NCT01219036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

February 3, 2012

Status Verified

February 1, 2012

Enrollment Period

2.7 years

First QC Date

October 12, 2010

Last Update Submit

February 1, 2012

Conditions

Asthma

Keywords

AsthmaNon-adherenceFractional exhaled nitric oxide

Outcome Measures

Primary Outcomes (1)

  • Fractional exhaled nitric oxide

    The change in fractional exhaled nitric oxide after 7 days of directly observed inhaled corticosteroids and comparison of between group differences

    7 days

Secondary Outcomes (2)

  • Sputum eosinophil count

    7 days

  • Asthma Control Questionnaire Score

    7 days

Study Arms (2)

Non-adherent

OTHER
Drug: Budesonide (directly observed)

Adherent

OTHER
Drug: Budesonide (directly observed)

Interventions

Budesonide (directly observed)DRUG

Budesonide 1600 micrograms daily directly observed for 7 days

Also known as: Pulmicort
AdherentNon-adherent

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Current smoker
  • Pregnancy
  • Other significant respiratory disease
  • Subjects with difficult to control asthma
  • FeNO \> 45 ppb at a flow rate of 50 ml/sec on 2 sequential occasions at clinical review
  • Current smoker
  • Pregnancy
  • Other significant respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Respiratory Centre, Belfast City Hospital

Belfast, BT9 7AB, United Kingdom

Location

Related Publications (1)

  • McNicholl DM, Stevenson M, McGarvey LP, Heaney LG. The utility of fractional exhaled nitric oxide suppression in the identification of nonadherence in difficult asthma. Am J Respir Crit Care Med. 2012 Dec 1;186(11):1102-8. doi: 10.1164/rccm.201204-0587OC. Epub 2012 Sep 28.

    PMID: 23024023DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Liam G Heaney, MD

    Belfast Health & Social Care Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant Physician

Study Record Dates

First Submitted

October 12, 2010

First Posted

October 13, 2010

Study Start

October 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

February 3, 2012

Record last verified: 2012-02

Locations

GB(1)