The Use of Fractional Exhaled Nitric Oxide (FeNO) and Induced Sputum in the Identification of Non-adherence in Difficult to Control Asthma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Fractional exhaled nitric oxide
Study Overview
Brief Summary
Asthma usually responds to standard doses of inhaled steroids with or without additional therapies to control their symptoms. However, approximately 5-10% do not respond to this treatment strategy and are referred to as having difficult asthma. Evidence shows that this poor response is not always related to asthma severity with non-adherence to treatment being a common underlying problem, in 35% of subjects. Recognising non-adherence in the clinic is problematic as there is no straightforward objective test to identify it.
Patients attending an asthma clinic whose symptoms are not controlled by standard treatment will be assessed for airway inflammation using fractional exhaled nitric oxide, and sputum analysis. These subjects will be observed taking their medication to determine if this reduces their level of airway inflammation. Prescription records will be used to ascertain if this test distinguishes those who are non-adherent with their treatment from those adults who have severe asthma.
Identifying patients who are non-adherent to treatment will allow an appropriate change in management and enable alternative strategies to be developed to tackle non-adherence in this population. Distinguishing patients who are adherent to treatment but have therapy resistant disease would significantly improve treatment effectiveness in this group by allowing these patients to be suitably targeted with expensive novel therapies such as Omalizumab.
Detailed Description
Hypothesis:
In a difficult asthma population, a significant reduction in fractional exhaled nitric oxide (FeNO) or sputum eosinophils after a directly observed inhaled steroid challenge will distinguish non-adherent subjects from subjects with refractory asthma.
Study Design The study will consist of two phases. The development phase will identify the response of FeNO / sputum eosinophils after directly observed inhaled steroid challenge, in non-adherent subjects and define cut-off values for a positive and negative test and identify the optimum length of steroid challenge. The validation phase will trial and validate the test in a 'real life' clinical setting.
Phase 1 - Development Phase
During this phase, two groups will be studied:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects with difficult to control asthma
- •FeNO > 45 ppb at a flow rate of 50 ml/sec on 2 sequential occasions at clinical review
- •Non-adherent group: < 50% prescription filling of inhaled corticosteroid therapy in the previous 6 months
- •Adherent group: > 75% prescription filling of inhaled corticosteroid therapy in the previous 6 months
Exclusion Criteria
- •Current smoker
- •Pregnancy
- •Other significant respiratory disease
- •Phase 2 Inclusion Criteria:
- •Subjects with difficult to control asthma
- •FeNO > 45 ppb at a flow rate of 50 ml/sec on 2 sequential occasions at clinical review
- •Phase 2 Exclusion Criteria:
- •Current smoker
- •Pregnancy
- •Other significant respiratory disease
Arms & Interventions
Non-adherent
Intervention: Budesonide (directly observed) (Drug)
Adherent
Intervention: Budesonide (directly observed) (Drug)
Outcomes
Primary Outcomes
Fractional exhaled nitric oxide
Time Frame: 7 days
The change in fractional exhaled nitric oxide after 7 days of directly observed inhaled corticosteroids and comparison of between group differences
Secondary Outcomes
- Sputum eosinophil count(7 days)
- Asthma Control Questionnaire Score(7 days)
Investigators
Liam Heaney
Consultant Physician
Belfast Health and Social Care Trust
