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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Belfast Health and Social Care Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Northern Ireland Chest Heart & Stroke
Information provided by (Responsible Party):
Liam Heaney, Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier:
NCT01526707
First received: February 1, 2012
Last updated: February 2, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Asthma
Drug: inhaled steroid

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Use of FKBP51 in the Identification of Non-adherence to Inhaled Corticosteroids in Difficult Asthma

Resource links provided by NLM:


Further study details as provided by Belfast Health and Social Care Trust:

Primary Outcome Measures:
  • Change in FKBP51 gene expression [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: inhaled steroid
inhaled steroid treatment for 7 days
Drug: inhaled steroid
inhaled budesonide for 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

This pilot study will investigate the following groups (n=10 per group):

  1. Healthy volunteers.
  2. Steroid naïve asthmatics.
  3. Refractory asthmatics adherent to high dose inhaled steroids.
  4. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01526707

Contacts
Contact: John Lindsay, MD j_t_lindsay@hotmail.com

Locations
United Kingdom
Belfast City Hospital Recruiting
Belfast, United Kingdom, BT9 7AB
Contact: John Lindsay, MD       j_t_lindsay@hotmail.com   
Sub-Investigator: John Lindsay, MD         
Sponsors and Collaborators
Liam Heaney
Northern Ireland Chest Heart & Stroke
  More Information

No publications provided

Responsible Party: Liam Heaney, Consultant Physician, Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT01526707     History of Changes
Other Study ID Numbers: 10174LH-AS, 10174LH-AS, 11/NI/0015
Study First Received: February 1, 2012
Last Updated: February 2, 2012
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by Belfast Health and Social Care Trust:
To identify changes in FKBP51 expression with inhaled steroid treatment in asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014