospital
London, London, United Kingdom, SW3 3NP