Status:
COMPLETED
The Use of FKBP51 in the Identification of Non-adherence to Inhaled Corticosteroids in Difficult Asthma
Lead Sponsor:
Liam Heaney
Collaborating Sponsors:
Northern Ireland Chest Heart and Stroke
Conditions:
Asthma
Eligibility:
All Genders
16-80 years
Phase:
NA
Brief 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 s...
Eligibility Criteria
Inclusion
- 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.
- Inclusion Criteria
- For inclusion into this study all participants must:
- 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
Exclusion
- 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 :
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01526707
Start Date
June 1 2011
End Date
August 1 2014
Last Update
October 10 2014
Active Locations (1)
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1
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB