Asthma Breath Biomarker Assessment

NCT ID: NCT03084016

Last Updated: 2022-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-06

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Asthma Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute asthma exacerbation

Recruited in secondary care when presenting with acute asthma exacerbation.

No interventions assigned to this group

At risk of acute asthma exacerbation

Recruited in outpatient clinics. Acute exacerbation within the previous 12 months.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of East Anglia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Wilson

Role: STUDY_DIRECTOR

University of East Anglia

Locations

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Norfolk and Norwich University Hospital

Norwich, Norfolk, United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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Other Identifiers

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197935

Identifier Type: -

Identifier Source: org_study_id

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