Cystic FibrosisNCT00220259
Cystic Fibrosis Withdrawal of Inhaled Steroids Evaluation Study (CF WISE Study)
A study of Cystic Fibrosis, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2001to Feb 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- .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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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) and/or 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Fluticasone or placebo
- Keywords
- Cystic Fibrosis, inhaled corticosteroids
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone or placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first respiratory exacerbation
Secondary outcomes (3)
Decline in lung function
New courses of antibiotics
Bronchodilator usage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMay 2001
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Trust, GlaxoSmithKline
- Investigators
- Ian M Balfour Lynn, MD, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220259
- Sponsor's protocol ID
- 01PRT/31
- Other IDs
- Cystic Fibrosis Trust, PJ498
- Status last verified
- Sep 2005
- First submitted
- 20 Sep 2005
- Last updated
- 8 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cystic Fibrosis Withdrawal of Inhaled Steroids Evaluation Study (CF WISE Study)
- ClinicalTrials.gov ID
- NCT00220259
- Acronym / sponsor ID
- 01PRT/31
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, inhaled corticosteroids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Trust, GlaxoSmithKline
- Study start
- May 2001
- Study completion
- Feb 2005
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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) and/or 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- .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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone or placebo | Drug | – |
Primary outcome
Time to first respiratory exacerbation
3 secondary outcomes
Decline in lung function
New courses of antibiotics
Bronchodilator usage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian M Balfour Lynn, MD principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cystic Fibrosis, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first respiratory exacerbation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2005.