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Clinical Trials/NCT01219036
NCT01219036CompletedNot Applicable

The Use of Fractional Exhaled Nitric Oxide (FeNO) and Induced Sputum in the Identification of Non-adherence in Difficult to Control Asthma

Liam Heaney1 site in 1 country40 target enrollmentStarted: October 2008Last updated:
Conditions
Interventions
Drugs

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

Other

Intervention: Budesonide (directly observed) (Drug)

Adherent

Other

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

Sponsor
Liam Heaney
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Liam Heaney

Consultant Physician

Belfast Health and Social Care Trust

Study Sites (1)

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