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

Primary Purpose

Asthma

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

inhaled steroid

About this trial

This is an interventional health services research trial for Asthma focused on measuring To identify changes in FKBP51 expression with inhaled steroid treatment in asthma

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

Belfast City Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

inhaled steroid

Arm Description

inhaled steroid treatment for 7 days

Outcomes

Primary Outcome Measures

Change in FKBP51 gene expression

Secondary Outcome Measures

Full Information

NCT ID

NCT01526707

First Posted

February 1, 2012

Last Updated

October 8, 2014

Sponsor

Liam Heaney

Collaborators

Northern Ireland Chest Heart and Stroke

1. Study Identification

Unique Protocol Identification Number

NCT01526707

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Liam Heaney

Collaborators

Northern Ireland Chest Heart and Stroke

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

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

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

inhaled steroid

Arm Type

Experimental

Arm Description

inhaled steroid treatment for 7 days

Intervention Type

Drug

Intervention Name(s)

inhaled steroid

Intervention Description

inhaled budesonide for 7 days

Primary Outcome Measure Information:

Title

Change in FKBP51 gene expression

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Facility Information:

Facility Name

Belfast City Hospital

City

Belfast

ZIP/Postal Code

BT9 7AB

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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