Asthma Clinical Trial
Official title:
The Use of FKBP51 in the Identification of Non-adherence to Inhaled Corticosteroids in Difficult Asthma
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.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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