AsthmaNCT01526707
The Use of FKBP51 in the Identification of Non-adherence to Inhaled Corticosteroids in Difficult Asthma
A study testing inhaled steroid in people with Asthma, run by Liam Heaney at 1 site in United Kingdom.
Trial summary
Approximately 5-10% of people with asthma do not respond to to standard therapy and are referred to as having difficult asthma. Evidence shows that this poor response is not always related to asthma severity and non-adherence to treatment is recognized as a common underlying problem, in 35% of these patients. Read more about this study
- Who is it for?
- Ages 16 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- inhaled steroid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to Aug 2014
- 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 16 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- This pilot study will investigate the following groups (n=10 per group):
- Healthy volunteers.
- Steroid naïve asthmatics.
- Refractory asthmatics adherent to high dose inhaled steroids.
- Non-adherent asthmatics.
- For inclusion into this study all participants must:
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- be 16 years old or older
- give written informed consent
- Healthy volunteers must:
- be in good general health as determined by past medical history and physical.
- have no other significant medical history and specifically no prior history of asthma or persistent respiratory symptoms.
- normal spirometry.
- Steroid naïve subjects
- have a diagnosis of asthma
- receiving treatment at Step 1 BTS/SIGN Guidelines i.e. no inhaled steroid
- Non-adherent subjects must
- have a diagnosis of asthma
- be non-adherent to ICS as determined by ICS prescription filling of </=50% in the previous 6 months
- Refractory asthmatic adherent subjects must:
- have a diagnosis of asthma receiving high dose ICS treatment (beclomethasone equivalent dose > 1000 µg per day)
- be adherent to ICS as determined by ICS prescription filling >75% in the previous 6 months
Who cannot join
- Participants who fulfill the following criteria will be excluded from study entry:
- Current smoker,
- Pregnant or lactating,
- Other significant respiratory disease
- Previous allergic reaction or known hypersensitivity to budesonide or any corticosteroid
- Healthy volunteers will be excluded if they have / are :
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- any significant medical history which the principal investigator (PI) deems appropriate to be excluded from the healthy control group
- obstructive lung function
- taking any medication
- a current or history of drug or alcohol abuse
- any significant illness during the screening period preceding entry into the study
- Steroid naïve / Non-adherent asthmatics will be excluded if they have:
- commenced or increase of oral corticosteroids in the previous 28 days
- a concurrent asthma exacerbation
- Refractory / Adherent asthmatics will be excluded if they have:
- commenced or increased of oral corticosteroids in the previous 28 days
- a concurrent asthma exacerbation
Trial locations and contacts
1 site in 1 country.
About this study
Approximately 5-10% of people with asthma do not respond to to standard therapy and are referred to as having difficult asthma. Evidence shows that this poor response is not always related to asthma severity and non-adherence to treatment is recognized as a common underlying problem, in 35% of these patients. Recognising non-adherence in the clinic is problematic as there is no straightforward objective test to identify it.
Previous studies have demonstrated up-regulation of FKBP51 gene expression following treatment with steroids, making it a potential biomarker of steroid exposure. It is therefore also a potential biomarker of non-adherence to inhaled corticosteroid therapy. The investigators plan to assess the feasibility of distinguishing non-adherent subjects who are by omission steroid naïve from adherent subjects, steroid exposed subjects using FKBP51 gene expression in sputum and throat swabs.
Read more
To do this the investigators will obtain throat swab and sputum samples from healthy volunteers, steroid naïve asthmatics and adherent asthmatics on high dose ICS to assess if FKBP51 gene expression is comparable in each group.
The investigators will then compare the FKBP51 gene expression response to directly observed inhaled steroid therapy in steroid naïve, non-adherent and adherent asthmatics. This will identify if the response in gene expression distinguishes steroid exposed (adherent) from steroid naïve (non-adherent) patients.
