Clinical trial NCT03084016: Asthma Breath Biomarker Assessment
Official title: Exhaled Breath Biomarkers in Acute Asthma: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma Acute
Lead sponsor: University of East Anglia
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 18+ with asthma diagnosis meeting British Thoracic Society guidelines.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Study feasibility - recruitment
timeFrame: 18 months
measure: Study feasibility - assessment
timeFrame: 18 months
measure: Study feasibility - patient acceptability
timeFrame: 18 months
Secondary outcomes:
measure: Breath profile of exhaled volatile organic compounds (VOCs).
timeFrame: 12 months
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: Norfolk
Study officials:
affiliation: University of East Anglia
name: Andrew Wilson
role: STUDY_DIRECTOR
References: