The Use of FKBP51 in the Identification of Non-adherence to Inhaled Corticosteroids in Difficult Asthma

NCT01526707 | Completed DMC

• 2 other identifiers: 10174LH-AS11/NI/0015
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Asthma

Keywords

To identify changes in FKBP51 expression with inhaled steroid treatment in asthma

Outcome Measures

Primary Outcomes (1)

• Change in FKBP51 gene expression

  7 days

Study Arms (1)

inhaled steroid

EXPERIMENTAL

inhaled steroid treatment for 7 days

Drug: inhaled steroid

Interventions

inhaled steroid DRUG

inhaled budesonide for 7 days

inhaled steroid

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Liam Heaney: lead
• Northern Ireland Chest Heart and Stroke: collaborator

Study Sites (1)

Belfast City Hospital

Belfast, BT9 7AB, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Physician

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: February 6, 2012
• Study Start: June 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 10, 2014

Record last verified: 2014-10

Locations

GB (1)