Identifying non-adherence will benefit patients by enabling appropriate tailored management for non-adherence to enhance treatment effectiveness. It will also identify patients with therapy resistant asthma who have an unmet need and may benefit from expensive novel therapies such as Omalizumab.
- Conditions
- Asthma
- Being tested
- inhaled steroid
- Keywords
- To identify changes in FKBP51 expression with inhaled steroid treatment in asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled steroidDrug
inhaled budesonide for 7 days
| Study group | Role | What they receive |
|---|---|---|
| inhaled steroid | Experimental | inhaled steroid treatment for 7 days Receives: Drug: inhaled steroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FKBP51 gene expression
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startJun 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liam Heaney
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Ireland Chest Heart and Stroke
- Responsible party
- Sponsor-investigator, Liam Heaney, Belfast Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526707
- Sponsor's protocol ID
- 10174LH-AS
- Other IDs
- 10174LH-AS, 11/NI/0015
- Status last verified
- Oct 2014
- First submitted
- 1 Feb 2012
- Last updated
- 10 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of FKBP51 in the Identification of Non-adherence to Inhaled Corticosteroids in Difficult Asthma
- ClinicalTrials.gov ID
- NCT01526707
- Acronym / sponsor ID
- 10174LH-AS
- Conditions
- Asthma
- Keywords
- To identify changes in FKBP51 expression with inhaled steroid treatment in asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Liam HeaneyUniversity, hospital or other
- Collaborators
- Northern Ireland Chest Heart and Stroke
- Study start
- Jun 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 6 Feb 2012 (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.
Approximately 5-10% of people with asthma do not respond to to standard therapy and are referred to as having difficult asthma. Evidence shows that this poor response is not always related to asthma severity and non-adherence to treatment is recognized as a common underlying problem, in 35% of these patients. Recognising non-adherence in the clinic is problematic as there is no straightforward objective test to identify it.
Previous studies have demonstrated up-regulation of FKBP51 gene expression following treatment with steroids, making it a potential biomarker of steroid exposure. It is therefore also a potential biomarker of non-adherence to inhaled corticosteroid therapy. The investigators plan to assess the feasibility of distinguishing non-adherent subjects who are by omission steroid naïve from adherent subjects, steroid exposed subjects using FKBP51 gene expression in sputum and throat swabs.
To do this the investigators will obtain throat swab and sputum samples from healthy volunteers, steroid naïve asthmatics and adherent asthmatics on high dose ICS to assess if FKBP51 gene expression is comparable in each group.
The investigators will then compare the FKBP51 gene expression response to directly observed inhaled steroid therapy in steroid naïve, non-adherent and adherent asthmatics. This will identify if the response in gene expression distinguishes steroid exposed (adherent) from steroid naïve (non-adherent) patients.
Identifying non-adherence will benefit patients by enabling appropriate tailored management for non-adherence to enhance treatment effectiveness. It will also identify patients with therapy resistant asthma who have an unmet need and may benefit from expensive novel therapies such as Omalizumab.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inhaled steroid | Experimental | Drug: inhaled steroidinhaled steroid treatment for 7 days |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- Healthy volunteers.
- Steroid naïve asthmatics.
- Refractory asthmatics adherent to high dose inhaled steroids.
- Non-adherent asthmatics.
- be 16 years old or older
Key exclusion criteria (17 listed)
- Current smoker,
- Pregnant or lactating,
- Other significant respiratory disease
- Previous allergic reaction or known hypersensitivity to budesonide or any corticosteroid
- any significant medical history which the principal investigator (PI) deems appropriate to be excluded from the healthy control group
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 |
|---|---|---|
| inhaled steroidinhaled budesonide for 7 days | Drug | inhaled steroid |
Primary outcome
Change in FKBP51 gene expression
Time frame: 7 days
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 10 Oct 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inhaled steroid in people with Asthma, run by Liam Heaney 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 21 inclusion and 17 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 10 Oct 2014. 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?
Change in FKBP51 gene expression (time frame: 7 days). 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 10 Oct 2014.