Asthma Breath Biomarker Assessment

NCT03084016 | Completed

• 1 other identifier: 197935
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma Acute

Outcome Measures

Primary Outcomes (3)

• Study feasibility - recruitment

  Recruitment rate

  18 months

• Study feasibility - assessment

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

  18 months

• Study feasibility - patient acceptability

  Patient acceptability of breath capture devices (assessed by questionnaire)

  18 months

Secondary Outcomes (1)

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

  12 months

Study Arms (2)

Acute asthma exacerbation

Recruited in secondary care when presenting with acute asthma exacerbation.

At risk of acute asthma exacerbation

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18+ with asthma diagnosis meeting British Thoracic Society guidelines.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of East Anglia: lead

Study Sites (1)

Norfolk and Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Related Links

• PhD thesis

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

Study Officials

• Andrew Wilson

  University of East Anglia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 20, 2017
• Study Start: March 6, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)