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Completed

NCT Number: NCT03084016

Asthma Breath Biomarker Assessment

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Norfolk and Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female
  • Aged 18 or above
  • Able to provide informed consent
  • A confirmed asthma diagnosis requiring treatment with inhaled bronchodilator therapy +/- inhaled corticosteroids.
  • Non-smoker (or ex-smoker of 6 months or more with a less than 10 pack year history).
  • Current exacerbation or exacerbation within the previous 12 months.
  • Within 24 hours of having presented to acute secondary care (applicable to current exacerbation only)

Exclusion criteria

  • Major chronic cardiorespiratory disease other than asthma
  • Significant comorbid condition
  • Receiving maintenance oral corticosteroid therapy or other immunosuppressant or immunomodulatory therapy (including biologics)
  • Pregnant
  • Participating in a clinical trial of an investigational medicinal product (CTIMP).
  • Unable to speak English.

Treatment and study plan

Primary outcomes

  1. Study feasibility - recruitment

    Time frame: 18 months

    Recruitment rate

  2. Study feasibility - assessment

    Time frame: 18 months

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

  3. Study feasibility - patient acceptability

    Time frame: 18 months

    Patient acceptability of breath capture devices (assessed by questionnaire)

Secondary outcomes

  1. Breath profile of exhaled volatile organic compounds (VOCs).

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

University of East Anglia

Other

Registry information

Official study title

Exhaled Breath Biomarkers in Acute Asthma: A Feasibility Study

Acronym: ABBA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 20, 2017
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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