Asthma Breath Biomarker Assessment

University of East Anglia84 enrolled

Overview

This study aims to assess the feasibility of capturing data on exhaled breath compounds during an acute asthma exacerbation. In addition to assessing the feasibility of such a study the investigators will collect data on exploratory outcomes including the ability of breath biomarkers to distinguish between controlled and exacerbated states and their ability to differentiate between triggers of exacerbation.

This will be a longitudinal observational study in which the investigators assess the ability to capture information on volatile organic compounds in exhaled breath during an acute asthma exacerbation using two different approaches: A) Recruitment and assessment of patients in secondary care during an acute exacerbation of their asthma; patients to be re-assessed once their asthma is stable and controlled. B) Recruitment of clinically stable outpatients who are at increased risk of exacerbation by virtue of having had an acute exacerbation within the previous 12 months. Participants to be followed for a period of up to 12 months; assessed in the event of an exacerbation; and re-assessed once controlled.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Asthma Acute

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female 2. Aged 18 or above 3. Able to provide informed consent 4. A confirmed asthma diagnosis requiring treatment with inhaled bronchodilator therapy +/- inhaled corticosteroids. 5. Non-smoker (or ex-smoker of 6 months or more with a less than 10 pack year history). 6. Current exacerbation or exacerbation within the previous 12 months. 7. Within 24 hours of having presented to acute secondary care (applicable to current exacerbation only) Exclusion Criteria: 1. Major chronic cardiorespiratory disease other than asthma 2. Significant comorbid condition 3. Receiving maintenance oral corticosteroid therapy or other immunosuppressant or immunomodulatory therapy (including biologics) 4. Pregnant 5. Participating in a clinical trial of an investigational medicinal product (CTIMP). 6. Unable to speak English.

Locations (1)

Norfolk and Norwich University Hospital

Norwich, Norfolk, United Kingdom

Outcomes

Primary Outcomes

Study feasibility - recruitment

Recruitment rate

Time frame: 18 months

Study feasibility - assessment

Percentage of participants who experience an exacerbation, contact the study team and complete an assessment

Time frame: 18 months

Study feasibility - patient acceptability

Patient acceptability of breath capture devices (assessed by questionnaire)

Time frame: 18 months

Secondary Outcomes

Breath profile of exhaled volatile organic compounds (VOCs).

A profile of VOCs in exhaled breath obtained through gas chromatography-mass spectrometry during asthma exacerbation and when stable.

Time frame: 12 months

Data from ClinicalTrials.gov

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